2-nitro-p-toluidine

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In vitro genetic toxicity of 2-nitro-p-toluidine to Salmonella typhimurium TA98 is found to be negative with and without 30% HLI and 30% RLI S9 metabollic activation system.

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:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Preincubation Method

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

30% induced male Sprague Dawley rat liver S9 and 30% induced male Syrian hamster liver S9

Test concentrations with justification for top dose:

0-3333 ug/Plate

Vehicle / solvent:

Dimethyl Sulfoxide

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Dimethyl Sulfoxide

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

control for test without S9 activation

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Dimethyl Sulfoxide

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene( with S9)

Remarks:

control for test with S9 activation

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

 Strain: TA98

Dose	No Activation (Negative)		30% HLI (Negative)		30% RLI (Negative)
Protocol	Preincubation		Preincubation		Preincubation
ug/Plate	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	16	1.7	35	5.2	20	2.3
10					21	1.7
33	18	1.8	32	2	19	2.3
100	15	0.6	37	1.5	23	3.2
333	14	2.1	40	6.7	21	2.7
500					18	3.2
1000	11	2.9	42	4.1
3333	3s	0.9	21	4.3
Positive Control	170	1.2	102	2.7	115	6.9

 

RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9

Conclusions:

Interpretation of results (migrated information):
negative

In vitro genetic toxicity of 2-nitro-p-toluidine to Salmonella typhimurium TA98 is found to be negative with and without 30% HLI and 30% RLI S9
metabollic activation system.

Executive summary:

In vitro genetic toxicity of 2-nitro-p-toluidine to Salmonella typhimurium TA98 is found to be negative with and without 30% HLI and 30% RLI S9 metabollic activation system.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

The various supporting studies with various Salmonella species as well as with rat lymphocytes and hepatocytes indicate that 2-nitro-p-toluidine is unlikely to have positive geno-toxic effect.

Justification for selection of genetic toxicity endpoint
Data is from authoritative database

Justification for classification or non-classification

There are various data to indicate that 2-nitro-p-toluidine is not a geno-toxic chemical