Registration Dossier

Diss Factsheets

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
Guideline:
other: 2000/32/EG, B.13, B.14 (Ames-Test)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Method

Species / strain
Species / strain / cell type:
bacteria, other: sat TA 98, 100, 102, 1535, 1537
Metabolic activation system:
S9 mix from livers of Aroclor 1254 treated rats.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 16 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 16 ... 5000 µg/plate
Vehicle / solvent:
Solvent: DMSO

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 50 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 50 µg/plate)
Additional information on results:
Observations:
There was no indication of a bacteriotoxic effect of the
test substance up to and including 50 µg per plate. Higher
doses had only a weak, strain specific bacteriotoxic effect.
Remarks on result:
other: other: main 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

Categories Display