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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
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
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:
Errol Zeiger, Beth Anderson, Steve Haworth, Timothy Lawlor, and Kristien Mortelmans
Year:
1988
Bibliographic source:
Environmental and Molecular Mutagenesis Volume 11, Supplement 12: 1-158 (1988)

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
The test chemical o-Amino benzenesulfonic acid was studied for its ability to induce mutations in strains of Salmonella typhimurium.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
2-aminobenzenesulphonic acid
EC Number:
201-810-9
EC Name:
2-aminobenzenesulphonic acid
Cas Number:
88-21-1
IUPAC Name:
2-aminobenzenesulfonic acid
Details on test material:
- Name of test material: o-Amino benzenesulfonic acid
- IUPAC name: 2-aminobenzene-1-sulfonic acid
- Molecular formula: C6H7AsNNaO3
- Molecular weight: 239.0373 g/mol
- Substance type: Organic
Specific details on test material used for the study:
- Name of test material: o-Amino benzenesulfonic acid
- IUPAC name: 2-aminobenzene-1-sulfonic acid
- Molecular formula: C6H7AsNNaO3
- Molecular weight: 239.0373 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 95%
- Impurities (identity and concentrations): 5%

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA100, TA1535, TA97 and TA98
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
10% and 30% HLI and RLI S-9 (9,000 g supernatant) fractions were prepared from Aroclor 1254-induced, male Sprague- Dawley rat and male Syrian hamster livers
Test concentrations with justification for top dose:
0, 10, 33, 100, 333, 1000, 3333, 3334 or 6667 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical is soluble in DMSO

Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
sodium azide
other: 4-nitro-o-phenylenediamine (TA98; -S9) and 2-aminoanthracene (all strains; +S9)
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- 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 available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available

SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available

NUMBER OF REPLICATIONS: Triplicate

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available

OTHER: No data available
Rationale for test conditions:
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 two fold 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 nonmutagenic (-) 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 nonmutagenicity.
Statistics:
Mean ± SD

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium, other: TA100, TA1535, TA97
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
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
without
Genotoxicity:
positive
Remarks:
Weakly
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data available
- Effects of osmolality: No data available
- Evaporation from medium: No data available
- Water solubility: No data available
- Precipitation: No data available
- Other confounding effects: No data available

RANGE-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. 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: Yes

ADDITIONAL INFORMATION ON CYTOTOXICITY: No data available
Remarks on result:
other: No mutagenic potential

Any other information on results incl. tables

Table: Mutagenicity of o-Amino benzenesulfonic acid

Dose (µg/plate)

TA100

-S9

10% HLI

30% HLI

10% RLI

30% RLI

Mean

SEM

Mean

SEM

Mean

SEM

Mean

SEM

Mean

SEM

0

102

4.6

77

7.8

130

2.4

87

4.7

121

9.0

10

 

 

 

 

 

 

 

 

 

 

33

99

2.0

91

2.1

112

11.1

73

5.8

121

2.2

100

101

5.7

110

11.0

115

2.0

72

3.6

126

12.1

333

95

2.0

86

2.7

120

2.5

76

3.1

121

9.1

1000

91

7.0

91

2.7

112

5.0

78

2.1

116

2.3

3333

93

4.6

84

5.4

115

4.0

75

0.3

127

5.0

3334

 

 

 

 

 

 

 

 

 

 

6667

 

 

 

 

 

 

 

 

 

 

Positive control

236

12.8

333

18.8

357

9.7

399

16.7

394

9.3

 

Dose (µg/plate)

TA1535

-S9

10% HLI

30% HLI

10% RLI

30% RLI

Mean

SEM

Mean

SEM

Mean

SEM

Mean

SEM

Mean

SEM

0

8

0.7

8

0.3

5

0.0

11

2.0

9

1.3

10

 

 

 

 

 

 

 

 

 

 

