Registration Dossier
Registration Dossier
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EC number: 213-552-4 | CAS number: 976-70-5
Endpoint summary
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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