Registration Dossier

Administrative data

Description of key information

Skin irritation (OECD 404): not irritating (BASF 18H0125/872240; 1987)

Eye irritation (OECD 405): eye irritating (BASF 11H0125/872092, 1987)

Key value for chemical safety assessment

Additional information

Skin irritation

The acute skin irritation potential of ethylenediamine, +4PO was tested in white New Zealand rabbits according to the OECD guideline 404 (BASF SE 18H0125/872240; 1987). 0.5 g test substance were topically applied to the skin of 3 rabbits for 4 hours under semi-occlusive dressing. No signs of local skin irritation were reported within the observation period of 72 h. Thus, the test substance can be considered as non irritating to the skin.

Eye irritation

To assess the acute eye irritation potential of ethylenediamine, +4PO a study according to OECD guideline 405 was performed in white New Zealand rabbits (BASF SE 11H0125/872092; 1995). An amount of 0.1 ml test substance was singly applied to the eyes of three rabbits. The mean conjuctivae score was 1 and the mean cornea score was 2 in each animal. The findings were reversible in all animals within 15 days after application. The mean scores for chemosis and iris were not significantly increased.

 Overall, the study can be considered reliable for assessment. Under the chosen testing conditions, ethylenediamine +4PO shows eye irritating potential.

Effect level: empty Endpoint conclusion: Adverse effect observed

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC):

The available study is considered reliable and suitable for classification purposes under 67/548/EEC. In conlcusion, ethylenediamine, +4PO does not require classification concerning skin and eye irritation.

 

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

The available experimental test data is reliable and suitable for classification purposes under EU Regulation 1272/2008. ethylenediamine, +4PO does not require classification for skin irritation. The eye irritating properties are classified as "irritating to eye" cat. 2 according to EU-GHS.