5-nitro-o-anisidine

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:

weight of evidence

Reliability:

4 (not assignable)

Data source

Reference

Reference 1

Reference Type:

other: Authoritative data base

Title:

Study ID: 116557

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

Reference 2

Reference Type:

other: QSAR toolbox

Title:

QSAR STUDY FOR CAS No.: 99-59-2

Year:

2011

Bibliographic source:

OECD QSAR toolbox version 2.2, 2011;NTP Program - P&G Inventory,P&G ,2000

Reference 3

Reference Type:

other: Authoritative data base

Title:

HSDB Number 4104

Year:

2011

Bibliographic source:

HSDB (Hazardous Substances Data Bank);US national Library of Medicine reviewed by SRC,IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Geneva: World Health Organization, International Agency for Research on Cancer, 1972

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Preincubation:
In the standard protocol (preincubation) for conducting the Ames assay, a test tube containing a suspension of one strain of Salmonella typhimurium (or E. coli) plus S9 mix or plain buffer without S9, is incubated for 20 minutes at 37º C with the test chemical. Control cultures, with all the same ingredients except the test chemical, are also incubated. In addition, positive control cultures are prepared; these contain the particular bacterial tester strain under investigation, the various culture ingredients, and a known potent mutagen*. After 20 minutes, agar is added to the cultures and the contents of the tubes are thoroughly mixed and poured onto the surface of Petri dishes containing standard bacterial culture medium. The plates are incubated, and bacterial colonies that do not require an excess of supplemental histidine appear and grow. These colonies are comprised of bacteria that have undergone reverse mutation to restore function of the histidine-manufacturing gene. The number of colonies is usually counted after 2 days.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

5-nitro-o-anisidine

EC Number:

202-770-5

EC Name:

5-nitro-o-anisidine

Cas Number:

99-59-2

Molecular formula:

C7H8N2O3

IUPAC Name:

2-methoxy-5-nitroaniline

Details on test material:

- Name of test material: 5-nitro-o-anisidine
- Molecular formula: C7H8N2O3
- Substance type: Organic
- Physical state: solid

Method

Target gene:

histidine-manufacturing gene

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535

Metabolic activation:

without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

0 - 3333 ug/Plate

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Dimethyl Sulfoxide

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

without S9

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535

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'.

Any other information on results incl. tables

Strain : TA98

Dose	No Activation  (Positive)		No Activation  (Positive)		10% HLI  (Positive)		10% HLI  (Positive)		10% RLI  (Positive)		10% RLI  (Positive)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	18	3.9	11	1.9	24	1.2	25	2.2	23	3.8	21	1.2
10			238	3.4			213	20.8			56	7.6
33	598	16.5			949	19.6			211	12.9
100	1686	33.1	1888	59.1	2555	58.6	2690	88.6	566	27.6	562	23.4
333	3513	89	3661	21.3	3939	223.5	4116	86	2938	57.9	2708	74.1
1000	4187	74.3	4031	20.8	4093	92.3	4249	14.6	4220	99.6	4289	18.3
2000			4083	33.2			4322	54.6			4225	33.2
3333	4302	33.2			3962	97.1			4193	30.9
Positive Control	1519	37.1	1780	12.6	1501	58.7	1279	49.7	817	57.4	1258	45.2

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 without metabolic activation

The Salmonella Mutagenicity Test or Ames Test for 5-nitro-o-anisidine found to be negative.The highest ineffective dose tested in any Salmonella typhimurium strain TA1535 was 3333 ug/plate without activation.

Executive summary:

5-nitro-o-anisidine was found to be negative when tested for mutagenicity in the Salmonella or Ames test preincubation assay using the standard protocol by the National Toxicology Program (NTP). 5-nitro-o-anisidine was tested in Salmonella typhimurium strains TA100 in the absence S-9, at doses of 0.00,10.00 33.000, 100.000, and 333.000, 1000, 2000 and 3333 ug/plate. The highest ineffective dose tested in any Salmonella typhimurium strain was 3333 ug/plate.