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EC number: 930-690-7
CAS number: -
In vitro gene mutation in bacterial cells
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, Shale Oil is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
In vitro gene mutation study in mammalian cells
The test substance did not induce a concentration-related increase in mutation frequency at the HPRT locus in V79 cells, both in the absence and presence of metabolic activation and under the test conditions the test product is not mutagenic in the cultured mammalian cells used.
In vitro cytogenicity / chromosome aberration study in mammalian cells
According to column 2 of REACH Annex VIII, information requirement 8.4.2, a study does not need to be conducted if the substance is known to be carcinogenic category 1A or 1B or germ cell mutagenic category 1A, 1B or 2. Since the registered substance is reasonably known to be mutagenic category 1B and carcinogenic category 1B, it is considered justified to omit testing for this endpoint.
Raw data from the bacterial mutagenicity tests (Tables 1 to 15) are
presented in the attached documents.
In the Ames test, with use of live strains of Salmonella Typhimurium (TA
97, TA 98, TA 100, TA 102 and TA 1535) Shale oils, heavy fraction was
tested with and without the addition of activation system (S9) for
mutagenicity in concentration range from 5 to 0.0001 mg/plate. The
experiment was conducted according to OECD guideline 471 and to GLP
The Shale oils heavy fraction produced neither a statistically
significant dose-related increase in the number of revertants nor a
statistically significant and reproducible positive response at any one
of the test points and according these results is considered non
mutagenic in this system.
A GLP compliant in vitro mammalian cell gene mutation test has
been conducted in accordance with OECD Guideline 476. The test substance
did not induce a concentration-related increase in mutation frequency at
the HPRT locus in V79 cells, both in the absence and presence of
metabolic activation and under the test conditions the test product is
not mutagenic in the cultured mammalian cells used.
This study was performed to investigate the potential of Shale Oil to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA. The study was conducted according to OECD Guideline 471 and to GLP standard.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment and Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
Experiment II: 1; 3; 10, 33; 100; 333; 1000; 2500; and 5000 μg/plate
Distinct toxic effects, evident as a reduction in the number of revertants, were observed at higher concentrations with and without metabolic activation in nearly all strains used. No substantial increase in revertant colony numbers of any of the five tester strains was
observed following treatment with Shale Oil at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
A GLP compliant in vitro mammalian cell gene mutation test has been conducted in accordance with the standardised guideline OECD Guideline 476, under GLP conditions. The test substance did not induce a concentration-related increase in mutation frequency at the HPRT locus in V79 cells, both in the absence and presence of metabolic activation and under the test conditions the test product is not mutagenic in the cultured mammalian cells used.
Although the available in vitro gene mutation studies provided negative results, the substance is classified as a mutagen (category 1B) in consideration of the presence of polyaromatic hydrocarbons (PAHs) analysed in the substance at a level greater than the generic cut-off limits for classification for mutagenicity. PAHs are widely acknowledged to possess CMR properties. The harmonised classification of the PAH substance benzo[a]pyrene is applied to this substance as it has been established that this substance is considered to be representative of the PAHs contained within the registered substance. Furthermore, the hazard of benzo[a]pyrene is well established in light of the wealth of toxicological data that are available on the substance.
Please refer to the document ‘Consideration of the long term toxicity of Distillates (shale oil)’, as included in section 13, for further information.
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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