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Diss Factsheets
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EC number: 271-635-0 | CAS number: 68603-08-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Endpoint summary
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 - 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)
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), 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 exposed.
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.
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 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 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 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% benzene.
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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