Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 701-004-1 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, animal experimental study, published in peer reviewed literature. Limitations or minor restrictions in design/reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Multiple activation pathways of benzene leading to products with varying genotoxic characteristics
- Author:
- Glatt H, Padykula R, Berchtold GA, Ludewig G, Platt KL, Klein J and Oesch F
- Year:
- 1 989
- Bibliographic source:
- Environmental Health Perspectives. Vol 82, pp 81-89
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- bacteria exposed to benzene vapour in desiccators.
- GLP compliance:
- no
- 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
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- other: S. typhimurium TA100 and TA1535
- Species / strain / cell type:
- other: S. typhimurium TA98, TA100, TA104, TA1535
- Metabolic activation:
- without
- Metabolic activation system:
- NADPH-fortified S9 from Aroclor induced rat liver
- Test concentrations with justification for top dose:
- 3-1000 ppm
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: no details reported
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- no details reported
- True negative controls:
- not specified
- Positive controls:
- not specified
- Evaluation criteria:
- Considered to be a positive for mutagenicity if the number of revertant colonies, at the optimal dose, exceeded the number of the solvent controls 2-fold (TA1535 and TA98) or 1.5 fold (all other strains).
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: S. typhimurium TA100 and TA1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium, other: TA100 and TA104
- Metabolic activation:
- with
- Genotoxicity:
- ambiguous
- Remarks:
- possible weak effect
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
Any other information on results incl. tables
Benzene mutagenicity of was observed in the presence, but not in the absence, of S9 mix from rat and mouse liver homogenate. TA1535 was the most responsive strain. A 2-fold increase above control in the number of mutants was seen at 10 ppm benzene although higher concentrations had only modest effects (maximal mutant number ~ 3-fold control).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
positive with metabolic activation S. typhimurium TA1535
Benzene was mutagenic in the presence, but not absence, of NADPH-fortified post-mitochondrial fraction (S9 mix) from rat and mouse liver homogenate. - Executive summary:
Mutagenicity of benzene was observed only in the presence, but not in the absence, of NADPH-fortified post-mitochondrial fraction (S9 mix) from rat and mouse liver homogenate. The most responsive strain was TA1535.
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