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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29. Sep to 02. Nov 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
study was conducted prior to implementation of OECD TG 423
Deviations:
yes
Remarks:
The application of 2000 mg/kg to three animals was repeated with three animals of a different sex.
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methoxyoestra-1,3,5(10)-trien-17-one
EC Number:
216-613-3
EC Name:
3-methoxyoestra-1,3,5(10)-trien-17-one
Cas Number:
1624-62-0
Molecular formula:
C19 H24 O2
IUPAC Name:
3-methoxyoestra-1,3,5(10)-trien-17-one
Specific details on test material used for the study:
- Solubility and stability of the test substance in the solvent/vehicle: The mycrorystalline suspensions were prepared fresh on application day for immediate application and administrations were carried out within approximately 2 hours after preparation. The stability of the test item was verified analytically. In addition all samples are considered prepared correctly with regard to the results of analysis.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Schering AG
- Weight at study initiation: males: 94-104 g; females: 91-97 g
- Fasting period before study: ca. 18-18.5 hours
- Housing: 1/cage
- Diet (e.g. ad libitum): pell. Altromin R, ad libitum
- Water (e.g. ad libitum): demineralized acidified water, pH 2-3, ad libitum
- Acclimation period: 7 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 48-58%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Miglyol 812
Doses:
2000 mg/kg
No. of animals per sex per dose:
3/sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: day 8 and 14
- Necropsy of survivors performed: yes
Statistics:
Not applicable.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
other: Transient clinical signs (apathy and atactic gait). All animals were without treatment-related findings from day 2 onwards.
Gross pathology:
no effects observed

Applicant's summary and conclusion

Conclusions:
The single oral administration of the test item to male and female Wistar rats at the dose of 2000 mg/kg resulted in transient clinical signs (apathy and atactic gait). All animals were without treatment-related findings from Day 2 onwards. No compound-related macroscopic findings were seen. The acute oral toxicity of the test item in rats is above 2000 mg/kg body weight.
Executive summary:

In an acute oral toxicity study similar to OECD TG 423, fasted Wistar rats (3/sex) were given a single oral dose by gavage of estrone-methylether in Miglyol 812 at the limit dose 2000 mg/kg and observed for 14 days.


The administration of the test item resulted in transient clinical signs (apathy and atactic gait). All animals were without treatment-related findings from Day 2 onwards. No compound-related macroscopic findings were seen. The acute oral toxicity of estrone-methylether in rats is above 2000 mg/kg body weight.