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Administrative data

Description of key information

Oral (Rat-Wistar, GLP, OECD TG423): LD50 >2000 mg/kg
(Schering AG, Report No: A03235; 2001-02-26)
Dermal (Rat-Wistar, GLP, OECD TG402): LD50 >2000 mg/kg
(Schering AG, Report No: A03234; 2001-02-26)
Additionally results of acute toxicity studies with aldona are cited in RTECS database (Feb 2010):
Intraperitoneal (rat); LD50: >700 mg/kg
(Journal of Pharmacology and Experimental Therapeutics. (Williams and Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10- v. 126, p. 123, 1959 (JPETAB))
Intraperitoneal (rat); LD50: 490 mg/kg
(Journal of Pharmacology and Experimental Therapeutics. (Williams and Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10- v. 126, p. 123, 1959 (JPETAB))

Key value for chemical safety assessment

Additional information

The single oral administration of ZK57564 to male and female Wistar rats (3/sex) at the dose of 2000 mg/kg resulted in transient rough hair coat, apathy, squatting position, decreased body temperature only in females. No compound-related macroscopic findings were seen. LD50 >2000 mg/kg [Schering AG, Report No: A03235; 2001-02-26]

Single dermal application of ZK 57564 to rats (3/sex) for 24 hours did not induce any clinical or pathological signs. LD50 >2000 mg/kg [Schering AG, Report No: A03234; 2001-02-26]

Additionally results of acute toxicity studies with aldona are cited in RTECS database (Feb 2010):

Intraperitoneal application of aldona to rats results in LD50: >700 mg/kg [Journal of Pharmacology and Experimental Therapeutics. (Williams and Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10- v. 126, p. 123, 1959 (JPETAB)]

Single intraperitoneal application to rat lreas to an LD50: 490 mg/kg [Journal of Pharmacology and Experimental Therapeutics. (Williams and Wilkins Co., 428 E. Preston St., Baltimore, MD 21202) V.1- 1909/10- v. 126, p. 123, 1959 (JPETAB)]

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.

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