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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

On the basis of the available information, the substance is expected to be not-PBT.


The substance is considered as neither readily nor inherently biodegradable in standard tests for biodegradability. Furthermore, abiotic degradation by hydrolysis is estimated to be a negligible degradation pathway due to the chemical structure and functional groups presents.

Thus, the substance should be considered as persistent.


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 Orange 118 has a low log Kow (-3.43 at pH 7/8) and a molecular weight higher than 900 g/mol, thus it has no bioaccumulative potential.


Adequate chronic toxicity data are not available, therefore the aquatic toxicity assessment and classification are based mainly on the short-term toxicity data available. 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 show evidence of chronic toxicity.

The substance is reasonably expected to be non-toxic.