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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 data for repeated dose toxicity are available with the substance identified as reaction mass of calcium fluoride (ca 47.5% w/w), calcium sulfate (ca 22.3% w/w) and calcium carbonate (ca 12.09% w/w). However, sub-acute or sub-chronic studies by oral and/or by inhalation are available on sodium fluoride as analogue of calcium fluoride, calcium sulfate or calcium carbonate. No adverse effects have been observed for CaSO4 and CaCO3. For NaF (the source substance for CaF2) effects have been observed to the bones and teeth in a 2-year carcinogenicity study. The reported LOAEL is 1.2 mg/kg bw/d CaF2 which corresponds to an effect level of 2.4 mg/kg bw/d reaction mass when taking into consideration that there is about 50% CaF2 in the reaction mass.
Based on a weight of evidence approach using the information on its constituents, no classification as STOT RE is warranted for the registered substance according to the criteria of CLP based on evidence repeated dose toxicity studies in animal and epidemiological studies with the constituents.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 2.4 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Reliable read across data based on sodium fluoride investigations.
- System:
- musculoskeletal system
- Organ:
- bone
- tooth
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 399 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The NOAEC of the substance is based on the NOAEC of Calcium carbonate (nano) determined in a GLP 90-day repeated dose toxicity study conducted in rat exposed by inhalation
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 1 753 mg/m³
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The NOAEC of the substance is based on the NOAEC of Calcium carbonate (nano) determined in a GLP 90-day repeated dose toxicity study conducted in rat exposed by inhalation. The NOAEC is based on some local effects (signs of inflammation at the highest dose). Taking into account that CaCO3 is present for typically 12.09 % in the reaction mass, the NOAEC could be calculated as 1753 mg/m3.
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
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 studies performed on its three main constituents, no additional classification is proposed regarding the repeated dose toxicity of the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP).
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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