Registration Dossier

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:

A fully guideline-compliant Magnusson Kligman Test (GPMT) is available (NOTOX, 1998). 1% aqueous carboxymethyl cellulose was used as a vehicle.In the main study, ten experimental animals were intradermally injected with a 2% concentration of aluminium potassium fluoride and epidermally exposed to a 50% concentration of the test substance at day 8 (for 48 hours). Five control animals were similarly treated, but with the vehicle (1% aqueous carboxymethyl cellulose) only. Approximately 24 hours before the epidermal induction (day 8) exposure all animals were treated with 10% SDS. Scabs, erythema and/or necrosis were noted at the injection sites and no skin reactions, except for some small scabs, were noted at the epidermal application sites. Two weeks after the epidermal application all animals were challenged (epidermal exposure) with a 50% test substance concentration and the vehicle using a dressing (24 hours exposure). At 24 and 48 hours after removal of the dressing, the treated sites were assessed for challenge reactions. After challenge, no skin reactions were observed in treated and control animals.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The airway sensitisating potential of an aerosol of aluminium potassium fluoride was studied in Brown Norway rats (TNO, 2004a). One group of 6 female rats was exposed to a target concentration of 100 mg/m3 aluminium potassium fluoride for six hours a day for 5 consecutive days (sensitisation phase). Approximately 14 days later these animals were exposed to the same concentration of aluminium potassium fluoride for 30 min (challenge phase). Two control groups, also of 6 female BN rats each, were used. One group was sensitised only, the other group was exposed to air during the sensitisation phase and challenged to 100 mg/m3 for 30 min approximately 14 days later. The day after challenge hyperresponsiveness to methacholine was tested in all animals; two days after challenge the animals were necropsied. To examine possible allergenicity of aluminium potassium fluoride, total and specific IgE levels, breathing pattern and frequency during challenge, hyperresponsiveness to methacholine one day after challenge, and histopathology of the respiratory tract and bronchoalveolar lavage fluid measurements two days after challenge were carried out.

No treatment-related abnormalities were observed. Also no changes in body weight gain and organ weights were noted.

No increases in specific IgE levels or treatment-related changes in cholinergic hyperresponsiveness upon methacholine challenge were noted. There were also no changes in breathing frequency and pattern during challenge, suggesting that aluminium potassium fluoride is not a respiratory tract sensitiser. Repeated inhalation of aluminium potassium fluoride induced histopathological changes in the nasal passages, larynx, and lungs. Focal olfactory epithelial degeneration, necrosis and regeneration were observed in the nasal passages. In the larynx, there was a focal granulomatous inflammation. In the lungs, alveolar bronchiolisation and typical alveolar macrophage accumulations were seen. Sensitised animals exhibited a significantly increased percentage of neutrophils and a significantly decreased percentage of ofeosinophils in bronchoalveolar lavage fluid.The tested concentration of 100 mg/m3 for both sensitisation as well as challenge phases was therefore considered sufficiently high enough in view of the observed histopathological and bronchoalveolar lavage fluid changes.

Justification for classification or non-classification

Aluminium potassium fluoride is not a skin and respiratory tract sensitiser. In accordance to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for sensitisation.