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Diss Factsheets

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:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Salmonella Mutagenicity Tests: 111. Results From the Testing of 255 Chemicals
Author:
Errol Zeiger, Beth Anderson, Steve Haworth, Timothy Lawlor, Kristien Mortelmans, and William Speck
Year:
1987
Bibliographic source:
Environmental Mutagenesis Volume 9, Supplement 9:l-110, 1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other:
Principles of method if other than guideline:
Preincubation Assay
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
2-amino-4-nitrophenol
EC Number:
202-767-9
EC Name:
2-amino-4-nitrophenol
Cas Number:
99-57-0
IUPAC Name:
2-amino-4-nitrophenol
Details on test material:
- Name of test material (as cited in study report): 2-amino-4-nitrophenol
- Substance type: Organic
- Physical state: solid

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 1537 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Rat or Hamster liver, S-9, Aroclor 1254 (10%)
Test concentrations with justification for top dose:
33-3333 UG/PLATE
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
other: 2-aminoanthracene

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 1535, TA 1537 and TA 100
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

TA100

Dose

No Activation 
(Negative)

10% HLI 
(Negative)

10% RLI 
(Negative)

Protocol

Preincubation

Preincubation

Preincubation

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

61

6.4

93

5.2

80

7.2

33     

59

9.8

85

10.1

66

7.5

100     

60

2.8

93

6.7

74

3.8

333     

59

4.8

93

14.8

71

2.4

1000     

51

2.7

85

8.1

85

8.7

3333     

27

3.5

42

1.7

28

7.2

Positive Control

1610

77.6

2524

217.1

1430

157.3

TA1535

Dose

No Activation 
(Negative)

10% HLI 
(Negative)

10% RLI 
(Negative)

Protocol

Preincubation

Preincubation

Preincubation

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

8

1.2

8

1.7

13

0.3

33     

6

0.3

11

1.5

11

2.6

100     

4

1.7

5

1.9

14

3.5

333     

6

1.5

14

1.3

6

1.2

1000     

5

0.3

9

2.2

5

1.9

3333     

1

0.7

0

0

0

0.3

Positive Control

117

8.4

46

8.4

43

4.2

TA1537

Dose

No Activation 
(Negative)

10% HLI 
(Negative)

10% RLI 
(Negative)

Protocol

Preincubation

Preincubation

Preincubation

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

13

1.2

16

1.5

16

1.8

33     

16

3.4

21

2.8

12

1.2

100     

17

4.2

16

0.7

11

1.7

333     

16

2.1

17

2.1

12

2.3

1000     

14

0.6

18

0.9

10

1.7

3333     

6

0.0

11

1.5

7

0.7

Positive Control

303

30.7

338

23.1

167

17.3

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The substance 2-amino-4-nitrophenol gives negative result for mutagenicity in Salmonella typhimurium strains TA 1535, TA 1537 and TA 100 in Ames assay with and without activation.
Executive summary:

The substance 2-amino-4-nitrophenol gives negative result for mutagenicity in Salmonella typhimurium strains TA 1535, TA 1537 and TA 100 in Ames assay with and without activation.