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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: published in a peer reviewed journal. Results were reproduced in 3 different laboratories. no strain was included for detecting cross-linking mutagens.

Data source

Reference
Reference Type:
publication
Title:
Salmonella Mutagenicity Tests: II. Results from Testing 270 Chemicals.
Author:
Mortelmans K., Haworth S., Lawlor T., Speck W., Tainer B., and Zeiger E.
Year:
1986
Bibliographic source:
Environmental Mutagenisis Volume 8, Supplement 7:1-119

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
4 strains used
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity >99%

Method

Target gene:
histidine mutation

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Test concentrations with justification for top dose:
Not reported
Vehicle / solvent:
Not reported

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative