Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
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.
