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Genetic toxicity in vitro

Link to relevant study records
Reference
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)
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
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
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
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'.
Conclusions:
Interpretation of results (migrated information):
negative
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Justification for selection of genetic toxicity endpoint
As only one study can be indicated as key study and as both key study and supporting studies reveal the same result, the first received report was indicated as key study and the second and third ones as supporting studies.

Justification for classification or non-classification