OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION **UNITED ST AT**  **ES ENVIRONMENT AL**  **PROTECTION A GENCY** 

WA SHINGTON, D.C. 20460

**MEMORANDUM DATE:**  December 3, 2012 **SUBJECT** : Toxicology Scoping Document for the Registration Review of 1 - Octen - 3 - ol

(Octenol) and (R) - ( - ) - 1 - Octen - 3 - ol (R - Octenol). **Registration Review Case Number:** 6033 **Chemical Class:** Biochemical **PC Code s**  **:** 069037 and 069038 **CAS Number:** 3391 - 86 - 4 and 3687 - 48 - 7 **FROM:** Leonard Cole, M.S., Senior Regulatory Associate /s/

Biochemical Pesticides Branch Biopesticides & Pollution Prevention Division (7511P ) **TO:** Linda A. Hollis, Chief

Biochemical Pesticides Branch Biopesticides & Pollution Prevention Division (7511P) **ACTION REQUESTED** The following scoping document contains the human health assessment for the biopesticide (R) - ( - ) - 1 - Octen - 3 - ol (Octenol) in support of the development of the Registration Review Preliminary Work Plan .Octenol ` PC Code: 069038

Ty pe of Review: Toxicology (Registration Review) **Executive Summary** Based on the available data and information, the Agency does not fore see the need for new data or a new human health risk assessment for this active ingredient. Hazard and exposure information, as well as Agency risk assessments on octenol were evaluated against current safety standards established b y statute, regulations, and the Agency ’s scientific policies, and it was determined that there is no need to conduct additional risk assessments. There is the potential for toxicity if ingested; therefore, the amount of octenol accessible to children is evaluated for each product before an octenol containing product is registered by EPA. All human health assessment data requirements under 40 CFR § 158.2050 have been fulfilled . **I. Background** Octenol is registered in two forms: A) the racemic mixture, 1 - Octen - 3 - ol, which includes all isomers of this chemical and B) R- ( - ) - 1 - Octen - 3 - ol which is a single isomer from the racemic mix. Both forms are generally referred to as Octenol. Octenol is an alcohol c ontained in human sweat and breath. Octenol attracts certain mosquitos and biting flies, but the chemical does not kill the insects. R- ( - ) - 1Octen - 3 - ol is less toxic on an acute basis than racemic 1 - Octen - 3 - ol (LD50 = 340 mg/kg) (Octenol RED Fact Sheet, 200 3). Octenol is used in combination with carbon dioxide to attract insects in order to kill them with certain electronic devices. These electronic devices are not registered b y the EPA. When Octenol is released into the air, it is not harmful to humans, to other non - target organisms, or to the environment ( Octenol RED Fact Sheet, 2003 ) . The ingredient was first registered b y the Agency in 1997 for use as a mosquito attractant (Octenol RED Fact Sheet, 2003 ). There are currently ten registered products containing the active ingredient. One of these products is a m anufacturing -use p roduct (MP); the remaining nine are end -use products (EPs). Octenol is the sole active ingredient in these products. **II. Tolerance s**  There are no approved food uses associated with octenol when used in pesticide formulations; consequentl y, there are no tolerances or tolerance exemptions for this active ingredient. **III. Incidents** During the timeframe from December 1995 to November 2012 , there were no incidents reported from the use of octenol to The National Pesticides Information Center (NPIC) database and The Office of Pesticide Programs' In cident Data System (IDS) . This included octenol as both an active ingredient and an inert ingredient. No adverse effects to human s , domestic animal s , or the environment were reported as a result of the use of the octenol as an insect attractant.Octenol ` PC Code: 069038

Ty pe of Review: Toxicology (Registration Review) **I V**  **. Toxicity Profile**  Sufficient data have been provided to fulfill the biochemical pesticide data requirements under 40 CFR 158.2050 for the current use patterns for this active ingredient . The data available to the Agency are summarized in Table 1 below. **Table 1. Human Health Assessment Data Requirem ents for Octenol (40 CFR § 158.2050)** 

**VI . References** 

cc: L.S. Cole, Jr., M.S., to L . Hollis, Chief BPPD , BPPD Science Review Fil e , IHAD/ARS L. S. Cole, Jr., M.S., FT, PY - S: **Data Requirement LD50**  **Toxicity Category MRIDs**  Ac ute Oral Toxicity OPPTS 870.1100 550 mg/kg III 468354 - 04 474757 - 03 Ac ute Dermal Toxicity OPPTS 870.1200 3300 mg/kg III 455039 - 02 474757 - 03 Ac ute Inhalation Toxicity OPPTS 870.1300 Lo w exposure based on anticipated low

rate of product release IV 455039 - 02 474757 - 03 Primary Eye Irritation OPPTS 870.2400 Based on low likelihood of exposure, except via handling III 455039 - 02 474757 - 03 Primary Dermal Irritation OPPTS 870.2500 Not an irritant IV 455039 - 02 474757 - 03 Dermal Sensitization OPPTS 870.2600 Not a sensitizer - 455039 - 02 474757 - 03 Genotoxicity 870.5100 Not a mutagen - 455039 - 02 474757 - 03 90 - day Oral Toxicity 870.3100 Waiver 474757 - 03 Developmental Toxicity 870.3700 Waiver - 474757 - 03 Immunotoxicity 870.3550 Waiver - 455039 - 02 474757 - 03