EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

EPA Registration Division contact: PV Shah



SEPPIC INC

IN-11003

	EPA has received a pesticide petition (IN-11003) from SEPPIC INC, 30 Two Brides Road requesting, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.960.

 
	1. To establish a polymer exemption under 40 CFR.180.960.

	
A. Residue Chemistry

	1. Plant metabolism.

	2. Analytical method.  

	3. Magnitude of residues.  


B. Toxicological Profile

	1. Acute toxicity.  Rapeseed Oil PEG-3 Esters and Rapeseed Oil PEG-20 Esters were evaluated for its health effects in the CIR "PEGylated Oils as Used in Cosmetics" of January 18, 2013. The CIR Expert Panel concluded that the 130 PEGylated oil ingredients are safe in the present
practices of use and concentration in cosmetics when formulated to be non-irritating. This conclusion supersedes the earlier conclusion issued by the Expert Panel in 1997.

According literature the analogues: rapeseed oil derivatives with 5,10,30 and 60 OE are not mutagenic, show an oral toxicity higher than 5000mg/kg and no primary eye and skin irritancy (Haefs R. and al (2002) Pest Manag Sci, 58, 825-833).

PMN for SEPPIC's SEPITER range of products-Dr. Cursio from The Solutous Group, E.PETERSEN from BRACEWELL & GIULIANI -June 03, 2005
The rapeseed oil derivative has significant environmental and human health advantages over petroleum based surfactants. It does not pose acute and / or chronic hazards to humans or the environment. It was assessed in a variety of mammalian and environmental toxicity studies using SEPITER 200(Polyoxyethylene (20) Rapeseed oil) as a midpoint ethoxylation range-indicator compound for any toxicological effects.
Acute Oral Toxicity study: the oral LD50 for this material was greater than 20 grams/kg in rats
Acute Dermal Evaluation: Based upon knowledge of ethoxylated vegetable oils used in cosmetic formulations, the product is judged to be a non irritant to human skin.
Acute Ocular Irritation: the product was evaluated and found to be non-irritating to very slightly irritating in rabbit eyes.

Based on these data, SEPIGREEN RANGE are not classified as dangerous for human health.
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	2. Genotoxicty. 

	3. Reproductive and developmental toxicity. According literature the analogues: rapeseed oil derivatives with 5,10,30 and 60 OE are not mutagenic, show an oral toxicity higher than 5000mg/kg and no primary eye and skin irritancy (Haefs R. and al (2002) Pest Manag Sci, 58, 825-833).
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	4. Subchronic toxicity.  

	5. Chronic toxicity.  

	6. Animal metabolism.  

	7. Metabolite toxicology.  

	8. Endocrine disruption.  

C. Aggregate Exposure

	1. Dietary exposure.  

	i. Food.  

	ii. Drinking water.  

	2. Non-dietary exposure.  

D. Cumulative Effects

	 

E. Safety Determination

	1. U.S. population.  

	2. Infants and children.  

F. International Tolerances

	 




