Registration Dossier

Administrative data

Description of key information

Skin irritation (Rabbit-NZW, non-GLP, OECD TG 404): slightly irritating to the skin
[Bayer AG, Report dated 1983-08-04]
Eye irritation (Rabbit-NZW, non-GLP, OECD TG 405): slightly irritating to the eye
[Bayer AG, Report dated 1983-08-03]
Eye irritation (Rabbit-NZW, GLP, OECD TG 405): corrosive to the eye
[Lonza AG, Report dated 2000-03-23]

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

In the skin irritation test all 3 animals exhibited erythema at the application sites. The greatest reactions could be observed shortly after removal of the tape (maximal grade 2) and dissolved fully within 3 days. No corrosive potential could be observed.

There are two eye irritation test available. Both were conducted according to OECD guideline but just one under GLP.

In the eye irritation test not conducted under GLP all animals showed a slight degree of cornea density after 48 to 72 h after instillation of test substance and had irritation signs at the conjunctivae. All effects were fully reversible within 2-14 days. In the second eye irritation study (conducted under GLP) methyl 3-aminocrotonate was slightly eye irritating to the eyes of two animals (all effects were fully reversible within 48 hours -9 day) but irreversible changes (an easily discernible translucent area of the cornea (score 2) from 1 h after instillation up to day 28) were seen in one animal. Therefore, methyl 3-aminocrotonate has to be classified as corrosive to the eye.

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the study results methyl 3 -aminocrotonate has to be classified with Xi, R41 according to Directive 67/548/EEC and Eye Corr. 1, H318 according to Regulation (EC) No. 1272/2008 (CLP).