# Significant New Uses of Certain Chemical Substances > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A98-1074 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** January 22, 1998 - **Citation:** 63 FR 3394 ## Text SUMMARY: EPA is promulgating significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 163 chemical substances which were the subject of premanufacture notices (PMNs) and subject to TSCA section 5(e) consent orders issued by EPA. Today's action requires persons who intend to manufacture, import, or process these substances for a significant new use to notify EPA at least 90 days before commencing the manufacturing or processing of the substance for a use designated by this SNUR as a significant new use. The required notice will provide EPA with the opportunity to evaluate the intended use, and if necessary, to prohibit or limit that activity before it occurs. EPA is promulgating this SNUR using direct final procedures. DATES: The effective date of this rule is March 23, 1998. This rule shall be promulgated for purposes of judicial review at 1 p.m. (e.s.t.) on February 5, 1998. If EPA receives notice before February 23, 1998 that someone wishes to submit adverse or critical comments on EPA's action in establishing a SNUR for one or more of the chemical substances subject to this rule, EPA will withdraw the SNUR for the substance for which the notice of intent to comment is received and will issue a proposed SNUR providing a 30-day period for public comment. ADDRESSES: Each comment or notice of intent to submit adverse or critical comment must bear the docket control number OPPTS-50628 and the name(s) of the chemical substance(s) subject to the comment. All comments should be sent in triplicate to: OPPT Document Control Officer (7407), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M Street, SW., Room G-099, East Tower, Washington, DC 20460. Comments and data may also be submitted electronically to: [email protected]. Follow the instructions under Unit X of this document. No Confidential Business Information (CBI) should be submitted through e-mail. All comments which contain information claimed as CBI must be clearly marked as such. Three sanitized copies of any comments containing information claimed as CBI must also be submitted and will be placed in the public record for this rulemaking. Persons submitting information on any portion of which they believe is entitled to treatment as CBI by EPA must assert a business confidentiality claim in accordance with 40 CFR 2.203(b) for each portion. This claim must be made at the time that the information is submitted to EPA . If a submitter does not assert a confidentiality claim at the time of submission, EPA will consider this as a waiver of any confidentiality claim and the information may be made available to the public by EPA without further notice to the submitter. FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director, Environmental Assistance Division (7408), Office of Pollution Prevention and Toxics, Environmental Protection Agency, Rm. E-543A, 401 M St., SW., Washington, DC 20460, telephone: (202) 554-1404, TDD: (202) 554-0551; e-mail: TSCA-H[email protected]. SUPPLEMENTARY INFORMATION: Electronic Availability: Electronic copies of this document are available from the EPA Home Page at the Federal Register-Environmental Documents entry for this document under ``Laws and Regulations'' (http://www.epa.gov/fedrgstr/). This SNUR will require persons to notify EPA at least 90 days before commencing manufacturing or processing a substance for any activity designated by this SNUR as a significant new use. The supporting rationale and background to this rule are more fully set out in the preamble to EPA's first direct final SNURs published in the Federal Register of April 24, 1990 (55 FR 17376). Consult that preamble for further information on the objectives, rationale, and procedures for the rules and on the basis for significant new use designations including provisions for developing test data. I. Authority Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a ``significant new use.'' EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, section 5(a)(1)(B) of TSCA requires persons to submit a notice to EPA at least 90 days before they manufacture, import, or process the substance for that use. The mechanism for reporting under this requirement is established under 40 CFR 721.10. II. Applicability of General Provisions General provisions for SNURs appear under 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. Persons subject to this SNUR must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs under section 5(a)(1)(A) of TSCA. In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by section 5 (h)(1), (2), (3), and (5), and the regulations at 40 CFR part 720. Once EPA receives a SNUR notice, EPA may take regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the activities on which it has received the SNUR notice. If EPA does not take action, EPA is required under TSCA section 5(g) to explain in the Federal Register its reasons for not taking action. Persons who intend to export a substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b). The regulations that interpret section 12(b) appear at 40 CFR part 707. Persons who intend to import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements, which are codified at 19 CFR 12.118 through 12.127 and 127.28. Such persons must certify that they are in compliance with SNUR requirements. The EPA policy in support of the import certification appears at 40 CFR part 707. III. Substances Subject to This Rule EPA is establishing significant new use and recordkeeping requirements for the following chemical substances under 40 CFR part 721, subpart E. In this unit, EPA provides a brief description for each substance, including its PMN number, chemical name (generic name if the specific name is claimed as CBI), CAS number (if assigned and and the specific chemical identity is not claimed as CBI), basis for the action taken by EPA in the TSCA section 5(e) consent order or as a non- [[Page 3395]] section 5(e) SNUR for the substance (including the statutory citation and specific finding), toxicity concern, and the CFR citation assigned in the regulatory text section of this rule. The specific uses which are designated as significant new uses are cited in the regulatory text section of this document by reference to 40 CFR part 721, subpart B where the significant new uses are described in detail. Certain new uses, including production limits and other uses designated in the rule are claimed as CBI. The procedure for obtaining confidential information is set out in Unit VII. of this preamble. Where the underlying TSCA section 5(e) order prohibits the PMN submitter from exceeding a specified production limit without performing specific tests to determine the health or environmental effects of a substance, the tests are described in this unit. As explained further in Unit VI. of this preamble, the SNUR for such substances contains the same production limit, and exceeding the production limit is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a significant new use notice (SNUN) at least 90 days in advance. In addition, this unit describes tests that are recommended by EPA to provide sufficient information to evaluate the substance, but for which no production limit has been established in the TSCA section 5(e) order. Descriptions of recommended tests are provided for informational purposes. Data on potential exposures or releases of the substances, testing other than that specified in the TSCA section 5(e) order for the substances, or studies on analogous substances, which may demonstrate that the significant new uses being reported do not present an unreasonable risk, may be included with significant new use notification. Persons submitting a SNUN must comply with the same notice requirements and EPA regulatory procedures as submitters of PMNs, as stated in 40 CFR 721.1(c), including submission of test data on health and environmental effects as described in 40 CFR 720.50. EPA is not publishing SNURs for PMNs P-95-266, 95-615/616, P-95- 941, P-95-973, P-95-1046, P-95-1115, P-95-1827, P-95-1854, P-95-2075, P-96-262, P-96-291, P-96-317, P-96-576 through P-96-581, P-96-726 through P-96-744, P-96-803/804, P-96-1277/78, P-96-1482/1483, P-96- 1708, P-96-1509/1519, P-96-1548 through P-96-1551, P-97-205 through P- 97-208, and P-97-276/277 which are subject to a final TSCA section 5(e) consent order. The TSCA section 5(e) consent orders for these substances are derived from an exposure finding based solely on substantial production volume and significant or substantial human exposure and/or release to the environment of substantial quantities. For these cases there were limited or no toxicity data available for the PMN substances. In such cases, EPA regulates the new chemical substances under TSCA section 5(e) by requiring certain toxicity tests. For instance, chemical substances with potentially substantial releases to surface waters would be subject to toxicity testing of aquatic organisms and chemicals with potentially substantial human exposures would be subject to health effects testing for mutagenicity, acute effects, and subchronic effects. However, for these substances, the short-term toxicity testing required by the TSCA section 5(e) order is usually completed within 1 to 2 years of notice of commencement (NOC). EPA's experience with exposure-based SNURs requiring short-term testing is that the SNUR is often revoked within 1 to 2 years when the test results are received. Rather than issue and revoke SNURs in such a short span of time, EPA will defer publication of exposure-based SNURs until either a NOC or data demonstrating risk are received unless the toxicity testing required is long-term. EPA is issuing this explanation and notification as required in 40 CFR 721.160(a)(2) as it has determined that SNURs are not needed at this time for these substances which are subject to a final TSCA section 5(e) consent order under TSCA. PMN Number P-87-323 Chemical name: (generic) Poly(oxy-1,2-ethanediyl), alpha substituted- omega-hydroxy-, C16-20 alkyl ethers. CAS number: Not available. Basis for action: The PMN substance will be used as an intermediate. Based on submitted fish, daphnia, and algae tests on the PMN substance, EPA expects toxicity to aquatic organisms at surface water concentrations as low as 20 parts per billion (ppb). EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance did not exceed a concentration of 20 ppb when released to surface waters. EPA has determined that other uses may result in releases to surface waters above 20 ppb. