Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

In one GLP guideline study none of the animals showed skin effects in both challenge treatments. The result of the first challenge was not reproducible by the second challenge. Taking this into account, the effects of the first challenge are interpreted to be caused by nonspecific hyperreactivity reaction to a subirritant concentration of the test substance.

However, in a second GLP guideline study 10 out of 10 female guinea pigs (100%) showed a positive response.

In summary, two sensitization studies with methyl 3 -aminocrotonate exist that are valid and GLP and guideline conform but gave different results (according to one study no classification required, according to the second study classification required). There are some discrepancies (e.g. no signs of irritation observed in the second study of up to 50-60% methyl 3-aminocrotonate formulated in maize oil after dermal application but within the first study already at 12% (formulated in liquid paraffin) some irritation seen) but anyhow, since one valid and reliable GLP and Guideline conform study demonstrated a skin sensitizing potential of methyl 3-aminocrotonate the substance has to be considered as a skin sensitizer.


Migrated from Short description of key information:
Skin Sensitisation, Maximization Test according to Magnusson and Kligman (Guinea pig, GLP, OECD TG 406): not sensitising
[Bayer AG, Report No. 26525, 1997-08-07]

Skin Sensitisation, Maximization Test according to Magnusson and Kligman (Guinea pig, GLP, OECD TG 406): sensitising
[Lonza AG, Report No. 3204, 2000-03-23]

Justification for classification or non-classification

Based on the study results methyl 3 -aminocrotonate has to be classified with Xi, R43 according to Directive 67/548/EEC and with Skin Sens. 1, H317 according to Regulation (EC) No. 1272/2008 (CLP), respectively.