33

7

0.3

9

0.9

8

2.0

9

0.9

12

1.7

100

6

1.5

11

1.5

5

1.7

6

1.0

7

1.8

333

7

1.8

12

1.5

8

1.2

9

1.8

12

2.1

1000

8

1.5

11

0.9

7

0.9

8

1.8

6

1.5

3333

6

0.7

6

0.9

7

1.0

5

0.9

9

0.6

3334

 

 

 

 

 

 

 

 

 

 

6667

 

 

 

 

 

 

 

 

 

 

Positive control

56

7.9

52

2.5

40

4.2

39

2.9

58

3.9

 

Dose (µg/plate)

TA97

-S9

10% HLI

30% HLI

10% RLI

30% RLI

Mean

SEM

Mean

SEM

Mean

SEM

Mean

SEM

Mean

SEM

0

90

1.7

107

4.9

184

4.5

104

4.1

155

5.8

10

 

 

 

 

 

 

 

 

158

7.3

33

77

8.5

107

3.8

209

13.2

104

4.7

162

4.3

100

77

7.8

115

9.7

206

13.5

95

4.9

154

12.8

333

66

6.8

89

5.7

209

5.8

99

4.3

159

3.5

1000

58

2.0

100

9.6

227

10.0

105

2.7

171

36.9

3333

78

3.5

103

9.2

203

12.8

99

2.9

 

 

3334

 

 

 

 

 

 

 

 

 

 

6667

 

 

 

 

 

 

 

 

 

 

Positive control

331

27.1

475

22.0

715

12.2

239

2.0

435

3.1

 

Dose (µg/plate)

TA98

-S9

-S9

-S9

10% HLI

30% HLI

10% RLI

30% RLI

Mean

SEM

Mean

SEM

Mean

SEM

Mean

SEM

Mean

SEM

 

 

 

 

0

19

4.2

14

0.9

16

2.7

32

2.0

24

0.6

30

0.9

20

0.6

10

 

 

 

 

 

 

 

 

 

 

 

 

 

 

33

15

2.1

14

2.8

 

 

28

5.2

22

2.7

24

1.2

19

2.8

100

15

0.9

19

4.0

20

4.4

24

4.0

23

4.1

24

2.4

20

2.0

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

3.0

30

3.4

19

3.5

3333

33

1.9

24

2.3

 

 

31

2.6

28

1.9

35

5.8

23

3.8

3334

 

 

 

 

27

0.6

 

 

 

 

 

 

 

 

6667

 

 

 

 

39

3.8

 

 

 

 

 

 

 

 

Positive control

164

12.5

143

18.1

148

7.2

154

9.6

90

6.4

72

5.8

87

5.7

 

S: Slight clearing of background lawn

Applicant's summary and conclusion

Conclusions:
o-Amino benzenesulfonic acid is not mutagenic to the Salmonella typhimurium TA100, TA1535, TA97 in the presence and absence of rat and hamster liver S9 metabolic activation system. Some mutagenic activity is noted for the strain TA98 in the absence of S9 metabolic activation system. Since the test chemical does not exhibit gene mutation activity in the presence of S9 metabolic activation system and hence the test chemical is considered to be non mutagenic in vitro.
Executive summary:

o-Amino benzenesulfonic acid was studied for its ability to induce mutations in strains of Salmonella typhimurium.

 

The test compound was dissolved in DMSO and was tested at concentration of 10, 33, 100, 333, 1000, 3333, 3334 or 6667 µg/plate using Salmonella typhimurium TA100, TA1535, TA97 and TA98 in the presence and absence of 10 % and 30 % rat and hamster liver S9 metabolic activation system. Preincubation assay was performed with a preicubation for 20 mins. The plates were observed for histidine independence after 2 days incubation period. Concurrent solvent and positive controls were included in the study.

 

o-Amino benzenesulfonic acidis not mutagenic to theSalmonella typhimurium TA100, TA1535, TA97 in the presence and absence of rat and hamster liver S9 metabolic activation system. Some mutagenic activity is noted for the strain TA98 in the absence of S9 metabolic activation system. Since the test chemical does not exhibit gene mutation activity in the presence of S9 metabolic activation system and hence the test chemical is considered to be non mutagenic in vitro.