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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 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 re place the instructions that appear in green , i.e., “ [ insert company

name ] ,” with the information specific to your action.

TEMPLATE:

Omex Agrifluids

IN

- 10777

EPA has received a pesticide petition IN

- 10777 from Ag

- Chem Consulting LLC,

1 22O8 Quinque Lane, Clifton VA 20124 on behalf of Omex Agrifluids, 24730 Avenue 13, Madera CA 93637 proposing, 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 .910 to establish an exemption from the requirement of a tolerance for salicylaldehyde (2

- hydroxybenzaldehyde) (CAS# 90

- 02

- 8) in or on f ood crops at no more than 14% of the pesticide formulation

.

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 d a ta at this time or whether the data supports granting of the petition. Additional data may be needed befo re EPA rules on the petition.2

A. Residue Chemistry NA

B. Toxicological Profile

1. Acute toxicity. The acute oral toxicity of 2

- hydroxybenzaldehyde was examined in female rats with 3 rats in 1 group, and a study was performed using the stepped method in which one

- time oral administrations were performed in stages
while checking the death conditions for a fixed dosage. From the above results, the general lethal amount in rat oral administration of 2

- hydroxybenzaldehyde is
estimated to be 500mg/kg. The d ermal LD 50 for s alicylaldehyde was determined to be greater than 23 gm/kg. Der m al irritation studies found it to be irritating, with eschar
formation and scarring 14 days after admin i stration .]

2. Genotoxicty. Male and female rats [Crl:CD(SD), 7 weeks at time of administration] were used to study the presence or absence of 2

- hydroxybenzaldehyde micronucleus inducement in rat bone marrow cells. From the above results, the tested substance 2

- hydroxybenzaldehyde had micronucleus test negativity under these t est conditions and that it has no clastogenicity in rat bone
marrow cells.

3. Reproductive and developmental toxicity

. No effects of administration of the tested substance were found on the female estrus cycle and estrus count, on the male
and female mat ing and impregnation, and on the female animal pregnancy period and parturition. No effects of administration of the tested substance were found on nursing Day 0 in the number of live birth infants, number of stillborns, sex ratio, parturition rate, and birth rate.

4. Subchronic toxicity. Although there are no subchronic data, based on the chronic data no subchronic are anticipated to occur

.

5. Chronic toxicity. At doses below 40 mg/kg, n o effects of administration of the
tested substance were found i n general conditions, weight, feed volume, hematological test values, blood chemistry test values, autopsy findings, and organ weight.

6. Animal metabolism. NA3

7. Metabolite toxicology

. NA

8. Endocrine disruption

. There is no evidence that salicylaldehyde has endocrine
effects

.

C. Aggregate Exposure

1. Dietary exposure. Salicylaldehyde is a naturally occurring fragrance ingested in 66, 470 kg of food annually. Use in this product in the formulation and applied by drip irrigation to crops will not increase the current daily ingestion of salicylaldehyde.

i. Food. Salicylaldehye is naturally occurring fragrance found in food, especially
buckwheat.

ii. Drinking water

. Salicylaldehyde is not expected to occur in drinking water

.

2. Non

- dietary exposure

. Additional exposure currently occurs through soaps, perfumes and other media where fragrances are added

.

D. Cumulative Effects

Unlike other pesticide ingredients for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mecha nism of toxicity finding as to s alicylaldehyde and any other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that s alicylaldehyde
has a common mechanism of t oxicity with other substances.]

E. Safety Determination

1. U.S. population. Salicylaldehyde occurs in 66, 470 kg of food annually. Salicylaldehyde is a naturally occurring fragrant. This use is not expected to increase current U.S. population exposure. ]4

2. Infants and children

. EP A concluded that the FQPA safety factor can be set to

1 X for Salicylaldehyde for the following reasons: T here is sufficient data to assess the toxicity of s alicylaldehyde. Studies have shown that this is a naturally occurring product. The incidental residues possible from application of this product are significantly less than the natural exposure of infants and children through ingestion
of food and other materials with added fragrances.

F. International Tolerances

There are no known international tolerances

.