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Toxicological information

Genetic toxicity: in vitro

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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD method, GLP compliance

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD GUIDELINE 471 (84/449/EEC B.13 AND B.14)
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 TYPHIRIUM TA 98,TA 100, TA 1535, TA 1537 ESCHERICHIA COLI WP2uvrA
Metabolic activation system:
RAT LIVER MICROSOMAL FRACTION (S9 MIX)
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation):321...5000 μg/plate
Concentration range in the main test (without metabolic activation):321...5000 μg/plate
Vehicle / solvent:
Solvent: DMSO (50 mg
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 5000 μg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
other: not provided by inquiry
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
other: not provided by inquiry
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 μg/plate)
Additional information on results:
Observations:
NO EVIDENCE OF INDUCTION OF POINT MUTATIONS IN PRESENCE OR ABSENCE OF METABOLIC ACTIVATION
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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