Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1992
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary source (ECB); similar to OECD Guideline 471, but only with three S. typhimurium strains.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
1992
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Ames, B.N. et al., Mutat. Res. 31, 347-364 (1975)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strainopen allclose all
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Test concentrations with justification for top dose:
8, 40, 200, 1000 or 5000 ug/plate.

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative