Estr-5(10)-en-3-one, 17-hydroxy-, (17.beta.)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 2005 to January 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

17 beta-Hydroxy-5(10)-estren-3-one

EC Number:

600-891-1

Cas Number:

1089-78-7

Molecular formula:

C18 H26 O2

IUPAC Name:

17 beta-Hydroxy-5(10)-estren-3-one

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Han: WIST

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: no data
- Weight at study initiation: males (101 - 117 g); females (102 - 110 g)
- Fasting period before study: approximately 18-19 hours
- Housing: one per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: ≥ 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 55 - 58
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 9.0 mg NaCl + 0.85 mg Myrj 53 ad 1 mL water for injection (Ampuwa)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg
- Lot/batch no.: I: N1630A01, II: N1637A01

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: Limit dose

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 21 days
- Frequency of observations and weighing: at least once daily (clinical observation), once weekly (body weight)
- Necropsy of survivors performed: yes

Statistics:

none (limit test)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50 cut-off

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died.

Clinical signs:

other: No compound-related findings occurred.

Gross pathology:

No treatment-related findings were observed.

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity of the test substance was low with a LD50 (cut-off value) > 2000 mg/kg bw in rats according to OECD TG 423. A slight increase in body weight gain was noted in female animals on day 8 and 15. This effect was reversible on day 21 of the study. No effect on body weight gain occured in male rats. Administration was tolerated without mortalities, clinical findings and gross pathological findings.