Registration Dossier

Toxicological information

Endpoint summary

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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

All Ames tests on C14-20 Aliphatics (≤2% aromatic) showed no mutagenic effect with and without metabolic activation. The chromosome aberration study in CHO cells on hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics,<2% aromatics also showed no signs of mutagenicity. A mouse lymphoma forward mutation assay performed with hydrodesulfurised kerosene also showed no mutagenic properties.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

Structurally analogous test materials, hydrodesulfurized kerosene and jet fuel A were non-mutagenic when tested in in vivo studies: mouse bone marrow micronucleus assay, mammalian bone marrow chromosome aberration test and a dominant lethal assay. 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Five studies (Ames tests) were available on the mutagenic properties of different hydrocarbon substances. None of these studies showed any mutagenic effect of the different test materials without and with metabolic activation.

One chromosome aberration study in CHO cells on Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics,<2% aromatics also showed no signs of mutagenicity (Murli, 1991). In sister chromatid exchange, a structurally analogous test material hydrodesulfurized kerosene was determined to be non-clastogenic. 

A mouse lymphoma forward mutation assay performed with hydrodesulfurised kerosene also showed no mutagenic properties (American Petroleum Institute, 1984).

Structurally analogous test materials, hydrodesulfurized kerosene and jet fuel A were also non-mutagenic when tested in in vivo studies: mouse bone marrow micronucleus assay, mammalian bone marrow chromosome aberration test and a dominant lethal assay. 

Justification for classification or non-classification

All in vitro and in vivo tests on test substances and analogues were negative, the substances are considered not to be mutagenic and should not be classified for mutagenicity according to the criteria of Annex VI of Directive 67/548/EEC and CLP Regulation 1272/2008.