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EC number: 295-442-6
CAS number: 92045-60-8
A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C5, predominantly C5, and boiling in the range of approximately minus 10°C to 35°C (14°F to 95°F).
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 - sister chromatid exchange assay in mammalian cells (similar or equivalent to OECD TG 479)
Genetic toxicity - in vivo chromosome aberration: not genotoxic in rats (OECD TG 475)
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), Chinese
hamster ovary (CHO) cells and
human lymphoblastoid cells, or in in vivo test systems, including rat
micronucleus and rat chromosome aberration assays.
Naphtha streams produced mixed results in in
vitro gene mutation assays but negative results in vivo. For
example, light straight run naphtha (CAS 64741-46-4) increased the
number of revertant colonies in a Salmonella assay, but other low
boiling point naphtha streams, sweetened naphtha (CAS 64741-87-3) and
light alkylate naphtha (CAS 64741-66-8), produced no evidence of
chromosomal damage in vivo. Where there were positive findings in mouse
lymphoma tests, these tended to be associated with the higher boiling
cracked streams, suggesting that there may have been small amounts of
mutagenic constituents present in these streams. The positive results
with the higher boiling fractions may not be directly relevant to human
health risk assessment since these higher boiling constituents are
unlikely to be present in the vapor to which humans would normally be
In the in vitro sister chromatid exchange
assay, Unleaded gasoline (API PS-6) was non-mutagenic. Test substance at
doses from 0 to 1600 nl/ml did not induce a statistically significant
increase sister chromatid exchange frequency with or without activation
in Chinese hamster ovary (CHO) cells.
It also seems unlikely that genetic toxicity
contributes to the tumorigenic response, as the mechanistic data are
more consistent with non-genotoxic processes. Further, the organs in
which in vivo mutagenic responses were found were not those in which
tumors developed (see further discussion in section 7.7
Carcinogenicity). Finally, the validity of some of the older mouse
lymphoma tests has been questioned (Caldwell J. 1993. Perspective on the
usefulness of the mouse lymphoma assay as an indicator of a genotoxic
carcinogen: ten compounds which are positive in the mouse lymphoma assay
but are not genotoxic carcinogens. Teratogenesis, Carcinogenesis and
Mutagenesis 13:185 -190), and the possibility that the positive
results in these studies are not actually evidence of mutagenic activity
must be considered.
Justification for selection of genetic toxicity endpoint
One of a large number of in-vitro and in-vivo genotoxicity studies available.
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 as well as the studies of the naphtha
blending stocks were 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
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 and/or naphtha
blending stocks 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 as
genotoxic gasoline and naphtha streams containing >0.1%
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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