Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Skin irritation/corrosion:

In the key study, that was performed according to OECD guideline 435 in compliance with GLP, the potential of Aminopropyl Vinyl Ether to cause dermal corrosion was assessed in the Corrositex assay (BASF SE, 2013). Based on the observed results and applying the evaluation criteria it was concluded, that Aminopropyl Vinyl Ether shows a corrosive potential in the Corrositex - Skin Corrosion Test under the test conditions chosen. The mean break through time determined in the in vitro membrane barrier test was 33 minutes and 27 seconds. The break through time indicates that the test substance has an intermediate corrosive potential and should be assigned to UN GHS skin corrosivity subcategories 1B.

The potential of Aminopropyl Vinyl Ether to cause dermal corrosion/irritation was assessed by a single topical application of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm™). The EpiDerm skin corrosion test showed the following results :

Viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 11%. Viability of the test-substance treated tissues determined after an exposure period of 1 hour was 7%.                                             

Based on the observed results and applying the evaluation criteria it was concluded, that Aminopropyl Vinyl Ether shows a severe corrosion potential in the EpiDerm™ skin corrosion test under the test conditions chosen. Therefore, the classification R34/ Cat 1B is warranted regarding the criteria laid down in 67/548/EEC and UN GHS, respectively.

The potential of Aminopropyl Vinyl Ether to cause serious damage to the eyes was assessed by a single topical application of 750 μL of the undiluted test substance to the epithelial surface of isolated bovine corneas (BASF SE, 2012). Three corneas were treated with the test substance for 10 minutes followed by a 2-hours post-incubation period. Corneal opacity was measured quantitatively as the amount of light transmission through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance relative to the control corneas.

The in Vitro Irritancy score (IVIS) of the test in the BCOP test was 227.6.

Based on the observed results and applying the evaluation criteria cited in chapter 3.10 it was concluded, that Aminopropyl Vinyl Ether causes serious eye damage in the Bovine Corneal Opacity and Permeability Test (BCOP Test) under the test conditions chosen.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data for irritation/corrosion are considered reliable and suitable for the purpose of classification. Therefore Aminopropyl Vinyl Ether is considered to be classified for irritation according to EU: C; R34, Corrosive, Causes burns.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data for irritation/corrosion are considered reliable and suitable for the purpose of classification. Therefore Aminopropyl Vinyl Ether has to be classified according to GHS: Category 1B, H314 Causes severe skin burns and eye severe damage.