Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
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:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
no guideline available
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):Scheroson F Kristallsuspension

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
intramuscular
Vehicle:
not specified
Doses:
5 mg/animals
No. of animals per sex per dose:
6/dose
Control animals:
no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 other: mg/animal
Based on:
test mat.

Any other information on results incl. tables

No clinical or macroscopic pathological findings. Microscopically findings were muscle fiber degradation and regeneration at control and test substance injection site.

Applicant's summary and conclusion

Conclusions:
LD50 >5 mg/animal
Executive summary:

Single intramuscular application of 5 mg hydrocortison-21 -acetate to 6 male rabbits did not results in any treatment-related findings: LD50 >5 mg/animal