8612 Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Proposed Rules

promote a significant interest of the

United States or for other good cause.

(9) If it otherwise is permissible, the

records custodian may authenticate,

upon the request of the party seeking

disclosure, copies of the records. No

employee of the Postal Service shall

respond in strict compliance with the

terms of a subpoena duces tecum unless

specifically authorized by the General

Counsel.

(e) Postal Service employees as expert

witnesses. No Postal Service employee

may testify as an expert or opinion

witness, with regard to any matter

arising out of the employee’s official

duties or the functions of the Postal

Service, for any party other than the

United States, except that in

extraordinary circumstances, the

General Counsel may approve such

expert testimony in private litigation. A

Postal Service employee may not testify

as such an expert witness without the

express authorization of the General

Counsel. A litigant must obtain

authorization of the General Counsel

before designating a Postal Service

employee as an expert witness.

(f) Substitution of Postal Service

employees. Although a demand for

testimony may be directed to a named

Postal Service employee, the General

Counsel, where appropriate, may

designate another Postal Service

employee to give testimony. Upon

request and for good cause shown (for

example, when a particular Postal

Service employee has direct knowledge

of a material fact not known to the

substitute employee designated by the

Postal Service), the General Counsel

may permit testimony by a named

Postal Service employee.

(g) Fees and costs. (1) The Postal

Service may charge fees, not to exceed

actual costs, to private litigants seeking

testimony or records by request or

demand. The fees, which are to be

calculated to reimburse fully the Postal

Service for processing the demand and

providing the witness or records, may

include, among others:

(i) Costs of time spent by employees,

including attorneys, of the Postal

Service to process and respond to the

demand;

(ii) Costs of attendance of the

employee and agency attorney at any

deposition, hearing, or trial;

(iii) Travel costs of the employee and

agency attorney;

(iv) Costs of materials and equipment

used to search for, process, and make

available information.

(2) All costs for employee time shall

be calculated on the hourly pay of the

employee (including all pay, allowance,

and benefits) and shall include the

hourly fee for each hour, or portion of

each hour, when the employee is in

travel, in attendance at a deposition,

hearing, or trial, or is processing or

responding to a request or demand.

(3) At the discretion of the Postal

Service, where appropriate, costs may

be estimated and collected before

testimony is given.

(h) Acceptance of service. This

section does not in any way abrogate or

modify the requirements of the Federal

Rules of Civil Procedure regarding

service of process.

An appropriate amendment to 39 CFR

265.1 to reflect these changes will be

published if the proposal is adopted.

Stanley F. Mires,

Chief Counsel, Legislative.

[FR Doc. 95–3702 Filed 2–14–95; 8:45 am]

BILLING CODE 7710–12–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[PA37–1–6370b; FRL–5144–3]

Approval and Promulgation of Air

Quality Implementation Plans;

Pennsylvania; SO2: Conewango

Township, Warren County

Implementation Plan

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to approve the

State Implementation Plan (SIP)

revision submitted by the

Commonwealth of Pennsylvania. This

revision provides for, and demonstrates,

the attainment of the national ambient

air quality standards (NAAQS) for sulfur

oxides in the Conewango Township,

Warren County nonattainment area. In

the final rules section of this Federal

Register, EPA is approving the

Commonwealth’s SIP revision as a

direct final rule without prior proposal

because the Agency views this as a

noncontroversial SIP revision and

anticipates no adverse comments. A

detailed rationale for the approval is set

forth in the direct final rule. If no

adverse comments are received in

response to this proposed rule, no

further activity is contemplated in

relation to this rule. If EPA receives

adverse comments, the direct final rule

will be withdrawn and all public

comments received will be addressed in

a subsequent final rule based on this

proposed rule. EPA will not institute a

second comment period on this action.

Any parties interested in commenting

on this action should do so at this time.

DATES: Comments must be received in

writing by March 17, 1995.

ADDRESSES: Written comments on this

action should be addressed to Thomas

J. Maslany, Director, Air, Radiation, and

Toxics Division (3AT00), U.S.

