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
Adequacy of study:
other information

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 2002/32/EC, B.13/14. OECD TG 471
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535.
Metabolic activation system:
Aroclor 1254 induced microsomes of rat livers S9.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 2.5 ... 600 µg/plate
Concentration range in the main test (without metabolic activation): 2.5 ... 600 µg/plate
Vehicle / solvent:
Solvent: The test substance was dissolved in DMSO.
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 600 µg/plate

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(>= 556 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 600 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 600 µg/plate)
Additional information on results:
Observations:
In none of the concentrations and in none of the strains
used a relevant increase of the mutation frequency was
observed. Metabolic activation did not change this result.

Results were reproduced in a second experiment.
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