Registration Dossier
Registration Dossier
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EC number: 203-313-2 | CAS number: 105-60-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Evaluation of Mutagenicity Testing with Salmonella typhimurium TA102 in Three Different Laboratories.
- Author:
- Mueller W., Engelhart G., Herbold B., Jaeckh R. and Jung R.
- Year:
- 1 993
- Bibliographic source:
- Environ. Health Persp. Suppl. 101, 33-36
- Reference Type:
- publication
- Title:
- Collaborative study of mutagenicity with Salmonella typhimurium TA102.
- Author:
- Jung R., Engelhart G., Herbolt B., Jaeckh R. and Mueller W.
- Year:
- 1 992
- Bibliographic source:
- Mut. Res. 278, 265-270
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The compound was tested for mutagenicity in a collaborative study (3 laboratories) as described by Maron and Ames (Mutat. Res. 133: 173-215, 1983) and as specified for TA102 by Levin et al. (Proc. Natl. Acad. Sci. U.S.A. 79: 7445-7449, 1982).
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- ε-caprolactam
- EC Number:
- 203-313-2
- EC Name:
- ε-caprolactam
- Cas Number:
- 105-60-2
- Molecular formula:
- C6H11NO
- IUPAC Name:
- azepan-2-one
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Caprolactam
- Analytical purity: highest purity
Method
- Target gene:
- Salmonella typhimurium: histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with
- Metabolic activation system:
- Aroclor 1254 induced liver S9 mix
- Test concentrations with justification for top dose:
- up to 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- As described by Maron and Ames (Mutat. Res. 133: 173-215, 1983) and as specified for TA102 by Levin et al (Proc. Natl. Acad. Sci. U.S.A. 79: 7445-7449, 1982).
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The test substance was found to be negative in TA102.
- Executive summary:
The test substance was tested for mutagenicity in a collaborative study (3 laboratories) and was found to be negative in TA102.
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