Environmental Protection Agency,

Region III, 841 Chestnut Building,

Philadelphia, Pennsylvania 19107.

Copies of the documents relevant to this

action are available for public

inspection during normal business

hours at the Air, Radiation, and Toxics

Division, U.S. Environmental Protection

Agency, Region III, 841 Chestnut

Building, Philadelphia, Pennsylvania

19107; the Air and Radiation Docket

and Information Center, U.S.

Environmental Protection Agency, 401

M Street SW., Washington, DC 20460;

and, Pennsylvania Department of

Environmental Resources Bureau of Air

Quality Control, P.O. Box 8468, 400

Market Street, Harrisburg, Pennsylvania

17105.

FOR FURTHER INFORMATION CONTACT:

David J. Campbell, Air & Radiation

Programs Branch (3AT11), U.S.

Environmental Protection Agency,

Region III, 841 Chestnut Building,

Philadelphia, Pennsylvania 19107,

phone: 215 597–9781.

SUPPLEMENTARY INFORMATION: See the

information provided in the direct final

action of the same title which is located

in the Rules and Regulations Section of

this Federal Register.

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Reporting and

recordkeeping requirements, Sulfur

oxides.

Authority: 42 U.S.C. 7401–7671q.

Dated: November 18, 1994.

Stanley L. Laskowski,

Acting Regional Administrator, Region III.

[FR Doc. 95–3681 Filed 2–14–95; 8:45 am]

BILLING CODE 6560–50–P

40 CFR Part 180

[PP 0E3882 and PP 4E4286/P598; FRL–

4932–3]

RIN 2070–AC18

Pesticide Tolerances for Metolachlor

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish

tolerances for the combined residues of

the herbicide metolachlor and its

metabolites in or on the raw agricultural

commodities celery and dry bulb onion.
Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Proposed Rules 8613

The proposed regulation to establish

maximum permissible levels for

residues of the herbicide was requested

in petitions submitted by the

Interregional Research Project No. 4 (IR–

4).

DATES: Comments, identified by the

document control number, [PP 0E3882

and PP 4E4286/P598], must be received

on or before March 17, 1995.

ADDRESSES: By mail, submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW,

Washington, DC 20460. In person, bring

comments to: Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA

22202.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the comment that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt L. Jamerson, Registration

Division (7505W), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location and telephone

number: Sixth Floor, Crystal Station #1,

2800 Jefferson Davis Hwy., Arlington,

VA 22202, (703)-308-8783.

SUPPLEMENTARY INFORMATION: The

Interregional Research Project No. 4 (IR4), New Jersey Agricultural Experiment

Station, P.O. Box 231, Rutgers

University, New Brunswick, NJ 08903,

has submitted pesticide petition (PP)

0E3882 and PP 4E4286 to EPA on behalf

of the named Agricultural Experiment

Stations. These petitions request that

the Administrator, pursuant to section

408(e) of the Federal Food, Drug, and

Cosmetic Act (FFDCA), 21 U.S.C.

346a(e), amend 40 CFR 180.368 by

establishing tolerances for combined

residues (free and bound) of the

herbicide metolachlor [2-chloro-N-(2-

ethyl-6-methylphenyl)-N-(2methoxy-1-

methylethyl)acetamide], and its

metabolites, determined as the

derivatives, 2-[(2-ethyl-6-

methylphenyl)amino]-1-propanol, and

4-(2-ethyl-6-methylphenyl)-2-hydroxy5-methyl-3-morpholinone, each

expressed as the parent compound in or

on certain raw agricultural commodities

as follows:

1. PP 0E3882. Petition submitted on

behalf of the Experimental Stations of

California, Florida, and Texas proposing

a tolerance for celery at 0.1 part per

million (ppm).

2. PP 4E4286. Petition submitted on

behalf of the Experimental Stations of

Arkansas, Michigan, New Jersey, New

York, Oklahoma, and Texas proposing a

tolerance for dry bulb onion at 1.0 ppm.

