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Key value for chemical safety assessment

Additional information

An Ames test was performed for GTL Gasoil according to Annex V guidelines and GLP (SafePharm, 2004). Strains tested were Salmonella typhimurim strains TA 98, TA 100, TA 1535 and TA 1537, and Escherichia coli strain WP2uvrA, both with and without metabolic activation (rat liver S9). A micronucleus test in human lymphocytes in vitro was carried out according to the draft OECD Test Guideline 487. The test results show that GTL Gasoil is not clastogenic or aneugenic (SafePharm, 2006d).

An in vitro chromosome aberration test in human lymphocytes with GTL Gasoil, carried out in accordance with OECD 473 was negative both with and without metabolic activation (Lacey, 2010). The test substances was therefore considered to be non-clastogenic to human lymphocytesin vitro.

An in vivo chromosome aberration study was carried out on GTL Gasoil 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 bwin 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 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). Negative with and without activation in human lymphocytes (OECD 473).

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

- In vivo:

Cytogenicity: negative in Mammalian Bone Marrow Chromosome Aberration Test (OECD 474/EU B.11)

Justification for selection of genetic toxicity endpoint
No study was selected, since all three in vitro studies and in vivo study were negative.

Short description of key information:
in vitro:
- OECD 471: negative;
- OECD 487 (Draft): negative;
- OECD 473: negative.
in vivo:
OECD 475: negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the availablein vitro and in vivo data GTL Gasoil is not genotoxic and does not require classification according to Regulation 1272/2008/EC.