GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS
GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS 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;
Clinical observations: No mortality; No clinical signs of toxicity; Positive control group animals were sacrificed 24 hours after dosing. Micronuclei score: No significant increase in micronucleated polychromatic erythrocytes (PCE) due to treatment with test substance at either sampling time; the positive control caused a significant increase in micronucleated PCE. Test method: OECD TG 474 Result: Gulftene 12-16 did not induce a significant increase in micronucleated PCEs in bone marrow cells of the mouse in vivo. 9.3.2.2 Mammalian Erythrocyte Micronucleus Test Using C20-C24 alkenes, branched and linear (Safepharm Laboratories Limited 1998) Test substance: C20-C24 alkenes, branched and linear Species/strain: mouse/Crl:CD-1 (ICR) BR Number and sex of animals: 7 males/24 hour, vehicle and positive control, and mid, low and high dose group; 7 males/48 hour, vehicle control and high dose group; 5 males/positive control group. Doses/Method of administration: Test substance: 500 mg/kg (low), 1 000 mg/kg (mid) or 2 000 mg/kg (high); Positive control: cyclophosphamide 50 mg/kg; Vehicle control: arachis oil; All administered via intraperitoneal injection at a constant volume of 10 mL/kg bw. Positive control was administered orally. Sampling schedule: Vehicle and positive control, low, mid and high dose animals were sacrificed 24 hours after dosing. Remaining animals of the vehicle control group and high dose animals were sacrificed 48 hours after dosing. Clinical observations: No mortality. No clinical signs of toxicity. Micronuclei score: No significant increase in micronucleated PCE due to treatment with test substance at either sampling time. No statistically significant decrease in the PCE/NCE ratio at 24 or 48 hours. FULL PUBLIC REPORT 26 April 2000 NA/713 Page 73 of 100
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Clinical observations: No mortality;<br />
No clinical signs of toxicity;<br />
Positive control group animals were sacrificed 24 hours<br />
after dosing.<br />
Micronuclei score: No significant increase in micronucleated polychromatic<br />
erythrocytes (PCE) due to treatment with test substance at<br />
either sampling time; the positive control caused a<br />
significant increase in micronucleated PCE.<br />
Test method: OECD TG 474<br />
Result: Gulftene 12-16 did not induce a significant increase in<br />
micronucleated PCEs in bone marrow cells of the mouse<br />
in vivo.<br />
9.3.2.2 Mammalian Erythrocyte Micronucleus Test Using C20-C24 alkenes,<br />
branched and linear (Safepharm Laboratories Limited 1998)<br />
Test substance: C20-C24 alkenes, branched and linear<br />
Species/strain: mouse/Crl:CD-1 (ICR) BR<br />
Number and sex of animals: 7 males/24 hour, vehicle and positive control, and mid,<br />
low and high dose group;<br />
7 males/48 hour, vehicle control and high dose group;<br />
5 males/positive control group.<br />
Doses/Method of<br />
administration:<br />
Test substance: 500 mg/kg (low), 1 000 mg/kg (mid) or<br />
2 000 mg/kg (high);<br />
Positive control: cyclophosphamide 50 mg/kg;<br />
Vehicle control: arachis oil;<br />
All administered via intraperitoneal injection at a constant<br />
volume of 10 mL/kg bw. Positive control was<br />
administered orally.<br />
Sampling schedule: Vehicle and positive control, low, mid and high dose<br />
animals were sacrificed 24 hours after dosing.<br />
Remaining animals of the vehicle control group and high<br />
dose animals were sacrificed 48 hours after dosing.<br />
Clinical observations: No mortality.<br />
No clinical signs of toxicity.<br />
Micronuclei score: No significant increase in micronucleated PCE due to<br />
treatment with test substance at either sampling time. No<br />
statistically significant decrease in the PCE/NCE ratio at<br />
24 or 48 hours.<br />
FULL PUBLIC REPORT 26 April 2000<br />
NA/713 Page 73 of 100