17β-hydroxy-17-(3-hydroxy-1-propynyl)androst-4-ene-3-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

other information

Study period:

Nov to Dec 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well reported 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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

3 instead of 5 animals/sex used according to acute-toxic-class-method (OECD 423)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

17 beta-Hydroxy-17 alpha-(3-hydroxy-1-propynyl)-4-androsten-3-one

IUPAC Name:

17 beta-Hydroxy-17 alpha-(3-hydroxy-1-propynyl)-4-androsten-3-one

Details on test material:

- Name of test material (as cited in study report): ZK 4829
- Batch No: 59002501

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

physiological saline

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

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 mortalities occurred. Reddened nose was observed in all animals at 1 hour after substance administration and in one of the three male animals and in two of the three female animals at 3 hours after substance administration. All animals were without clinical findings from the second day after treatment onwards. The body weight of one male decreased between day 1 and day 8 of the study. From day 8 to day 15 body weight gain was, compared to the other male animals, only slightly lower. As all other animals did not show this effect, the significance of the finding remains unclear. No compound-related findings were observed at necropsy. Moreover, no compound-related local findings were observed. The mean values of findings at the time-points 1, 24, 48 and 72 h after administration were 0 for swelling, reddening and scab formation.

Applicant's summary and conclusion

Executive summary:

The single dermal administration of the test substance (ZK 4829) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality. Reddened nose was observed in all animals at 1 hour after substance administration and in one of the three male animals and in two of the three female animals at 3 hours after substance administration. All animals were without clinical findings from the second day after treatment onwards. The body weight of one male decreased between day 1 and day 8 of the study. From day 8 to day 15 body weight gain was, compared to the other male animals, only slightly lower. As all other animals did not show this effect, the significance of the finding remains unclear. No compound-related findings were observed at necropsy.

The acute dermal toxicity of Hydroxypropinol in rats is therefore above 2000 mg/kg body weight.

Moreover, no compound-related local findings were observed. The mean values of findings at the time-points 1, 24, 48 and 72 h after administration were 0 for swelling, reddening and scab formation.