Registration Dossier
Registration Dossier
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EC number: 211-525-1 | CAS number: 658-79-7
Endpoint summary
Administrative data
Description of key information
According to Annex XI, 1.2 of Regulation (EC) No 1907/2006 (REACH) testing for skin sensitisation is scientifically not justified for the following reasons:
1) the dipeptide N-glycyl-L-tyrosine is an ubiquitously occuring dipeptide, which is known to be an integral constituent in the metabolism of nearly every organism;
2) the substance does not fall within the applicability domain of the currently available in chemico and in vitro testing methods. Thus, and for reasons of animal welfare testing is scientifically not justified.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- 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-glycyl-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´.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information the substance does not need to be classified as a sensitizer according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labeling of Chemicals (GHS).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
