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:

Evaluation of the cutaneous delayed hypersensitivity of beta-cyclodextrin was performed in the albino Dunkin-Hartley guinea-pig, according to a maximized protocol using one treated group of 20 animals of both sexes according to a guideline equivalent to the Magnusson Kligman maximation test in OECD Guideline 406.The 7 applications corresponding to the induction phase and the challenge application were conducted with the test article as supplied and at. the dose level of 0.40 g per guinea-pig (quantity corresponding to a volume of 0,5 ml) under an occlusive patch moistened with 0.5 ml of purified water.Macroscopic cutaneous examinations were performed according to the Draize scale to the challenge application site, 6, 24 and 48 hours after removal of the occlusive patches.Histopathological examinations of the skin were carried out in the6guinea-pigs showing doubtful reactions at 6 hours.Macroscopic and histopathological examinations did not reveal any lesion of "delayed hypersensitivity with cell mediation" type in the guinea-pigs.From the results obtained under the experimental conditions employed, the test article did not provoke any reaction of cutaneous sensitization.

Migrated from Short description of key information:
The substance beta-cyclodextrin did not exhibit any signs of allergic skin reaction when applied on the skin of Dunkin-Hartley guinea pigs.

Justification for classification or non-classification