Prasterone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Study period:

Sept - Oct 1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Short report of study with limited documentation; study conducted before GLP principles were implemented

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Principles of method if other than guideline:

Daily application (28 days) of the substance formulated in fatty ointment on the intact or scarified skin of 5 rabbits (3 males and 2 females). Macroscopic and microscopic evaluation of treated areas.

GLP compliance:

no

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 animals

Species:

rabbit

Strain:

not specified

Remarks:

Albinos

Test system

Type of coverage:

not specified

Preparation of test site:

other: intact and scarified skin

Vehicle:

other: fatty ointment

Controls:

other: yes, concurrent vehicle (fatty ointment)

Amount / concentration applied:

0.25g of fatty ointment containing the test item (10 g/ 100g)

Duration of treatment / exposure:

Daily for 28 days

Observation period:

28 days

Number of animals:

3 males and 2 females

Results and discussion

Any other information on results incl. tables

Approximate translation of the text of study report:
Besides slight (in one case moderate) erythema, 3 animals exhibited additionally a moderate oedema on the test substance treated skin, accompanied by a low up to medium increase of the skin folds thickness. These findings partly expanded to large areas; partly did they fully cover the treated area. Microscopically, the picture of a slight irritation was seen after treatment, which means for instance low hyperkeratosis and akanthosis; 2 animals additionally showed sporadic epithelial cell necrosis, mixed cellular infiltration and congestive hyperemia in corium.
Animals only treated with the vehicle (fatty ointment) showed essentially the same macroscopic and microscopic changes, but the findings were increased in numbers.
No differences were concluded between intact or scarified skin.
Overall, the observed findings have to be seen as signs of a slight unspecific irritation that could probably mainly be ascribed to mechanical stress. The lower degree of findings in the test substance treated animals could be indicative for an anti-inflammatory effect of the substance.

Conclusion: Based on the findings and taking into account the higher skin sensitivity of rabbits it is unlikely that local intolerance reactions will occur for humans after skin contact to the substance.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No irritation due to test item; slight irritation findings based on the formulation.

Executive summary:

The local tolerance to the test substance formulated in fatty ointment was tested on the intact or scarified skin of rabbits. Therefore, 5 animals (3 males and 2 females) were treated daily for 28 days with the formulated substance (no concentration of active ingredient given) or with the fatty ointment as negative control.

No differences could be observed between intact or scarified skin. Animals of the negative control (only vehicle fatty ointment) showed essentially the same macroscopic and microscopic changes, but the findings were increased in numbers. It was concluded in the study report that the observed findings have to be seen as indication for a slight unspecific irritation that could probably mainly be ascribed to mechanical stress. The lower degree of findings in the test substance treated animals compared to controls were seen as possibly indicative for an anti-inflammatory effect of the substance.

It was concluded that based on the findings and taking into account the higher sensitivity of rabbit skin it would be unlikely that local intolerance reactions would occur for humans after skin contact to the substance.