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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: GLP - Guideline study.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 471
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
other: Salmonella typhimurium, TA98, TA100, TA1535, TA1537, and TA1538
Metabolic activation system:
Liver microsomal enzymes from male Spraque-Dawley rats
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 667 ... 10000 µg/plate
Concentration range in the main test (without metabolic activation): 667 ... 10000 µg/plate
Vehicle / solvent:
Solvent: Acetone
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 667 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:
(5000µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>5000µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>10000µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>10000µg/plate)
Additional information on results:
Observations:
The vehicle control value for tester strain TA98 in the presence of microsomal enzymes was outside the acceptable range. Therefore, tester strain TA98 was retested in the presence of microsomal enzymes.
Remarks on result:
other:
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