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:

The contact sensitization of ITTFEP (purity 82.3%) to guinea pigs (Ibn: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted)) was determined in a GLP compliant test according to OECD 406, EU Method B.2 and OPPTS 870.2600. Since the study from Acrelin (2001) was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. 

 

For the contact sensitization test 10 males and 10 females were first intradermally inducted (Day 1), then epidermally inducted (day 8) and epidermally challenged for 24 hours on day 22. Readings were performed 24 and 48 hours after removing the dressings. FCA was used in combination as vehicle. Concentrations were 5% for intradermal and 100% for epidermal applications.

 

There were no clinical findings during the study. In none of the readings any unusual sensitization findings other than in the controls were found.

  

It can be concluded that under the experimental conditions the test substance is not a skin sensitizer for guinea pigs according to the testing scheme from Magnuson and Kligman.

Justification for classification or non-classification

According to the classification criteria set out in Directive 67/548/EEC and Regulation (EC) No. 1272/2008 the substance does not fulfil the criteria for classification as skin sensitizer.