Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vivo

Description of key information

Genetic toxicity - in vitro gene mutation: not genotoxic in bacterial cells (OECD TG 471)

Genetic toxicity - in vitro gene mutation: not genotoxic in mammalian cells (OECD TG 476)

Genetic toxicity - in vivo micronucleus assay: not genotoxic in rats (OECD 474)

Genetic toxicity - in vivo chromosome aberration: not genotoxic in rats (OECD TG 475)

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vivo:

There is a relatively large database on genetic toxicity studies of gasoline covering both in vivo and in vitro tests. Blended gasoline was not mutagenic, either with or without metabolic activation, in in vitro test systems, including Salmonella typhimurium, Saccharamyces cerevisiae, a mammalian cell line (L5178Y), and human lymphoblastoid cells, or in in vivo test systems, including rat micronucleus and rat chromosome aberration assays.

Justification for selection of genetic toxicity endpoint

One of a large number of in-vitro and in-vivo genotoxicity studies available.

Justification for classification or non-classification

Many of the “standard” assays, i.e., Salmonella, mouse lymphoma, in vivo cytogenetics, and the dominant lethal test of gasoline were conducted prior to the publication of regulatory protocols or the promulgation of good laboratory practice guidelines. Nevertheless, they followed the recommendations of the developers of the various assays, and were, therefore, consistent with the guidelines that were subsequently developed. There are no obvious errors or omissions in the various tests. The micronucleus test of gasoline was conducted more recently and were in accordance with regulatory guidelines and procedures. Thus the data can be used without reservations for regulatory purposes. The remaining data come from published articles and have been independently peer-reviewed. The available information goes far beyond the minimum data requirements; accordingly, no additional testing for genetic toxicity is recommended. Further, the data indicate that classification of gasoline is not warranted.

It should be noted that, although the data do not support classification of gasoline per se for genotoxic potential according to EU CLP Classification (EC no. 1272/2008), there is a regulatory requirement to classify gasoline as genotoxic gasoline as it contains >0.1% benzene.