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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: William Cutchin, 703

- 305

- 7990

INSTRUCTIONS: Please utilize this outline in prep aring 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:

Dow AgroSciences L.L.C

.

I N

- 107 86

EPA has received a pesticide petition ( IN

- 107 86 ) from DowAgroSciences], 9330 Zionsville Road, Indianapolis, IN 46268

, pro posing, 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 to establish an exemption from the re quirement of a tolerance for propanoic acid, 2

- methyl

- , monoester with 2,2,4

- trimethyl

- l,3

- penfanediol ( TMB; CAS no. 25265

- 77

- 4) under 40 CFR 180.910 when used as an inert ingredient as a solvent or co

- solvent within a pesticidal product.

EPA has determined that the petition contains data or information regarding the

elements set forth in s ection 408 (d)(2) of FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted d a ta 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

Because an exemption from the requirement of a tolerance is requested, no field residue studies are required.

B. Toxicological Profile

1. Acute toxicity. TMB has low acute toxicity in lab animals with oral LD 50 values>3200 mg/kg body weight (bw), d erma l LD 50 values >14000 mg/kg bw and,

inhalation LD 50 values > 3.55 mg/ L air

.

2. Genotoxicty. TMB was negative in the Ames assay and in an in vivo mouse micronucleus assay.2

3. Reproductive and developmental toxicity. In a combined repeat dose toxicity

a nd developmental and reproductive toxicity screening test in rats, no reproductive or developmental toxicity was observed at doses up to 1000 mg/kg bw/day.

4. Subchronic toxicity. In a 15

- day oral gavage study in rats, the NOAEL was >1000 mg/kg bw/day. In a combined repeat dose toxicity and developmental and reproductive toxicity screening test in rats, th e NOAEL for systemic toxicity w as >1000 mg/kg bw/day.

5. Chronic toxicity. No chronic toxicity studies were available; however, the lack of systemic toxicity in two shorter repeat dose studies at the limit dose of 1000 mg/kg bw/day suggests that chronic toxicity is not a concern. QSAR modeling did not indicate any concerns for human carcinogenicity.

6. Animal metabolism. TMB is a mixture of the 1

- s ubstituted (

- 65%) and the 3

- substituted (

- 35%) monoisobutyrate isomers of 2,2,4

- trimethyl

- l,3

- pentanediol. The half

life of the 1

- substituted isomer in human and rat blood is between 15 to 22 minutes.

7. Metabolite toxicology

. No specific information is available on toxicity of TMB metabolites. However, TMB is rapidly metabolized in rat blood, and toxicity of parent

TMB in rats w as not observed at doses up to 1000 mg/kg bw/day, so metabolite toxicity is anticipated to be low.

8. Endocrine disruption

. TMB does not belong to a class of chemicals known or suspected to have adverse effects on the estrogen receptor or endocrine system.

C. Aggregate Exposure

1. Dietary exposure

.

i . Food

. An assessment based on the general results of the EPA screening le vel dietary exposure model I

- DEEM is provided. I

- DEEM is based on a screening level dietary assessment of 57 of the most "significant" active ingredients used as surrogates for inerts within the Dietary Exposure Evaluation Model software with food Commodit y Intake Database (DEEM

- FCID, Version 3.16). Exposures were compared to a chronic reference dose (cR f D) and chronic population adjusted dose (cPAD) of 10 mg/kg bw/day based on a NOAEL of >1000 mg/kg bw/day and a 100% uncertainty factor and an FQPA safety f actor of IX. All exposures were below the cRf D/cPAD and pass the screening level dietary risk assessment process for inerts without further refinement.

ii. Drinking water . Drinking water estimates have been included in the I

- DEEM

model and are included i n the conclusion of a passing dietary risk assessment as

discussed above.

2. Non

- dietary exposure

. No uses of TMB in pesticidal products for non

- crop uses are indicated in publically available databases. Non

- dietary consumer exposures to TMB are possible due to its use in formulations of products such as paints, floor finishes,3

adhesives, and caulks. A risk assessment of consumer exposure through application of paint containing TMB inside a residential home revealed acceptable margins of exposure (MOEs ), e.g. >100. Aggregate MOEs incorporating both dietary and non

- dietary exposures were also acceptable (>100).

D. Cumulative Effects

Unlike for pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, for TM B EPA has not made a common mechanism of toxicity finding. Consideration of a common mode of toxicity is not appropriate given that there is no information available that indicates potential toxic effects, if any, would be cumulative with any other compoun ds.]

E. Safety Determination

1. U.S. population. Dietary exposures for the US population calculated using I

DEEM were all below the cRfD, and MOEs for aggregate exposures, including food and drinking water as well as non

- dietary exposures from TMB in pai nts, were acceptable. A reasonable certainty of no harm has been established for the general population for the proposed use of TMB as an inert ingredient in pesticide formulations.]

2. Infants and children

. The available information does not indicate any qualitative or quantitative evidence of increased susceptibility to infants and children for TMB. Therefore no additional safety factor is required for the protection of infants and children. Assessment of the various child subpopulations is included in t he I

- DEEM analysis and for all subpopulations, exposures are below the cPAD. Aggregate exposures for children, including food and drinking water as well as non

- dietary exposures from TMB in paint s, were acceptable. A reasonable certainty of no harm has bee n established

for children as w ell.

F. International Tolerances

No international tolerances have been established for TMB.