Registration Dossier

Administrative data

Description of key information

No study on the substance is available. However, in vivo studies on each of the 3 main constituents show that they are not sensitisers. Therefore, the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate is not considered to be a skin or respiratory sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Reliable studies on the three main constituents of the substance - Calcium fluoride (OECD 429, LLNA), Calcium sulfate (OECD406, Buelher) and Calcium carbonate (OECD429, LLNA) - are available. No signs of sensitisation were observed. Therefore the substance is not considered to be a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are no specific animal studies to assess respiratory sensitisation but the inhalation studies on the three main constituents of the substance showed no evidence of respiratory sensitisation potential.

Therefore, the reaction mass of calcium fluoride and calcium sulfate and calcium carbonate is not considered to be a respiratory sensitiser.

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).

 

Seulf classification

Based on the available data on its three main constituents, no additional self-classification is proposed regarding Skin or Respiratory Sensitisation according to the Regulation (EC) No. 1272/2008 (CLP).