Androsta-1,4-diene-3,17-dione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Aug to Sep 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Remarks:

- but a QA check was not performed

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Androsta-1,4-diene-3,17-dione

EC Number:

212-977-2

EC Name:

Androsta-1,4-diene-3,17-dione

Cas Number:

897-06-3

Molecular formula:

C19H24O2

IUPAC Name:

androsta-1,4-diene-3,17-dione

Constituent 2

Reference substance name:

1,4-Androstadiene-3,17-dione

IUPAC Name:

1,4-Androstadiene-3,17-dione

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 900 mg NaCl + 85 mg Myrj 53 ad 100 ml bidest water

Doses:

2000 mg/kg

No. of animals per sex per dose:

3 females

Control animals:

no

Results and discussion

Effect levels

Sex:

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. The main clinical findings after administration of 2000 mg/kg ZK 4947 were apathy, disturbances in gait, prone or lateral position while conscious, vocalization, biting of objects, convulsions, eyelid closure, sialorrhea and disturbances in respiration mainly on the application day. All animals were without compound-related findings from day 3 onwards. The body weight gain on days 8 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 (gavage) of the test substance to female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, effects on body weight gain and gross pathological findings. The main clinical findings were apathy, disturbances in gait, prone or lateral position while conscious, vocalization, biting of objects, convulsions, eyelid closure, sialorrhea and disturbances in respiration mainly on the application day. All animals were without compound-related findings from day 3 onwards. According to OECD TG 423 the oral LD50 of ZK 4947 (androstadiendion) in female rats is therefore > 2000 mg/kg body weight.