Prasterone

Endpoint summary

Description of key information

There is one study available that investigates the local tolerance of rabbits to the substance after a 28-days repeated application. Although only limited data were provided  the study does not give evidence for a skin irritating potential of the substance, especially taking into account the repeated exposure.
[Schering AG, Report No. 909, 1973-02-22]

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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

Species:

rabbit

Strain:

not specified

Remarks:

Albinos

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There is one study on skin irritation available. In this study the local tolerance to the test substance was tested on the intact or scarified skin of 5 rabbits, which were treated daily for 28 days with the formulated substance or with the vehicle (fatty ointment) as negative control.

Since animals of the vehicle control showed essentially the same macroscopic and microscopic changes no evidence for an acute irritation property of the substance was concluded. Moreover, skin evaluation was performed after a daily treatment for 28 days! The authors of the study stated that based on the findings and taking into account the higher sensivity of the rabbit skin it would be unlikely that local intolerance reactions would occur for humans after skin contact to the substance.

Justification for classification or non-classification

Based on the available in vivo data the substance is not classified for skin irritation/ corrosion according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008 (CLP).