UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 WASHINGTON, D.C. 20460

OFFICE OF PESTICIDES AND TOXIC SUBSTANCES 

MEMORANDUM

DATE: August 25, 2011

SUBJECT: Preliminary Human Health Assessment for the Registration Review of Methyl 

Anthranilate

Registration Review Case #: 6056

PC Code: 128725

CAS #: 134-20-3

Chemical Class: Biochemicals

FROM: Sadaf Shaukat, Biologist

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

TO: Chris Pfeifer, Regulatory Action Leader

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

ACTION REQUESTED

The following is a preliminary human health assessment for methyl anthranilate in support of the 

development of the Registration Review Work Plan. 
 

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RECOMMENDATIONS AND CONCLUSIONS

Executive Summary

Based on the available data and information, the Agency does not foresee the need for new data 

or for a new human health risk assessment for this active ingredient. Hazard and exposure 

information as well as Agency risk assessments on methyl anthranilate were evaluated against 

current safety standards established by the Agency’s scientific policies and regulations and it was 

determined that there is no need to conduct an additional human health risk assessment. Methyl 

anthranilate is a naturally-occurring substance found in many plant species such as corn, 

sunflowers, grapes, and cherries. It is extremely volatile and degrades rapidly into non-toxic 

components such as anthranilic acid. There is reasonable certainty that no harm will result to the 

general population from exposure to methyl anthranilate in the products containing this active 

ingredient when they are used according to label instructions. 

 

I. Background

Uses for products containing methyl anthranilate as the active ingredient include goose and bird 

repellents. Currently, there are eight end-use products that are registered with BPPD containing 

methyl anthranilate as the active ingredient. 

II. Tolerances

§ 180.1143 Methyl anthranilate; exemption from the requirement of a tolerance.

Residues of methyl anthranilate, a biochemical pesticide, are exempt from the requirement of a 

tolerance in or on all food commodities, when used in accordance with good agricultural 

practices.

[67 FR 51088, Aug. 7, 2002]

III. Incidents

Three incidents were reported from January 1, 1992 to October 29, 2010. Each of the three 

incidents were attributable to either misuse or the inerts in the product, not the active ingredient 

methyl anthranilate.

IV. Toxicity Profile

Methyl anthranilate is a naturally-occurring substance found in many plant species such as corn, 

sunflowers, grapes, and cherries. It has been determined that due to the nature of this ingredient,

it is unlikely that products containing it will have adverse effects on human health. All 

toxicology data requirements have been satisfied and it is unlikely that any additional data will be 

required. Toxicology data and or rationale to fulfill or waive these requirements are available on 
 

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the currently registered EPs; all of which indicate that these products are of low toxicity. 

Please see the tables below for detailed information regarding the toxicity data requirements.

Available toxicity data as required by 40 CFR 158.2050 regarding flower oils are summarized 

below in Tables 1-7.

Table 1. Methyl Anthranilate: Acute Oral Toxicity/OPPTS 870.1100

Active Ingredient LD50 Toxicity Category MRID

Methyl Anthranilate 3,633 mg/kg (males)

3,000mg/kg (females)

3,288 mg/kg (sexes 

combined)

III 42608802

Table 2. Methyl Anthranilate: Acute Dermal Toxicity/OPPTS 870.1200

Active Ingredient LD50 Toxicity Category MRID

Methyl Anthranilate > 2,000 mg/kg* III* 42608803

 * 2,000 mg/kg was the highest dose tested in the study

Table 3. Methyl Anthranilate: Acute Inhalation Toxicity/OPPTS 870.1300

Active Ingredient LC50 Toxicity Category MRID

Methyl Anthranilate Waived (See 

Attachment A)

Table 4. Methyl Anthranilate: Acute Eye Irritation/OPPTS 870.2400

Active Ingredient Results Toxicity Category MRID

Methyl Anthranilate Slight to moderate 

conjunctival irritation; all 

cleared by 72 hours after 

treatment

III 42608804

Table 5. Methyl Anthranilate: Acute Dermal Irritation/OPPTS 870.2500

Active Ingredient Results at 72 hrs Toxicity Category MRID

Methyl Anthranilate No irritation IV 42608805
 

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Table 6. Methyl Anthranilate: Skin Sensitization/OPPTS 870.2600

Active Ingredient Results MRID

Methyl Anthranilate Not a sensitizer 42608806

870.3100 90-day Oral Waived (See Attachment B)

870.3250 90-day Dermal Waived (See Attachment B)

870.3465 90-day Inhalation Waived (See Attachment B)

870.3700 Prenatal Dev. Waived (See Attachment B)

870.5100 Bacterial rev. mut Waived (See Attachment B)

870.5300 & 5375 In vitro mammalian cell assay Waived (See Attachment B)

Based on the information presented above, the Agency does not foresee the need for new data or 

for a new human health risk assessment. There is reasonable certainty that no harm will result to 

the general population from exposure to methyl anthranilate in the products containing this active 

ingredient when they are used according to label instructions. 

cc: S. Shaukat, C. Pfeifer, BPPD Science Review File

S. Shaukat, FT, PY-S: 8/25/11