9.3.1.6 Genotoxicity of 1-octadecene (EU 1995) In Vitro The following data are taken from the HEDSET data sheet for 1-octadecene. The full study reports were not provided in the submission. The HEDSET documents indicate tests were not conducted in accordance with GLP or OECD or EC testing guidelines. 1-Octadecene was considered not mutagenic or clastogenic in the following test systems: Test Comment Result Bacterial Reverse TA98, TA 100, TA 1535, Negative S. typhimurium Mutation AssayH18 TA 1537, TA 1538. WP2, WP2uvrA. E. coli 0.2 to 2 000 g/plate; with and without metabolic activation. Mitotic JD1. Negative S.cerevisiae RecombinationH18 0.01 to 5.0 mg/mL; with and without metabolic activation. Chromosome Rat liver RL1 cells. Negative AberrationH18 0 to 500 g/mL as acetone solution. With and without metabolic activation. 9.3.2 In Vivo 9.3.2.1 Mammalian Erythrocyte Micronucleus Test Using Gulftene 12-16 (Gulf Life Sciences Center 1983) Gulftene 12-16 Test substance: Mouse/Crl:CD-1 (ICR) BR Species/strain: 5/sex/group Number and sex of animals: Test substance: 1 000, 2 500 or 5 000 mg/kg; of administration: Vehicle control: corn oil; Test and vehicle control administered dermally to shaven of mice once per day for 2 days; Positive control, cyclophosphamide 75 mg/kg, administered via intraperitoneal injection; Test and vehicle control animals were sacrificed 24 or 48 Sampling schedule: hours after last dosing;
9.3.1.6 In Vitro Genotoxicity of 1-octadecene (EU 1995) The following data are taken from the HEDSET data sheet for 1-octadecene. The full study reports were not provided in the submission. The HEDSET documents indicate tests were not conducted in accordance with GLP or OECD or EC testing guidelines. 1-Octadecene was considered not mutagenic or clastogenic in the following test systems: Test Comment Result Bacterial Reverse Mutation AssayH18 S. typhimurium TA98, TA 100, TA 1535, TA 1537, TA 1538. E. coli WP2, WP2uvrA. 0.2 to 2 000 g/plate; with and without metabolic activation. Negative Mitotic RecombinationH18 S.cerevisiae JD1. 0.01 to 5.0 mg/mL; with and without metabolic activation. Negative Chromosome AberrationH18 Rat liver RL1 cells. 0 to 500 g/mL as acetone solution. With and without metabolic activation. Negative 9.3.2 In Vivo 9.3.2.1 Mammalian Erythrocyte Micronucleus Test Using Gulftene 12-16 (Gulf Life Sciences Center 1983) Test substance: Gulftene 12-16 Species/strain: Mouse/Crl:CD-1 (ICR) BR Number and sex of animals: 5/sex/group of administration: Test substance: 1 000, 2 500 or 5 000 mg/kg; Vehicle control: corn oil; Test and vehicle control administered dermally to shaven of mice once per day for 2 days; Positive control, cyclophosphamide 75 mg/kg, administered via intraperitoneal injection; Sampling schedule: Test and vehicle control animals were sacrificed 24 or 48 hours after last dosing;
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