Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
other: secondary literature
Title:
NITE - Chemical Management Field - GHS Information GHS Classification Result
Year:
2011
Bibliographic source:
GHS-J [Internet]. National Institute of Technology and Evaluation (NITE): GHS Classification Results by the Japanese Government. Available from: http://www.echemportal.org

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified
Type of assay:
other: not specified

Test material

Specific details on test material used for the study:
not specified

Method

Target gene:
not specified
Test concentrations with justification for top dose:
not specified
Vehicle / solvent:
not specified
Details on test system and experimental conditions:
not specified
Rationale for test conditions:
not specified
Evaluation criteria:
not specified
Statistics:
not specified

Results and discussion

Test results
Key result
Species / strain:
not specified
Metabolic activation:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
not specified
Remarks on result:
other: qualitative result available
Remarks:
there is a negative or a positive in an Ames test

Any other information on results incl. tables

not specified

Applicant's summary and conclusion

Conclusions:
The Classification related to the class "Germ cell mutagenicity" was not possible due to no in vivo test data.
Besides, there is a negative or a positive in an Ames test as an in vitro test.