Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

According to the OECD Guideline for Testing of Chemicals, OECD 406, skin irritation on guinea pigs was tested for lead oxide (which workers are most frequently exposed) and for lead phosphite (inorganic compound with low water solubility).

In view of the lack of toxicity, irritation or reports of sensitisation from occupational exposure settings, lead and sparingly soluble lead compounds do not appear to pose risk of sensitisation and the classification for these endpoints is not indicated.

These results can be assigned to lead silicate since a read across based on a grouping of substances (Pb substances) is applied.


Migrated from Short description of key information:
Protocol:
The potential skin sensitising properties were assessed by using 10 test and 5 control animals in the main test. Following the induction exposure to the test article (50% in petrolatum) or the vehicle petrolatum (control article), the animals of both groups were subjected two weeks later to a challenge exposure with the test article (50% in petrolatum) as well as the control article. Responses to the challenge procedure were evaluated 24 and 48 hours after the end of the exposure period.

Results:
No allergic skin reactions occurred in test animals 24 and 48 hours after the end of the challenge procedure. The sensitisation rate was 0%
-No findings were observed in control animals (reaction rate:0%).

Justification for classification or non-classification