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 key study for sensitization was a LLNA test in mice (Sanders, 2007e); this study was conducted according to internationally accepted testing and GLP guidelines. Following a preliminary screening test, three groups, each of five animals, were treated with 50 µl of the undiluted test material or the test material as solution in acetone/olive oil 4:1 at concentrations of 25% or 50% v/v. A further group of 5 animals was treated with acetone/olive oil 4:1 alone. The stimulation index was 2.33, 1.94 and 2.97 for the 25, 50 and 100% solutions. All test groups were therefore negative for sensitization.

A skin sensitization (maximization test) test in guinea pig was available as a supporting study. Six intracutaneous injections were given to both test animals (20 in total) and control animals (10 animals), three on each side of the body, containing (i) FCA (ii) 10% test substance in corn oil (test animals) or corn oil only (control) and (iii) FCA in corn oil. After 1 week a patch was placed with 100% of the test substance for 48h (for the test animals). After 2 weeks, a filter paper drenched with 100% of the test substance was applied (in all groups). Reactions were observed 24h and 48h after removal of the patch. None of the animals showed any positive reaction towards the test substance, both after 24 and 48h after removal of the patch. It is concluded that the test substance causes no skin sensitization in guinea pig in the maximization test.


Migrated from Short description of key information:
The key study for skin sensitization was a LLNA test (OECD 429) in mice. A maximization test in guinea-pigs was a supporting study. Both studies were negative for sensitization.

Justification for classification or non-classification

As there was no skin sensitization, classification as such is not warranted.