Prasterone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Sep to Oct 1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Short report of study; basic scientific principles are met; study conducted before GLP principles were implemented

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

pre-guideline study

Principles of method if other than guideline:

Single oral administration of one substance concentration formulated in fatty ointment (10 g in 100 g) to rats (5 males and 5 females); Observation period was 22 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Prasterone

EC Number:

200-175-5

EC Name:

Prasterone

Cas Number:

53-43-0

Molecular formula:

C19H28O2

IUPAC Name:

3-hydroxyandrost-5-en-17-one

Test material form:

solid: bulk

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: fatty ointment

Doses:

33 g/kg formulation (equivalent to 3.3 g/kg active ingredient)

No. of animals per sex per dose:

5

Control animals:

other: yes, concurrent vehicle (fatty ointment)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 300 mg/kg bw

Based on:

act. ingr.

Any other information on results incl. tables

2 h up to 5 days after application apathy and occasionally lacrimation, ruffled fur and cachexia were observed.

Two animals (1 male and 1 female) died on day 3 and one female animal died on day 4. All other animals were sacrificed on day 22 without clinical symptoms.

Autopsy of the animals which died revealed substance remains in the stomach and hyperaemia of the cutaneous gastric mucosa. Furthermore petechiae and haemorrhagic erosions of the glandular gastric mucosa were found. No treatment-related pathological findings were observed for the sacrificed animals.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute oral LD50 of the substance in rats was concluded to be > 3300 mg/kg.

Executive summary:

The acute oral toxicity of the substance formulated in fatty ointment was investigated in male and female rats after one single administration of 3300 mg/kg (based on active ingredient) and within an observation period of 22 days.

2 h up to 5 days after application apathy and occasionally lacrimation, ruffled fur and cachexia were observed. Three animals (1 male and 2 females) died on day 3 or 4. Autopsy of these animals revealed substance remains in the stomach and hyperaemia of the cutaneous gastric mucosa. Furthermore petechiae and haemorrhagic erosions of the glandular gastric mucosa were found. All other animals were sacrificed on day 22 without clinical symptoms. No treatment-related gross pathological findings were observed in these animals.

Therefore, the acute oral LD₅₀ of the substance in rats was concluded to be > 3300 mg/kg.