Registration Dossier

Administrative data

skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
According to Annex XI, 1.2 of Regulation (EC) No 1907/2006 (REACH) testing for the endpoint skin sensitisation is scientifically not justified as explained below.
Currently there are three in vitro test systems and one in vivo testing system that are frequently used to determine the sensitising potential of a certain substance. In order to become an allergen according to present state of science an adverse outcome pathway needs to be passed, at least the substance must pass three mile stones to become a sensitiser. First it has to penetrate the skin (stratum corneum), second it must be able to react with proteins and third the substance protein complex must be at least 15 amino acid residues in size to become recognized by the immune system. Although, penetration of the skin cannot be excluded, N-alanyl-L-tyrosine is not considered to fulfil the other two steps of the adverse outcome pathway required to mediate sensitising properties. For further informations please refer to the next section `Attached justification´.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

No skin sensitising potential is concluded for L-Alanyl-L-tyrosine.