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EC number: 201-321-0 | CAS number: 81-07-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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
- 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
- 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
- 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
- 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
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Genetic toxicity in vitro
Studies for genetic toxicity from reliable sources having Klimisch rating 1, 2 and 4.
The summary of the results are presented below
Sr.No |
Endpoint |
Interpretation of Results |
Species/Strain |
Sources |
1. |
Gene mutation |
Negative with and without metabolic activation |
S. typhimurium TA100,TA1535,TA1537 and TA98 |
Experimental data for target chemical |
2. |
Gene mutation |
Negative with metabolic activation |
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 |
Experimental data for target chemical |
3. |
Chromosome Aberration |
Negative with metabolic activation |
Chinese hamster Lung (CHL) |
Predicted data for target chemical |
4. |
Chromosome Aberration |
Negative without metabolic activation |
Chinese hamster Lung (CHL) |
Experimental data for target chemical |
5. |
Gene mutation |
Negative with and without metabolic activation |
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 |
Experimental data for RA chemical: 128-44-9 |
6. |
DNA damage and/or repair |
Negative |
WI-38 human diploid fibroblasts |
Experimental data for RA chemical: 128-44-9 |
On the basis of the above results, it can be concluded that the substance 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, is non-genotoxic.
Genetic toxicity in vivo:
In an in vivo gene DNA damage and/or repair toxicity study, male ddY mice were exposed to saccharin in the concentration of 100, 1000 or 2000 mg/kg for 3 hours and 2000 mg/kg for 24 hours. The choice of method for analysis was the comet assay. Significant migration of nuclear DNA was observed in colon at 3 hour after treatment with 1000 and 2000 mg/kg at 3 hour, and at 24 hours after treatment with 2000 mg/kg. It was also shown that non-nuclear DNA migrated in glandular stomach, liver, kidney, bladder, lung, brain and bone marrow at 3 and 24 hours. Therefore, saccharin was considered to be positive, i.e. have mutagenic effects, for colon, while being negative for all other investigated organs/tissues in male ddYmale mice after exposure tosaccharin for 3 and/or 24 hours.
Justification for selection of genetic toxicity endpoint
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. Also the chromosome aberration is based on the prediction for in-vitro mammalian chromosome aberration test on Chinese hamster Lung (CHL) with S9 metabolic activation it was estimated that 1,2-benzisothiazol-3(2H)-one 1,1-dioxide does not exhibit positive chromosomal effect.
Justification for classification or non-classification
1,2-benzisothiazol-3(2H)-one 1,1-dioxide shows negative effect in bacterial mutation studies as well as mammalian chromosome abberation studies.
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