Document GKn7kb64RE012q6KvadvvoO3Y

AR226-3389 Genetic Toxicology of 8-2 Telomer B Alcohol G.L. Kennedy^ R. Jung2 H. Iwai,3 S. Shin-ya4 S. Murphy,5 N. Drouot,5 C. Finlay,1 EM. Donner,1 G.L. Erexson6 andL.F. Stanko\vski, Jr6 1. The DuPont Company, Haskell Laboratory for Health and Environmental Sciences, Newark, Delaware, USA Clariant GmbH, Salzbach, Germany Daikin Industries, Ltd., Osaka, Japan Asahi Glass Company, Ltd., Tokyo, Japan Atofina Chemicals, Philadelphia, Pennsylvania, USA, and Paris, France Covance Laboratories, Vienna, Virginia, USA WAbstract 8-2 Teiomer B Alcohol is a fluorinated chemical intermediate produced and used worldwide to manufacture specialty polymers and surfactants used to a) treat surfaces such as textiles to make them oil and water repellant and b) as a wetting and leveling agent in coatings and cleaning products, respectively. The global telomer producers have initiated a scientific program to develop toxicity data for this chemical. 8-2 Telomer B Alcohol was evaluated for bacterial routagenicity, in two independent experiments, in S. lyphimuriitm strains TA98, TA100, TA1535, andTA1537 and E. coli strain WP2yvrA, at doses of 33.3 to 5,000 ^g/plate with and without metabolic activation (S9). Normal growth was observed in ail strains and revertani frequencies for all doses of 8-2 Telomer B Alcohol, with and without S9, approximated vehicle controls. In a micronucteus test, male rats were given a single oral (limit) dose of 2,000 mg/kg, and the bone marrow cells subsequently examined for the possible induction of micronucleated polychromatic erytnrocytes (MN-PCE). As in earlier studies, this limit dose elicited no clinical signs of toxicity. No signs of clinical or bone marrow toxicity, and no statistically significant increases in MN-PCE frequencies were observed. Under the conditions of these tests, 8-2 Telomer B Alcohol did not induce an increase in reverse mutations in S. typhimurium or E. coli, or an increase in MNPCEs in rat bone marrow. (Studies supported by the TRP* Toxicology Program.) * Teloraer Research Program | Salmonella - E.coU Mammalian Microsome Reverse Mutation Assay Laboratory: Covance (Virginia) Dales of Conduci: October 23,2001 - December 10,2001 Direcior OECD Guidelines; LF. Slankowski, Jr. 471.July 21. 1997 Tester Strains: TA98. TA100, TA1535. TA1537, WP2uwA Standard Conditions: with and willinutSSniice Revertant Background (Acceptable Range for Controls) TA100 TA1535 TA1537 WP2mTA 2-Nitiofluorene 2-Aininoantliraeene ICR-191 4.Nitroquinoline-N- ixide TA100. TA1535. TA1537,WP2ui.rA TA100,TAI533 TA1537 WPZuvrA Assay considered positive if producing at least a 2x increase in mean revertants per plale or at least 1 of these tester strains over mean revertani per plate of appropriate vehicle control. This increase had to be accompanied by a dose response to increasing concentrations of the test article. (TA98, TA100. WP2uvrA) [3x forTA1535 andTA1537] 8-2 Telomer B Alcohol Initial Assay 8-2 Telomer B Alcohol Connrmatory Assay SS Purity of Test Sample CF3-[CFi]7-CH2-CH;-OH* 99.3% CF3-[CF;]6-CF=CH-CHi-OH 0.6% CF,-lCF2]n-CH=CHz 0-1% ysjyBConclusions The results of the Salmonella - Escherichia coli/ MammaIian-Microsome Reverse Mutation Assay indicate that under the conditions of this study, 8-2 Telomer B Alcohol was not mutagenic in any of the tester strains in the presence or absence of an exogenous metabolic activation system containing induced hepatic microsomal enzymes from AroclorTM 1254-treatedrats. fRat Micro Laboratory: Covanc Dales of Conduct: October Director: G.L. Er OECD Guidelines- 474, Ju Conditions: Rat. ora Examin The criteria for a posit significant increase in siatisiically significant induce both of these re significance was not th Director also considere evaluation. Micro Posilive Control CP ?.0 tn Test Anicle 500 mglhg (000 tiig/l 2000 mg/h ss^ m|| Conclusion The test article, 8-2 Te toxicity in maie rats ex for this assay. In addi bone marrow at up to significant decrease in cyloloxicity induced b In the micronucleus as statistically significant tested. Therefore, 8-2 bone marrow roicronu