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EC number: 919-284-0 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 471 guidelines. GLP.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 471 guidelines. GLP.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Toxicity pretest was performed from doses of 556, 1667, 5000 ug/plate using all strains. Toxicity was observed at all of these doses and in phase 2 of the study, the doses were reduced to 0, 32, 63, 125, 250, 500 ug/plate.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results: negative
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 and is not classified 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, C10-C13, aromatics, >1% naphthalene based on analogue read across.
Test material was examined for mutagenic activity in the bacterial reverse mutation test using histidine-requiring Salmonella typhimurium strains TA 1535, 1537, 98, and 100, and the E. coli strain WP2 uvr A in the absence and presence of a liver S9 fraction for metabolic activation. Concentrations above 500 ug/plate were found to be cytotoxic and so the test was performed in triplicate using doses of 0, 32, 63, 125, 250, 500 ug/plate. 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 and is not classified 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:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hydrocarbons, C10-C13, aromatics, >1% naphthalene
- EC Number:
- 926-273-4
- Molecular formula:
- None available - not a single isomer - see remarks
- IUPAC Name:
- Hydrocarbons, C10-C13, aromatics, >1% naphthalene
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver fractions from Aroclor exposed rats
- Test concentrations with justification for top dose:
- Tests (done in triplicate) with and without Metabolic Activation: 0, 32, 63, 125, 250, 500 ug/plate
Positive controls:
TA 1535 (S9-: sodium azide 1.0 ug/plate) (S9+: 2-aminoanthracene: 2.0 ug/plate)
TA 1537 (S9-: 9-aminoacridine 80 ug/plate) (S9+: benzo(a)pyrene: 4.0 ug/plate)
TA 98 (S9-: 2-nitrofluorene 2.0 ug/plate) (S9+: 2-aminoanthracene: 2.0 ug/plate)
TA 100 (S9-: sodium azide 1.0 ug/plate) (S9+: 2-aminoanthracene: 2.0 ug/plate)
WP2 uvr A (S9-: N-ethyl-N-nitrosourea 100 ug/plate) (S9+: 2-aminoanthracene: 80 ug/plate) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- yes
- Remarks:
- non treated
- Positive controls:
- yes
- Positive control substance:
- other: See Test Concentrations
- 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 increase 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 or 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 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Toxicity pretest was performed from doses of 556, 1667, 5000 ug/plate using all strains. Toxicity was observed at all of these doses and in phase 2 of the study, the doses were reduced to 0, 32, 63, 125, 250, 500 ug/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
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 and is not classified under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP). - Executive summary:
Test material was examined for mutagenic activity in the bacterial reverse mutation test using histidine-requiring Salmonella typhimurium strains TA 1535, 1537, 98, and 100, and the E. coli strain WP2 uvr A in the absence and presence of a liver S9 fraction for metabolic activation. Concentrations above 500 ug/plate were found to be cytotoxic and so the test was performed in triplicate using doses of 0, 32, 63, 125, 250, 500 ug/plate. 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 and is not classified under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
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