Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.