GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS

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 these 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 Assay H18
Mitotic
Recombination H18
Chromosome
Aberration H18
9.3.2 In Vivo
S. typhimurium TA98, TA 100, TA 1535,
TA 1537, TA 1538. E. coli WP2, WP2uvrA.
0.2 to 2 000 µg/plate;
with and without metabolic activation.
S.cerevisiae JD1.
0.01 to 5.0 mg/mL;
with and without metabolic activation.
Rat liver RL1 cells.
0 to 500 µg/mL as acetone solution.
With and without metabolic activation.
FULL PUBLIC REPORT 26 April 2000
NA/713 Page 72 of 100
Negative
Negative
Negative
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
Doses/Method 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
backs 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;