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
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9 mix

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
yes
Remarks:
at the highest dose-level in the absence of S9 in TA1535, TA1537,TA100, TA102.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The test substance did not induce two fold increases in the number of revertant colonies at any dose-level, either in the absence or presence of S9 metabolism.

Toxicity as indicated by thinning of the background lawn, was observed at the highest dose-level in the absence of S9 metabolism in all tester strains with the exception of TA1538 and TA98. Tester strains TA100 and TA102 appeared to be more susceptible to the toxic effect of the test substance and reductions in revertant numbers, thinning of the background lawn and/or microcolony formation were observed at higher dose-levels, in the absence and presence of S9 metabolism.

Positive control treatments produced marked increases in revertant numbers, indicating the correct functioning of the assay system.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test substance does not induce reverse mutation in Salmonella typhimurium with and without metabolic activation, under the reported experimental conditions.