Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report date:
1968

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Gestonorone caproate
EC Number:
215-010-2
EC Name:
Gestonorone caproate
Cas Number:
1253-28-7
Molecular formula:
C26H38O4
IUPAC Name:
17-acetyl-3-oxoestr-4-en-17-yl hexanoate

Test animals

Species:
mouse
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Doses:
4000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw

Any other information on results incl. tables

Transient clinical signs (apathy) immediately after administration.

All animals were without compound-related clinical signs from Day 2 onwards.

Applicant's summary and conclusion

Executive summary:

No acute toxicity studies were conducted with ZK 5624 (gestonorone acetate). Results of studies conducted with a different ester of gestonorone (gestonorone caproate, ZK 5623) are regarded as representative as most likely ester cleavage occurs in vivo after administration.

The single intraperitoneal administration of a microcristalline suspension of ZK 5623 (gestonorone caproate) to male mice at a dose of 4000 mg/kg caused transient clinical signs (apathy) immediately after administration. All animals were without compound-related clinical signs from Day 2 onwards. No compound-related macroscopic pathological signs were observed. The acute i.p. toxicity of ZK 5623 in male mice is above 4000 mg/kg body weight.