Registration Dossier
Registration Dossier
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EC number: 603-033-4 | CAS number: 1251-28-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Sep to Oct 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 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
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 21-Acetoxy-6 alpha-fluoro-16 alpha-methyl-4-pregnene-3,20-dione
- EC Number:
- 603-033-4
- Cas Number:
- 1251-28-1
- Molecular formula:
- C24 H33 F O4
- IUPAC Name:
- 21-Acetoxy-6 alpha-fluoro-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: 0.9 % NaCl solution + 0.085 % Myrj 53 in bidest water
- Doses:
- 200 and 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
No animal died in the course of the study. After single oral application of 2000 mg/kg slight apathy, atactic gait (females only ) and ruffled fur (both sexes) were observed during the first post observation day. All animals were without findings from day 2 onwards. At 200 mg/kg no clinical signs were observed in male and female rats. The body weight gain on days 7 and 14 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:
A single oral administration of the test substance by gavage to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, effects on body weight gain and gross pathological findings. At 2000 mg/kg clinical signs (slight apathy, atactic gait and ruffled fur) were observed during the first post observation day. According to OECD TG 423 the oral LD50 of ZK 4841 is therefore > 2000 mg/kg body weight.
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