Registration Dossier
Registration Dossier
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EC number: 218-378-2 | CAS number: 2137-18-0
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported pre-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
- Report date:
- 1966
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): 17-alpha-hydroxy-19-norproegsteronecaproate
Constituent 1
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- female
Administration / exposure
- Route of administration:
- intramuscular
- Vehicle:
- castor oil
- Doses:
- 500 and 2000/animal; max 150 mg/kg bw
- No. of animals per sex per dose:
- 2/dose
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 150 mg/kg bw
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- Conclusions:
- Based on the results there is no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).
- Executive summary:
No acute toxicity studies were 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 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).
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