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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.

Justification for classification or non-classification

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