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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:
other: well documented study, no GLP

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
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Norethisterone enantate
EC Number:
223-326-7
EC Name:
Norethisterone enantate
Cas Number:
3836-23-5
Molecular formula:
C27H38O3
IUPAC Name:
17-ethynyl-3-oxoestr-4-en-17-yl heptanoate
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. Hagemann
- Weight at study initiation: 90-100 g
- Fasting period before study: 18 h
- Housing: 5 per cage, Macrolon type III; conventional
- Diet (e.g. ad libitum): Altromin R, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 17 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 55-65
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: benzylbenzoate + castor oil (4+6)
Details on oral exposure:
VEHICLE
- benzyl bezoate / castor oil
- Concentration in vehicle: 50 g/100 mL
- Dose volume: 0.6 ml/100 g bw
Doses:
3000 mg/kg
No. of animals per sex per dose:
10 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 22 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Based on:
test mat.
Mortality:
1/10 female died on day 3
Clinical signs:
1/10 female was comatose on day 1-2 and died on day 3;
the other animals did not show any clinical signs
Gross pathology:
1/10 females showed stomach overloading, stomach hyperaemia, enteritis;
no other effects were noted at necropsy

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:
GHS criteria not met
Conclusions:
LD50 female rat (oral) norethisterone enanthate > 3000 mg/kg body weight
Executive summary:

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.


 

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