The petitioner proposed that use of

metolachlor on dry bulb onion be

limited to onion production areas east of

the Rocky Mountains based on the

geographical representation of the

residue data submitted. Additional

residue data will be required to expand

the area of usage. Persons seeking

geographically broader registration

should contact the Agency’s

Registration Division at the address

provided above.

The scientific data submitted in the

petition and other relevant material

have been evaluated. The toxicological

data considered in support of the

proposed tolerance include:

1. A 1-year feeding study with dogs

fed diets containing 0, 100, 300, or 1,000

ppm with a systemic no-observed-effectlevel (NOEL) of 300 ppm (9.7 mg/kg/

day) based on decreased body weight in

females.

2. A 2-year feeding/carcinogenicity

study with rats fed diets containing 0,

30, 300, 1,000 or 3,000 ppm (equivalent

to 0, 1.5, 15, 50, or 150 mg/kg/day) with

a compound-related increase in liver

adenomas and combined adenomas/

carcinomas in female rats at the highdose level. This study was classified as

supplemental data due to inadequate

clinical chemistry determinations and

dietary preparation records.

3. A 2-year feeding/carcinogenicity

study with rats fed diets containing 0,

30, 300, or 3,000 ppm (equivalent to 0,

1.5, 15, or 150 mg/kg/day) with a

systemic NOEL of 300 ppm based on

decreased body weight at the 3,000-ppm

dose level. A statistically significant

increase in liver neoplasia was found in

female rats at the 3,000-ppm dose level,

as well as evidence for a neoplastic

response in the nasal turbinates of both

sexes.

4. A 2-year carcinogenicity study in

mice fed diets containing 0, 300, 1,000

and 3,000 ppm (highest dose level

equivalent to 428 mg/kg/day) with no

treatment-related carcinogenic effects

observed under the conditions of the

study.

5. A second 2-year carcinogenicity

study in mice fed diets containing 0,

300, 1,000, or 3,000 ppm with no

treatment-related carcinogenic effects

observed under the conditions of the

study.

6. A two-generation reproduction

study in rats fed diets containing 0, 30,

300, or 1,000 ppm with a reproductive

NOEL of 300 ppm (equivalent to 23.5-

26 mg/kg/day) based on reduced pup

weights in the F1a and F2a litters at the

1,000-ppm dose level (equivalent to 75.8

to 85.7 mg/kg/day). The NOEL for

parental toxicity is equal to or greater

than the 1,000-ppm dose level.

7. A developmental toxicity study in

rabbits given gavage doses at 0, 36, 120,

or 360 mg/kg/day on gestation days 6 to

18. The NOEL for maternal toxicity was

established at 120 mg/kg/day based on

lacrimation, miosis, reduced food

consumption, and body weight gain.

There was no developmental toxicity

observed under the conditions of the

study.

8. A developmental toxicity study in

rats given gavage doses of 0, 60, 180, or

360 mg/kg/day on gestation days 6 to

15. There were no signs of maternal or

developmental toxicity observed under

the conditions of the study.

9. A second developmental toxicity

study in rats given gavage doses of 0, 30,

100, 300, or 1,000 mg/kg/day on

gestation days 6 to 15. The NOEL’s for

maternal and developmental toxicity

were established at 300 mg/kg/day. The

NOEL for maternal toxicity was based

on deaths, salivation, lacrimation,

convulsions, reduced body weight, and

food consumption at the 1,000-mg/kg/

day dose level. The NOEL for

developmental toxicity was based on

reduced mean fetal body weight,

reduced number of implantations/dam

with resulting decreased litter size, and

a slight increase in resorptions/dam

with resulting increase in postimplantation loss.

10. Metolachlor was not found to be

mutagenic in any tests. Mutagenicity

data include gene mutation assays in

Salmonella and mouse lymphoma cells;

structural chromosome aberration tests

including an in vivo micronucleus assay

in Chinese hamsters and a dominant

lethal assay in mice; and other

genotoxic activity tests including DNA

damage/repair assays in rat hepatocytes

and in human fibroblasts, and an in

vivo/in vitro unscheduled DNA

synthesis assay.

