Registration Dossier
Registration Dossier
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EC number: 203-265-2 | CAS number: 105-05-5
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Results of an study conducted in accordance with generally accepted scientific principles. Possible deficiencies in the reporting of the endopoint do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,4-diethylbenzene
- EC Number:
- 203-265-2
- EC Name:
- 1,4-diethylbenzene
- Cas Number:
- 105-05-5
- Molecular formula:
- C10H14
- IUPAC Name:
- 1,4-diethylbenzene
- Details on test material:
- Commercial purity: 97.2%
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
- Species / strain / cell type:
- other: S. Typhimirium TA 1539
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S-9 fraction from Phenobarbital and 5,6-benzoflavone pretreated male SD rats with NADPH-generating system.
- Test concentrations with justification for top dose:
- 0, 2.4-78.12 µg/plate
- Details on test system and experimental conditions:
- Procedure: pre-incubation
Plates/test: 3
Media: Histidine selective
Number of replicates: 2
Results and discussion
Test results
- Species / strain:
- other: as described above
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 50 µg/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 (migrated information):
negative without metabolic activation
negative with metabolic activation - Executive summary:
Reverse gene mutation assays were conducted in line with Guidelines for Screening Mutagenicity Testing of Chemicals (Japan) and OECD Test Guidelines 471 and 472, using the pre-incubation method. This study was well controlled and regarded as a key study.
1,4 -diethylbenzene showed negative results in Salmonella Typhimurium TA100, TA1535, TA98, TA1537 and Eschirichia Coli WP2 uvrA at concentrations up to 50 µg/plate with or without metabolic activation (MHW, 1993c)
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