Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral: (Rat-Wistar, GLP, OECD TG 423): LD50 > 2000 mg/kg
[Schering AG, Report No. B060; 1999-02-22]
Dermal (Rat-Wistar, GLP, OEDD TG 402 & 404): LD50 > 2000 mg/kg
[Nihon Schering KK, Report No A11512, 2004-06-18]

Key value for chemical safety assessment

Additional information

The single oral administration of ZK 90965 to male and female Wistar rats was well tolerated with only minor clinical signs immediately after administration in one male. No other clinical signs and effects on body weight were observed. Acute oral toxicity (LD50) of ZK 90965 in Wistar rats is above 2000 mg/kg.

The single dermal administration of ZK 90965 to male and female Spraque Dawley rats was well tolerated without compound-related findings on clinical signs, body weight, and gross pathology. Acute dermal toxicity (LD50) of ZK 90965 in rats is above 2000 mg/kg. No skin irritative or corrosive potential of ZK 90965 was observed.

Justification for classification or non-classification

Not classified according to EEC criteria since LD50 > 2000 mg/kg after oral and dermal administration

Category 5 for oral and dermal administration according to GHS criteria since LD50 > 2000 mg/kg