11. Several metabolism studies have

been performed with metolachlor, and

the available data indicate the

compound is readily absorbed after oral

dosing and excreted in approximately

equal amounts in urine and feces.
8614 Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Proposed Rules

Metolachlor was evaluated by the

Office of Pesticide Programs’ Peer

Review Committee in 1991 and

classified as a Group C (possible

carcinogen) with a recommendation for

the quantification of estimated potential

human risk using a linearized low-dose

extrapolation (Q*). This

recommendation was based on the

finding of liver tumors in female rats at

the 3,000-ppm dose level in both rat

studies and the apparent induction of a

small number of nasal turbinate tumors

in both sexes of rats at the 3,000-ppm

dose level. Nasal turbinate tumors have

also been associated with dietary

administration of acetochlor and

alachlor, structurally related herbicides

that are classified as Group B2

carcinogens (probable human

carcinogens).

The Peer Review Committee’s

decision was presented to the FIFRA

Scientific Advisory Panel on September

18, 1991. The Panel concluded that liver

tumors were benign and hyperplasia

was evident in rats of both sexes. The

Panel also concluded that the

occurrence of nasal turbinate tumors in

rats was low and not statistically

significant, but of concern since

metolachlor is structurally related to

acetochlor and alachlor. The Panel

considered the carcinogenicity evidence

to be minimal but sufficient for the

classification of metolachlor as a Group

C carcinogen.

The Office of Pesticide Programs’

Health Effect Division Carcinogenicity

Peer Review Committee met on July 27,

1994, to revaluate the weight-of-theevidence on metolachlor, with

particular reference to its

carcinogenicity, based on newly

submitted metabolism and mutagenicity

studies. The registrant submitted data to

show that the metabolism of

metolachlor is substantially different

from the metabolism of acetochlor and

alachlor. Metolachlor does not

metabolize to form a reactive quinone

imine, which is presumed to be the

carcinogenic metabolite of acetochlor

and alachlor. There was also no

evidence for mutagenic potential of

metolachlor. Based on these data and in

consideration of the full weight-of-theevidence, the Carcinogenicity Peer

Review Committee concluded that the

classification of metolachlor should

remain as a Group C carcinogen, but

recommended that the RfD approach

should be used for quantification of

human risk.

A NOEL of 15 mg/kg/day from the 2-

year rat feeding study was determined

to be appropriate for use in the Margin

of Exposure carcinogenic risk

assessment. The chronic reference dose

(RfD) is currently based on a systemic

NOEL of 9.7 mg/kg/day from the 1-year

feeding study in dogs, and any cancer

concerns from chronic exposure are

already addressed by the lower NOEL,

which is the basis for the current RfD.

The Reference Dose (RfD) is

established at 0.1 mg/kg of body weight

(bwt)/day, based on a NOEL of 9.7 mg/

kg/day and an uncertainty factor of 100.

Available information on anticipated

residues and/or percent of crop treated

were used to estimate the Anticipated

Residue Contribution (ARC) from

residues of metolachlor in the human

diet. The ARC from established

tolerances and the proposed tolerances

for celery and onions is estimated at

0.0006 mg/kg bwt/day and utilizes 0.6

percent of the RfD for the U.S.

population. The ARC for non-nursing

infants (the subgroup most highly

exposed) utilizes 2 percent of the RfD.

EPA believes these uses of metolachlor

pose a negligible cancer risk to humans.

An adequate analytical method, gas

chromatography, is available for

enforcement purposes. The analytical

method for enforcing this tolerance has

been published in the Pesticide

Analytical Manual, Vol. II (PAM II). The

nature of the residue in plants is

adequately understood. There is no

reasonable expectation that secondary

residues will occur in milk, eggs, or

meat of livestock and poultry since

there are no livestock feed items

associated with this action.

There are currently no actions

pending against the continued

registration of this chemical.

Based on the information and data

considered, the Agency has determined

that the tolerances established by

amending 40 CFR part 180 would

protect the public health. Therefore, it is

proposed that the tolerances be

established as set forth below.

