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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
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: 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, 102, 1535, 1537
Metabolic activation system:
S9-mix of Aroclor 1254 induced rats.
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): .5 ... 158 µg/plate
Concentration range in the main test (without metabolic activation): .5 ... 158 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:
(> 16 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 16 µg/plate)
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 at doses up to and including 16 µg per plate.
The total bacteria counts consistently produced results
comparable to the negative controls. No inhibition of growth
was noted as well. Higher doses had a strong strain-
specific bacteriotoxic effect.
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