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Diss Factsheets
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EC number: 207-439-9 | CAS number: 471-34-1
- 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
Bulk calcium carbonate is not a skin sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Bulk calcium carbonate and uncoated nano calcium carbonate are chemically identical. The only difference between them is the particle size, which may result in minor differences in physico-chemical properties. However, in biological systems and in the environment, both bulk and uncoated nano calcium carbonate are expected to have identical (eco)toxicological and environmental fate properties.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Uncoated nano calcium carbonate (Source): Refer to IUCLID section 1.2 for information on purity and impurities.
Bulk calcium carbonate (Target): Refer to IUCLID section 1.2 for information on purity and impurities.
The majority of new studies have been performed using uncoated nano calcium carbonate as the test material, hence it has been designated as the ‘Source’ in the read-across justification. However, for some endpoints data on bulk calcium carbonate are available and used to read-across to uncoated nano calcium carbonate so for these endpoints, marked with a * in the read-across justification document, bulk calcium carbonate is the ‘Source’.
3. ANALOGUE APPROACH JUSTIFICATION
Please refer to the justification attached in Section 13 of the dataset
4. DATA MATRIX
Please refer to the justification attached in Section 13 of the dataset - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Specific details on test material used for the study:
- Bulk calcium carbonate
- Parameter:
- SI
- Value:
- 1.74
- Test group / Remarks:
- 5 %w/w
- Parameter:
- SI
- Value:
- 1.13
- Test group / Remarks:
- 10 %w/w
- Parameter:
- SI
- Value:
- 1.19
- Test group / Remarks:
- 25 %w/w
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data are available for bulk calcium carbonate. However, a study is available for uncoated nano calcium carbonate. In the study, performed according to OECD TG 429 under GLP, the substance was applied topically to the dorsal surface of the ears of mice (CBA/Ca) [Bradshaw 2010]. Three groups, each of four animals, were treated with 50 µL (25 µL per ear) of the test substance as a suspension in dimethyl formamide at concentrations of 5 %, 10 % or 25 %w/w. A further group of four animals was treated with dimethyl formamide alone. The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group was 1.74, 1.13 and 1.19 at concentrations of 5, 10 and 25 %w/w, respectively. The test material was considered to be a non sensitiser under the conditions of the test.
The nano form of calcium carbonate was tested because this form was anticipated to represent the worst case as the smaller size particles are more likely to be transported through the skin. However, the results are directly applicable to the bulk form of calcium carbonate.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of an OECD TG 429 study performed using nano calcium carbonate and read across to bulk calcium carbonate, where the Stimulation Index was < 3, bulk calcium carbonate is considered to be a non-sensitiser and does not require classification.
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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