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Diss Factsheets
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EC number: 910-697-1 | 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
Endpoint summary
Administrative data
Description of key information
No study is available on the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate. However, reliable acute inhalation, oral and dermal toxicity studies are available on its three main constituents registered individually. None of the three main constituents are considered to be harmful by inhalation and oral route, and the dermal route is considered to be not relevant. Therefore, the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate is also not considered to be hazardous by inhalation, oral or dermal routes.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Reliable LD50 results are available on the 3 individual constituents registered.
The LD50 of calcium fluoride and calcium carbonate were above 2000 mg/kg (no mortality observed). In a GLP-Acute toxicity study in rat exposed to calcium sulfate dihydrate by oral route the LD50 was above 2000 mg/kg (no mortality observed). The calculated LD50 of the anhydrous form is < 1581 mg/kg. It is however more likely that the reaction mass contains partially hydrated calcium sulfate.
When considering the experimental results on the constituents, the Acute Toxicity Estimate for the reaction mass can be calculated as > 2277 mg/kg.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Reliable LD50 results are available on the 3 individual constituents registered, tested individually at their respective maximum technically achievable concentration without inducing mortality or adverse clinical signs.
Therefore, no adverse effect are expected from acute inhalation exposure to the reaction mass.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The LD50 of the substance is based on the LD50 of Calcium carbonate determined in a GLP-Acute toxicity study in rat exposed to the nano form of calcium carbonate by dermal route
Additional information
Acute toxicity : oral route
A key study was identified for each of the three main constituents of the reaction mass substance. A study was performed according to the 423 OECD Guideline on the calcium fluoride (Cords & Lammer, 2010). Studies were performed according to the 420 OECD Guideline on the calcium sulfate dihydrate (NIER, 2003) and on the nano calcium carbonate (Bradshow, 2008). In these three studies, rats received a dose of 2000 mg/kg bw (limit test). No mortality and no clinical signs were observed in any case. Therefore, acute oral LD50 is considered to be higher than 2000 mg/kg bw for calcium fluoride and calcium carbonate, and higher than 1581 mg/kg bw for calcium sulfate anhydrous (ca. based on the LD50 of calcium sulfate dihydrate > 2000 mg/kg bw). Based on these available data, the worst-case value was chosen for the registered dossier. Hence, the acute oral LD50 of the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate is considered to be higher than 1581 mg/kg bw.
Acute toxicity : inhalation
A key study was identified for each of the three main constituents of the reaction mass substance. Nose-only limit-test studies were performed according to the 403 OECD Guideline on the calcium fluoride (Mommers, 2002), the calcium sulfate dihydrate (Griffiths, 2010) and the nano calcium carbonate (Schuler, 2010). Rats were exposed for 4 hours up to 5.07 g/m3 for calcium fluoride, 3.26 mg/L for calcium sulfate dihydrate and 3 mg/L for nano calcium carbonate. These concentrations were the highest technically achievable. No mortality and no adverse clinical signs were observed in any case. Therefore, acute inhalation LC50 is considered to be higher than 5.07 g/m3 for calcium fluoride, higher than 3 mg/L for calcium carbonate, and higher than 2.61 mg/L for calcium sulfate anhydrous (ca. based on the LC50 of calcium sulfate dihydrate). Based on these available data, the worst-case value was chosen for the registered dossier. Hence, the acute inhalation LC50 of the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate is considered to be higher than 2.61 mg/L (2610 mg/m3).
Acute toxicity : dermal route
A Key study was identified for the calcium carbonate, performed according to the OECD Guideline 402 (Bradshow, 2010). The nano calcium carbonate was applied as a paste in arachis oil to the skin of rats at a dose of 2000 mg/kg bw and covered with a semi-occlusive dressing for 24 hours. No death and no clinical signs of systemic effects were observed. The LD50 is considered to be higher than 2000 mg/kg bw.
Calcium fluoride and calcium sulfate are shown to be of inherently low toxicity by the oral and inhalation routes. Dermal absorption is also likely to be insignificant for this inorganic salt of low solubility, therefore it can be reliably predicted that the acute dermal toxicity of the substance will be very low. A study of acute dermal toxicity is scientifically unjustified and additionally cannot be supported for reasons of animal welfare.
Therefore, the acute dermal LD50 of the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate is considered to be higher than 2000 mg/kg bw.
Justification for classification or non-classification
Harmonised classification
Reaction mass of calcium fluoride and calcium sulfate and calcium carbonate has no harmonised classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification
Based on the available data on its three main constituents, no additional self-classification is proposed regarding :
- Acute oral, dermal, and inhalation toxicity and,
- Specific target organ toxicity – single exposure
according to the Regulation (EC) No. 1272/2008 (CLP) as the studies were performed up to the highest recommanded doses or highest achievable concentrations.
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.