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 CTFEP (purity 91.4%) 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 with PEG as vehicle. Concentrations were 5% for intradermal and 50% for epidermal applications.

 

After the intradermal induction one male and one female died. The mortality was not considered test item related. 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.

 

The 0% incidence of challenge skin reactions to the test item is below the threshold (30% of adjuvant tests) set in the Commission Directive 96/54/EEC. Therefore, the test item is not required to be classified as skin sensitizer.

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.