Registration Dossier
Registration Dossier
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EC number: 262-553-6 | CAS number: 60996-20-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Since no skin sensitization study is available for potassium cryolite, the results from the structural analogue multiconstituent aluminium potassium fluoride are used instead (for details see Read-across justification as attached in section 13).
A reliable skin sensitization study, performed according to OECD Guideline 406 and GLP is available for multiconsituent aluminium potassium fluoride. In this study, the skin sensitisation potential of multiconstituent aluminium potassium fluoride was investigated in a guinea pig maximisation test. Test substance concentrations selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 2% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with the vehicle (1% aqueous carboxymethyl cellulose) only. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after epidermal application all animals were challenged with a 50% test substance concentration in the vehicle. No evidence was obtained that the test substance had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result indicates a sensitization rate of 0 per cent.
Based on these results, the substance potassium cryolite is also considered as not sensitising to skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the read-across with multiconstituent aluminium potassium fluoride, potassium cryolite is not considered as sensitising to skin. In accordance to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for sensitisation.
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