17-hydroxy-3-methoxyestra-2,5(10)-diene-17-carbonitrile

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Study period:

from June to August 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

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)

Deviations:

yes

Remarks:

- all three dose levels were testd although no mortalities occured after 2000 mg/kg in both sexes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

17-hydroxy-3-methoxyestra-2,5(10)-diene-17-carbonitrile

EC Number:

241-083-5

EC Name:

17-hydroxy-3-methoxyestra-2,5(10)-diene-17-carbonitrile

Cas Number:

17006-17-6

Molecular formula:

C20H27NO2

IUPAC Name:

(3aS,3bR,9bS,11aS)-1-hydroxy-7-methoxy-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,6H,9H,9bH,10H,11H,11aH-cyclopenta[a]phenanthrene-1-carbonitrile

Test animals

Species:

rat

Strain:

other: HAN:WIST (SPF)

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.9 % NaCl + 0.085 % Myrj 53 in bidist. water

Doses:

25, 200 and 2000 mg/kg

No. of animals per sex per dose:

3

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.

Any other information on results incl. tables

No animal died in the course of the study. After single oral application 25, 200 or 2000 mg/kg no clinical findings were observed in male and female animals. The body weight gain on days 7 and 14 was within the normal range for rats of this age and strain, which are routinely used in the laboratory. Autopsy revealed no compound-related findings.

Applicant's summary and conclusion

Executive summary:

A single oral administration of the test substance by gavage to male and female rats at 25, 200 and 2000 mg/kg was tolerated without mortalities, clinical signs, effects on body weight gain and gross pathological findings. According to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight.