Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 234-448-5 | CAS number: 12004-14-7
- 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
Description of key information
For Ettringite:
No acute oral or dermal toxicity was observed up to the highest tested doses. LD50 (oral)/ LD50 (dermal): > 2000 mg/kg bw.
Further data and assessment from CaSO4 according to justification for read across (see separate document in iuclid chapter 13).
LD50 (dihydrate, mouse, oral) = 4704 mg/kg bw
LD50 (hemihydrate, mouse, oral) = 5824 mg/kg bw
LD50 (dihydrate, rat, oral) = 9934 mg/kg bw
LD50 (hemihydrate, rat, oral) = 9934 mg/kg bw
NOEC (Inhalation) = 3.26 mg/L calcium sulphate dihydrate
In the registration dossier of CaSO4 is stated:
Calcium sulfate is not considered to be harmful by the oral or inhalation route. The dermal toxicity of calcium sulfate is not considered to be relevant. Calcium sulfate is an inorganic ionic solid and is not expected to penetrate the skin. Furthermore, calcium sulfate is commonly used in plaster of Paris, and is not known to have been associated with any toxic effects.
Key value for chemical safety assessment
Additional information
In the registration dossier of CaSO4 is stated:
Acute toxicity: Oral route
In a reliable OECD guideline study (NIER 2003) calcium sulfate dihydrate was administered by gavage at 2,000 mg/kg bw to 4 female rats. Rats were observed for clinical signs and mortality for 14 days. No dead animals were observed in the limit test after 14 days observation so the oral LD50 for rats was > 2000 mg/kg bw. Based on this result the oral LD50 of calcium sulfate anhydrous is >1581 mg/kg b.w.
Khodykina 1996 (supporting study): Calcium sulphate (either as dihydrate or as hemihydrate) was administered to mice and rats by oral gavage. The following LD50 values were determined:
LD50 (dihydrate, mouse, oral) = 4704 mg/kg bw
LD50 (hemihydrate, mouse, oral) = 5824 mg/kg bw
LD50 (dihydrate, rat, oral) = 9934 mg/kg bw
LD50 (hemihydrate, rat, oral) = 9934 mg/kg bw
In the key study (NIER 2003), neither mortality nor any signs of systemic toxicity were observed after single oral administration of calcium sulphate dihydrate up to a maximum concentration of 2000 mg/kg bw to rats. Khodykina et al. (1996) have administered calcium sulphate (either as dihydrate or hemihydrate) in much higher concentrations (up to 10000 mg/kg bw) to both rats and mice. For either substance, animal and route of administration, the determined LD50 values were >4000 mg/kg bw, in fact doubling the requested benchmark dose for toxicity classification.
It can therefore be stated that calcium sulphate in either form can be regarded as non-toxic.
Acute toxicity: Inhalation route
In the current study, no signs of systemic toxicity were observed in rats up to a concentration of 3.26 mg/L calcium sulphate dihydrate.
It is recognised that the mean achieved atmosphere concentration is lower than 5 mg/L which is the required concentration for classification and labelling. During characterisation, the generation system was adapted to maximise the amount of particles <4 μm, as recommended by OECD (Series on Testing and Assessment Number 39: Guidance Document on Acute Inhalation Toxicity Testing, p37): “When testing aerosols, the primary goal should be to achieve a respirable particle size (MMAD of 1-4 μm). This is possible with most test articles at a concentration of 2 mg/L. Aerosol testing at greater than 2 mg/L should only be attempted if a respirable particle size can be achieved” and EC Guidelines (Regulation EC No. 1272/2008 section 3.1.2.3.2.): “Inhaled particles between 1 and 4 microns mean mass aerodynamic diameter (MMAD) will deposit in all regions of the rat respiratory tract. […] In order to achieve applicability of animal experiments to human exposure, dusts and mists would ideally be tested in this range in rats.”
Using a higher concentration of total dust would have led to a lower amount or respirable (<4 µm) particles. It can therefore be estimated that also at higher particle concentrations no toxicity after inhalation exposure has to be expected
Acute toxicity: Dermal route.
Calcium sulfate is an inorganic ionic solid. It is expected to partition strongly to water rather than organic media. While it is not possible to measure or accurately predict an octanol/water partition coefficient for inorganic ionic substance, such a value would be expected to be very low. Electrolytes are also known not to penetrate the skin in any significant quantity. Given the physico-chemical properties of CaSO4, it is not expected that the substance would penetrate the skin in any significant quantity and so would therefore not cause any toxic effects following acute dermal exposure.
Furthermore, plaster of Paris, containing mainly the hemihydrous calcium sulfate, has been used in the immobilization of broken bones and is not known to have been associated with any toxic effects, despite intimate skin contact, for periods of the order of one month, over considerable areas of skin. As this use simulates the acute dermal toxicity, it can safely be inferred that an acute dermal exposure test would be unlikely to cause any toxic effects.
Justification for classification or non-classification
Classification according to Regulation (EC) No 1272/2008 (CLP) and Directive 67/548/EEC and subsequent regulations
- No classification needed: the data are conclusive but not sufficient for classification.
In the registration dossier of CaSO4 is stated:
Acute oral:
The acute oral toxicity of calcium sulphate was determined in two different studies. NIER 2003 found that the LD50 of calcium sulphate dihydrate after single oral application to rats is >2000 mg/kg bw. Khodykina et al. (1996) have administered much higher concentrations and found LD50 values >4000 mg/kg bw in both, rats and mice.It can therefore be stated that calcium sulphate in either form can be regarded as non-toxic and no classification is needed
Acute inhalation:
Although the current experiment does not reach the dust concentrations for classification according to Regulation EC 1272/2008 (max. limit dose of 5 mg/L) conditions were altered to achieve a maximum concentration of respirable particles (<4 µm). It can therefore be concluded that, even at higher dust concentrations, no systemic toxicity would arise.Taking into account the OECD Guidance Document on Acute Inhalation Toxicity Testing as well as Regulation EC No. 1272/2008, no classification of calcium sulphate as toxic by inhalation is justified
Acute dermal:
Calcium sulfate is an inorganic ionic solid not likely to penetrate the skin in any significant quantity. Furthermore, orthopaedic gypsum casts can be deemed to simulate acute dermal toxicity study conditions, are used for longtime without noticed any toxic effects. Therefore, it can safely be inferred that acute dermal exposure would be unlikely to cause any systemic toxic effects and therefore no classification for dermal toxicity is justified
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.