Hydrocarbons, C13-C20, n-alkanes, isoalkanes, cyclic, aromatics (40-60%)

Endpoint summary

Additional information

In vitro

The genotoxic potential of Hydrocarbons, C13-C20, n-alkanes, isoalkanes, cyclics, 40-60% aromatics was tested in an Ames test by Wenzel-Hartung, 1990. DMSO extracts of the test substance up to 60 µL/plate were negative in Salmonella typhimurium TA 98 with metabolic activation. S9-mix was prepared from livers of male Syrian Goldhamsters treated with Aroclor.

In addition, there are data for structurally related substances. Thus read-across was performed. Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) were examined for mutagenic activity in the bacterial reverse mutation test using Salmonella typhimurium strain TA 98 in the absence and presence of a liver S9 fraction for metabolic activation. In this series of tests, the test material did not induce any significant changes in the number of revertant colonies (Dow, 1987). In another study a modification of the standard Ames test was used to examine the genotoxic potential of middle distillate fuels (CAS no. 64742-47-8, 8008-20-6). Three changes were made in the standard assay. The first was the use of an extraction step to concentrate the potentially mutagenic aromatic components. The second was the use of S-9 from Aroclor-induced hamster liver at 8 times the recommended concentration. The third was the exclusive use of TA98, the tester strain most responsive to complex mixtures of PAH’s. The revertants levels at all doses were less than twice control values, so sample was judged to be non-mutagenic (McKee, R. H. et al., 1994). C9-C14 aliphatics, 2-30% aromatics was tested in a non-GLP guideline study (OECD TG 473) for the potential to induce chromosomal aberrations (DHC Solvent Chemie GmbH, 1984). Under the test conditions C9-C14 aliphatics, 2-30% aromatics caused no significant chromosomal damage to human peripheral lymphocytes. Moreover, hydrodesulfurized kerosene was tested negative in sister chromatid exchange assay in CHO cells with and without metabolic activation system. The assay was performed equivalent or similar to OECD TG 479 by American Petroleum Institute, 1987. The same substance was examined for mutagenic activity in the mouse lymphoma forward mutation assay in the absence and presence of a liver S9 fraction. The test material did not induce significant increases in the mutant frequency at the TK locus in L5178Y mouse lymphoma cells. Treatments up to 37.5 nL/mL without activation and 62.5 nL/mL with activation were assayed and high toxicities were induced without inducing significant increases in the mutant frequency (American Petroleum Institute, 1984). Based on these results there are no indices for a mutagenic potential of hydrocarbons, C13-C20, n-alkanes, isoalkanes, cyclics, 40-60% aromatics in vitro.

In vivo

There are no data available for hydrocarbons, C13-C20, n-alkanes, isoalkanes, cyclics, 40-60% aromatics. However, some investigations on genetic toxicity in vivo are available for structurally related substances. Kerosene was tested in the mammalian bone marrow micronucleus assay using CD-1 mice by McKee, R. H. et al, 1994. Kerosene was neither cytotoxic nor clastogenic in CD-1 mouse bone marrow cells at doses up to 5 g/kg bodyweight administered by oral gavage. Kerosene, hydrodesulfurized was also negative in a GLP-guideline study according to OECD TG 475 (American Petroleum Institute, 1984). Single intraperitoneal doses of up to 3 g/kg bodyweight did not cause chromosome aberrations in Sprague-Dawley rat bone marrow cells. Jet Fuel A was evaluated for its ability to induce dominant lethal mutations in sperm cells of CD-1 male mice (OECD TG 483, American Petroleum Institute, 1980). The test material was administered at two exposure levels of 520 and 2080 mg/m3 via inhalation exposure, 6 hours per day, 5 days per week for 8 weeks. The results show that the test article did not cause significant increases in either pre- or post-implantations loss of embryos when statistically compared with the negative control. Published studies with straight run kerosene in mammalian bone marrow chromosome aberration test according to OECD TG 475 were summarized negative by American Petroleum Institute, 2003. So it is assumed by read across, that C13-C20, n-alkanes, isoalkanes, cyclics, 40-60% aromatics is not genotoxic in vivo.

The following information is taken into account for any hazard / risk assessment:

The available in vitro and in vivo data indicate that hydrocarbons, C13-C20, n-alkanes, isoalkanes, cyclics, 40-60% aromatics are not genotoxic.

Value used for CSA: Genetic toxicity: negative

Short description of key information:
The available data indicate that hydrocarbons, C13-C20, n-alkanes, isoalkanes, cyclics, 40-60% aromatics are not genotoxic.

Genetic Toxicity in vitro – Bacterial reverse mutation assay (OECD TG 471)
Genetic Toxicity in vitro – In vitro Mammalian Chromosome Aberration Test (OECD TG 473)
Genetic Toxicity in vitro – Genetic Toxicology: In Vitro Sister Chromatid Exchange Assay in Mammalian Cells (OECD TG 479)
Genetic Toxicity in vivo - Mammalian Spermatogonial Chromosome Aberration Test (OECD TG 483)
Genetic Toxicity in vivo – Micronucleus Assay in Mouse Bone Marrow (OECD TG 474)
Genetic Toxicity in vivo – Mammalian Bone Marrow Chromosome Aberration Test (OECD TG 475)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on one Ames test for the substance itself and read across from structurally related substances, the available data on the genotoxic potential of hydrocarbons, C13 -C20, n-alkanes, isoalkanes, cyclics, 40 -60% aromatics are conclusive but not sufficient for classification.