Kerosine (Fischer-Tropsch), full-range, C8-16-branched and linear

Endpoint summary

Additional information

A bacterial reverse mutation assay with 'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear' (Ames test) found no significant increase in the frequency of revertant colonies recorded for any of the bacterial strains with any dose of the test material, either with or without metabolic activation (Bowles, 2006). The test material was considered to be non-mutagenic under the conditions of this test.

A micronucleus test in human lymphocytesin vitrowith 'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear' found the test material toxic only in the 20 hour exposure group without metabolic activation (Durward, 2006). It did not induce any statistically significant increase in the frequency of cells with micronuclei in either of the two experiments using a dose range that included the lowest moderately precipitating dose level or was limited by test material toxicity. The test material was therefore considered to be non-clastogenic and non-aneugenic to human lymphocytes in vitro.

Noin vitromammalian cell mutagenicity data are available for 'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear', or related UVCB substances. However, IUCLID 2000 (citing Lankaset al., 1978) indicates that the constituent substance n-tetradecane (C14) is not mutagenic without activation in V79 Chinese hamster cells.

No in vivomutagenicity studies are available for 'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear'. Anin vivochromosome aberration study was carried out on 'Distillates (Fischer-Tropsch), C8 -26 - branched and linear' according to OECD 475 and under GLP (Morris, 2011). Male Wistar rats were dosed orally at 0,0.5, 1.0 and 5.0 g/kg bw in arachis oil. No increase in the incidence of cells with chromosome aberrations excluding gaps or of polyploid cells was observed in bone marrow up to the highest dose tested. No premature deaths or clinical signs were observed at any dose level. The positive control item produced a marked increase in the frequency of chromosome aberration. The read-across is supported by published data for shorter carbon chain lengths (see below).

A mouse micronucleus test was also carried out for n-C10-C13 alkanes according to OECD TG 474 (EMBSI, 1991c cited by ACC, 2004). Male and female CD-1 mice were dosed via gavage at 0, 1.0, 2.5 and 5.0 g/kg in corn oil. Exposure periods were 24, 48 and 72 hours. No increase in micronuclei or polychromatic erythrocytes was observed in bone marrow up to the highest dose tested. The NOEL was 5.0 g/kg under the conditions of the test.

 

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

In vitro:

- Gene mutation (Bacterial reverse mutation assay / Ames test): negative with and without activation inSalmonella typhimuriumstrains (TA 98, 100, 1535, 1537) andEscherichia coliWP2uvrA (OECD 471).

- Cytogenicity in mammalian cells: negative with and without activation in human lymphocytes (OECD Draft Guideline 487).

- Mutagenicity in mammalian cells: read-across from constituent substance (n-tetradecane) negative in V79 Chinese hamster cells without activation (no guideline stated).

In vivo:

- Read-across from the related substance (GTL Gasoil): negative in Mammalian Bone Marrow Chromosome Aberration Test (OECD 474/EU B.11)

- Read-across from the related substance (n-C10-C13 alkanes): negative in mammalian micronucleus assay (OECD 474/EU B.12)

Justification for selection of genetic toxicity endpoint
The endpoint was selected because it is a well-documented guideline study, compliant with GLP and was performed on human lymphocytes derived from a human volunteer, so it is more relevant for human risk assessment than data gained with bacteria or permanent cell lines.
However, all studies on required endpoints, i.e. in vitro gene mutation study in bacteria, in vitro cytogenicity study in mammalian cells or in vitro micronucleus study, and in vitro gene mutation study in mammalian cells (indicative from n-tetradecane), have a negative outcome, the selection of the endpoint has no influence of the relevant key information.

Short description of key information:
Genetic toxicity, in vitro:
Gene mutation: (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 1535, TA 1537, TA 98 and TA 100,E. coli WP2 uvr A: negative with and without metabolic activation (according to OECD 471, GLP)
Chromosome aberration: Human lymphoctes: negative with and without metabolic activation (according to OECD 473, GLP)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available in vitro and in vivo data on 'Kerosine (Fischer-Tropsch), full range, C8-C16 - branched and linear' and related substances, 'Kerosine (Fischer-Tropsch), full range, C8-C16 - branched and linear' is not genotoxic and does not require classification according to Regulation 1272/2008/EC.