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i). Recommended testing: EPA has determined that a chronic 60-day fish early life stage toxicity test in rainbow trout (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.3488. PMN Number P-88-1108 Chemical name: (generic) Alcohols, C6-12, ethoxylated, reaction product with maleic anhydride. CAS number: Not available. Basis for action: The PMN substance will be used as a plastics additive. Based on analogy to anionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 300 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters in significant quantities. EPA has determined that other uses of the substance may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.524. PMN Number P-90-581 Chemical name: (generic) Brominated phthalate ester. CAS number: Not available. Effective date of section 5(e) consent order: March 21, 1996. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to health and the environment. Toxicity concern: Similar chemicals have been shown to form dibenzodioxins and dibenzofurans when incinerated under combustion conditions of municipal incinerators. [[Page 3396]] Recommended testing: An incineration simulation study is required to help characterize the potential for the formation of dibenzodioxins or dibenzofurans when plastics or resins containing the PMN substance are incinerated. The PMN submitter has agreed not to exceed the production volume limit without performing this study. CFR citation: 40 CFR 721.3085. PMN Numbers P-91-1131 and P-90-564 Chemical name: (generic) Imidazolethione. CAS number: Not available. Effective date of section 5(e) consent order: October 25, 1995. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. Toxicity concern: Based on the submitted 90-day subchronic study, the PMN substance causes thyroid and other systemic effects in test animals. Based on the submitted developmental toxicity study, the PMN substance causes developmental toxicity in test animals. Based on analogy to structurally similar substances the PMN substance may cause thyroid cancer. Recommended testing: A 2-year, two-species oral bioassay in rats (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) is recommended to help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.4469. PMN Number P-92-314 Chemical name: (generic) Aryloxyarene. CAS number: Not available. Effective date of section 5(e) consent order: March 11, 1996. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to the environment. Toxicity concern: Based on test data on this substance, there is concern for toxicity to aquatic organisms, particularly effects on daphnid reproduction, at concentrations as low as 1 ppb in surface waters. Recommended testing: A 28-day chironomid sediment toxicity study (OPPTS 850.1790 test guideline (public draft; 61 FR 16486, April 15, 1996)) (FRL-5363-1) is recommended to help characterize the toxicity of the PMN substance to benthic organisms. CFR citation: 40 CFR 721.977. PMN Numbers P-93-204 and P-94-1870 through P-94-1874 Chemical name: (generic) Phenyl substituted triazolinones. CAS numbers: Not available. Effective date of section 5(e) consent order: July 23, 1996. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that these substances may present an unreasonable risk of injury to human health and the environment. Toxicity concern: Data on several of the PMN substances and a chemical similar to P-94-1870 have shown developmental and reproductive effects, blood and liver effects, and neurotoxicity in test animals. Recommended testing: An oral developmental toxicity study in rats (40 CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the human health effects. A semi-continuous activated sludge (SCAS) study (OPPTS 835.3210 test guideline (public draft; 61 FR 16486, April 15, 1996)) (FRL-5363-1), a ready biodegradability study (OPPTS 835.3110 test guideline (public draft; 61 FR 16486, April 15, 1996)) (FRL-5363-1), and a soil sediment adsorption isotherm (40 CFR 796.2750 or OPPTS 835.1220 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1) would help characterize the environmental effects of the substance. CFR citation: 40 CFR 721.9825. PMN Number P-93-568 Chemical name: (generic) Polysubstituted piperidine. CAS number: Not available. Basis for action: The PMN substance will be used as an intermediate. Based on submitted test data, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 30 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters above a level of 30 ppb. EPA has determined that other uses of the substance may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i). Recommended testing: EPA has determined that a chronic 60-day fish early life stage toxicity test in rainbow trout (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.6165. PMN Number P-93-761 Chemical name: 2-Pyrrolidinone, 1,1'-(2-methyl-1,5-pentanediyl)bis-. CAS number: 146453-62-5. Effective date of section 5(e) consent order: September 6, 1995. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. Toxicity concern: Test data on the PMN substance and similar chemicals have shown that these types of chemicals cause systemic toxicity and neurotoxicity in test animals. Recommended testing: A 90-day oral subchronic study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) with additional neurotoxicity endpoints following NTIS-PB91-154617 (functional observation battery, neurohistopathology and motor activity) would help to characterize the systemic and neurotoxicity effects. The PMN submitter has agreed not to exceed the production volume limit without performing this test. CFR citation: 40 CFR 721.9005. PMN Number P-93-1369 Chemical name: (generic) N,N'-di(alkyl heteromonocycle)amino chlorotriazine. CAS number: Not available. Effective date of section 5(e) consent order: June 13, 1995. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to health and the environment. Toxicity concern: Similar chemicals have been shown to cause systemic toxicity, developmental toxicity, and cancer in test animals. In addition, similar chemicals have been shown to be toxic to aquatic organisms. Recommended testing: EPA has determined that a 90-day subchronic toxicity test in rats via gavage (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, [[Page 3397]] June 20, 1996) (FRL-5367-7)), a two-species developmental study (rodent and non-rodent) (40 CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL- 5719-5) and a 2-year, one-species bioassay (rats) (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) would help characterize the human health effects of the PMN substance. The 90-day subchronic toxicity test should include special emphasis on hematology; weight of the spleen and thymus; cellularity of the bone marrow, thymus, and spleen; and histopathology of the liver, kidney, heart, and all endocrine glands for which weight changes are observed. In addition natural killer cell activity should be evaluated on the same population of test animals, and IgM antibody plaque-forming cells should be enumerated in two satellite groups of animals (10 in the high-dose group and 10 in the control group). EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. The consent order contains two production volume limits. The PMN submitter has agreed not to exceed the first production volume limit without performing the 90-day subchronic toxicity test. The PMN submitter has also agreed not to exceed the second higher production volume limit without performing the two-species developmental study and the 2-year, one-species bioassay if the results of the 90-day test indicate biological activity at low levels (i.e., activity levels comparable to those for triazines). CFR citation: 40 CFR 721.2094. PMN Number P-93-1631 Chemical name: (generic) Substituted naphtholazo-substituted naphthalenyl-substituted azonaphthol chromium complex. CAS number: Not available. Basis for action: The PMN substance will be used as a dye. Based on analogy to structurally similar substances, EPA is concerned that cancer will occur in exposed workers. Based on submitted test data, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. EPA determined that use of the substance did not present an unreasonable risk because significant worker or environmental exposure is not expected because the substance was used as a liquid and was not manufactured domestically. EPA has determined that domestic manufacture of the substance and use as a solid may result in significant worker or environmental exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(4)(i) and (b)(1)(i)(D). Recommended testing: EPA has determined that a 2-year, two-species oral bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) would help characterize the health effects of the PMN substance and a chronic 60-day fish early life stage toxicity test in rainbow trout (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.981. PMN Number P-93-1654 Chemical name: (generic) Substituted polyoxyethylene. CAS number: Not available. Basis for action: The PMN substance will be used as an emulsifier for paint and adhesives. Based on submitted test data and analogy to nonionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 9 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters. EPA has determined that other uses of the substance may result in releases to surface water at concentrations above 9 ppb. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.7378. PMN Number P-94-209 Chemical name: Phenol, 2,4-dimethyl-6-(1-methylpentadecyl)-. CAS number: 134701-20-5. Basis for action: The PMN substance will be used as an antioxidant. Based on submitted test data, there is concern for liver toxicity, kidney toxicity, adrenal toxicity, and blood toxicity. Based on submitted test data and analogy to phenols, EPA is also concerned that toxicity to aquatic organisms will occur at concentrations as low as 1 ppb. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because workers would not be subject to significant dermal exposures and there were no significant environmental releases. EPA has determined that other uses of the substance may result in significant dermal exposures to workers and significant environmental releases. Based on this information the PMN substance meet the concern criteria at Sec. 721.170 (b)(3)(i) and (b)(4)(i). Recommended testing: EPA has determined that a dermal absorption study, a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)), a chronic 60-day fish early life stage toxicity test in rainbow trout (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and a 21-day daphnid chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.5725. PMN Number P-94-921 Chemical name: Phenol, 4,4'-methylenebis[2,6-dimethyl-. CAS number: 5384-21-4. Effective date of section 5(e) consent order: July 5, 1995. