Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Dermal (Rat-Wistar, GLP, OECD TG402): non-irritant
(Schering AG, Report No: A03234; 2001-02-26)
Eye irritation (Rabbit-Albino, GLP, OECD TG405): non-irritant
(Schering AG, Report No: A03230, 2001-02-26)

Key value for chemical safety assessment

Additional information

In the acute dermal toxicity study in rats (3/sex) no signs of skin irritation could be identified; non-irritant

[Schering AG, Report No: A03234; 2001-02-26]

The acute eye irritation of ZK 57564 was tested in 3 Albino rabbits. None of the animals showed clinical signs or signs of systemic effects 24 h after instillation. ZK 57564 is no eye irritant. [Schering AG, Report No: A03230, 2001-02-26)]

Justification for classification or non-classification

Based on the study results a classification according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP) is not required.