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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data is from peer reviewed publication

Data source

Reference
Reference Type:
publication
Title:
SALMONELLA MUTAGENICITY TESTS: IV. RESULTS FROM THE TESTING OF 300 CHEMICALS;
Author:
ZEIGER,E, ANDERSON,B, HAWORTH,S, LAWLOR,T AND MORTELMANS,K;
Year:
1988
Bibliographic source:
Environmental and Molecular Mutagenesis, 11(SUPPL.12):1-158, 1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other:
Principles of method if other than guideline:
Gene mutation toxicity study was performed to evaluate the mutagenic nature of the test compound 2-aminobenzenesulphonic acid
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: 2-aminobenzenesulphonic acid- Molecular formula: C6H7NO3S- Molecular weight: 173.1913 g/mol- Substance type: Organic- Physical state: Solid- Purity: 95%

Method

Target gene:
Histidine auxotrophs
Species / strain
Species / strain:
other: TA97, TA98, TA100, TA1535
Details on mammalian cell lines (if applicable):
Not applicable
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
HAMSTER, LIVER, S-9, AROCLOR 1254 (10 OR 30%)
Test concentrations with justification for top dose:
0, 10, 33, 100, 333, 1000, 3333, 3334, 6667 µg/plate
Vehicle:
DMSO
Controlsopen allclose all
Negative controls:
not specified
Solvent controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
For strains tested with S9
Negative controls:
not specified
Solvent controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
For strains TA100 and TA1535 tested in the absence of S9
Negative controls:
not specified
Solvent controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
For strains TA98 tested in the absence of S9
Negative controls:
not specified
Solvent controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
For strains TA97 tested in the absence of S9
Details on test system and conditions:
Details on test system and conditionsMETHOD OF APPLICATION: preincubationDURATION- Preincubation period: 20 mins- Exposure duration: 48 hrs- Expression time (cells in growth medium): 48 hrs- Selection time (if incubation with a selection agent): No data- Fixation time (start of exposure up to fixation or harvest of cells): No dataSELECTION AGENT (mutation assays): No dataSPINDLE INHIBITOR (cytogenetic assays): No dataSTAIN (for cytogenetic assays): No dataNUMBER OF REPLICATIONS: At least five doses of each chemical were tested in triplicateNUMBER OF CELLS EVALUATED: No dataDETERMINATION OF CYTOTOXICITY- Method: mitotic index; cloning efficiency; relative total growth; other: No dataOTHER EXAMINATIONS:- Determination of polyploidy: No data- Determination of endoreplication: No data- Other: No dataOTHER: No data
Evaluation criteria:
Evaluations were made at both the individual trial and overall chemical levels. Individual trials were judged mutagenic (+), weakly mutagenic (+ W), questionable (?), or nonmutagenic (-), depending on the magnitude of the increase of his+ revertants, and the shape of the dose-response. A trial was considered questionable (?) if the dose-response was judged insufficiently high to support a call of “ +W,” if only a single dose was elevated over the control, or if the increase seen was not dose related. The distinctions between a questionable mutagenic response and a nonmutagenic or weak mutagenic response, and between a weak mutagenic response and mutagenic response are highly subjective. It was not necessary for a response to reach twofold over background for a chemical to be judged mutagenic.A chemical was judged mutagenic (+) or weakly mutagenic (+ W) if it produced a reproducible dose-related reponse over the solvent control in replicate trials. A chemical was judged questionable (?) if the results of individual trials were not reproducible, if increases in his+ revertants did not meet the criteria for a “+W” response, or if only single doses produced increases in his+ revertants in repeat trials. Chemicals were judged non-mutagenic (-) if they did not meet the criteria for a mutagenic or questionable response. The chemicals were decoded by the chemical repository only after a determination had been made regarding their mutagenicity or non-mutagenicity.
Statistics:
No data available

Results and discussion

Test results
Species / strain:
other: TA97, TA98, TA100, TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
yes
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Additional information on results:
Additional information on resultsTEST-SPECIFIC CONFOUNDING FACTORS- Effects of pH: No data- Effects of osmolality: No data- Evaporation from medium: No data- Water solubility: No data- Precipitation: No data - Other confounding effects: No dataRANGE-FINDING/SCREENING STUDIES: All chemicals were tested initially in a toxicity assay to determine the appropriate dose range for the mutagenicity assay. The toxicity assay was performed using TA100 or the system developed by Waleh et al. Toxic concentrations were those that produced a decrease in the number of his+ colonies, or a clearing in the density of the background lawn, or both.COMPARISON WITH HISTORICAL CONTROL DATA: No dataADDITIONAL INFORMATION ON CYTOTOXICITY: No data

Any other information on results incl. tables

Strain TA100

Dose

No Activation 
(Negative)

No Activation 
(Negative)

10% HLI 
(Negative)

30% HLI 
(Negative)

10% RLI 
(Negative)

10% RLI 
(Negative)

30% RLI 
(Negative)

