17β-hydroxy-17-(3-hydroxypropyl)androst-4-ene-4-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Dec 2000 to Mar 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well reported GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

17β-hydroxy-17-(3-hydroxypropyl)androst-4-ene-4-one

EC Number:

259-701-7

EC Name:

17β-hydroxy-17-(3-hydroxypropyl)androst-4-ene-4-one

Cas Number:

55542-27-3

Molecular formula:

C22H34O3

IUPAC Name:

17 beta-Hydroxy-17 alpha-(3-hydroxypropyl)-4-androsten-3-one

Details on test material:

- Name of test material (as cited in study report): ZK 57797
- Batch No.: 59012052, white powder
- Purity: approx. 91.2% (DC)

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5% (m/v) solution of Tylose MH 1000 in distilled water

Doses:

2000 mg/kg (3 male and 3 females) and 200 mg/kg (3 females)

No. of animals per sex per dose:

3 (at 200 mg/kg only 3 females)

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

One female animal of the 2000 mg/kg dose group died one day after administration. None of the male animals and of the female animals of the 200 mg/kg dose group died. Strong clinical signs were observed only in female animals of the 2000 mg/kg dose group (rough hair coat, squatting abdominal or lateral position, apathy, coma) shortly after administration until three days after administration. None of the male animals and of the female animals of the 200 mg/kg dose group showed alterations of the general state of well-being. The strong difference between male and female animals is very conspicuous. The body weight gain was not affected in the surviving animals with exception of one female animal of the high dose group. In this case it was normal during the first week but decreased in the second week. Only in the died female animal macroscopic pathological findings (stomach content grey and thin-mushy, small intestine mucous membrane partial haemorrhagic, lung haemorrhagic infarcted) were observed. Macroscopic pathological findings were not observed in the surviving animals.

Applicant's summary and conclusion

Executive summary:

The single oral administration of the test substance (ZK 57797) to male and female rats at a dose of 2000 mg/kg and to female rats at a dose of 200 mg/kg led to death of one female animal of the 2000 mg/kg dose group died. All other treated animals survived the 14 day observation period. Strong clinical signs were observed only in female animals of the 2000 mg/kg dose group (rough hair coat, squatting abdominal or lateral position, apathy, coma) shortly after administration until three days after administration. None of the male animals and of the female animals of the 200 mg/kg dose group showed alterations of the general state of well-being. The body weight gain was not affected in the surviving animals with exception of one female animal of the high dose group. In this case it was normal during the first week but decreased in the second week. Only the died female animal showed macroscopic pathological findings (stomach content grey and thin-mushy, small intestine mucous membrane partial haemorrhagic, lung haemorrhagic infarcted).

The acute oral toxicity of Hydroxypropyltesto in rats is above 2000 mg/kg body weight.