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EC number: 201-321-0 | CAS number: 81-07-2
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Salmonella mutagenicity tests. II. Results from the testing of 270 chemicals
- Author:
- Mortelmans, K., Haworth, S., Lawlor, T., Speck, W., Tainer, B., and Zeiger, E.
- Year:
- 1 986
- Bibliographic source:
- Environ. Mutagen. Vol. 8 (Suppl 7) (1986) 1-119
- Reference Type:
- other: Authoritative data base
- Title:
- Study ID : 659833
- Author:
- NTP Database
- Year:
- 2 012
- 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
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- in vitro bacterial gene mutation assay of Saccharin by using Salmonella strains TA1535, TA1537, TA97, TA98, and TA100
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide
- EC Number:
- 201-321-0
- EC Name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide
- Cas Number:
- 81-07-2
- Molecular formula:
- C7H5NO3S
- IUPAC Name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide
- Details on test material:
- - Name of test material (as cited in study report): 1,2-benzisothiazol-3(2H)-one 1,1-dioxide
- Substance type: Organic
- Physical state: solid
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1537
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- with 10 % & 30 % HLI = induced male Syrian hamster liver S9 and 10% & 30 % RLI = induced male Sprague Dawley rat liver S9
- Test concentrations with justification for top dose:
- 100-10000 µg/Plate
- Vehicle / solvent:
- Water
Controlsopen allclose all
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- For strains tested with S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- 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
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- For strain TA97 and TA1537 tested in the absence of S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamin
- Remarks:
- For strain TA98 tested in the absence of S9
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and 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
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and 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
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and 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
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and 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'. Remarks: Bacterial
Any other information on results incl. tables
Strain:
TA100
| Dose |
No Activation
(Negative) |
No Activation
(Negative) |
10% RLI
(Negative) |
10% RLI
(Negative) |
10% HLI
(Negative) |
10% HLI
(Negative) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Protocol | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | ||||||
| ug/Plate | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM |
0 |
148 | 8.9 | 159 | 3.2 | 148 | 16.9 | 216 | 5.7 | 152 | 4 | 156 | 6.4 |
100 |
120 | 6.4 | 167 | 14.4 | 125 | 6.7 | 201 | 6.7 | 141 | .7 | 158 | 14.3 |
333 |
142 | 11.9 | 164 | 6.7 | 119 | 7.8 | 198 | 4 | 138 | 10.7 | 161 | 5.8 |
1000 |
138 | 6 | 172 | 7.9 | 134 | 3.8 | 192 | 9.2 | 142 | 3.7 | 173 | 4.6 |
3333 |
133 | 4.2 | 170 | 8.9 | 129 | 11.8 | 189 | 2 | 143 | 6.1 | 166 | 7.4 |
10000 |
134 | 6.7 | 161 | 9.8 | 124 | 9.5 | 202 | 5 | 149 | 14.3 | 162 | 7 |
| Positive Control | 960 | 80.3 | 1504 | 29.3 | 1048 | 28.7 | 1100 | 61.4 | 1267 | 9 | 1259 | 30 |
| Dose |
No Activation
(Negative) |
No Activation
(Negative) |
10% RLI
(Negative) |
10% RLI
(Negative) |
10% HLI
(Negative) |
10% HLI
(Negative) |
||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Protocol | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | Preincubation | ||||||
| ug/Plate | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM | Mean | ±SEM |
0 |
28 | 3.2 | 28 | 3.8 | 13 | 2.9 | 12 | 4.3 | 10 | 1.2 | 15 | 2.4 |
100 |
20 | 2 | 34 | 2.2 | 12 | 4 | 14 | 1.5 | 10 | 1.2 | 19 | 1.8 |
333 |
23 | 2.9 | 31 | 1.9 | 11 | 3 | 15 | .7 | 8 | 2 | 17 | 1.8 |
1000 |
26 | 5.8 | 26 | 2.4 | 15 | 1.2 | 17 | 1.9 | 13 | 2 | 22 | 1.8 |
3333 |
23 | 0 | 34 | 2.3 | 8 | 1.5 | 16 | 3 | 9 | .9 | 20 | 2.9 |
10000 |
25 | 1.3 | 27 | 2.7 | 9 | 2.1 | 18 | 2.5 | 9 | 3.5 | 18 | .6 |
| Positive Control | 797 | 55.8 | 1114 | 67.8 | 91 | 4.6 | 111 | 9 | 120 | 16 | 128 | 3.5 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In an Ames test , 1,2-benzisothiazol-3(2H)-one 1,1-dioxide , in water from doses 100-10000 µg/Plate was not mutagenic in Salmonella typhimurium strains TA100,TA1535,TA1537 and TA98 with and without addition of S9 liver fractions from Aroclor induced hamsters. The same has been observed for rats as well. - Executive summary:
In an Ames test , 1,2-benzisothiazol-3(2H)-one 1,1-dioxide , in water from doses 100-10000 µg/Plate was not mutagenic in Salmonella typhimurium strains TA100,TA1535,TA1537 and TA98 with and without addition of S9 liver fractions from Aroclor induced hamsters. The same has been observed for rats as well.
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