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Toxicological information

Acute Toxicity: other routes

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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 study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):norethisterone enanthate (ZK5410)

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 (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 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 ZK 5410 in rats is above 1000 mg/kg body weight.