Protocol

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

90

2

102

4.6

77

7.8

130

2.4

98

2.7

87

4.7

121

9

33     

81

4.2

99

2

91

2.1

112

11.1

72

11.1

73

5.8

121

2.2

100     

96

7.8

101

5.7

110

11

115

2

101

12.8

72

3.6

126

12.1

333     

91

0.7

95

2

86

2.7

120

2.5

89

6.4

76

3.1

121

9.1

1000     

80

7.3

91

7

91

2.7

112

5

84

7.3

78

2.1

116

2.3

3333     

85

2.5

93

4.6

84

5.4

115

4

90

5.9

75

0.3

127

5

Positive Control

290

8.1

236

12.8

333

18.8

357

9.7

198

23.4

399

16.7

Strain TA1535

Dose

No Activation 
(Negative)

No Activation 
(Negative)

10% HLI 
(Negative)

30% HLI 
(Negative)

10% RLI 
(Negative)

30% RLI 
(Negative)

Protocol

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

18

3.2

8

0.7

8

0.3

5

0

11

2

9

1.3

33     

16

1.3

7

0.3

9

0.9

8

2

9

0.9

12

1.7

100     

10

0.3

6

1.5

11

1.5

5

1.7

6

1

7

1.8

333     

15

1.8

7

1.8

12

1.5

8

1.2

9

1.8

12

2.1

1000     

16

1.2

8

1.5

11

0.9

7

0.9

8

1.8

6

1.5

3333     

17

1.2

6

0.7

6

0.9

7

1

5

0.7

9

0.6

Positive Control

186

9.6

56

7.9

52c

2.5

40

4.2

39

2.9

58

3.9

Strain TA97

Dose

No Activation 
(Not a Valid Test)

No Activation 
(Negative)

No Activation 
(Negative)

10% HLI 
(Negative)

30% HLI 
(Negative)

10% RLI 
(Negative)

30% RLI 
(Negative)

30% RLI 
(Negative)

Protocol

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

82

9.7

103c

2.5

90

1.7

107

4.9

184c

4.5

104

4.1

226

10.4

155

5.8

10     

 

 

 

 

 

 

 

 

 

 

 

 

 

 

158

7.3

33     

80

5

93

0.3

77

8.5

107

3.8

209

13.2

104

4.7

197

10.2

162

4.3

100     

73

5.8

107

15.5

77

7.8

115

9.7

206

13.5

95

4.9

221

13.5

154

12.8

333     

79

4.4

85

8

66

6.8

89

5.7

209

5.8

99

4.3

192

5.9

159

3.5

1000     

79

2.7

94

14.3

58

2

100

9.6

227

10

105

2.7

196

12.5

171

36.9

3333     

90

3.8

109c

0

78

3.5

103

9.2

203

12.8

99

2.9

233

22.8

 

 

Positive Control

114

13.3

237

11.1

331

27.1

475

22

715

12.2

239

2

338

8.4

435

3.1

Strain 98

Dose

No Activation 
(Equivocal)

No Activation 
(Equivocal)

No Activation 
(Weak Positive)

10% HLI 
(Negative)

30% HLI 
(Negative)

10% RLI 
(Negative)

30% RLI 
(Negative)

Protocol

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

19

4.2

14

0.9

16

2.7

32

2

24

0.6

30

0.9

20

0.6

33     

15

2.1

14

2.8

 

 

28

5.2

22

2.7

24

1.2

19

2.8

100     

15

0.9

19

4

20

4.4

24

4

23

4.1

24

2.4

20

2

333     

19

1.2

16

2.2

18

3.2

33

1.2

17

1.3

24

2.1

18

2.6

1000     

19

1.3

17

2.6

17

2.6

32

5.5

24

3

30

3.4

19

3.5

3333     

33

1.9

24

2.3

 

 

31

2.6

18

1.9

35

5.8

23

3.8

3334     

 

 

 

 

27

0.6

 

 

 

 

 

 

 

 

6667     

 

 

 

 

39

3.8

 

 

 

 

 

 

 

 

Positivecontrol

164

12.5

143

18.1

148

7.2

154

9.6

90

6.4

72

5.8

87

5.7

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):negative with and withoutThe test compound 2-aminobenzenesulphonic acid failed to induce gene mutation in the Salmonella typhimurium strains TA100,TA1535,TA98 and TA97 with and without addition of S9 liver fractions from Aroclor induced hamsters and hence is not likely to classify for gene mutation in vitro..
Executive summary:

Gene mutation toxicity study was performed for the test chemical 2-aminobenzenesulphonic acid to evaluate its mutagenic nature. Preincubation protocol was followed at dose levels of 0, 10, 33, 100, 333, 1000, 3333, 3334, 6667 µg/plate using Salmonella typhimurium strains TA100,TA1535,TA98 and TA97 with and without addition of S9 liver fractions from Aroclor induced hamsters. The test compound was tested in triplicate in the mutagenic study. The test compound 2-aminobenzenesulphonic acid failed to induce gene mutation in the Salmonella typhimurium strains TA100,TA1535,TA98 and TA97 with and without addition of S9 liver fractions from Aroclor induced hamsters and hence is not likely to classify for gene mutation in vitro..