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Diss Factsheets
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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The data from read across chemical 1,2-benzisothiazol-3(2H)-one 1,1-dioxide sodium salt is considered to be just the salt coumpound of the target chemical and which have more than 87.8 % structural similarity. Thus it is expected to have the similar toxicological impact.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt
- EC Number:
- 204-886-1
- EC Name:
- 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt
- Cas Number:
- 128-44-9
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test System
1. Test Species : New Zealand white rabbit
2. Age : 10 to 12 weeks
3. Sex : Female
4. Body weight range : 1.60kg ±200g
5. No. of animals : Three
6. Acclimatization : The rabbit was acclimatized to standard laboratory condition for 24 hours in experimental room before study.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Duration of treatment / exposure:
- Irrigation:
The eyes of the test animal did not washed for at least 24 hours following instillation of the test compound. At 24 hours a washout may be used if considered appropriate.
Dose level:
A dose of 0.1gm of test substance was applied into the one eye of the rabbits. The other eye, which remains untreated, serves as a control. - Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after test substance application. The grades of ocular reaction (conjunctiva, cornea and iris) were recorded at each observation. To determine the reversibility of the effect the animal was observed normally for 21 days. Any other lesions in the eye viz pannus, staining were observed and scored accordingly. Examination of reactions was facilitated by use of biomicroscope and hand slit lamp. After recording the observations at 24 hours, the eyes were further examined with the aid of fluorescein. Individual animal weight before and during the study was also observed
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Results
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Other effects:
- Irritation Scoring
The test compound Sodium saccharin when applied to the eye of New Zealand white rabbit at the dose level of 0.1 gm did not produced any lesions such as pannus, staining throughout the observation period of 72 hours. However some blood vessels of conjunctiva were observed hyperemic at 1 to 24th hour after the application of test substance.
Clinical Signs
The test compound Sodium saccharin applied in conjunctival sac of rabbits did not show any observable clinical signs throughout the observation period of 21 days.
Any other information on results incl. tables
GRADING OF OCULAR LESIONS
S.NO |
SEX |
OBSERVATION |
Score |
Total score |
|||
1 |
F |
1 hour |
24hours |
48 hours |
72 hours |
||
Cornea |
0 |
0 |
0 |
0 |
0 |
||
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
1 |
0 |
0 |
0 |
1 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
||
2 |
F |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
1 |
0 |
0 |
0 |
1 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
||
3. |
F |
Cornea |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
1 |
0 |
0 |
0 |
1 |
||
Chemosis |
0 |
0 |
0 |
0 |
0 |
||
Grand total |
3 |
||||||
Total mean |
1 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The result obtained from current Acute Eye Irritation study concludes that the test compound 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt (Sodium saccharin) in the amount of 0.1gm is practically non irritant to the eyes of New Zealand white rabbit when applied at the dose level of 0.1 gm.
- Executive summary:
The result obtained from current Acute Eye Irritation study concludes that the test compound 1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt (Sodium saccharin) in the amount of 0.1gm is practically non irritant to the eyes of New Zealand white rabbit when applied at the dose level of 0.1 gm.
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