Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Quality of whole database:
Because of the different LD50 with equal quality (but need for application depending on the substance purity):
- no endpoint conclusion and no effect level is mentioned above
- as only one study can be indicated as key study, both studies were equally indicated as weight of evidence

Additional information

Justification for selection of acute toxicity – oral endpoint
One study reveals an LD50>5000mg/kg and the other an LD50 between 500 and 2000mg/kg for a substance 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 LD50>5000mg/kg, thus not classified for this endpoint, while the less pure tested substance corresponds to the LD50 between 500 and 2000mg/kg, thus classified as H302 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 H302.
Unable to complete data of dossier UUID SNIF-12a03ae4-ee7c-3818-aadd-acdaeedbefd7 because no data owner found.
Dossier UUID SNIF-3d17584d-4daa-344e-b0d5-176185bd8408 (owned by Fuji) overruled by more severe result (see 'acute toxicity: oral.002').
No additional value (= same result + no higher reliability possible) of non-shared data from FEW vs. 'acute toxicity: oral.001'.

Justification for classification or non-classification