Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 913-353-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
A negative LLNA is available for calcium difluoride.
Sodium chloride is considered as a non-sensitizer.
Potassium chloride is considered as a non-sensitizer. For Trisodium hexafluoroaluminate no adverse effect observed (not sensitising)
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Remmele (2010) reports a negative result in a LLNA performed with calcium difluoride. Calcium difluoride did not cause increases in ³H-thymidine incorporation or in the auricular lymph node cell counts. There was no increase in lymph node weights or ear weights. Sodium chloride is categorised under GRAS (Generally Recognised as Safe) by the FDA (U.S. Food and Drug Administration) and based on the results of the in-vitro study, Sodium chloride can be considered as a non-sensitizer. Migrated from Short description of key information: In a Magnusson Kligman Test with guinea pigs, no skin sensitisation was observed for Trisodium hexafluoroaluminate ( Cryolite)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No adverse health effects have been reported in RAL 3.0 product preparation workers or in those using this product.
Justification for classification or non-classification
A modern test guideline compliant LLNA demonstrates that calcium difluoride does not have skin sensitisation potential. There is no indication that the substance is a respiratory sensitiser. No classification is proposed under the CLP Regulation (1272/2008/EC). 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) and UN-GHS. For potassium chloride, 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 sensitisation. For trisodium hexafluoroaluminate, 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 sensitisation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
