Registration Dossier

Administrative data

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation. Study accepted by competent national authorities (ELINCS substance) from EU member states. Reference see section 13 Assessment Reports, ECHA derogation statement.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Annex V (67/548/EWG)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
other: Salmonella typhimurium: TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
with and without
Metabolic activation system:
Arcolor-induced rat liver S9
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 0....5000 μg/plate
Concentration range in the main test (without metabolic activation): <.000001....5000 μg/plate
Vehicle:
solvent: acetone
Details on test system and conditions:
Concentration of the test substance resulting in precipitation: 5000 μg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: Salmonella typhimurium: TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
with
Cytotoxicity:
yes
Remarks:
>5000 μg/plate
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.
Species / strain:
other: Salmonella typhimurium: TA98, TA100, TA1535, TA1537, TA1538
Metabolic activation:
without
Cytotoxicity:
yes
Remarks:
>5000 μg/plate
Remarks on result:
other: other:
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Observations: there were no significant increases in the numbers of revertants, with or without S-9

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation