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Toxicological information

Carcinogenicity

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Description of key information

On the basis of the available evidence it can be concluded that butylene oligomers are not genotoxic and are unlikely to be carcinogenic

Key value for chemical safety assessment

Additional information

There are no carcinogenicity studies for the butylene oligomers category members.

Butylene oligomers are simple olefins that do not carry alerts for genotoxic activity.

Butylene oligomers have been tested in a number of well recognised assays for genotoxicity and have shown no significant genotoxic activity in vitro and in vivo. In vitro assays comprise six bacterial reverse mutation assays with olefins ranging from C8 to C20/24 and two mammalian chromosome aberration tests with C8. In vivo mutagenicity assays comprise four mammalian erythrocyte micronucleus tests in the mouse or the rat covering three different routes of administration oral, inhalation and intraperitoneal and olefins ranging from C8 to C20/C24. The results are consistent throughout the category and indicate that butylene oligomers are not expected to be genotoxic carcinogens.

Repeat dose toxicity studies with higher olefins spanning the range C8 to C20 indicate that these materials are of low toxicity in rats.  There is a consistent finding of male rat kidney effects indicative of alpha-2u-globulin nephropathy with the C8 to C14 higher olefins. Although α2u-Globulin has been associated with chemically induced renal toxicity and neoplasia in the male rat, the nephropathy is a syndrome that occurs exclusively in male rat kidney and is not relevant for humans.

There is no evidence of target organ toxicity or pre-neoplastic changes in repeated dose studies with butylene oligomers which suggest that they are likely to be genotoxic.

Hard GC, Rodgers IS, Baetcke KP, Richards WL, McGaughy RE, and Valcovic LR (1993)Environ Health Perspect.1993 March;99: 313–349.Hazard evaluation of chemicals that cause accumulation of alpha 2u-globulin, hyaline droplet nephropathy, and tubule neoplasia in the kidneys of male rats.

Justification for classification or non-classification

There is no data to suggest that classification of butylene oligomers is warranted under DSD or CLP.