Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

Because of the different results for skin sensitisatin (no skin sentisation vs skin sensitisation) with equal validity (but need for application depending on the substance purity):

- no endpoint conclusion is mentioned above

- as only one study can be indicated as key study, both studies were equally indicated as weight of evidence


Justification for selection of skin sensitisation endpoint:
One study reveals no skin sensitisation and the other reveals skin sensitisation for a subtance with the same ECnumber. After an analytical sameness check (see §1.4 of this dossier), the conclusion is that the most pure tested substance corresponds to the no skin sensitising result, thus not classified for this endpoint, while the less pure tested substance corresponds to the skin sensitising result, thus classified as H317 for this endpoint. As Agfa's substance is less pure, although we do not know the toxicity of our impurities, we include the worse classification and thus will include H317.
No additional value (= same result + no higher reliability possible) of non-shared data from FEW.

Justification for classification or non-classification