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
Study period:
1980
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
publication
Title:
Screening of tobacco smoke constituents for mutagenicity using the ames test
Author:
Florin, I., et al.
Year:
1980
Bibliographic source:
Toxicology, volume 18, 1980, page 219-232

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: refer to article
Deviations:
no
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain characteristics:
not specified
Metabolic activation:
with
Metabolic activation system:
Histidine and biotin
Test concentrations with justification for top dose:
0,05 micromol histidine/biotin; 10 micromol histidine and 0,05 micromol biotin
Vehicle:
Revertants were scored on glucosenminimal salts medium supplemented with 0,05 micromol histidine and 0,05 micromol biotin. Plates used for viable counts contained 10 micromol histidine (and 0,05 micromol biotin).
Controls
Negative controls:
not specified
Solvent controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: N-methyl-N-nitro-N-nitrosoguanidin and 2-aminoanthracene

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity:
no
Vehicle controls valid:
not applicable
Negative controls valid:
not applicable
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion