Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 92/69/EEC (Ames)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium TA1535, TA97, TA98, TA100, TA102
Metabolic activation system:
Phenobarbital and beta-naphthoflavone-induced rat liver S9.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): .33 ... 333 μg/plate
Concentration range in the main test (without metabolic activation): .33 ... 333 μg/plate
Vehicle / solvent:
Solvent: Dimethylsulfoxide
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 100 μg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 333 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 333 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 333 μg/plate)
Additional information on results:
Observations:
Positive and negative controls responded as expected. There
was no increase in the numbers of revertants in any strain
at any dose level.
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

.

Applicant's summary and conclusion

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