Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vitro, other
Remarks:
bacteria, mammalian cells
Type of information:
other: data from collection of data
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Cross-reference
Reason / purpose:
read-across: supporting information

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Method

Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9 mix from livers of male rats or Syrian hamsters
Test concentrations with justification for top dose:
up to 1000µg/plate
Details on test system and conditions:
pre-incubation test

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not determined
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not determined
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not determined
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not determined

Any other information on results incl. tables

In other experiments in vitro (with Escherichia coli, Bacillus subtilis, Salmonella typhimurium or Saccharomyces cerevisiae, as well as in the Chinese hamster cells) no genetic toxicity was found.

In the CHO-test sister chromatid exchange in the fraction with S9 -mix was reported, but no dose-response appeared.

Applicant's summary and conclusion

Conclusions:
No in vitro toxicity found in assays using bacterial cells.