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Genetic toxicity in vitro

Description of key information
The Substance N,N-dimethyl-p-toluidine is not mutagenic
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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Data is from Environmental Molecular Mutagenesis
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium, other: TA 97,TA 98,TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Test concentrations with justification for top dose:
0, 1, 2.5, 5, 10, 40, 70, 100 ug/plate
Species / strain:
S. typhimurium, other: TA 97,TA 98, TA 100
Metabolic activation:
with and 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
Additional information on results:
Cytotoxic Concentration: 100 ug/plate
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Conclusions:
Interpretation of results (migrated information):
negative

Bacterial reverse mutation at dose concentration of 0-100 UG/PLATE of N,N-dimethyl-p-toluidine with and without metabolic activation to S. typhimurium TA 97,TA 98, TA 100 was examined as NEGATIVE.
Executive summary:
Bacterial reverse mutation at dose concentration of 0-100 UG/PLATE of N,N-dimethyl-p-toluidine with and without metabolic activation to S. typhimurium TA 97,TA 98, TA 100 was examined as NEGATIVE.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Based on studies of target substance CAS NO 99-97-8 reviewed for genetic toxicity from reliable sources having Klimisch rating 2 and 4 based on the category approach of organic functional group along with similar mechanistic approach and having structural similarities defined by QSAR toolbox. The results is summarized as follows.

 

The summary of the results are presented below

 

Sr. No

End point

Effect

Species

 

Remarks

1

 In vitro Genetic toxicity

 

Negative with and without metabolic activation

 

 S. typhimurium TA 97,TA 98, TA 100

 

Data is from publication for target chemical

2

 In vitro Genetic toxicity

 

 

 Negative with and without metabolic activation S9 derived from induced hamster or rat liver.

 

 S. typhimurium strains TA97, TA98, TA100, or TA1535

 

Data is from study for target chemical

3

 In vitro Genetic toxicity

 

negative with and without 10% rat liver S9 for exogenous metabolic activation

S. typhimurium strains TA98 and TA100 and E. coli WP2 uvr A pKM 101

Data is from study for target chemical

4

chromosome aberration

negative without metabolic activation

B6C3F1/N mice micronucleated erythrocytes

Data is from study for target chemical

5

 In vitro Genetic toxicity

 

negative with and without metabolic activation

S. typhimurium strains TA 98, TA 1537, TA 1538, TA 100

Data is from study for target chemical

6

chromosome aberration

negative with metabolic activation

Chinese hamster Lung

Predicted data for target chemical

7

chromosome aberration

negative without metabolic activation

Chinese hamster Lung

Predicted data for target chemical

 

Based on the results summarized in above table for the target chemical CAS NO 99-97-8, it can be concluded that the substance is non-genotoxic with and without metabolic activation.Thus N,N-dimethyl-p-toluidine is considered to be non-genetic toxic as per CLP criteria.


Justification for selection of genetic toxicity endpoint
Bacterial reverse mutation at dose concentration of 0-100 UG/PLATE of N,N-dimethyl-p-toluidine with and without metabolic activation to S. typhimurium TA 97,TA 98, TA 100 was examined as NEGATIVE.

Justification for classification or non-classification

From the above studies it can be concluded that the substance N,N-dimethyl-p-toluidine is not genotoxic