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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13. July to 14. Aug 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

3 instead of 5 animals/sex used

GLP compliance:

yes

Test type:

fixed dose procedure

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

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: 109-115 g; females: 96-107 g
- Fasting period before study: ca. 19 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 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-24°C
- Humidity (%): 42-60%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

not specified

Vehicle:

physiological saline

Remarks:

900 mg NaCI + 85 mg Myrj® 53 ad 100 ml bidist. water

Duration of exposure:

24 hours

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 observations and weighing: start (day 1), on day 7 and at the end (day 14) of the study
- Necropsy of survivors performed: yes
- Other examinations performed: evaluation of local tolerance 24, 48 and 72 hours after the end of administration

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 occurred

Clinical signs:

other: The test substance was tolerated without any clinical findings.

Gross pathology:

The test substance was tolerated without any macroscopic pathological findings.

Applicant's summary and conclusion

Conclusions:

The single dermal, 24 h-administration of estrone methylether to male and female Wistar rats at the dose of 2000 mg/kg was tolerated without any clinical or macroscopic pathological findings. The acute dermal toxicity of the test item is above 2000 mg/kg body weight.

Executive summary:

In an acute dermal toxicity study similar to OECD TG 402 performed as a combined study on acute toxicity and on local tolerance Wistar rats (3/sex) (3/sex) were dermally exposed to estrone methylether in physiological saline for 24 hours at a limit dose of 2000 mg/kg bw. Animals then were observed for 14 days.

The administration of the test substance was tolerated without any clinical or macroscopic pathological finding. The dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.