2-nitro-p-toluidine

Genetic toxicity: in vitro

Administrative data

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)

Data source

Reference

Reference Type:

other: Authoritative data base

Title:

Study ID: 341805

Author:

NTP database

Year:

2012

Bibliographic source:

NTP (National Toxicological Program)by Agency for Toxic Substances and Disease Registry; Division of Toxicology/Toxicology Information Branch, 1600 Clifton Road NE, E-29, Atlanta, Georgia 30333

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

2-nitro-p-toluidine

EC Number:

201-924-9

EC Name:

2-nitro-p-toluidine

Cas Number:

89-62-3

Molecular formula:

C7H8N2O2

IUPAC Name:

4-methyl-2-nitroaniline

Details on test material:

- Name of test material: 2-nitro-p-toluidine
- Molecular formula: C7H8N2O2
- Molecular weight: 152.15
- Substance type: organic

Method

Species / strain

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

Controls

Controls 1

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

Controls 2

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

Results and discussion

Test results

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'.

Any other information on results incl. tables

 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

Applicant's summary and conclusion

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.