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Toxicological information

Genetic toxicity: in vitro

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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:
1993
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:
1992
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

Constituent 1
Chemical structure
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
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.