**UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460** 

**OFFICE OF PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM**  **DATE:** August 25 , 2011 **SUBJECT** : Preliminary H uman Health Assessment for the Registration Review of Methyl Anthranilate **Registration Review Case #: 6056**  **PC Code: 128725**  **CAS #: 134**  **- 20**  **-3 Chem**  **ical Class:** Biochemical s **FROM:** Sadaf Shaukat , Biologist

Biochemical Pesticides Branch Biopesti cides & Pollution Prevention Division (7511P) **TO:** Chris Pfeifer , Regulatory Action L eader Biochemical Pesticides Branch Biopesticides & Pollution Prevention Division (7511P)

**ACTION REQUES TED**  The following is a preliminary human h e alth assessmen t for methyl anthranilate in support of the development of the Registration Review Work Plan
.2

**RECOMMENDATIONS AND CONCLUSIONS Executive Summary**  Based on the available data and information, th e Agency does not foresee the need for new data or for a new human health risk assessmen t for t his 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 co rn, sunflowers, grapes, and cherries. I t 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** U ses for products containing methyl anthranilate as the active ingredient include goose and b ird repellents. Currently , there are eight end
- use products that are regist ered with BPPD containing methy l anthranilate as the active ingredient
. **II. Tolerances §**  **180.1143 Methyl anthranilate; exemption from the requirement of a tolerance.**  Residues of methyl anthranilate, a biochemical pesti cide, 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] **I II**  **. Incidents** Three incidents were reported from January 1, 1992 to October 29, 201 0. Each of the three incidents were attributable to either misuse or the inerts in the product, not the active ingredient methy l anthranilate. **I V**  **. Toxicity Profile** Methy l anthranilate is a naturally
- occurring substance found in many plant species such a s corn, sunflowers, grapes, and cherries
. Ithas been determine d that d ue 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 an y additional data will be required . Toxicology

data and or rationale to fulfill or waive these requirements are available on3

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 reg arding flower oils are summarized below in Tables 1
- 7.
T able 1. Methyl Anthranilate : Acute Oral Toxicity/OPPTS 870.1 100

**Active Ingredient LD**  **50 Toxicity Category**  **MRID** Methyl Anthranilate 3,633 mg/kg (males)

3,000m g/kg (females) 3,288 mg/kg (sexes combined) III 42608802

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

**Active Ingredient LD**  **50 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 LC**  **50 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 426088054

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 Inhala tion 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 act ive 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