Registration Dossier

Administrative data

Description of key information

A Modified Draize-Shelanski Repeat Insult Patch Test was carried out to test for sensitisation (Induction 2.5 % in petrolatum, Challenge 1% in petrolatum) .There was no irritation or sensitisation from this material. It is unlikely that this material would present a danger of irritation or sensitisation in normal, intended use.

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 was carried out with registered substance as a key test to investigate sensitisation with a test item containing 96% active ingredient (Kligman 1976). Approximately 300 mg of the test material (2.5% test material in petrolatum) was applied as induction to patch sites on the backs or volar forearms of 100 subjects for ten alternate-day 24 hour periods under occlusion. Following a seven-day rest period, challenge patches (1% test material in petrolatum) were applied in the same manner to fresh sites on the backs 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 sensitisation from this material on the Draize-Shelanski Test. It is unlikely that this test item would present a danger of irritation or sensitisation in normal, intended use.

Further information supporting the absende 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).



Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

As there was no indication for sensitisation from the Human Patch test for current substance and category analogues, classification for skin sensitisation is not needed according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008).