3-methoxyoestra-1,3,5(10)-trien-17-one

Acute Toxicity: oral

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

Test material information

Constituent 1

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.