Any person who has registered or

submitted an application for registration

of a pesticide, under the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA) as amended, which

contains any of the ingredients listed

herein, may request within 30 days after

publication of this notice in the Federal

Register that this rulemaking proposal

be referred to an Advisory Committee in

accordance with section 408(e) of the

FFDCA.

Interested persons are invited to

submit written comments on the

proposed regulation. Comments must

bear a notation indicating the document

control number, [PP 0E3882 and PP

4E4286/P597]. All written comments

filed in response to these petitions will

be available in the Public Response and

Program Resources Branch, at the

address given above from 8 a.m. to 4

p.m., Monday through Friday, except

legal holidays.

Under Executive Order 12866 (58 FR

51735, Oct. 4, 1993), the Agency must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

all the requirements of the Executive

Order (i.e., Regulatory Impact Analysis,

review by the Office of Management and

Budget (OMB)). Under section 3(f), the

order defines ‘‘significant’’ as those

actions likely to lead to a rule (1) having

an annual effect on the economy of $100

million or more, or adversely and

materially affecting a sector of the

economy, productivity, competition,

jobs, the environment, public health or

safety, or State, local or tribal

governments or communities (also

known as ‘‘economically significant’’);

(2) creating serious inconsistency or

otherwise interfering with an action

taken or planned by another agency; (3)

materially altering the budgetary

impacts of entitlement, grants, user fees,

or loan programs; or (4) raising novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in this Executive

Order.

Pursuant to the terms of this

Executive Order, EPA has determined

that this rule is not ‘‘significant’’ and is

therefore not subject to OMB review.

Pursuant to the requirements of the

Regulatory Flexibility Act (Pub. L. 96-

354, 94 Stat. 1164, 5 U.S.C. 601-612),

the Administrator has determined that

regulations establishing new tolerances

or raising tolerance levels or

establishing exemptions from tolerance

requirements do not have a significant

economic impact on a substantial

number of small entities. A certification

statement to this effect was published in

the Federal Register of May 4, 1981 (46

FR 24950).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: January 30, 1995.

Stephen L. Johnson,

Director, Registration Division, Office of

Pesticide Programs.

Therefore, it is proposed that 40 CFR

part 180 be amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

Authority: 21 U.S.C. 346a and 371.
Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Proposed Rules 8615

2. In § 180.368, paragraph (a) is

amended by adding and alphabetically

inserting the entry for celery, and

paragraph (c) is amended by adding and

alphabetically inserting the entry for

onion (dry bulb), to read as follows:

§ 180.368 Metolachlor; tolerances for

residues.

(a) * * *

Commodity Parts per

million

* * * * *

Celery ........................................ 0.1

* * * * *

* * * * *

(c) * * *

Commodity Parts per

million

Onion (dry bulb) ........................ 1.0

* * * * *

[FR Doc. 95–3386 Filed 2–14–95; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[PP 6E3460/P597; FRL–4932–2]

RIN 2070–AB78

Pesticide Tolerance for Prometryn

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to establish a

tolerance for residues of the herbicide

prometryn in or on the raw agricultural

commodity parsley. The proposed

regulation to establish a maximum

permissible level for residues of the

herbicide was requested in a petition

submitted by the Interregional Research

Project No. 4 (IR-4).

DATES: Comments, identified by the

document control number [PP 6E3460/

P597], must be received on or before

March 17, 1995.

ADDRESSES: By mail, submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW,

Washington, DC 20460. In person, bring

comments to: Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA

22202.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the comment that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: By

mail: Hoyt L. Jamerson, Registration

Division (7505W), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St. SW., Washington, DC

20460. Office location and telephone

number: Sixth Floor, Crystal Station #1,

2800 Jefferson Davis Hwy., Arlington,

VA 22202, (703) 308-8783.

SUPPLEMENTARY INFORMATION: The

Interregional Research Project No. 4 (IR4), New Jersey Agricultural Experiment

Station, P.O. Box 231, Rutgers

University, New Brunswick, NJ 08903,

has submitted pesticide petition (PP)

6E3460 to EPA on behalf of the

Agricultural Experiment Station of

California. This petition requests that

the Administrator, pursuant to section

408(e) of the Federal Food, Drug, and

Cosmetic Act (FFDCA), 21 U.S.C.

