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EPA REGISTRATION DIVISION COMPANY 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 preparing the pesticide petition. In 

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

maintain the outline. Please do not change 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 Cosmetic 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 set 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 petition. 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 additive in packaging. This clearance is from 

the use of butylene carbonate in packaging glue and other indirect food additive uses. 

Little or no migration into the food substance is expected from 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 exemption. No specific plant metabolism data is 

available, nor is it required for the establishment 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-emergence 
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ground applications, post-emergence foliar applications and post harvest applications. 

No specific residue data is available, nor is it required for the establishment of a tolerance 

exemption.

B. Toxicological Profile

 1. Acute toxicity. Acute oral toxicity results for butylene carbonate chemicals 

range from LD50 values of greater than 5000 mg/kg. The dermal LD50 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 butylene carbonate were negative, as 

was a 24-month mouse skin painting carcinogenicity study with propylene carbonate. 

The mutagenicity battery included a mouse micronucleus UDS and gene mutation. A 

chromosome aberration assay was butylene carbonate was also negative.

 3. Reproductive and developmental toxicity. In a developmental toxicity study in 

rats, all reproductive parameters investigated showed 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 reproductive 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 death was not identified at necropsy. All the 

remaining high dose animals exhibited treatment 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 exhibited 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 carcinogenicity data has been found in 

the scientific literature 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 metabolites of toxicological concern are expected.

 8. Endocrine disruption. Butylene carbonate does not belong to a class of 

chemicals known or suspected of having adverse effects on the estrogen receptor or 

endocrine system.
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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 packaging glue and other indirect food additive 

uses. Little or no migration into the food substance is expected from these uses according 

to the information included in 21 CFR.

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

 ii. Drinking water. Drinking water exposure from butylene carbonate is expected 

to be negligible.

 2. Non-dietary exposure. Butylene carbonate is a solvent used in surface cleaners, 

degreasers, dyes, fibers. plastics, batteries, and as a gelling agent for clays. Therefore, 

non-dietary exposure to butylene carbonate 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 closest related compound, ethylene carbonate, is 

used in similar, non-agricultural applications, but does not have any uses which would 

result in agricultural exposure 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 exposure to more toxic inert solvents.

 2. Infants and children. There is a complete database for butylene carbonate 

which includes pre-and post-natal developmental toxicity data. The toxicological effects 

of butylene carbonate on rodents are well understood. 

In a developmental toxicity study in rats, all reproductive parameters investigated showed 

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 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.