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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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).       Sodium chloride is considered to be slightly to not irritating to the skin, and moderately irritating to the eyes.                                                                                                                            Potassium chloride, based on the available data from an in-vitro experiment, limited animal data, is considered to be non-irritating to the skin and to the eyes.   Cryolite is not irritating to the skin, eyes and respiratory tract.

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)

Respiratory irritation

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

Additional information

Calcium fluoride was tested for acute dermal irritation, according to OECD Guideline 404. No signs of dermal irritation were observed in any of the three rabbits (Prinsen, 2002). Calcium fluoride was tested for acute eye irritation, according to OECD Guideline 405. At 48 hours all eye effects had resolved completely.                                                                                            Sodium chloride based on the studies available for skin and eye irritation/corrosion, is considered not irritating to the skin, and to the eyes.           Potassium chloride was applied to the skin of rabbit and was evaluated as practically not irritating to the skin. Overall, based on the available data there is some evidence of an potential eye irritation of potassium chloride, but no classification is therefore proposed.      For Cryolite, as part of the available skin sensitisation study, a preliminary irritation study was conducted (NOTOX, 1998). The scores for erythema and edema were zero at both time points for all tested concentrations. For eye irritation, a primary eye irritation study was available (Raltech Scientific Services, 1981b). Based on both the mean and individual scores, cryolite is not considered irritating to the eyes.

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). No classification is therefore proposed. Sodium chloride is not formally classified in the EU (according to Regulation EC No. 1272/2008 Annex VI, Table 3.1 and Regulation EC No. 1272/2008 Annex VI, Table 3.2). Based on the considerations above, no classification is proposed for Potassium chloride.  For Cryolite,in accordance to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for skin, eye and respiratory tract irritation based on the available data.