346a(e), amend 40 CFR 180.222 by

establishing a tolerance for residues of

the herbicide prometryn (2,4-

bis(isopropylamino)-6-methylthio-striazine) in or on the raw agricultural

commodity parsley at 0.1 part per

million (ppm). The petitioner proposed

that use of prometryn on parsley be

limited to California only based on the

geographical representation of the

residue data submitted. Additional

residue data will be required to expand

the area of usage. Persons seeking

geographically broader registration

should contact the Agency’s

Registration Division at the address

provided above.

The scientific data submitted in the

petition and other relevant material

have been evaluated. The toxicological

data considered in support of the

proposed tolerance include:

1. A 2-year feeding study with dogs

fed diets containing 0, 15, 150, or 1,500

ppm (equivalent to 0, 0.375, 3.75, or

37.5 milligrams (mg)/kilogram (kg)/day)

with a no-observed-effect level (NOEL)

of 150 ppm (3.75 mg/kg/day) based on

degenerative hepatic changes, renal

tubule degeneration, and bone marrow

atrophy at the 1,500-ppm dose level.

2. A 104-week chronic feeding/

carcinogenicity study with rats fed diets

containing 0, 10, 100, 750, or 1,500 ppm

(equivalent to 0, 0.38, 3.90, 29.45, or

60.88 mg/kg/day for males and 0, 0.49,

4.91, 37.25, or 80.62 mg/kg/day for

females) with a systemic NOEL of 750

ppm (29.45 mg/kg/day in males and

37.25 mg/kg/day in females) based on

decreased body weight gain in both

sexes, and renal lesions (mineralized

concretions) in males at the 1,500-ppm

dose level. There were no carcinogenic

effects observed under the conditions of

the study.

3. A carcinogenicity study with mice

fed diets containing 0, 10, 1,000, or

3,000 ppm (equivalent to 0, 1, 100, or

300 mg/kg/day) for 102 weeks with a

systemic NOEL of 1,000 ppm (100 mg/

kg/day) based on decreased body weight

gain in female mice at the 3,000-ppm

dose level. There were no carcinogenic

effects observed under the conditions of

the study.

4. A two-generation reproduction

study in rats fed diets containing 0, 10,

750, or 1,500 ppm (equivalent to 0, 0.6,

47.8, 96.7 mg/kg/day in males and 0,

0.7, 53.6, or 105.6 mg/kg day in females)

with a NOEL for reproductive effects of

10 ppm (0.6 mg/kg/day in males and 0.7

mg/kg/day in females) based on

decreased pup weight at the 750-ppm

dose level. The NOEL for parental

systemic toxicity was also established at

10 ppm based on decreased food

consumption, body weight, and body

weight gain at the 750-ppm dose level.

5. A developmental toxicity study in

rabbits given gavage doses of 0, 2, 12, or

72 mg/kg/day with a NOEL of 12 mg/kg/

day for maternal toxicity based on

decreased food consumption at the

highest dose tested (72 mg/kg/day). The

NOEL for developmental effects was

established at 12 mg/kg/day based on

increased fetal resorption at the highest

dose tested.

6. A developmental toxicity study in

rats given gavage doses of 0, 10, 50, or

250 mg/kg/day during gestational days 6

to 15 with a NOEL of 50 mg/kg/day for

maternal toxicity based on salivation

and decreases in body weight and food

consumption at the highest dose tested

(250 mg/kg/day). A NOEL for

developmental toxicity was established

at 50 mg/kg/day based on decreased

fetal body weight and increased

incomplete ossification of sternebrae

and metacarpals at the 250-mg/kg/day

dose level.

7. Mutagenicity studies as follows: a

gene mutation test (Ames assay),

negative up to cytotoxic solubility

limits; structural chromosome

aberration tests, negative for anomalies

in micronuclei in bone marrow cells of