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EPA REGISTRATION DIVISION CO MPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: W. Cutchin, 703-305-7990

INSTRUCTIONS: Please utilize this outline in p reparing the pesticide petition. In

cases where the outline element does not apply, please insert “NA-Remove” and

maintain the outline. Please do not chan ge the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green , i.e., “ [insert company name] ,” with the information specific to your action.

TEMPLATE:

Huntsman Corporation

1E7837

EPA has received a pesticide petition 1E7837 from Huntsman Corporation, 10003 Woodloch Forest Drive,TheWoodlands,Texas,77380 requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosme tic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.960 to establish an exemption from the requirement of a

tolerance for butylene carbonate; 1, 3- dioxolan-2-one, 4-ethyl (CAS RN 4437-85-8) in or on all raw agricultural commodities. EPA has determined that the petition contains data or information regarding the elements se t forth in section 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the peti tion. Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry Butylene carbonate is cleared as an indirect food additive under 21

CFR 175.105 for use as an indirect food additi ve in packaging. Th is clearance is from the use of butylene carbonate in packaging gl ue and other indirect food additive uses. Little or no migration into th e food substance is expected fr om these uses according to

the information included in 21 CFR .]

1. Plant metabolism. NA- Remove based on fact this information is not required for the establishment of a tolerance exemp tion. No specific plant metabolism data is available, nor is it required for the establ ishment of a tolerance exemption. However available information indicates that butylene carbonate binds tightly to soil, is not taken up from soil by plants, and is not translocated in plants

2. Analytical method. An analytical residue method utilizing chromatography with a flame-ionization detector is available for enforcement purposes.

3. Magnitude of residues. Butylene carbonate may be applied as pre-emergence2

ground applications, post-emergence foliar applic ations and post harvest applications. No specific residue data is ava ilable, nor is it required for the establishment of a tolerance exemption.

B. Toxicological Profile

1. Acute toxicity. Acute oral toxicity results fo r butylene carbonate chemicals range from LD 50 values of greater than 5000 mg/kg. The dermal LD 50 is greater than 2000 mg/kg. Butylene carbonate is minimally irritating to eyes, non -irritating to skin

and not a sensitizer

.

2. Genotoxicty. Mutagenicity studies with butylen e carbonate were negative, as was a 24-month mouse skin painting carci nogenicity study with propylene carbonate. The mutagenicity battery included a mouse micronucleus UDS and gene mutation. A chromosome aberration assay was buty lene carbonate was also negative

.

3. Reproductive and developmental toxicity. In a developmental toxicity study in rats, all reproductive parameters investigated show ed no treatment-related effects except slightly retarded growth rate. Maternal effects were seen at 5,000 mg/kg/day without developmental effects. The NOAEL for re productive effects in offspring is 5,000 mg/kg/day

.

4. Subchronic toxicity. In oral subchronic toxicity studies, rats treated with butylene carbonate by gavage at doses of 0, 500, 1000 mg/kg/day resulted in transient reductions in body weight gains and clinical signs. Two of the high dose females died on days 7 and 13, respectively. The cause of deat h was not identified at necropsy. All the remaining high dose animals exhibited treatm ent related clinical signs of salivation, hunched posture, lethargy and abnormal gait. These signs, with the exception of lethargy, were seen in the low dose females and low dose males exhi bited salivation and piloerection. These clinical signs were seen on multiple occasions in the treated animals,

but not in control animals. A NOAEL was not achieved in this study. The salivation was considered to be a possible sign of mucous membrane irritation.

5. Chronic toxicity. No chronic toxicity or carcinog enicity data has been found in

the scientific literatu re for butylene carbonate

.

6. Animal metabolism. No data has been found in the scientific literature describing the metabolism of butylene carbonate.

7. Metabolite toxicology

. For the glycol metabolites several developmental and/or reproductive-teratology studies were identified in the literature. However, based on the plausible metabolic pathways, no metabolite s of toxicological concern are expected

.

8. Endocrine disruption

. Butylene carbonate does not belong to a class of chemicals known or suspected of having adve rse effects on the estrogen receptor or endocrine system

.3

C. Aggregate Exposure

1. Dietary exposure. Butylene carbonate is cleared as an indirect food additive

under 21 CFR 175.105 for use as an indirect food additive in packaging. This clearance is from the use of butylene carbonate in pack aging glue and other indirect food additive uses. Little or no migration into the food s ubstance is expected from these uses according

to the information included in 21 CFR.

i. Food. Dietary exposure from butylene carbonat e is expected to be negligible.

ii. Drinking water. Drinking water exposure from but ylene carbonate is expected to be negligible.

2. Non-dietary exposure

. Butylene carbonate is a solv ent used in surface cleaners, degreasers, dyes, fibers. plastics , batteries, and as a gelling agent for clays. Therefore, non-dietary exposure to butylene carbona te is expected to be minimal.

D. Cumulative Effects

Butylene carbonate is a member of a class of compounds with structures containing the carbonate moiety. The clos est related compound, ethylene carbonate, is used in similar, non-agricultural applicatio ns, but does not have any uses which would result in agricultural expo sure or dietary exposure

.

E. Safety Determination

1. U.S. population. Owing to the very high reference dose, it is not reasonable to assume any acute or chronic health effects to the U.S. population. Butylene carbonate is

a reduced-risk inert which will reduce e xposure to more toxic inert solvents

.

2. Infants and children

. There is a complete database for butylene carbonate which includes pre-and post-natal developmenta l toxicity data. The toxicological effects of butylene carbonate on r odents are well understood.

In a developmental toxicity study in rats, all reproductive parameters investigated showed no treatment-related effects except slightly re tarded growth rate. Maternal effects were seen at 5,000 mg/kg/day wit hout developmental effects. The NOAEL for reproductive effects in offspring is 5,000 mg/kg/day

.

F. International Tolerances

A maximum residue level has not been set for butylene carbonate by the Codex

Alimentarius Commission

.