Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

In a guideline GLP Ames study, the substance did not produce toxcologically significant elevated counts of revertant colonies in any of the five bacterial strains tested (TA98, TA100, TA1535, TA1537 and WP2uvra-) at doses up to 5000ug/plate, with and without S9 metabolic activation. At levels of 1500ug/plate and above there was evidence that the solubility limit had been exceeded in the system. All positive controls responded as expected.

In an in vitro forward gene mutation assay in cultured CHO cells, a C36-C48 hydrogenated polyalphaolefin did not elicit an increase in the mutant frequency at the HGPRT locus in the presence or absence of metabolic activation when tested up to the maximum recommended dose of 5000ug/ml. An in vitro cytogenicity assay using human lymphocytes treated with the same C36 -C48 hydrogenated polyalphaolefin, with and without metabolic activation, did not show any evidence of cytogenetic properties when tested at the maximum recommended concentration. The potential of a C30 -72 hydrogenated polyalphaolefin to produce damage to chromosomes or aneuploidy when administered intraperitoneally to mice was studied. There was no evidence of bone marrow toxicity, or of a statistically significant increase in the incidence of micronucleated polychromatic erythrocytes in animals dosed with test material at the maximum recommended level of 5000mg/kg when compared to the concurrent vehicle control group. These results can be read across to the C28 -C80 hydrogenated polyalphaolefin "Pentadecane, 7-methylene mixed with 1-tetradecene, dimers and trimers, hydrogenated."


Short description of key information:
Genetic toxicity in vitro: Ames test: Not mutagenic
Gene mutation on a surrogate substance in vitro: Not mutagenic
Chromosome aberration on a surrogate substance in vitro: Not mutagenic
Mouse micronucleus on a surrogate substance in vivo: not mutagenic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No evidence for mutagenic behaviour from all available information