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to health and the environment. Toxicity concern: Similar phenols have been shown to cause kidney and liver toxicity, and blood effects in test animals. In addition, chronic fish and daphnid tests and a high bioconcentration potential indicated a concern concentration of 6 ppb. Recommended testing: EPA has determined that a 90-day subchronic [[Page 3398]] oral toxicity test in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help to characterize the human health effects of the PMN substance. EPA has also determined that a modified SCAS test (OPPTS 835.3210 test guideline (public draft; 61 FR 16486, April 15, 1996)) (FRL-5363-1), an aerobic aquatic biodegradation test (40 CFR 796.3100 or OPPTS 835.3100 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1), and an anaerobic biodegradability of organic chemicals (OPPTS 835.3400 test guideline (public draft; 61 FR 16486, April 15, 1996)) (FRL-5363-1) would help to charactarize the environmental effects. The PMN submitter has agreed not to exceed the production volume limit without performing the 90-day subchronic toxicity test. CFR citation: 40 CFR 721.5730. PMN Number P-94-1017 Chemical name: Urea, tetraethyl-. CAS number: 1187-03-7. Basis for action: The PMN substance will be used as an intermediate. Based on submitted test data EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppm of the PMN substance in surface waters. Based on analogy to similar ureas and submitted test data EPA is concerned that acute toxicity, mutagenicity, developmental effects, and reproductive effects could occur to exposed workers. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters and exposed workers would wear adequate protective equipment to prevent dermal exposure. EPA has determined that other uses of the substance may result in releases to surface waters which exceed the concern concentration or dermal exposure to workers. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(2), (b)(3)(ii), and (b)(4)(i). Recommended testing: EPA has determined that a chronic 60-day fish early life stage toxicity test in rainbow trout (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. EPA has determined that a dermal developmental toxicity test in rabbits and rats (40 CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) and a chromosome aberration assay in mice (40 CFR 798.9538) (62 FR 43850, August 15, 1997) (FRL- 5719-5) or a micronucleus assay in mice (40 CFR 798.9539) (62 FR 43853, August 15, 1997) (FRL-5719-5) would help characterize the health effects of the PMN substance. The PMN submitter has agreed to conduct the health tests before reaching the production volume limit in the SNUR. CFR citation: 40 CFR 721.9928. PMN Number P-94-1018 Chemical name: Guanidine, pentaethyl-. CAS number: 13439-89-9. Basis for action: The PMN substance will be used as an intermediate. Based on submitted test data, EPA is concerned that acute toxicity, corrosivity, and neurotoxicity could occur to exposed workers. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because exposed workers would wear adequate protective equipment to prevent dermal exposure. EPA has determined that other uses of the substance may result in exposure to workers. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(2) and (b)(3)(i). Recommended testing: None. CFR citation: 40 CFR 721.4085. PMN Number P-94-1019 Chemical name: Ethanaminium, N-[bis(diethylamino)-methylene]-N-ethyl-, bromide. CAS number: 89610-32-2. Basis for action: The PMN substance will be used as a catalyst. Based on submitted test data, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 10 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters. EPA has determined that other uses of the substance may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i). Recommended testing: EPA has determined that a chronic 60-day fish early life stage toxicity test in rainbow trout (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.4090. PMN Number P-94-1143 Chemical name: Butanoic acid, antimony (3+) salt. CAS number: 53856-17-0. Effective date of section 5(e) consent order: July 7, 1995. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to health. Toxicity concern: Similar chemicals have been shown to cause cancer, dermal and ocular irritation, cardiovascular effects, neurotoxic effects, reproductive toxicity, and developmental toxicity in test animals. Recommended testing: A pharmacokinetic test (OPPTS 870.8223 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) is recommended to help determine the bioavailability of the PMN substance after dermal administration. The PMN submitter has agreed not to exceed the production volume limit without performing this test. CFR citation: 40 CFR 721.1930. PMN Number P-94-1743 Chemical name: (generic) Isophorone diisocyanate neopentyl glycol adipate polyurethane prepolymer. CAS number: Not available. Effective date of section 5(e) consent order: December 8, 1995. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. Toxicity concern: Test data on the substance and similar diisocyanates have shown them to cause skin sensitization and chronic lung toxicity in test animals. Recommended testing: EPA has determined that the results of an acute inhalation study (OPPTS 870.1300 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)), a 28-day subchronic inhalation study in rats, (Organization for Economic Cooperation and Development (OECD) guideline no. 412), and a 90-day subchronic inhalation toxicity study in rats (40 CFR 798.2450 or OPPT 870.3465 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help to characterize the health effects caused by the substance. The PMN submitter has agreed not to exceed the [[Page 3399]] production volume limit without performing these tests. CFR citation: 40 CFR 721.8079. PMN Number P-94-2159 Chemical name: (generic) Anthraquinone dye. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on submitted test data and analogy to aliphatic amines EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 2 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters. EPA has determined that other uses of the substance may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(4)(i). Recommended testing: EPA has determined that a fish acute toxicity study modified with humic acid (40 CFR 797.1400 or OPPTS 850.1085 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.723. PMN Number P-95-168 Chemical name: Phosphonic acid, methylenebis-, tetrakis(1-methylethyl) ester. CAS number: 1660-95-3. Effective date of section 5(e) consent order: September 20, 1995. Basis for section 5(e) consent order: The Order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. Toxicity concern: Similar dimethyl methyl phosphonate (DMMP) and diisopropyl methylphosphonate (DIMP) chemical substances have been shown to cause oncogenicity in test animals. In addition the PMN substance was demonstrated to be a chromosome mutagen in a mouse lymphoma study. Recommended testing: The Agency has determined that the results of a 2- year bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL- 5719-5) would help to characterize possible human effects of the substance. CFR citation: 40 CFR 721.6075. PMN Number P-95-243 Chemical name: Phenol, 4-(1,1-dimethylethyl)-, homopolymer. CAS number: 30813-81-1. Effective date of section 5(e) consent order: October 5, 1995. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to the aquatic environment. Toxicity concern: The PMN substance has been shown to be toxic to aquatic organisms. However, the substance also has the advantages of eliminating or reducing volatile organic solvents, and reducing exposures to residual monomers. EPA has evaluated two processor/use sites where releases sometimes exceed the concern level. In light of the benefits of the substance, EPA determined these releases did not constitute an unreasonable risk and will allow releases at these sites in the section 5(e) consent order and SNUR. Recommended testing: EPA has determined that an activated sludge adsorption isotherm study (OPPTS 835.1110 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1), a chronic 60-day fish early life stage toxicity test in rainbow trout (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a 21-day daphnid chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), or a chironomid sediment toxicity test (OPPTS 850.1790 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize possible effects of the PMN substance in the aquatic environment. The consent order contains two production limits. The PMN submitter has agreed not to exceed the first production limit without performing the activated sludge adsorption isotherm test. The PMN submitter has also agreed not to exceed the second higher production limit without performing either the fish early life stage with rainbow trout and the daphnid chronic toxicity tests, or the chironomid sediment toxicity test, depending on the results of the activated sludge adsorption isotherm test. CFR citation: 40 CFR 721.538. PMN Number P-95-535 Chemical name: Reaction products of formalin (37%) with amine C12. CAS number: Not available. Basis for action: The PMN substance will be used as an oilfield chemical. Based on analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 20 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters. EPA has determined that other uses of the substance may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.9285. PMN Numbers P-95-605/606 Chemical name: (generic) Trifunctional ketoximino silane. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on analogy of the hydrolysis product of the PMN substances to similar compounds, EPA is concerned that cancer and blood effects could occur to exposed workers. EPA determined that use of the substances as described in the PMN did not present an unreasonable risk because exposed workers would wear adequate protective equipment to prevent dermal exposure. EPA has determined that other uses of the substance may result in dermal exposure to workers. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(D) and (b)(3)(iii). Recommended testing: EPA has determined that a 90-day subchronic study in rats by the oral route (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) and a 2-year, two-species bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) would help characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.9497. PMN Number P-95-633 Chemical name: (generic) Sodium salt of azo acid dye. CAS number: Not available. Basis for action: The PMN substance will be used in a non-dispersive use. [[Page 3400]] Based on analogy of the azo reduction products to structurally similar substances, EPA is concerned that cancer and systemic toxicity will occur in exposed workers. EPA determined that use of the substance did not present an unreasonable risk because significant worker exposure is not expected because the substance was not manufactured, processed, or used as a powder. EPA has determined that manufacture, processing, and use of the substance as a powder may result in significant worker exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(D) and (b)(3)(iii). Recommended testing: EPA has determined that a 90-day subchronic study in rats by the oral route with special attention to the liver, kidney, spleen, and blood (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the health effects of the substance. CFR citation: 40 CFR 721.980. PMN Number P-95-637 Chemical name: 2-Pentene, 1,1,1,2,3,4,4,5,5,5-decafluoro-. CAS number: 72804-49-0. Basis for action: The PMN substance will be used as an intermediate. Based on toxicity data submitted with the PMN, EPA identified health concerns for neurotoxicity. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because significant human exposure is not expected. EPA has determined that use of the substance other than as described in the PMN may result in significant human exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(i). Recommended testing: None. CFR citation: 40 CFR 721.5708. PMN Number P-95-638 Chemical name: Pentane 1,1,1,2,2,3,4,5,5,5,-decafluoro. CAS number: 138495-42-8. Basis for action: The PMN substance will be used as described in the PMN. Based on toxicity data submitted with the PMN, EPA identified health concerns for neurotoxicity. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because significant human exposure is not expected. EPA has determined that use of the substance other than as described in the PMN may result in significant human exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(i). Recommended testing: None. CFR citation: 40 CFR 721.5645. PMN Number P-95-666 Chemical name: (generic) Polyether acrylate. CAS number: Not available. Basis for action: The PMN substance will be used in a radiation curing formulation. Based on analogy to acrylates, EPA identified concerns for toxicity to aquatic organisms. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because significant environmental exposure is not expected. EPA has determined that other uses may result in releases to water which are significant environmental exposures. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.405. PMN Numbers P-95-677/724 Chemical name: (generic) Antimony double oxide. CAS number: Not available. Effective date of section 5(e) consent order: March 12, 1996. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health and the environment. Toxicity concern: Similar chemicals have been shown to cause cancer, lung toxicity and ocular effects in test animals. In addition to human health concerns, an aquatic toxicity concern has been identified if the substance is released to surface waters. A concern concentration of 5 ppb has been established. Recommended testing: EPA has determined that a 2-year, one-species rat inhalation bioassay, which has an additional holding period, analyses of lung burdens, and determination of clearance rates of particles (as described at (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL- 5719-5) would help characterize the carcinogenicity, lung toxicity and ocular effects of the PMN substance. In addition, EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363- 1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363- 1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.5547. PMN Numbers P-95-1103, P-95-1104, and P-96-1235 Chemical name: (generic) Substituted resorcinols. CAS number: Not available. Basis for action: The PMN substances will be used as components of a material for integrated circuit fabrication. Based on submitted toxicity data and analogy to phenols, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 9 ppb of P-95- 1103/P-95-1104 and 1 ppb of P-96-1235 in surface waters. EPA determined that use of the substances as described in the PMNs did not present an unreasonable risk because the substances would not be released to surface waters in significant quantities. EPA has determined that other uses of the substances may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(i) and (b)(4)(ii). Recommended testing: EPA has determined that a chronic 60-day fish early life stage toxicity test in rainbow trout (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of P-95-1103 and P-95-1104. EPA has also determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, [[Page 3401]] April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of P-96-1235. CFR citation: 40 CFR 721.9488. PMN Number P-95-1128 Chemical name: (generic) Brominated aromatic ester. CAS number: Not available. Effective date of section 5(e) consent order: November 5, 1996. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and 5(e)(1)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health and the environment. Toxicity concern: Similar chemicals have been shown to: (1) Degrade in the environment resulting in substances that may cause aquatic toxicity, and (2) form dibenzodioxins and dibenzofurans when incinerated under combustion conditions of municipal incinerators. EPA has determined that halogenated dioxins and furans are probable human carcinogens and may cause toxic effects in aquatic and terrestrial organisms. Recommended testing: The consent order contains two production volume limits. The PMN submitter has agreed not to exceed the first production volume limit without performing an incineration simulation study (guidelines available from EPA) to help characterize the potential for the formation of dibenzodioxins or dibenzofurans when plastics or resins containing the substance are incinerated, and a porous pot test (OPPTS 835.3220 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1) to determine the extent of environmental degradation of the substance. The PMN submitter has also agreed not to exceed the second, higher production volume limit without performing a shake flask die-away test (OPPTS 835.3170 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1), a fish bioconcentration test (OPPTS 850.1730 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)). CFR citation: 40 CFR 721.2925. PMN Number P-95-1213 Chemical name: (generic) Hydroxy terminated polyester. CAS number: Not available. Basis for action: The PMN substance will be used as an intermediate. Based on analogy to esters, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 200 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters. EPA has determined that other uses of the substance may result in releases to surface water at concentrations above 200 ppb. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.6485. PMN Number P-95-1235 Chemical name: 2-Naphthalenesulfonic acid, 3-[[4-[(2,4-dimethyl-6- sulfophenyl)azo]-2-methoxy-5-methylphenyl]azo]-4-hydroxy-7- (phenylamino)-, sodium salt, compd. With 2,2',2''-nitrilotris [ethanol] (9CI). CAS number: 94213-53-3. Basis for action: The PMN substance will be used in an open non- dispersive use. Based on analogy of the azo reduction products to similar substances, EPA is concerned that cancer, systemic toxicity, developmental toxicity, methemoglobinemia, and skin sensitization will occur in exposed workers. EPA determined that use of the substance did not present an unreasonable risk because significant worker exposure is not expected because the substance was not manufactured, processed, or used as a powder or manufactured domestically. EPA has determined that manufacture, processing, and use of the substance as a powder or domestic manufacture may result in significant worker exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(iii). Recommended testing: EPA has determined that an Ames assay with the Prival modification with a concurrent positive control would help characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.5281. PMN Number P-95-1282 Chemical name: (generic) Reaction product of dichlorobenzidine and substituted alkylamide. CAS number: Not available. Effective date of section 5(e) consent order: July 29, 1996. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and 5(e)(1)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to health. Toxicity concern: 3,3'-dichlorobenzidine (DCB) and possible reduction products have been shown to cause oncogenicity and mutagenicity in test animals. Recommended testing: The following studies would help characterize the health effects of the PMN substance: Monitoring data to detect the presence of DCB under actual conditions of use in polymer coloration or sheet metal coating use (Az, R., Dewald B. and Scnaitmann, D. 1991. Pigment Decomposition in Polymers in Applications at Elevated Temperatures (Dyes and Pigments 15:1-14). Monitoring data would include the following elements: Extrusion or other process), monitoring data to detect airborne concentrations of DCB during high-temperature coloration or sheet metal coating use (see TSCA section 8(e) data e.g., section 8(e)-962 supp.), radio-labeled pharmacokinetic study (oral) in rats on the pigment (with the radio-label on the DCB) (OPPTS 870.7485 test guideline (public draft; 60 FR 45158, August 30, 1995) (FRL-4973- 2)) plus radio-label), and a 2-year, two-species bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5). CFR citation: 40 CFR 721.9265. PMN Number P-95-1288 Chemical name: 2-Naphthalenol, mono and dioctyl derivs. CAS number: Not available. Basis for action: The PMN substance will be used as an intermediate. Based on analogy to phenols, EPA is concerned that toxicity to aquatic organisms may occur at a concentrations as low as 1 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance did not exceed a concentration of 1 ppb when released to surface waters. EPA has determined that increased production [[Page 3402]] volume may result in releases to surface waters above 1 ppb. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.5255. PMN Number P-95-1317 Chemical name: (generic) Hydrochlorofluorocarbon. CAS number: Not available. Basis for action: The PMN substance will be used as an intermediate. Based on toxicity data submitted with the PMN, EPA identified health concerns for neurotoxicity. Based on analogy to structurally similar chemicals, EPA identified health concerns for cardiac sensitization, liver toxicity, kidney toxicity, and skin irritation. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because significant human exposure is not expected. EPA has determined that use of the substance other than as described in the PMN may result in significant human exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(i) and (b)(3)(ii). Recommended testing: None. CFR citation: 40 CFR 721.4462. PMN Number P-95-1326 Chemical name: 3,8-Dioxa-4,7-disiladecane, 4,4,7,7-tetraethoxy-. CAS number: 16068-37-4. Basis for action: The PMN substance will be used in treatment of laminates for printed circuit boards and sol-gel ceramics. Based on analogy to alkoxysilanes, EPA is concerned that a significant risk of lung toxicity and severe irritation to skin, eyes, and mucous membranes could occur. EPA determined that use of the substance did not present an unreasonable risk because the substance would not be manufactured, processed, or used in a manner that generated a vapor, mist, or aerosol and significant worker inhalation exposure is not expected. EPA has determined that manufacture, processing, or use of the substance in a manner that generated a vapor, mist, or aerosol may result in significant worker inhalation exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii). Recommended testing: EPA has determined that a 90-day subchronic inhalation study in rats (40 CFR 798.2450 or OPPTS 870.3465 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.3155. PMN Number P-95-1347 Chemical name: (generic) Aliphatic polyisocyanate. CAS number: Not available. Basis for action: The PMN substance will be used in an open non- dispersive use. Based on analogy to diisocyanates, there is concern for lung toxicity, pulmonary sensitization, and irritation to mucous membranes. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because workers would not be subject to significant inhalation exposures. EPA has determined that uses of the substance that generate a mist, aerosol, or vapor may result in significant inhalation exposures to workers. Based on this information the PMN substance meet the concern criteria at Sec. 721.170(b)(3)(ii). Recommended testing: EPA has also determined that a 90-day subchronic inhalation study in rats (40 CFR 799.9346) (62 FR 43828, August 15, 1997) (FRL-5719-5) would help characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.6495. PMN Number P-95-1356 Chemical name: (generic) Silylated polyurethane. CAS Number: Not available. Basis for action: The PMN substance will be used as a moisture curable polymer. Based on analogy of the PMN substance to alkoxysilanes, EPA expects irritation to mucous membranes and lung toxicity. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because there were no significant inhalation exposures. EPA has determined that use of the substance generating an aerosol or a mist may result in significant inhalation exposures. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii). Recommended testing: EPA has determined that a 90-day subchronic inhalation study (40 CFR 798.2450 or OPPTS 870.3465 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.8095. PMN Number P-95-1386 Chemical name: Benzene, 1,1'-methylanebis[4-isocyanato-, homopolymer, Bu alc.-blocked. CAS number: 186321-98-2. Basis for action: The PMN substance will be used as described in the PMN. Based on analogy to diisocyanates, EPA is concerned that a significant risk of oncogenicity, respiratory sensitization, and chronic lung effects could occur. EPA determined that use of the substance did not present an unreasonable risk because the substance would not be manufactured, processed, or used in a manner that generated a vapor, mist, or aerosol and significant worker inhalation exposure is not expected. EPA has determined that manufacture, processing, or use of the substance in a manner that generated a vapor, mist, or aerosol may result in significant worker inhalation exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(ii). Recommended testing: EPA has determined that a 90-day inhalation study in rats (40 CFR 799.9346) (62 FR 43828, August 15, 1997) (FRL-5719-5) would help characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.2535. PMN Number P-95-1411 Chemical name: Propanedioic acid, [(4-methoxyphenyl)methylene]-, bis(1,2,2,6,6-pentamethyl-4-piperidinyl) ester (9CI). CAS number: 147783-69-5. Effective date of section 5(e) consent order: November 22, 1995. Basis for section 5(e) consent order: The order was issued under section 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. Toxicity concern: Similar chemicals have been shown to cause toxicity to the immune system, liver, blood, the male reproductive system and the G.I. tract in test animals. Recommended testing: A 90-day subchronic oral toxicity study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the human health effects. The PMN submitter has agreed not to exceed the production volume limit without performing this test. [[Page 3403]] CFR citation: 40 CFR 721.4589. PMN Number P-95-1466 Chemical name: (generic) Substituted aromatic aldehyde. CAS number: Not available. Basis for action: The PMN substance will be used as described in the PMN. Based on analogy to phenols and aldehydes EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 3 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMNs did not present an unreasonable risk because the substance would not be released to surface waters. EPA has determined that other uses of the substance may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.526. PMN Number P-95-1467 Chemical name: Benzaldehyde, 2-hydroxy-5-nonyl-, oxime, branched. CAS number: 174333-80-3. Basis for action: The PMN substance will be used as described in the PMN. Based on analogy to phenols, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters. EPA has determined that other uses of the substance may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.528. PMN Numbers P-95-1557/1558 Chemical name: (generic) Substituted imines. CAS number: Not available. Basis for action: The PMN substances will be used as intermediates. Based on analogy to aliphatic amines EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substances in surface waters. EPA determined that use of the substances as described in the PMNs did not present an unreasonable risk because the substances would not be released to surface waters. EPA has determined that other uses of the substances may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substances meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.4476. PMN Numbers P-95-1575/1576/1577 Chemical name: Chromate(3-), bis[3-[[5-(aminosulfonyl)-2- hydroxyphenyl]azo]-4-hydroxy-7-[[2-oxo-1-[(phenylamino)carbonyl] propyl]azo]-2-naphthalenesulfonato(3-)]-, trisodium (9CI) (P-95-1575), Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5-(aminosulfonyl)-2- hydroxyphenyl]azo]-4-hydroxy-2-naphthalene-sulfonato (3-)]-, trisodium (9CI) (P-95-1576), Chromate(3-), bis[7-[(aminohydroxyphenyl)azo]-3-[[5- (aminosulfonyl)-2-hydroxyphenyl] azo]-4-hydroxy-2-naphthalenesulfonato (3-)]-,-[[5-(aminosulfonyl) -2-hydroxyphenyl]azo]-4-hydroxy-7-[[2- hydroxy-1-[(phenylamino) carbonyl]-1-propenyl]azo]-2- naphthalenesulfonato(3-)]-, trisodium (9CI) (P-95-1577). CAS number: 119535-63-6 (P-95-1575), 118716-62-4 (P-95-1576), and 118716-61-3 (P-95-1577). Basis for action: The PMN substances will be used as leather dyes. Based on analogy to similar substances, EPA is concerned that cancer, developmental, kidney, and liver toxicity will occur in exposed workers. EPA determined that use of the substances did not present an unreasonable risk because significant worker exposure is not expected because the substances were not manufactured, processed, or used as a powder. EPA has determined that manufacture, processing, and use of the substances as a powder may result in significant worker exposure. Based on this information the PMN substances meet the concern criteria at Sec. 721.170 (b)(1)(i)(B), (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii). Recommended testing: EPA has determined that a 2-year, two-species oral bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5), an oral 2-generation reproduction study in rats (40 CFR 799.9380) (62 FR 43834, August 15, 1997) (FRL-5719-5), and a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the health effects of the PMN substances. CFR citation: 40 CFR 721.9575 (P-95-1575), 40 CFR 721.9576 (P-95-1576), and 40 CFR 721.9577 (P-95-1577). PMN Number P-95-1578 Chemical name: (generic) Hydrofluorocarbon alkyl ether. CAS number: Not available. Basis for action: The PMN substance will be used as an intermediate. Based on analogy to similar substances, EPA identified concerns for cancer, cardiotoxicity, cardiosensitization, respiratory failure, neurotoxicity, and irritation to membranes. Based on submitted test data EPA identified concerns for acute toxicity. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because significant human exposure is not expected. EPA has determined that use of the substance without the worker protection cited in the PMN or if the substance is used other than as an intermediate may result in significant human exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii). Recommended testing: EPA has determined that a 2-year, two-species bioassay (40 CFR 799.9420) (62 FR [[Page 3404]] 43838, August 15, 1997) (FRL-5719-5) and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) will address the potential health effects of the PMN substance. CFR citation: 40 CFR 721.3485. PMN Numbers P-95-1650/1651/1652/1653 Chemical name: (generic) Alkyl phenyl polyetheramines. CAS number: Not available. Basis for action: The PMN substances will be used as intermediates. Based on analogy to aliphatic amines EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 3 ppb of the PMN substances in surface waters. EPA determined that use of the substances as described in the PMNs did not present an unreasonable risk because the substances would not be released to surface waters. EPA has determined that other uses of the substances may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substances meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.6490. PMN Number P-95-1750 Chemical name: (generic) Pentanediol light residues. CAS number: Not available. Basis for action: The PMN substance will be used as a solvent. Based on potential consumer exposures, EPA has determined that the PMN substance may cause significant or substantial human exposure. EPA determined that use of the substance as described in the PMN did not cause significant or substantial exposure from use as an industrial solvent. EPA has determined that exposures from consumer use may result in significant or substantial human exposures. Based on this information activities other than those described in the PMN may result in significant changes in human exposure. Recommended testing: EPA has determined that a 28-day oral study in rats (OECD guideline no. 407), an acute rat oral study (OPPTS 870.1100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367- 7)), an ames assay (40 CFR 798.5265 or OPPTS 870.5265 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)), a mouse micronucleus assay by the intraperitoneal route (40 CFR 799.9539) (62 FR 43853, August 15, 1997) (FRL-5719-5), and a developmental toxicity study in one species by the oral route (40 CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) would help characterize possible health effects of the substance. EPA will require any manufacturer importer, or processor who distributes this substance for use in a consumer product to perform this testing. CFR citation: 40 CFR 721.5650. PMN Number P-95-1772 Chemical name: (generic) Polyalkyl phosphate. CAS number: Not available. Basis for action: The PMN substance will be used as a specialty additive. Based on analogy to neutral organic substances, EPA expects toxicity to aquatic organisms at surface water concentrations as low as 1 ppb. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance did not exceed a concentration of 1 ppb when released to surface waters. EPA has determined that other uses may result in releases to surface waters above 1 ppb. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.5995. PMN Number P-95-1806 Chemical name: (generic) Quaternary ammonium hydroxide. CAS number: Not available. Basis for action: The PMN substance will be used as an additive. Based on analogy to cationic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 4 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance was not released to surface waters. EPA has determined that other uses may result in releases to surface waters above the concern concentration. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.4467. PMN Number P-95-1825 Chemical name: Thieno[3,4-b]-1,4-dioxin, 2,3-dihydro- (9CI). CAS number: 126213-50-1. Basis for action: The PMN substance will be used in an open non- dispersive use. Based on analogy to structurally similar substances, EPA identified concerns for cancer and based on submitted test data EPA identified concerns for liver toxicity and neurotoxicity. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because significant human exposure is not expected. EPA has determined that use of the substance without the worker protection cited in the PMN or if the substance is manufactured domestically may result in significant human exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(C) and (b)(3)(i). Recommended testing: EPA has determined that a 2-year, two-species bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) will address the potential health effects of the PMN substance. CFR citation: 40 CFR 721.9662. PMN Number P-95-1891 Chemical name: Siloxanes and silicones, Me hydrogen, reaction [[Page 3405]] products with 2,2,6,6-tetramethyl-4-(2-propenyloxy)piperdine. CAS number: 182635-99-0. Basis for action: The PMN substance will be used as an ultraviolet light stabilizer for polymers. Based on analogy to hindered amines, there is concern for toxicity to the immune system and the G.I. tract, liver toxicity, blood toxicity, and toxicity to the male reproductive system. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because workers would not be exposed by inhalation. EPA determined that use as a powder may result in inhalation exposure to workers. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii). Recommended testing: EPA has determined that a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.6170. PMN Number P-95-1950 Chemical name: (generic) Substituted ethoxyethylamine phosphonate. CAS number: Not available. Basis for action: The PMN substance will be used as a scale inhibitor. Based on analogy to polyanionic monomers, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 30 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance was not released to surface waters. EPA has determined that other uses may result in releases to surface waters above 30 ppb. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.6078. PMN Number P-95-2101 Chemical name: Hydrazine, (2-fluorophenyl). CAS Number: 2368-80-1. Basis for action: The PMN substance will be used as an intermediate. Based on analogy of the PMN substance to hydrazines EPA is concerned that oncogenicity, liver and kidney effects, lung effects, and blood effects will occur to exposed workers and that toxicity will occur to aquatic organisms. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because there were no significant worker or environmental exposures. EPA has determined that domestic manufacture of the substance may result in significant worker and environmental exposures. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(C), (b)(3)(ii), and (b)(4)(ii). Recommended testing: EPA has determined that a 2-year, two-species oral bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the health effects of the PMN substance. A fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.4257. PMN Number P-96-19 Chemical name: Lithiated metal oxide (LiNiO2). CAS number: 12031-65-1. Effective date of section 5(e) consent order: June 26, 1996. Basis for section 5(e) consent order: The order was issued under section 5(e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health and the environment. Toxicity concern: Similar chemicals have been shown to cause cancer and systemic toxicity in test animals. In addition, based on Structure Activity Relationship (SAR) analysis derived from test data on structurally similar compounds, EPA expects toxicity to aquatic organisms to occur at a concentration of 30 ppb PMN substance in surface waters. Recommended testing: The results of a 90-day subchronic inhalation toxicity study in rats (40 CFR 799.9346) (62 FR 43828, August 15, 1997) (FRL-5719-5) and a 2-year, two-species bioassay via inhalation (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) would help characterize the human health concerns. The results of a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) conducted using static method and nominal concentrations, would help to characterize the toxicity of the substance. The consent order contains two production volume limits. The PMN submitter has agreed not to exceed the first production volume limit without performing the 90-day subchronic toxicity test. The PMN submitter has also agreed not to exceed the second higher production volume limit without performing the bioassay. CFR citation: 40 CFR 721.5549. PMN Number P-96-33 Chemical name: Cyclopropanecarboxaldehyde. CAS number: 1489-69-6. Effective date of section 5(e) consent order: November 27, 1996. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. Toxicity concern: Similar aldehydes have been shown to cause lung irritation, carcinogenicity, mutagenicity, and liver toxicity in test animals. Developmental effects are possible based on the acid. Recommended testing: EPA has determined that an in vitro mouse lymphoma assay (40 CFR 799.9530) (62 FR 43846, August 15, 1997) (FRL-5719-5) and an in vivo mouse micronucleus assay (40 CFR 799.9539) (62 FR 43853, August 15, 1997) (FRL-5719-5), a 90-day inhalation test in rats (OECD guideline no. 413), a 2-year, one-species bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) would help characterize the human health effects. The consent order contains two production volume limits. [[Page 3406]] The PMN submitter has agreed not to exceed the first production volume limit without performing the in vitro mouse lymphoma, in vivo mouse micronucleus assays, and the 90-day inhalation test in rats. The PMN submitter has also agreed not to exceed the second production volume limit without performing a 2-year, one-species bioassay, which EPA may elect not to require depending on the results of the mutagenicity studies and the 90-day test. CFR citation: 40 CFR 721.2280. PMN Number P-96-92 Chemical name: (generic) 1,4-benzenediol, 2-(1,1,3,3-tetramethylbutyl) and Bis(dimethylamino substituted) carbomonocycle. CAS number: Not available. Basis for action: The PMN substance will be used in a consumer article. Based on analogy to hydroquinones, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters in significant quantities. EPA has determined that other uses of the substance may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.1155. PMN Number P-96-93 Chemical name: Benzenamine, 4,4'-methylenebis[2-methyl-6-(1- methylethyl)]-. CAS number: 16298-38-7. Basis for action: The PMN substance will be used in a non-dispersive use. Based on submitted test data EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 20 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters. EPA has determined that other uses of the substance may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(i). Recommended testing: EPA has determined that a chronic 60-day fish early life stage toxicity test in rainbow trout (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.1105. PMN Number P-96-236 Chemical name: 1-Tridecyn-3-ol, 3-methyl. CAS Number: 100912-15-0. Basis for action: The PMN substance will be used as an intermediate. Based on analogy of the PMN substance to 1-hexyn-3-ol and other structurally similar substances, EPA is concerned that liver toxicity, kidney toxicity, neurotoxicity, reproductive toxicity, and cardiotoxicity will occur to exposed workers. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because significant worker exposures were not expected. EPA has determined that domestic manufacture of the substance or use of the substance without dermal protective equipment may result in significant worker exposures. