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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Based on the prediction for in-vitro mammalian chromosome aberration test on Chinese hamster Lung (CHL) without S9 metabolic activation it was estimated that 4-nitroaniline does not exhibit positive chromosomal effect.
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:
supporting study
Reliability:
4 (not assignable)
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Data is from ACToR database
GLP compliance:
not specified
Type of assay:
bacterial gene mutation assay
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with
Metabolic activation system:
S9 mix
Species / strain:
S. typhimurium TA 98
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative

Genetic toxicity with Metabolic Activation of S9 mix by bacterial gene mutation assay to TA98 AMES SALMONELLA TYPHIMURIUM was examined as
NEGATIVE.
Executive summary:

Genetic toxicity with Metabolic Activation of S9 mix by bacterial gene mutation assay to TA98 AMES SALMONELLA TYPHIMURIUM was examined as 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
Based on the prediction for in-vitro bacterial reverse mutation assay test on Salmonella typhimurium strains TA 1538; TA 1535; TA 1537; TA 100; TA 97; TA 98 with S9 metabolic activation it was estimated that 4-nitroaniline does not exhibit positive gene mutation effect

Justification for classification or non-classification

4 -nitroaniline exhibited negative genotoxicity in bacteria as well as in mammalian cell and was therefore not classified as a chemical exhibiting genetic toxicity