Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 938-989-4 | CAS number: -
- 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:
- 7 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):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 69.65 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- systemic effects observed
- AF for dose response relationship:
- 1
- Justification:
- ECHA Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- secondary evaluations (EFSA/JECFA) concluding that Ca sulfate is a non-toxic food a
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA Guidance
- AF for other interspecies differences:
- 1
- Justification:
- human experience with Ca sulfate as food additive
- AF for intraspecies differences:
- 5
- Justification:
- ECHA Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA Guidance
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:
- 10 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 395 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- NOAEL for systemic effects in oral study: 79 mg/kg/d, adjustment for differences in absorption (oral 50%, dermal 10%)
- AF for dose response relationship:
- 1
- Justification:
- ECHA Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- secondary evaluations (EFSA/JECFA) concluding that Ca sulfate is a non-toxic food additive / long-term use experience as food additive
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA Guidance
- AF for other interspecies differences:
- 1
- Justification:
- human experience with Ca sulfate as food additive
- AF for intraspecies differences:
- 5
- Justification:
- ECHA Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA Guidance
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:
- medium hazard (no threshold derived)
Additional information - workers
DNEL derivation is based on the lowest NOAEL for any of the key components. A NOAEL of 79 mg/kg bw/day was derived from an OECD 422 guideline study with Ca sulfate, which constitutes about 50% of the submission substance. The NOAEL for repeated dose toxicity for phosphate is 250 mg/kg bw/day. In a conservative approach the NOAEL from the Ca sulfate study was taken as NOAEL for the submission substanc.
Starting points for DNEL derivation after route-to-route extrapolation were corrected for differences in absorption:
The following absorption fractions were assumed: oral 50%, inhalation 100%, dermal 10%.
For both Ca sulfate and phosphate evalutions by EFSA and JECFA confirm their low toxiicty and ample long-term experience exist with its occurrence in food. Ca sulfate is an approved food additive. Therefore no additional assessment factor for differences between species is considered necessary and a factor of 2 for extrapolation to chronic exposure situations is considered sufficient.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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:
- no hazard identified
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
No DNELs were derived for the general population as no consumer uses were identified
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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