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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 replace 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, 

122O8 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 food 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 data at this time or whether the data supports granting 

of the petition. Additional data may be needed before EPA rules on the petition.
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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 dermal LD50 for salicylaldehyde was determined to be 

greater than 23 gm/kg. Dermal irritation studies found it to be irritating, with eschar 

formation and scarring 14 days after administration.]

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 test 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 mating 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, no effects of administration of the 

tested substance were found in general conditions, weight, feed volume,

hematological test values, blood chemistry test values, autopsy findings, and organ 

weight.

6. Animal metabolism. NA
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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 

mechanism of toxicity finding as to salicylaldehyde and any other substances. For the 

purposes of this tolerance action, therefore, EPA has not assumed that salicylaldehyde 

has a common mechanism of toxicity 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.]
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2. Infants and children. EPA concluded that the FQPA safety factor can be set to 

1X for Salicylaldehyde for the following reasons: There is sufficient data to assess the 

toxicity of salicylaldehyde. 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.