5-nitro-o-anisidine

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

5-nitro-o-anisidine was found to be non-genotoxic.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: other: "Gene Mutation"

Type of information:

(Q)SAR

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Justification for type of information:

QSAR prediction: migrated from IUCLID 5.6

Principles of method if other than guideline:

Prediction is done using QSAR Toolbox version 2.3.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium TA 97

Additional strain / cell type characteristics:

not specified

Metabolic activation:

without

Metabolic activation system:

S9

Species / strain:

S. typhimurium TA 97

Metabolic activation:

without

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'.

The prediction was based on dataset comprised from the following descriptors: "Gene mutation"
Estimation method: Taking highest mode value from the 5 nearest neighbours
Domain logical expression:Result: In Domain

(("a" and "b" ) and ("c" and "d" ) )

Domain logical expression index: "a"

Similarity boundary:Target: c1(OC)c(N)cc(N(=O)=O)cc1
Threshold=50%,
Dice(Atom pairs)

Domain logical expression index: "b"

Similarity boundary:Target: c1(OC)c(N)cc(N(=O)=O)cc1
Threshold=60%,
Dice(Atom pairs)

Domain logical expression index: "c"

Parametric boundary:The target chemical should have a value of log Kow which is >= 1.52

Domain logical expression index: "d"

Parametric boundary:The target chemical should have a value of log Kow which is <= 1.55

Conclusions:

Interpretation of results (migrated information):
negative without metabolic activation

Based on the prediction for in-vitro bacterial reverse mutation assay (e.g. Ames test) on S. typhimurium TA 97 without S9 metabolic activation it was estimated that 5-nitro-o-anisidine was non mutagenic.

Executive summary:

Based on the prediction for in-vitro bacterial reverse mutation assay (e.g. Ames test) on S. typhimurium TA 97 without S9 metabolic activation it was estimated that 5-nitro-o-anisidine was non mutagenic.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Ames test

Based on the prediction for in-vitro bacterial reverse mutation assay (e.g. Ames test) on S. typhimurium TA 97 without S9 metabolic activation it was estimated that 5-nitro-o-anisidine was non mutagenic. Also from the various sources it was found that 5-nitro-o-anisidine is non mutagenic by both gene mutation as well as Chromosome aberration test

The various weight of evidence studies can be summarised as follows :

Sr.No	Type of genotoxicity	Type of study	Species	Metabolic Activation	Genotoxicity	Cytotoxicity
1	Gene mutation	Ames test	S. typhimurium TA 97	Without S9	negative	No data
2	Chromosome aberration	In vitro mammalian chromosome aberration test	Chinese hamster Lung (CHL)	without S9	negative	No data
3	Gene mutation	Ames test	S. typhimurium TA 1535	Without S9	negative	No data
4	Chromosome aberration	in vitro mammalian chromosome aberration test	Chinese hamster Ovary (CHO)	With and without Induced Rat Liver S9	negative	no
5	DNA damage and/or repair	sister chromatid exchange assay in mammalian cells	Chinese hamster Ovary (CHO)	With and without Induced Rat Liver S9	negative	no
6	Gene mutation	Bacterial gene mutation assay	S. typhimurium TA 100	without	negative	No data

 

Justification for selection of genetic toxicity endpoint
Based on the prediction for in-vitro bacterial reverse mutation assay (e.g. Ames test) on S. typhimurium TA 97 without S9 metabolic activation it was estimated that 5-nitro-o-anisidine was non mutagenic.