Document ID: EPA-HQ-OPP-2012-0940-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2013-03-27T04:00Z

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OFFICE OF CHEMICAL SAFETY
AND POLLUTION PREVENTION
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, 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 Codes: 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.  
 

Executive Summary

Based on the available data and information, the Agency does not foresee 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 by 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 contained 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, 2003). 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 by 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 by 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 manufacturing-use product (MP); the remaining nine are end-use products (EPs). Octenol is the sole active ingredient in these products. 

II. Tolerances

There are no approved food uses associated with octenol when used in pesticide formulations; consequently, 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' Incident Data System (IDS). This included octenol as both an active ingredient and an inert ingredient.  No adverse effects to humans, domestic animals, or the environment were reported as a result of the use of the octenol as an insect attractant.  

IV. 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 Requirements for Octenol (40 CFR § 158.2050)
		Data Requirement
                                     LD50
                               Toxicity Category
                                     MRIDs
                              Acute Oral Toxicity
                                OPPTS 870.1100
                                   550 mg/kg
                                      III
                                   468354-04
                                   474757-03
                             Acute Dermal Toxicity
                                OPPTS 870.1200
                                  3300 mg/kg
                                      III
                                   455039-02
                                   474757-03
                           Acute Inhalation Toxicity
                                OPPTS 870.1300
         Low 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

VI. References

cc:   L.S. Cole, Jr., M.S., to L. Hollis, Chief BPPD, BPPD Science Review File, IHAD/ARS
 	  L.S. Cole, Jr., M.S., FT, PY-S: