Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics has been tested for mutagenicity to bacteria in a study conducted according to OECD TG 471 and in compliance with GLP (Westerink, 2014c). No evidence of substance induced increase in the frequency of revertants was noted in the presence or absence of metabolic activation in Salmonella typhimurium strains TA1535, TA1537, TA98 and Escherichia coli WP2 uvrA when tested up to limit concentrations. Similar results were obtained in two independent experiments using plate incorporation. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.

Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromaticshas been tested for potential for cytogenicity in a chromosome aberration study conducted according to OECD TG 473 and in compliance with GLP in two independent experiments (Bohnenberger, 2014). No biologically relevant evidence of a test substance induced increase in the number of cells with aberrations was observed when tested in peripheral human lymphocytes in the presence or absence of metabolic activation up to cytotoxic or limit concentrations. A single statistically significant increase in the number of cells with aberrations was observed in the first experiment, which was within the range of historical controls so not considered biologically relevant. An increase above the level of historical controls was observed at one concentration in experiment 2, but this was neither statistically significant nor dose-dependent so not considered biologically relevant. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for clastogenicity under the conditions of the test.

In sister chromatid exchange, a worst-case read-across 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).

Worst-case 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.

These results are read across to Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics (on the basis of alkane constituents).  


Short description of key information:
All Ames tests on substances relevant to Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics, including a study on the registered substance, showed no mutagenic effect with and without metabolic activation. The chromosome aberration study in human lymphocytes with Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics "hydrocarbons also showed no signs of mutagenicity. A mouse lymphoma forward mutation assay performed with worst-case test material hydrodesulfurised kerosene also showed no mutagenic properties. This result is read across to Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All in vitro and in vivo tests on test substances and analogues were negative, Hydrocarbons, C15-C19, n-alkanes, isoalkanes, <2% aromatics is 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 Regulation (EC) No 1272/2008.