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii). Recommended testing: EPA has determined that an oral 2-generation reproduction study in rats (40 CFR 799.9380) (62 FR 43834, August 15, 1997) (FRL-5719-5) and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.9830. PMN Number P-96-238 Chemical name: (generic) Azo monochloro triazine reactive dye. CAS number: Not available. Basis for action: The PMN substance will be used as a dye. Based on analogy to structurally similar substances and submitted test data, EPA is concerned that liver toxicity, blood toxicity, oncogenicity, neurotoxicity, and developmental toxicity will occur in exposed workers. EPA determined that use of the substance did not present an unreasonable risk because significant worker exposure is not expected because the substance was manufactured, processed, or used as liquids. EPA has determined that manufacture, processing, or use of the substance as a solid may result in significant worker exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(i), (b)(3)(ii), and (b)(3)(iii). Recommended testing: EPA has determined that an oral two-species developmental toxicity test (40 CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPT 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.9717. PMN Number P-96-273 Chemical name: (generic) Chloroalkane. CAS number: Not available. Basis for action: The PMN substance will be used as an intermediate. Based on toxicity data submitted with the PMN and by analogy to chlorinated solvents, EPA identified health concerns for liver toxicity, kidney toxicity, neurotoxicity, and oncogenicity. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because significant human exposure is not expected. EPA has determined that use of the substance other than as described in the PMN may result in significant human exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(C), (b)(3)(i), and (b)(3)(ii). Recommended testing: EPA has determined that a 2-year, two-species oral bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) and a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPT 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.2091. PMN Number P-96-346 Chemical name: (generic) Aminofunctional alkoxy alkyl siloxane. CAS number: Not available. Basis for action: The PMN substance will be used as an adhesion promoter. [[Page 3407]] Based on analogy to aliphatic amines and ethoxysilanes, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 10 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance was not released to surface waters. EPA has determined that other uses may result in releases to surface waters above 10 ppb. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.9515. PMN Numbers P-96-399/400/401/402/403/404 Chemical name: (generic) Alkyl polycarboxylic acids, esters with ethoxylated fatty alcohols, reaction products with maleic anhydride. CAS number: Not available. Basis for action: The PMN substances will be used as site-limited production intermediates. Based on analogy to nonionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 9 ppb of the PMN substances in surface waters. EPA determined that use of the substances as described in the PMNs did not present an unreasonable risk because the substances were not released to surface waters. EPA has determined that other uses may result in releases to surface waters. Based on this information the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.6477. PMN Numbers P-96-406/407/408 Chemical name: (generic) Alkyltri, tetra, and pentaamines. CAS number: Not available. Basis for action: The PMN substances will be used as industrial lubricants and fuel additives. Based on analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substances in surface waters. EPA determined that use of the substances as described in the PMNs did not present an unreasonable risk because the substances were not released to surface waters. EPA has determined that other uses may result in releases to surface waters. Based on this information the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.2350. PMN Numbers P-96-554/555/556/557/558/559/560/561/564/565 Chemical name: (generic) Alkyl polycarboxylic acids, esters with ethoxylated fatty alcohols. CAS number: Not available. Basis for action: The PMN substances will be used as intermediates. Based on analogy to nonionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 20 ppb of the PMN substances in surface waters. EPA determined that use of the substances as described in the PMN did not present an unreasonable risk because the substances would not be released to surface waters. EPA has determined that other uses of the substances may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substances meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.6475. PMN Number P-96-573 Chemical name: (generic) Ethoxylated alkyl quaternary ammonium compound. CAS Number: Not available. Basis for action: The PMN substance will be used in an open dispersive use. Based on analogy of the PMN substance to cationic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because there were no significant environmental exposures. EPA has determined that any use of the substance other than for the specific use described in the PMN may result in significant environmental exposures. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.655. PMN Number P-96-585 Chemical name: (generic) Salt of a substituted polyalkylenepolyamine. CAS number: Not available. Basis for action: The PMN substance will be used as a processing aid. Based on analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance was not released to surface waters. EPA has determined that other uses may result in [[Page 3408]] releases to surface waters. Based on this information the PMN substance meet the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.6197. PMN Number P-96-702 Chemical name: (generic) Substituted phenyl azo substituted sulfo carbopolycycle. CAS number: Not available. Basis for action: The PMN substance will be used in an open nondispersive use. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because it did not result in significant human or environmental exposure. EPA has determined that increased use of the substance may result in significant environmental and human exposure. Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an activated sludge adsorption isotherm (OPPTS 835.1110 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1) would help characterize the environmental effects of the PMN substance. A murine immune allergic response study (Toxicology and Applied Pharmacology 112:190-197 (1992)) would help characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.2122. PMN Numbers P-96-767/773 Chemical name: (generic) Substituted pyridine azo substituted phenyl. CAS number: Not available. Basis for action: The PMN substances will be used as textile dyes. Based on analogy to structurally similar substances, EPA is concerned that liver toxicity, kidney toxicity, oncogenicity, blood toxicity, neurotoxicity, and developmental toxicity will occur in exposed workers. EPA determined that use of the substances did not present an unreasonable risk because significant worker exposure is not expected because the substances were not manufactured domestically. EPA has determined that domestic manufacture of the substances may result in significant worker exposure. Based on this information the PMN substances meet the concern criteria at Sec. 721.170 (b)(1)(i)(C) and (b)(3)(ii). Recommended testing: EPA has determined that a 2-year, two-species oral bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5), a two-species oral developmental toxicity study (40 CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5), and a subchronic oral study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the health effects of the PMN substances. CFR citation: 40 CFR 721.8780. PMN Number P-96-795 Chemical name: (generic) Mixed fatty alkylamines, salt. CAS number: Not available. Basis for action: The PMN substance will be used as a processing aid. Based on analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance was not released to surface waters. EPA has determined that other uses may result in releases to surface waters. Based on this information the PMN substance meet the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.567. PMN Number P-96-813 Chemical name: (generic) Phenothiazine derivative. CAS number: Not available. Basis for action: The PMN substance will be used as a mediator in enzyme catalyzed reactions. Based on analogy to phenothiazines and submitted toxicity data, EPA is concerned that blood toxicity, liver toxicity, kidney effects, adrenal toxicity, spleen toxicity, reproductive toxicity, and neurotoxicity will occur in exposed workers. Based on submitted test data EPA is also concerned that toxicity to aquatic organisms will occur at concentrations as low as 7 ppb. EPA determined that use of the substance did not present an unreasonable risk because the use as described in the PMN would not result in significant worker exposure or environmental release. EPA has determined that domestic manufacture of the substance as a powder may result in significant worker exposure or environmental release. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(3)(i), (b)(3)(ii), and (b)(4)(i). Recommended testing: EPA has determined that a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)), a chronic 60-day fish early life stage toxicity test in rainbow trout (40 CFR 797.1600 or OPPTS 850.1400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) and a 21-day daphnid chronic toxicity test (40 CFR 797.1330 or OPPTS 850.1300 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the health and environmental effects of the PMN substance. CFR citation: 40 CFR 721.5913. PMN Number P-96-824 Chemical name: (generic) Acrylate ester. CAS number: Not available. Basis for action: The PMN substance will be used as a monomer. Based on analogy to acrylates, EPA identified concerns for toxicity to aquatic organisms at concentrations as low as 6 ppb. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because significant environmental exposure is not expected. EPA has determined that other uses may result in releases to water which are significant environmental exposures. