Registration Dossier

Administrative data

Description of key information

Calcium fluoride was found to be non-irritant in a modern proprietary guideline and GLP-compliant study (Prinsen, 2002) and was found to be a slight eye irritant in a modern proprietary guideline and GLP-compliant study (Prinsen, 2002).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation

Calcium fluoride was tested for acute dermal irritation in New Zealand White rabbit, according to OECD Guideline 404. The skin was exposed to the test substance for 4 hours under semi-occlusive conditions. At 1-72 hours after treatment, no signs of dermal irritation were observed in any of the three rabbits (Prinsen, 2002).

Eye irritation

Calcium fluoride was tested for acute eye irritation in New Zealand White rabbits, according to OECD Guideline 405. Calcium fluoride caused slight erythema and slight to moderate conjunctival chemosis. At 48 hours all eye effects had resolved completely.

Respiratory irritation

There is no evidence of respiratory irritation either from the available animal data or from experience of use.

Justification for classification or non-classification

Calcium fluoride was found to be non-irritating to skin and a mild eye irritant in guideline-compliant studies; the results do not trigger classification of the substance as 'Irritant' according to the CLP Regulation (1272/2008/EC). There is no evidence of respiratoty irritation either from the available animal data or from experience of use. No classification is therefore proposed.