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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 938-988-9 | 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:
- 22 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:
- 220.4 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:
- available long-term toxicity data on phosphate leading to higher NOAELs, secondary evaluations (JECFA) concluding that phosphate is a non-toxic food additive
- 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:
- 31 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:
- 1 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- NOAEL for systemic effects in oral study: 250 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:
- available long-term toxicity data on phosphate leading to higher NOAELs, secondary evaluations (JECFA) concluding that phosphate 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 phosphate 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 the analogue substance TSP (triple super phosphate). A NOAEL of 250 mg/kg bw/day was derived from an OECD 422 guideline study.
A slightly lower NOAEL of 79 mg/kg bw/day was derived from another OECD 422 guideline study with
Ca sulfate, which constitutes only about 5% of the submission substance. Based on the low content of Ca sulfate and the similar NOAEL it is considered that the NOAEL derived from TSP is a suitable basis to derive DNELs.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 toxicity and ample long-term experience exist with its occurrence in food. Both Ca sulfate and phosphate are approved food additives. 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 consumer uses 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.