GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS
GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS
Result: C20-C24 alkenes, branched and linear were not considered mutagenic in the bacterial strains tested 9.3.1.2 Genetic Toxicology: DNA Damage and Repair/Unscheduled DNA Synthesis (UDS) using Gulftene 12-16 In Vitro (Gulf Life Sciences Center 1984) Test substance: Gulftene 12-16 Cells: Primary hepatocytes from Fischer 344 rats Dosing schedule: 0, 100, 1 000, 2 000, 4 000 µg/mL of test substance was tested in triplicate: Positive Control: 2-acetylaminofluorene 0.2 µg/mL; Cultures were exposed to test substance and 1 mCi/mL 3 Hthymidine for 18 hours. Test method: OECD TG 482 Comment: In the range finding study, cytotoxicity was reported at and above 256 µg/mL. Toxicity data was not available for the main test. The test substance at any concentration did not elicit an increased mean net nuclear grain count above the concurrent negative control. The positive control gave the expected response for UDS. Result: Gulftene 12-16 was negative for unscheduled DNA synthesis 9.3.1.3 BALB/3T3 Transformation Test Using Gulftene 12-16 (Gulf Life Sciences Center 1983) Test substance: Gulftene 12-16 Cells: Mouse embryo cells BALB/3T3-A31-1-1 Dosing schedule: 0, 10, 20, 30, 1 500 µg/mL of test substance was tested in duplicate: Positive Control: 3-methylcholanthrene 1 µg/mL; Cultures were exposed to test substance for two days. Test method: Not stated Comment: Cytotoxicity was evident at 20 µg/mL and above leaving only one viable dose level, 10 µg/mL. The number and type of transformed foci at any test substance concentration was not increased above the FULL PUBLIC REPORT 26 April 2000 NA/713 Page 68 of 100
negative control. The positive control gave the expected response for transformation. Result: At the low dose available for adequate evaluation Gulftene 12-16 was negative for cell transformation. 9.3.1.4 In Vitro Mammalian Cell Gene Mutation Test: Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Assay (HPRT) using Gulftene 12-16, (Gulf Life Sciences Center 1982) Test substance: Gulftene 12-16 Cells: Chinese Hamster Ovary (CHO) Metabolic activation system: Liver fraction (S9) from rats pretreated with Aroclor 1254 Dosing schedule: 0, 4, 16, 128, 512, 1 024, 2 048 µg/mL each concentration was tested in triplicate with or without metabolic activation (S9), Positive controls: Without S9: ethyl methanesulphonate 100µg/mL; With S9: benzo[a]pyrene 4 µg/mL; Exposure period was 5 hours Test method: OECD TG 476 CHO cells, HGPRT locus Comment: Toxicity was observed at 1 024, 2 048 µg/mL in the presence and absence of metabolic activation; The test substance did not cause any significant increases in the incidence of mutant colonies in the presence or absence of metabolic activation; Positive controls used in the test caused marked increases in the incidence of mutant colonies and the activity of the S9 fraction was found to be satisfactory. Result: Gulftene 12-16 did not induce gene mutations in CHO cells. 9.3.1.5 In Vitro Chromosomal Aberration Test: Human Lymphocytes using C20- C24 alkenes, branched and linear (Safepharm Laboratories Limited 1998) Test substance: C20-C24 alkenes, branched and linear Cells: Human Peripheral Lymphocytes Metabolic activation system: Liver fraction (S9) from rats pretreated with Aroclor 1254 FULL PUBLIC REPORT 26 April 2000 NA/713 Page 69 of 100
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negative control.<br />
The positive control gave the expected response for<br />
transformation.<br />
Result: At the low dose available for adequate evaluation Gulftene<br />
12-16 was negative for cell transformation.<br />
9.3.1.4 In Vitro Mammalian Cell Gene Mutation Test: Chinese Hamster Ovary<br />
Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Assay (HPRT)<br />
using Gulftene 12-16, (Gulf Life Sciences Center 1982)<br />
Test substance: Gulftene 12-16<br />
Cells: Chinese Hamster Ovary (CHO)<br />
Metabolic activation system: Liver fraction (S9) from rats pretreated with Aroclor 1254<br />
Dosing schedule: 0, 4, 16, 128, 512, 1 024, 2 048 µg/mL each concentration<br />
was tested in triplicate with or without metabolic activation<br />
(S9),<br />
Positive controls:<br />
Without S9: ethyl methanesulphonate 100µg/mL;<br />
With S9: benzo[a]pyrene 4 µg/mL;<br />
Exposure period was 5 hours<br />
Test method: OECD TG 476 CHO cells, HGPRT locus<br />
Comment: Toxicity was observed at 1 024, 2 048 µg/mL in the<br />
presence and absence of metabolic activation;<br />
The test substance did not cause any significant increases in<br />
the incidence of mutant colonies in the presence or absence<br />
of metabolic activation;<br />
Positive controls used in the test caused marked increases in<br />
the incidence of mutant colonies and the activity of the S9<br />
fraction was found to be satisfactory.<br />
Result: Gulftene 12-16 did not induce gene mutations in CHO cells.<br />
9.3.1.5 In Vitro Chromosomal Aberration Test: Human Lymphocytes using C20-<br />
C24 alkenes, branched and linear (Safepharm Laboratories Limited<br />
1998)<br />
Test substance: C20-C24 alkenes, branched and linear<br />
Cells: Human Peripheral Lymphocytes<br />
Metabolic activation system: Liver fraction (S9) from rats pretreated with Aroclor 1254<br />
FULL PUBLIC REPORT 26 April 2000<br />
NA/713 Page 69 of 100