Registration Dossier
Registration Dossier
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EC number: 609-766-6 | CAS number: 39987-86-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Nov to Dec 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione
- EC Number:
- 609-766-6
- Cas Number:
- 39987-86-5
- Molecular formula:
- C22 H32 O3
- IUPAC Name:
- 21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 900 mg NaCl + 85 mg Myrj 53 ad 100 ml bidest water
- Doses:
- 200 and 2000 mg/kg
- No. of animals per sex per dose:
- 200 mg/kg: 3 males and 3 females; 2000 mg/kg: 3 males
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: LD50 cut-off
- Effect level:
- > 300 - < 500 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
All male animals died after application of 2000 mg/kg bw on day 1. After application of 200 mg/kg bw all male and female animals survived.
The main clinical findings were apathy, disturbances in position and in gait at 200 and 2000 mg/kg bw. Retarded respiration and eyelid closure were also observed after application of 2000 mg/kg bw. All surviving animals were without findings from day 2 onwards.
The body weight gain on days 7, 14 and 21 was within the normal range for rats of this age and strain, which are routinely used in the laboratory.
Autopsy revealed no compound-related findings.
Applicant's summary and conclusion
- Executive summary:
The acute oral toxicity of ZK 9340 was moderate with a LD50 > 300 - < 500 mg/kg bw in rats (cut-off value) according to OECD TG 423. All males died after administration of 2000 mg/kg bw. All males and females of the dose group 200 mg/kg bw survived. Clinical signs were observed at 200 mg/kg bw and above in both genders. Body weight development was not affected until 2000 mg/kg bw. Autopsy revealed no compound-related findings.
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