Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

A GLP study was performed to determine if delta-damascone would induce a hypersensitivity response in mice as measured by the proliferation of lymphocytes in the draining lymph nodes, according to OECD Guideline 429 (Calvert Laboratories, 2004).

Five groups of 5 CBA/J female mice were treated on the dorsal surface of both ears once per day for 3 days with 7.5%, 15% or 30% (w/v) of delta-damascone, with the vehicle (diethyl phthalate/ethanol in a ratio of 3:1) or with the positive control (35% hexylcinnamaldehyde [HCA]). The data indicated that the delta-damascone had skin sensitisation properties. The EC3 was calculated to be 9.6%.

Migrated from Short description of key information:
In a Local Lymph Node Assay with mice, skin sensitisation was observed. The EC3 was calculated to be 9.6%.

Justification for classification or non-classification

Based on the available data and in accordance with Directive 67/548/EEC, delta-damascone has to be classified for skin sensitisation, Xi – R43: May cause sensitisation by skin contact.

In accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, the substance has to be classified for skin sensitisation, Cat 1. – H317: May cause an allergic skin reaction.