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EC number: 200-753-7 | CAS number: 71-43-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Main parameters measured are comparable to guideline study, GLP status unknown, limitations in design and reporting but otherwise acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Tests with a preincubation modification of the Salmonella/microsome assay
- Author:
- Zeiger E and Haworth S.
- Year:
- 1 985
- Bibliographic source:
- Progress in Mutation Research, 5: 187-199
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- no TA102 used
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Benzene
- EC Number:
- 200-753-7
- EC Name:
- Benzene
- Cas Number:
- 71-43-2
- Molecular formula:
- C6H6
- IUPAC Name:
- benzene
- Details on test material:
- - Name of test material (as cited in study report): benzene
- Analytical purity: not stated
- no further details
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium strains TA97, TA98, TA100 and TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced S9 from male Sprague-Dawley rats and Syrian hamsters
- Test concentrations with justification for top dose:
- 0, 0.01, 0.033, 0.1, 0.333, 1.0 mg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine 4 µg/plate and 2-aminoanthracene 0.75, 1.5 and 2 µg/plate
- Remarks:
- TA97 with and without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine 12 µg/plate and 2-aminoanthracene 0.75, 1.5 and 2 µg/plate
- Remarks:
- TA98 with and without S9
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide 2.5 µg/plate and 2-aminoanthracene 0.75, 1.5 and 2 µg/plate
- Remarks:
- TA100 and TA1535 with and without S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Preincubation method used (20 min), then plated onto agar
- In the first experiment, the concentration of S9 in the S9 mix was 10%. If all tests (nonactivation, rat S9 and hamster S9) were negative, they were repeated, with the S9 concentrations at 30% instead of the original 10%. If the repeat tests were also negative, the chemical was declared nonmutagenic
-Chemicals in this study were tested at a minimum of five doses up to a toxic dose or the limit of solubility, to a maximum dose of 10 mg/plate. Benzene was tested to a maximum dose of 1 mg/plate.
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- A positive response was defined as a dose-related increase over the control, regardless of its magnitude; an equivocal response was a non dose-related increase over the control or an elevated response at only a single dose. A chemical was declared mutagenic if it gave a reproducible, dose-related increase in any strain-activation combination.
Results and discussion
Test results
- Species / strain:
- other: Salmonella strains TA97, TA98, TA100 and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Benzene was not mutagenic under the conditions of the assay. - Executive summary:
Genotoxicity of benzene was assessed in vitro in a pre-incubation modification of the Salmonella microsome assay. Testing was performed with and without metabolic activation by Arochlor-1254 induced rat and hamster S9. Salmonella typhimurium strains TA97, TA98, TA100 and TA1535 were used.
Benzene was not mutagenic under the conditions of the assay.
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