Registration Dossier
Registration Dossier
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EC number: 608-291-1 | CAS number: 2890-61-1
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: GLP study according EU/OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-methylcyclohexane-1-carbonyl chloride
- EC Number:
- 608-291-1
- Cas Number:
- 2890-61-1
- Molecular formula:
- C8H13ClO
- IUPAC Name:
- 1-methylcyclohexane-1-carbonyl chloride
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 98 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 16, 50, 158, 500, 1581, 5000 µg/plate
- Vehicle / solvent:
- test substance: EGDE
positive controls: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- EGDE
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (Na-azide) (only TA1535), nitrofurantoin (NF) (only TA 100), 4-nitro-1,2-phenylene diamine (4-NPDA) (only TA 1537 and TA 98), cumene hydroperoxide (Cumene) (only TA 102) and 2-aminoanthracene (2-AA)
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 98 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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 - Executive summary:
The test substance was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.
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