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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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 131.3 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- other: NOAEL
- Value:
- 9 845 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- NOAEL(animal)
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute data
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Oral to Inhalation: do not apply factor for allometric scaling
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- Justification:
- K2 dats
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 18.75 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 625 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL (animal)
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Toxicokinetics
From the studies conducted in humans as well as rats that were administered saccarin as part of their diet, majority of the administered saccharin was excreted out of the living system unmetabolized via the urine and some through feaces. Majority of the toxico-kinetic studies report no metabolites.Thus, saccharin is expected to have low bio-accumulation potential under normal concentrations of intake bby humans and animals.
Skin & eye irritation
The available studies indicate that substance 1,2-benzisothiazol-3(2H)-one 1,1-dioxide is not classified as a skin and eye irritant according to CLP regulation.
Skin sensitizer
According to the quantitative structure activity relationship model prediction, 1,2-benzisothiazol-3(2H)-one 1,1-dioxide was predicted as not being sensitising to guinea pig skin by Guinea pig maximisation test.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- other: NOAEL
- Value:
- 7 500 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Oral to Inhalation: do not apply factor for allometric scaling
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.233 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 339.5 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL(animal)
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- General Population
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 7 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL (animal)
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- Justification:
- general population
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
DNEL derivation
The substance 1,2-benzisothiazol-3(2H)-one 1,1-dioxide is not expected to show acute toxicity effect by the oral, inhalation and dermal route and thus will not be considered for further classification.The substance 1,2-benzisothiazol-3(2H)-one 1,1-dioxide was found to be not irritating in skin and eye category.Available studies also indicate that the chemical does not exhibit genotoxicity and is not a reproductive toxin within the dose levels mentioned in the end points.
In the absence of local effects following short-term or long-term exposure, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for local exposure are therefore not calculated.
In the absence of acute systemic toxicity, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for acute systemic effects are therefore not calculated.
A standard approach to deriving DNEL values would be to use the repeated dose toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the NOAEL of 7500 mg/kg bw/d in oral category.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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