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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
The results of all in vitro tests in bacterial and mammalian cells were negative with and without metabolic activation. They consistently indicate that the test substance is not mutagenic.
Link to relevant study records
Reference
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: see 'Remark'
Remarks:
The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. However the reliability is estimated to be at level 1: Study conducted in accordance with generally accepted scientific principles. Possible deficiencies do not affect the quality of relevant results.
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: Reverse mutation assay (Ames test + E. Coli). OECD Guideline n° 471 (1983) EEC Directive 84/449 (1984) - Annex V - Method B14
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Test material information:
Composition 1
Species / strain:
other: Salmonella Typhimurium TA98 - TA100 - TA1535 - TA1537 - TA1538 Escherichia coli tryptophan auxotroph WP2uvrA
Metabolic activation system:
S9 Mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 100 ... 5000 μg/plate
Concentration range in the main test (without metabolic activation): 100 ... 5000 μg/plate
Vehicle:
Solvent: Dimethylsulfoxide (DMSO)
Details on test system and conditions:
Concentration of the test substance resulting in precipitation: 1000 μg/plate
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
not specified
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
not specified
Cytotoxicity:
yes
Remarks:
(> 5000 μg/plate)
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification