Document ID: EPA-HQ-OPP-2009-0113-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-03-26T04:00Z

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

 		     WASHINGTON, D.C. 20460

 ADVANCE \d61 	OFF		ICE OF PREVENTION,

OFFICE OF PESTICIDES AND TOXIC SUBSTANCES        

MEMORANDUM

DATE:		January 29, 2009

SUBJECT:	Registration Review:  Product Chemistry Data Review for the
Repellent Garlic Oil.

Registration Review Case #:		4007

PC Codes:						128827  

CAS Numbers:					8000-78-0

Chemical Class:					Biochemical

FROM:		Jacob Moore, Chemist /s/ 01/29/09

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P)

THROUGH : Russell S. Jones, Ph.D. Senior Biologist /s/ 01/29/09

				Biochemical Pesticides Branch

				Biopesticides & Pollution Prevention Division (7511P)

TO:			Cheryl Greene, Regulatory Action Leader

Biochemical Pesticides Branch

Biopesticides & Pollution Prevention Division (7511P) 

ACTION REQUESTED

	A preliminary assessment of available information on product chemistry
data associated with the repellent garlic oil and its biochemical
products in support of the development of a Registration Review Work
Plan.

Introduction

	The EPA has made the determination that there is adequate information
available on Allium sativum and does not foresee the need to require
additional data.  Allium sativum (Garlic) is a biochemical pesticide
used mainly as an insect and animal repellent.  Allium sativum is a food
item that is listed as generally recognized as safe (GRAS) by FDA (21
CFR 182.20).  Garlic and garlic oil are also listed as minimum risk
pesticides by EPA in 40 CFR 152.25(f)(1), and as such, is exempt from
the requirements of FIFRA when used according to the guidelines
contained in 40 CFR 152.25(f).  The EPA first registered a product
containing Allium sativum in 1983.  This chemical is currently
registered as an active ingredient in 11 products.  The labels of these
products list the active ingredient as Garlic Oil, Garlic Juice, Garlic
Water, or Garlic.  All products are water-based compounds with extract
of Allium sativum or powder.  The EPA considers all such variations of
Allium sativum under the PC Code 128827 and CAS Registry Number
8000-78-0.

	Concerning the product chemistry of Allium sativum, an active
ingredient registered as a biochemical would normally require a complete
data set on the technical grade active ingredient per the guidelines in
40 CFR 158.2030.  Since there is no reasonable certainty of harm to the
general population and Allium sativum is a commonly consumed food item,
some of the product chemistry data requirements have been waived.1 
Allium sativum is often used in conjunction with other products; much
information is available on the end use products containing it.  The two
products containing >1% Allium satium contain inert ingredients from the
list 4A or 4B inert ingredients.  All other currently registered
pesticides exist at a concentration of Allium sativum < 0.12%.  The RED
for Allium sativum suggests that basic product chemistry data should be
required for products containing Allium sativum.  While no further
product chemistry data are necessary for the products currently
registered, future products must satisfy all of the product chemistry
data requirements through studies or waiver requests.  As an oil/water
mixture, it has proved difficult for registrants to obtain isolated data
on the TGAI.  Therefore, testing in support of several of the product
chemistry data requirements is done on the EP.2  These end use products
have been required to satisfy the complete data set. Table 1 provides
basic information on garlic.  Table 2 provides a summary of data on
Allium sativum.

Table 1.  Garlic Oil Chemical Identity

Common Name	Garlic, Garlic Oil, Garlic Juice, Garlic Water

Chemical Name	Extract of Allium sativum

IUPAC	N/A

Trade Names	N/A

Molecular Weight	varies

PC Code	128827

CAS Registry Number	8000-78-0

Empirical Formula	N/A

Registration Review Case Number	4007

Chemical Structure	N/A

.

Product Chemistry Summary

	The Agency has conducted a review of the available product chemistry
data and information.  These data are summarized below.

Table 4.  Product Chemistry Data Requirements Summary

Guideline No.	Physical and Chemical Properties	Status1	Value

830.1100	Product Identity and Composition	A	Refer to Table 1.

830.1200	Description of starting materials, production and formulation
process	A	CBI

830.1400	Discussion of formation of impurities	A	CBI

830.1700	Preliminary analysis	A	CBI (EP)

830.6302	Color	A	Light tan to dark green

830.6303	Physical state		A	Liquid or powder

830.6304	Odor	A	Strong Garlic

830.6313	Stability to normal and elevated temperatures, metals and metal
ions	A	Stable

830.7000	pH	A	5.5-6.0

830.7220	Boiling point/boiling range	N/A	Testing done on EP

830.7300	Density	N/A	Testing done on EP

830.7520	Particle size, fiber length, and diameter distribution	N/A
Testing done on EP

830.7550

830.7560

830.7570	Partition coefficient (n-Octanol/Water)	N/A	Partially soluble
in water

830.7840	Water solubility 	N/A	Testing done on EP

830.7950	Vapor pressure	A	10 Mm @ 20oC

A=Acceptable, N/A=Not Applicable, N/D=Not Determined

Sources

EPA Reregistration Eligibility Document (RED) Allium sativum (Garlic). 
June 1992.

40 CFR 158.2030.  Footnote 8.  Reads, “If the TGAI cannot be isolated,
data are required on the practical equivalent of the TGAI.  EP testing
may  also be appropriate.

Garlic Oil			Case #:  4007B

128827

Garlic Oil			Case #:  4007B

128827