Amides, vegetable-oil, N,N-bis(hydroxyethyl)

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In Vitro test

Strains TA97, TA98, TA100, and TA1535 were incubated in triplicate with five doses of CASRN 68603-42-9 (0.0-333.0 μg/plate) in the presence or absence of metabolic activation. The selection of the high dose of 333.0 μg/plate was based on cytotoxicity. Negative and positive controls responded as expected. The mean number of revertants/plate for all strains, with and without metabolic activation, was comparable to the control value. Amides, coco, N,N-bis(hydroxyethyl) was not mutagenic in this assay.

Strains TA97, TA98, TA100, and TA1535 were incubated in triplicate with fived oses of CASRN 93-83-4 (0.0-200.0 μg/plate) in the presence or absence of metabolic activation. The selection of the high dose of 200.0 μg/plate was based on cytotoxicity. Negativeand positive controls responded as expected. The mean number of revertants/plate for all strains,with and without metabolic activation, was comparable to the control value.Oleamide N,N-bis(2-hydroxyethyl)- was not mutagenic in this

assay.

L5178Y mouse lymphomacells were incubated with CASRN 68603-42-9 for four hours, with and without metabolicactivation. Each trial used different concentrations of CASRN 68603-42-9. Trials withmetabolic activation used concentrations that ranged from 0 - 20 μg/ml, and those withoutmetabolic activation used concentrations that ranged from 0 to 15 μg/ml. After incubation withtest substance, cells were resuspended in fresh medium and incubated for 2 additional days toexpress the mutant phenotype (i.e., a genetic change at the thymidine kinase locus). There wasno increase in the frequency of mutant colonies of L5178Y mouse lymphoma cells afterexposure to CASRN 68603-42-9.Amides, coco, N,N-bis(hydroxyethyl) was not mutagenic in this assay.

L5178Y mouse lymphomacells were incubated with CASRN 93-83-4 at 0-20 μg/ml for four hours, with and withoutmetabolic activation. After incubation with test substance, cells were resuspended in freshmedium and incubated for 2 additional days to express the mutant phenotype (i.e., a geneticchange at the thymidine kinase locus). Average mutant fractions and other test parameterssatisfied the finding of CASRN 93-83-4 as not causing point mutations.Oleamide N,N-bis(2-hydroxyethyl)- was not mutagenic in this assay.

Chinese hamster ovary cells(CHO) were incubated with CASRN 68603-52-9 at 0, 16, 30 and 50 μg/ml with and withoutmetabolic activation. After incubation and subsequent removal of treatment medium, Colcemidwas added, and the cells were harvested. Cells were scored for chromosomal aberrations. Aberrations in treated cells were comparable to those of the solvent control. Amides, coco, N,N-bis(hydroxyethyl) did not cause an elevation in chromosomal aberrations in this assay.

In Vivo test

Male and female mice were administered CASRN 93-83-4 via the dermal route at doses ≤ 800mg/kg/day . Peripheral blood samples in each of 5 animals per dose group were assessed for micronucleated normochromatic erythrocytes after 14 weeks of treatment. The frequency of micronucleated normochromatic erythrocytes in blood samples from the treatedgroups was equivalent to that of controls.Oleamide N,N-bis(2-hydroxyethyl)- did not cause chromosomal effects (increases in micronuclei) in this study.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Justification for classification or non-classification

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