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Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
NR deficient strains
Principles of method if other than guideline:
The traditional strains used for OECD 471 will be checked in parallel with the same strains deficient in the nitro-reductasi enzyme (present only in bacteria) as to avoid the NO2 group reduction present in the test item. Reduction of the nitro groups in fact produce in the substance aromatic amines that typically give false positive for the traditional tested strains.
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Additional strain / cell type characteristics:
nitroreductase deficient
Remarks:
TA98NR, TA100 NR
Metabolic activation:
with and without
Metabolic activation system:
reductive (Prival) metabolic activation system
Test concentrations with justification for top dose:
Highest dose tested: 5000 μg/plate unless limited by cytotoxicity or solubility
Species / strain:
other: all strains
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

Ames test is on going and is ecxpected to be negative.