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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:
key study
Study period:
29. Sep to 02. Nov 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
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:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
not specified
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:
24508-10-9
Molecular formula:
C19 H24 O2
IUPAC Name:
3-methoxy-1,3,5(10)-estratriene-17β-ol
Test material form:
solid
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

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

Results and discussion

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

Applicant's summary and conclusion

Interpretation of results:
other: no substance related mortality observed
Conclusions:
The acute oral toxicity of estrone-methylether in rats is above 2000 mg/kg body weight.
Executive summary:

The single oral administration of estrone-methylether 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 estrone-methylether in rats is above 2000 mg/kg body weight.