Registration Dossier

Administrative data

Description of key information

Ammonium hexafluorosilicate is considered to be not sensitising to the skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vitro
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Currently no studies evaluating sensitisation potential of ammonium hexafluorosilicate are available. However, a structurally similar substance, sodium hexafluorosilicate has been investigated in humans.

A case of pustules being seen in a worker after the exposure to foam rubber was reported by Dooms-Goossens et al, 1984. The authors suspected this being the result of sodium fluorosilicate, one of the ingredients of the foam rubber and conducted investigations through patch and scratch testing.

Scratch testing with the sodium hexafluorosilicate (2% aq.) and water was carried out, in which the applications were done 3 times a day on the forearm. The observations were carried out after 48 and 96 hours the applications. The test was negative after 48 as well as 96 hours. At the 48 hour observation, slight itching and barely visible papules were seen with subjecs treated with water. Patch testing with sodium hexafluorosilicate, 0.5% aq. was also found to be negative after 48 and 96 h.

Based on these results, sodium hexafluorosilicate can be concluded to be not a sensitiser to the skin. Hence, using the principles of read across, ammonium hexafluorosilicate is also considered not to be a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, ammonium hexafluorosilicate is conisdered to be not sensitising to the skin, hence it does not require classification according to the CLP (Regulation EC No. 1272/2008) criteria.