Registration Dossier
Registration Dossier
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EC number: 200-681-6 | CAS number: 68-22-4
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented study, no GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 968
- Report date:
- 1968
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- After appropriate acclimation period rats were treated with a single intramuscular dose of norethisterone enanthate. All animals were housed under standard conditions and observed daily for clinical signs. Surviving animals were sacrificed 21 days after application and examined macroscopically.
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Norethisterone enantate
- EC Number:
- 223-326-7
- EC Name:
- Norethisterone enantate
- Cas Number:
- 3836-23-5
- Molecular formula:
- C27H38O3
- IUPAC Name:
- 17-ethynyl-3-oxoestr-4-en-17-yl heptanoate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intramuscular
- Vehicle:
- castor oil
- Doses:
- 1000 mg/kg
- No. of animals per sex per dose:
- 10/sex
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
Weight loss in 2 animals after 6 - 9 days after applicaction. All male animals showed minimal decrease in testis size. All animals survived the observation period (21 days).
Applicant's summary and conclusion
- Conclusions:
- LD50 (intramuscular) norethisterone enanthate greater than 1000 mg/kg
- Executive summary:
No acute toxicity studies were conducted with ZK 5378 (norethisterone). Results of studies conducted with an ester of norethisterone (norethisterone enanthate, ZK 5410) are regarded as representative as most likely ester cleavage occurs in vivo after administration.
The single intramuscular administration of a northisterone enanthate (1000 mg/kg) to rats (10/sex) caused weight loss in 2 animals after 6 - 9 days after applicaction. All male animals showed minimal decrease in testis size. All animals survived the observation period (21 days). The LD50 (intramuscular) of acute toxicity of the test item in rats is above 1000 mg/kg body weight.
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