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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
4. to 31. Dec 1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
castor oil
Doses:
3000 mg/kg
No. of animals per sex per dose:
10 female
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

The test substance was tolerated without any compound-related clinical signs. One female rat died on day 3. In all sacrifices animals no macroscopic pathological signs were observed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 female rat (oral) norethisterone enanthate > 3000 mg/kg body weight
Executive summary:

No acute toxicity studies were conducted with ZK 5378 (norethiosterone). 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 oral administration of ZK 5410 to 10 rats/sex at a dose of 3000 mg/kg was tolerated without any compound-related clinical signs. One female rat died on day 3. In all sacrificed animals no macroscopic pathological signs were observed.

The acute oral toxicity of ZK 5410 in rats is >3000 mg/kg body weight. [Schering AG, report no: 1063/1064, 1969-03-27]