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:

The sensitising potential of MDEA was investigated in a Maximisation test according to the method of Magnusson and Kligman (similar to OECD 406) in guinea pigs (10/sex) (Leung et al, 1988).The test material was administered at 5% (in propylene glycol), for the intradermal induction, and at 100%, for the topical induction, to 20 Dunkin Hartley guinea pigs (10/sex).Fourteen days after the last induction exposure, the challenge treatment was administered topically at 100%. Dermal evaluations were made approximately 24 and 48 hours after the removal of challenge/re-challenge (see below) patches. All 10 animals challenged with 0.1% of the positive control DNCB showed clear skin response while all the irritation control animals were free of skin response. Eighteen of the 20 animals challenged with 100% MDEA exhibited clear dermal responses. However, all ten irritation control animals also exhibited clear dermal responses. As the results at the challenge were equivocal, a re-challenge was performed in the same manner as the challenge, but at concentrations of 50% and 10% MDEA. In order to differentiate dermal reactions produced by irritation from those produced by sensitisation, 20 animals (5/sex/challenge; treated concurrently during induction with only vehicle or FCA/water emulsion) were subjected to the same challenge or re-challenge procedures as the animals which received test material during the induction exposures. All test group animals re-challenged with 50% and 10% MDEA were free of dermal responses. In addition, all irritation control animals were free of dermal responses, confirming that non-irritating concentrations were administered.

Under conditions of this study, MDEA produced sporadic irritation, but did not produce dermal sensitisation in guinea pigs.

Migrated from Short description of key information:
MDEA is not a skin sensitiser in animals as tested in a Maximisation test with guinea pigs (similar to OECD guideline 406).

Justification for classification or non-classification

Based on the available data, MDEA does not need to be classified for skin sensitisation according to Annex I of Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.