Registration Dossier
Registration Dossier
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EC number: 285-561-1 | CAS number: 85117-09-5 Mixtures of chemical substances produced by burning (below 1200°C) natural variants of limestone or chalk containing from 10 to 20%, or more, of clayey or siliceous materials which are predominantly SiO2, Al2O3 and iron oxide. Consist primarily of 2CaOsb.2, Ca(OH)2, CaO and 2CaOsb.2O3. 3CaO.2SiO2, 4CaOsb.2O3. Fe2O3, 2CaOsb.2O3sb.2, CaCO3 and SiO2 may also be included.
Endpoint summary
Administrative data
Description of key information
Lime (chemical), hydraulic: No studies are available. However,
sensitisation by or intolerance to an abundantly available essential
element such as calcium would be grossly implausible and can therefore
safely be excluded for lime (chemical) hydraulic.
Calcium carbonate: Not sensitising in a murine LLNA (Bradshaw, 2010).
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There is no evidence of any sensitization potential for calcium compounds like lime (chemical) hydraulic. Calcium is abundantly available in the environment, in food and extensively distributed throughout the human body. Sensitisation by or intolerance to an abundantly available essential element such as calcium would be grossly implausible and can therefore safely be excluded.
This conclusion is supported by the results of a study performed according to OECD TG 429 under GLP in which calcium carbonate (nano) 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 calcium carbonate 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. Calcium carbonate was considered to be a non sensitiser under the conditions of the test. None of the other constituents or impurities are known to have sensitising properties.
In conclusion, all grades of lime (chemical) hydraulic are considered to be non-sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No information of any sensitising potential of calcium released from hydraulic lime (chemical) is available. Hydraulic lime (chemical) does not need to be classified for sensitisation. This is supported by data available for calcium carbonate.
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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