Registration Dossier
Registration Dossier
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EC number: 920-008-6 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented study report which meets basic scientific principles.
- Justification for type of information:
- Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented study report which meets basic scientific principles.
- Justification for type of information:
- Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- not cytotoxic up to 50uL/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- not applicable
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- not applicable
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- not applicable
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- not applicable
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Additional information on results:
- Toxicity was noted at doses above 25 uL/plate.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results: negative
It is concluded in this study that the test material is not a mutagenic agent. Classification is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. - Executive summary:
This data is being read across from the source study that tested Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) based on analogue read across.
The test material was examined for mutagenic activity in the bacterial reverse mutation test using histidine-requiring Salmonella typhimurium strain TA 98 in the absence and presence of a liver S9 fraction for metabolic activation. The test was performed in triplicate using doses of 0, 1, 5, 10, 50, 100 uL/plate. Concentrations above 25 uL/plate were found to be cytotoxic. In all cases, the test material did not induce any significant changes in the number of revertant colonies. It is concluded in this study that the test material is not a mutagenic agent. Classification is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only one strain of Salmonella was used
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30 %)
- EC Number:
- 919-006-8
- IUPAC Name:
- Hydrocarbons, C16-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30 %)
- Details on test material:
- The test substance was identified as a hydrocarbon solvent with the following characterization: density at 15 deg C: 0.831 kg/L; aromatics : 28.7% v/v; flash point 128 deg.C; BP range 264-287deg C.
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver fractions from Aroclor exposed rats
- Test concentrations with justification for top dose:
- Tests with and without Metabolic Activation: 0, 1, 5, 10, 25, 50, and 100 uL/plate (2mL test material dissolved in 3mL cyclohexane)
Control Plate: 10uL DMSO - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO/ cyclohexane
- Justification for choice of solvent/vehicle: Positive controls dissolved into DMSO, Test substance soluble in acetone
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 10uL DMSO Plate
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene; benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS:
- triplicate
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of revertants and/or clearing of the background lawn of bacterial growth - Evaluation criteria:
- The mutagenicity study is considered valid if the mean colony counts of the control values of the strains are within acceptable ranges, if the positive controls meet the criteria for a positive response and if no more than 5% of the plates are lost through contamination or other unforeseen events.
A test substance is considered to be positive in the bacterial gene mutation test if the mean number of revertant colonies on the test plates increases in a concentration-related manner and/or if a reproducible two-fold or more increase is observed compared to that on the negative control plates.
A test substance is considered negative in the bacterial gene mutation test if it produces neither a dose-related increase in the mean number of revertant colonies nor a reproducible positive response at any of the test points.
Positive results from the bacterial reverse mutation test indicate that a substance induces point mutations by base substitution for frameshifts in the genome of Salmonella typhimurium. Negative results indicate that under the test conditions, the test substance is not mutagenic. - Statistics:
- The mean plate count and standard deviation for each dose point were determined. Any test value that was equal to or greater than two times the mean value of the concurrent vehicle control was considered to be a positive dose.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- not cytotoxic up to 50uL/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- not applicable
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- not applicable
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- not applicable
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- not applicable
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Additional information on results:
- Toxicity was noted at doses above 25 uL/plate.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
It is concluded in this study that the test material is not a mutagenic agent. Classification is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations. - Executive summary:
The test material was examined for mutagenic activity in the bacterial reverse mutation test using histidine-requiring Salmonella typhimurium strain TA 98 in the absence and presence of a liver S9 fraction for metabolic activation. The test was performed in triplicate using doses of 0, 1, 5, 10, 50, 100 uL/plate. Concentrations above 25 uL/plate were found to be cytotoxic. In all cases, the test material did not induce any significant changes in the number of revertant colonies. It is concluded in this study that the test material is not a mutagenic agent. Classification is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
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.
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