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Administrative data

Description of key information

There is no acute toxicity study conducted with ZK 5686; read across approach with results of studies with gestonorone coproate (ZK 5623):
Oral (Mouse, non-GLP): LD50 > 4000 mg/kg
[Schering AG, 1968-07-31]
Oral (Rat, non-GLP): LD50 > 4000 mg/kg
[Schering AG, 1971-07-08]
Subcutaneous (Mouse, non-GLP): LD50 > 4000 mg/kg
[Schering AG, 1968-07-31]
Subcutaneous (Guinea pig-White Pirbright, non-GLP): LD50 > 8000 mg/kg
[Schering AG, 1965-04-13]
Intraperitoneal (Mouse, non-GLP): LD50 > 4000 mg/kg
[Schering AG, 1968-07-31]
Intraperitoneal (Mouse-NMRI, non-GLP): LD50 = 6000 mg/kg
[Schering AG, 1965-04-13]
Intraperitoneal (Rat-Wistar, non-GLP): LD 50 = 7000 mg/kg
[Schering AG, 1965-04-13]
Intramuscular (Dog-Beagle, female, non-GLP): LD50 > 150 mg/kg (2000 g/dog)
[Schering AG, 1966-11-29]

Key value for chemical safety assessment

Additional information

There is no acute toxicity study conducted with ZK 5686 (gestonorone). Results of studies conducted with an ester of gestonorone (gestonorone caproate, ZK 5623) are regarded as representative as most likely ester cleavage occurs in vivo after administration.

The single oral administration of a microcristalline suspension of ZK 5623 to male and female mice at a dose of 4000 mg/kg caused transient clinical signs (apathy) immediately after administration. All animals were without compound-related clinical signs from Day 2 onwards. No compound-related macroscopic pathological signs were observed. The acute oral toxicity of ZK 5623 in mice is above 4000 mg/kg body weight. [Schering AG, 1968-07-31]

The single oral administration of a microcristalline suspension of ZK 5623 to male and female rats at a dose of 4000 mg/kg was tolerated without any compound-related clinical or macroscopic pathological signs. The acute oral toxicity of ZK 5623 in rats is above 4000 mg/kg body weight. [Schering AG, 1971-07-08]

The single subcutaneous administration of a microcristalline suspension of ZK 5623 to male and female mice at a dose of 4000 mg/kg was tolerated without any compound-related clinical or macroscopic pathological signs. The acute subcutaneous toxicity of ZK 5623 in mice is above 4000 mg/kg body weight. [Schering AG, 1968-07-31]

The single subcuatenous administration of a microcristalline suspension of ZK 5623 to male and female guinea pigs at 8000 and 16000 mg/kg revealed transient apathy at the high dose. All animals were without symptoms from Day 2 onwards during the observation period. The acute subcutaneous toxicity of ZK 5623 in guinea pigs is above 8000 mg/kg body weight. [Schering AG, 1965-04-13]

The single intraperitoneal administration of a microcristalline suspension of ZK 5623 to male and female mice at a dose of 4000 mg/kg caused transient clinical signs (apathy) immediately after administration. All animals were without compound-related clinical signs from Day 2 onwards. One female animal (1/10) died on Day 10. No compound-related macroscopic pathological signs were observed. The acute i.p. toxicity of ZK 5623 in male mice is above 4000 mg/kg body weight. [Schering AG, 1968-07-31]

The single intraperitoneal administration of a microcristalline suspension of ZK 5623 to male mice revealed a LD50 of 6000 mg/kg. Animals died on Days 2 to 3 after administration. Clinical signs in moribund animals were apathy and prone position. [Schering AG, 1965-04-13]

The single intraperitoneal administration of a microcristalline suspension of ZK 5623 to male rats revealed a LD50 of 7000 mg/kg. Animals died on Days 2 to 4 after administration. Clinical signs in moribund animals were apathy. [Schering AG, 1965-04-13]

The single intramuscular administration of a microcristalline suspension of ZK 5623 to female Beagle dogs at a maximum dose of appr. 150 mg/kg caused transient local intolerance reactions at the application site up to Day 10 after administration and secondary effects on general condition in one animal at the high dose (increased body temperature, apathy and anorexia). All animals survived the observation period. No necropsy was performed. The acute toxicity of ZK 5623 after intramuscular administration in Beagle dogs is above approximately 150 mg/kg (2000 g/dog) [Schering AG, 1966-11-29]

Justification for classification or non-classification

For oral administration classification according to Directive 67/548/EEC and Regulation 1272/2008/EC is not required since LD50 <2000 mg/kg.