Registration Dossier
Registration Dossier
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EC number: 215-137-3 | CAS number: 1305-62-0
Endpoint summary
Administrative data
Description of key information
Calcium dihydroxide: 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 calcium dihydroxide.
Calcium carbonate: Not sensitising in a murine LLNA (Bradshaw, 2010).
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There is no evidence of any sensitization potential for calcium compounds. 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.
In conclusion, all grades of calcium dihydroxide 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 lime is available. Lime does not need to be classified for sensitisation. This is supported by data available for calcium carbonate.
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