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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
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

Materials and methods

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

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:
female
Details on test animals or test system and environmental conditions:
weight 18 - 20 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1.2 g CMC ad 100 ml Aqua dest.
Doses:
4000 mg/kg
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

The single oral administration of a microcristalline suspension of ZK 5623 (gestonorone caproate) to female 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. 2 of 10 animals showed miliary grey-white spots in the liver. 1 of 10 animals showed miliary grey-white spots in the cortex of the left kidney. Two mesenteric lymph nodes were increased in size.

The acute oral toxicity of ZK 5623 in mice is above 4000 mg/kg body weight.

Applicant's summary and conclusion

Executive summary:

The single oral administration of a microcristalline suspension of ZK 5623 (gestonorone caproate) to female mice at a dose of 4000 mg/kg caused transient clinical signs (apathy) immediately after administration. The LD50 >4000 mg/kg was established after application of gestonoron caproate.