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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:

A modified Draize-Shelanski Repeat Insult Patch Test (Kligman,1976) was carried out as a key test to investigate sensitization of the test item containing 97% active ingredient. The study design was as follows: aproximately 300 mg of the test item (2.5%) was applied to patch sites on the back or volar forearms of 100 subjects for ten alternate-day 24 hour period under occlusion. Following a seven-day rest period, challenge patches of the test item (1%) were applied in the same manner to fresh sites on the back or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter. There were no instances of irritation or sensitization from this material on the Draize-Shelanski Test. It is unlikely that this material would present a danger of irritation or sensitization in normal, intended use.

Further information supporting the absence of sensitisation potential is provided in the read across justification for the Diester category, showing that all substances in the group were negative for human patch testing on the human arm skin (justification with data matrix separately attached in Section 13).

 


Migrated from Short description of key information:
A modified Draize-Shelanski Repeat Insult Patch Test was carried out to test for sensitization with Aerosol AY (Introduction 2.5%, in petrolatum; challenge 1%, in petrolatum). There was no irritation or sensitization from this material. It is unlikely that this material would present a danger of irritation or sensitization in normal, intended use.

Justification for selection of skin sensitisation endpoint:
Key study

Justification for classification or non-classification

As there was no indication for sensitisation from the Human Patch Test with current substance and category analogues, classification for skin sensitisation is not needed.