N,N-dimethyl-p-toluidine

Endpoint summary

Key value for chemical safety assessment

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

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

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