Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Hydrocarbons, C14-C16, 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, C14-C16, n-alkanes, isoalkanes, <2% aromatics has 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 (Sokolowski, 2014). The study was carried out using human lymphocytes in the presence of metabolic activation (four hours exposure) and in the absence of metabolic activation (four and twenty two hours (continuous) exposure). After four hours exposure in the absence of metabolic activation in the first test, significant increases in chromosomal aberrations were observed at the lowest and median concentrations (out of five concentrations tested). The increase at the lowest concentration was within the range of historical control data, and therefore considered to be biologically irrelevant. The increase at the median concentration exceeded the range of historical control data. In the absence of dose dependency and as the findings were not observed when the experiment was repeated using the same exposure times, nor with continuous exposure in the absence of metabolic activation, it is concluded that this increase did not represent a potential for cytogenicity. 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, C14-C16, n-alkanes, isoalkanes, <2% aromatics (from their alkane constituents).

Short description of key information:
All Ames tests on substances relevant to Hydrocarbons, C14-C16, 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, C14-C16, n-alkanes, isoalkanes, <2% aromatics 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, C14-C16, 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, C14-C16, 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.