Significant New Uses of Certain Chemical Substances

Federal RegisterJan 22, 1998

Ask Donna

What actually matters in this document.

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