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Toxicological information

Genetic toxicity: in vitro

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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

Referenceopen allclose all

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 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 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:
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

Reference
Name:
Unnamed
Type:
Constituent
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.