Registration Dossier
Registration Dossier
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EC number: 257-775-5 | CAS number: 52238-69-4
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
On the basis of the currently available information, the substance is not-PBT.
PERSISTENCE
The substance is considered as neither readily nor inherently biodegradable in standard tests for biodegradability. Furthermore, abiotic degradation by hydrolysis is excluded estimated to be negligible degradation pathway due to the chemical structure and functional groups presents.
Thus, based on the available information the substance can be considered as potentially P or vP.
BIOACCUMULATION
Many substances with a molecular mass greater than 700 are not readily taken up by fish, because of possible steric hindrance at passage of gill membranes or cell membranes of respiratory organs. Direct Yellow 142 has a negative low log Kow and has a molecular weight higher than 800 g/mol, thus it is unlikely to be characterized by a bioaccumulative potential.
Thus, the B/vB criteria are not met.
TOXICITY
Adequate chronic toxicity data are not available, therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data available. Short-term toxicity studies show that the substance is not expected to be harmful/toxic to aquatic life, according to the criteria of CLP Regulation (EC) No 1272/2008. Direct and indirect exposure is unlikely due to the risk management measures that will be applied at industrial level and discussed in details within the exposure scenario to avoid any release of the substance directly in the municipal waste water treatment.
The substance is not classified as carcinogenic, germ cell mutagenic, or toxic for reproduction and it does not meet the criteria of CLP Regulation (EC) No 1272/2008 to be classified for specific target organ toxicity after repeated exposure evidence of chronic toxicity.
Therefore, the substance is reasonable expected to be non-toxic.
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