Registration Dossier
Registration Dossier
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EC number: 221-728-7 | CAS number: 3214-47-9
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
One BASF Study and one Boruta study are available for the endpoint acute toxicity: oral, on Direct Yellow 50 EC: 221-728-7.
In BASF study the acute oral LD50 in rats was established to be > 15000 mg/Kg.
In Boruta study the conclusion is that the dye should not be classified for acute oral toxicity.
Both the studies are missing some details on the tested substance or the method therefore they cannot be used as key study to cover the endpoint.
However, their results are consistent and together they can give a clear conclusion on the acute oral toxicity of the substance.
Moreover, this result is confirmed also by the prevision made with the QSAR model.
Therefore, Direct Yellow 50 can be considered as not classified for acute oral toxicity (LD50 > 2000 mg/kg bw).
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
The oral LD50 value was established to be greater than 2000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity.
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