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test [[Page 3409]] guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363- 1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.2805. PMN Number P-96-866 Chemical name: (generic) Derivative of substituted carbomonocyclic carboxylic acid-amine distillation stream byproduct reaction product. CAS number: Not available. Basis for action: The PMN substance will be used as a processing aid. Based on analogy to aliphatic amines, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance was not released to surface waters. EPA has determined that other uses may result in releases to surface waters. Based on this information the PMN substance meet the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.2082. PMN Number P-96-897 Chemical name: (generic) Terpene residue distillates. CAS number: Not available. Basis for action: The PMN substance will be used as an odor enhancer. Based on analogy to neutral organic substances, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 10 ppb of the PMN substance in surface waters. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters above a level of 10 ppb. EPA has determined that other uses of the substance may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.9635. PMN Number P-96-941 Chemical name: (generic) Ceteareth-25 sorbate. CAS number: Not available. Basis for action: The PMN substance will be used as an intermediate. Based on analogy to nonionic surfactants, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 1 ppb of the PMN substance in surface waters. EPA determined that use of the substance as an intermediate did not present an unreasonable risk because the substance would not be released to surface waters in significant amounts. EPA has determined that other uses of the substance may result in releases to surface waters which significantly exceed the concern concentration. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. CFR citation: 40 CFR 721.2145. PMN Number P-96-942 Chemical name: Methanone, [5-[[3-(2H-benzotriazol-2-yl)-2-hydroxy-5- (1,1,3,3- tetramethylbutyl)phenyl]methyl]-2-hydroxy-4- (octyloxy)phenyl]phenyl-. CAS number: 162245-07-0. Effective date of section 5(e) consent order: September 24, 1996. Basis for section 5(e) consent order: The order was issued under section 5 (e)(1)(A)(i) and (e)(1)(A)(ii)(I) of TSCA based on a finding that this substance may present an unreasonable risk of injury to human health. Toxicity concern: Section 8(e) data and data on analogous hindered phenol benzotriazoles have shown similiar substances to cause increased organ weight (liver and kidney, with associated histopathology at higher doses); hematological effects (decreased hemoglobin, packed cell volume, and erythrocytes); and immune systems effects(weight changes in thymus, spleen, lymph nodes; decreased leukocytes) in test animals. Recommended testing: EPA has determined that a 90-day gavage study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) with special attention to hematology would help characterize systemic toxicity and reproductive toxicity. The PMN submitter has agreed not to exceed the production volume limit without performing this test. CFR citation: 40 CFR 721.4885. PMN Numbers P-96-945/946/947/948 Chemical name: (generic) Mixture of hydrochlorofluoro alkanes and hydrochlorofluoro alkene. CAS number: Not available. Basis for action: The PMN substances will be used as intermediates. Based on analogy to similar substances, EPA is concerned that lung toxicity, neurotoxicity, irritation, oncogenicity, liver toxicity, kidney toxicity, and cardiac sensitization will occur in exposed workers. EPA determined that use of the substance as an intermediate did not present an unreasonable risk because it did not result in significant worker exposure. EPA has determined that use other than an intermediate may result in significant worker exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(ii). Recommended testing: EPA has determined that a 90-day subchronic oral study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) and a 2-year, two- species oral bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) would help characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.4464. PMN Numbers P-96-950/951 Chemical name: (generic) Polymers of C13C15 oxoalcohol ethoxolate, ammonia, and maleic anhydride. [[Page 3410]] CAS number: Not available. Basis for action: The PMN substances will be used as described in the PMN. Based on structure activity relationships to nonionic surfactants- alkylethoxylates, EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 9 ppb of the PMN substances in surface waters. EPA determined that use of the substances as described in the PMNs did not present an unreasonable risk because the substances would not be released to surface waters. EPA has determined that other uses of the substances may result in releases to surface waters which exceed the concern concentration. Based on this information the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substances. CFR citation: 40 CFR 721.6505. PMN Number P-96-1176 Chemical name: Cyclohexanamine, N,N-dimethyl-, compd. with alpha- isotridecyl-omega-hydroxypoly(oxy-1,2-ethanediyl) phosphate. CAS Number: 164383-18-0. Basis for action: The PMN substance will be used as a pigment dispersant for color dispersion. Based on analogy to phosphate based anionic surfactants, EPA expects toxicity to aquatic organisms at surface water concentrations as low as 20 ppb. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because there were no significant environmental exposures. EPA has determined that any use of the substance other than for the specific use described in the PMN may result in significant exposures. Based on this information the PMN substances meet the concern criteria at Sec. 721.170(b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance CFR citation: 40 CFR 721.2222. PMN Number P-96-1177 Chemical name: Tungstate (W12(OH)2O386-) hexasodium (9CI). CAS Number: 12141-67-2. Basis for action: The PMN substance will be used in an open non- dispersive use. Based on submitted test data, EPA is concerned that hepatotoxicity, kidney toxicity, neurotoxicity, reproductive toxicity, eye and skin irritation, and toxicity to the GI tract, spleen, lungs, pancreas, urinary bladder, and the lymph system may occur. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because there were no significant inhalation exposures. EPA has determined that any use of the substance other than for the specific use described in the PMN may result in significant inhalation exposures. Based on this information the PMN substance meets the concern criteria at Sec. 721.170(b)(3)(i). Recommended testing: EPA has determined that a 2-year, two-species oral bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) and a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)) would help characterize the health effects of the PMN substance. CFR citation: 40 CFR 721.9840. PMN Number P-96-1216 Chemical name: Benzoic acid, 3-amino-, diazotized, coupled with 6- amino-4-hydroxy-2-naphthalenesulfonic acid, diazotized, (3- aminophenyl)phosphonic acid and diazotized 2,5-diethoxybenzenamine. CAS number: 163879-69-4. Basis for action: The PMN substance will be used as a coloring material. Based on submitted toxicity data on the PMN substance and analogy to the azo reduction products, EPA is concerned that eye irritation, skin sensitization, reproductive toxicity in males, blood toxicity, liver toxicity, kidney toxicity, reproductive toxicity, spleen effects, oncogenicity, neurotoxicity, and developmental toxicity will occur in workers exposed via inhalation. EPA determined that use of the substance as described in the PMN does not present an unreasonable risk. Significant worker inhalation exposure is not expected because the substance will not be manufactured, processed, or used as a powder. EPA has determined that manufacture, processing, and use of the substance as a powder may result in significant worker inhalation exposure. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(D), (b)(3)(i), and (b)(3)(iii). Recommended testing: EPA has determined that a 2-year, two-species oral bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL-5719-5) and a 2-generation reproductive toxicity study (40 CFR 799.9380) (62 FR 43834, August 15, 1997) (FRL-5719-5) would help characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.1705. PMN Number P-96-1233 Chemical name: (generic) Reaction product of epoxy with anhydride and glycerol and glycol. CAS number: Not available. Basis for action: The PMN substance will be used as molding compound. Based on analogy to diepoxides and esters EPA is concerned that toxicity to aquatic organisms may occur at a concentration as low as 30 ppb of the PMN substance in surface waters. Based on analogy to similar substances there is concern for oncogenicity, developmental toxicity, reproductive toxicity, and neurotoxicity to exposed workers. EPA determined that use of the substance as described in the PMN did not present an unreasonable risk because the substance would not be released to surface waters and workers would not be exposed by inhalation. EPA has determined that other uses or uses as a powder may result in releases to surface waters which exceed the concern concentration or inhalation exposure to workers. Based on this information the PMN substance meets the concern criteria at Sec. 721.170 (b)(1)(i)(c), (b)(3)(ii), and (b)(4)(ii). Recommended testing: EPA has determined that a fish acute toxicity study (40 CFR 797.1400 or OPPTS 850.1075 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), a daphnid acute toxicity study (40 CFR 797.1300 or OPPTS 850.1010 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)), and an algal acute toxicity study (40 CFR 797.1050 or OPPTS 850.5400 test guideline (public draft; 61 FR 16486, April 15, 1996) (FRL-5363-1)) would help characterize the environmental effects of the PMN substance. EPA has also determined that a 2-year, two-species oral bioassay (40 CFR 799.9420) (62 FR 43838, August 15, 1997) (FRL- [[Page 3411]] 5719-5), a 90-day subchronic inhalation study in rats (40 CFR 798.2650 or OPPTS 870.3100 test guideline (public draft; 61 FR 31522, June 20, 1996) (FRL-5367-7)), and a two-species oral developmental toxicity test (40 CFR 799.9370) (62 FR 43832, August 15, 1997) (FRL-5719-5) would characterize the human health effects of the PMN substance. CFR citation: 40 CFR 721.9270. PMN Number P-96-1239 Chemical name: (generic) Aliphatic polyisocyanate homopolymer. CAS number: Not available. Basis for action: The PMN substance will be used as an intermediate. Based on analogy to structurally similar substances, EPA is concerned that pulmonary sensitization and irritation will occur in exposed workers. EPA determined that use of the substance did not present an unreasonable risk because significant worker exp [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A98-1074. Public record. Not legal advice.