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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Additional strain / cell type characteristics:
other: histidine mutations: hisC3076, hisD3052/plasmid pKM101, hisG46, hisG46/plasmid pKM101, Trp
Metabolic activation:
with and without
Metabolic activation system:
S9-fraction
Test concentrations with justification for top dose:
Dose range finding: tested up to concentrations of 5000µg/plate in the absence and presence of S9-mix, resulted in precipitations at 333µg/plate and toxicity in TA100
Main study (first and second mutation assay): 3, 10, 33, 100 and 333µg/plate in the absence and presence of S9-mix
Vehicle / solvent:
dimethyl sulfoxide
Controls
Untreated negative controls:
yes
Remarks:
dimethyl sulfoxide
Negative solvent / vehicle controls:
yes
Remarks:
dimethyl sulfoxide
Positive controls:
yes
Remarks:
see positive control substances below
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
sodium azide
methylmethanesulfonate
other: daunomycine; 2-aminoanthracene
Remarks:
The chemical used for positive control depends on the strain and the absence/presence of S9

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
all strains, both in the presence and absence of the S9-metabolic activation
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
precipitation at 333µg/plate; cytotoxicity only in TA1537, TA98 and TA100
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative