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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: GMP Compliance

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EWG, B.14 (Ames-Test)
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: bacteria, sat TA 98,100,1535,1537
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induzierterattenleber S9-Mix
Test concentrations with justification for top dose:
Concentration range in the main test ( with metabolic activation): 20....5000µg/plate
Concentration range in the main test ( without metabolic activation): 20....5000µg/plate
Vehicle / solvent:
solvent: Acetone
Details on test system and experimental conditions:
C0ncentration of the test substance resulting in precipitation: 313 µg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>5000µg/plate
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
> 5000µg/plate
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 both with and without metabolic activation

The substance shows no mutagenic tendencies.
Executive summary:

Limited data provided by ECHA. Not possible to make further conclusions.