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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Hexadecyl hydrogen Maleate
Type of composition:
legal entity composition of the substance
State / form:
other: flakes
Reference substance:
Hexadecyl hydrogen Maleate
PBT status:
the substance is not PBT / vPvB

The PBT Assessment for the substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT/ vPvB assessment (ECHA, 2017).


The substance is not readily biodegradable. Hydrolysis in environmental conditions is also not expected. Thus, the test substance meets the screening criterion for persistence and it could be considered to be P or vP.


The substance is not expected to biaccumulate based on the predicted BCF value. The uptake of an organic substance is driven by its hydrophobicity. For organic substances with a Log Kow value below 4.5 it is assumed that the affinity for the lipids of an organism is insufficient to exceed the B criterion, i.e. a BCF value of 2000 (based on wet weight of the organism, which refers to fish in most cases) (Chapter R.11, version 3.0, June 2017). The substance has a LogKow higher than 6.5. However, the predicted BCF of the substance (10 l/kg) suggests that the BCF of the substance is much lower than BCF threshold value for bioaccumulation (2000 l/kg). Thus the substance is not considered to be B or vB.


No long term toxicity data is available for the aquatic organisms, while during the short term toxicity studies no hazard is identified. Studies on the acute oral toxicity of the substance showed that it is not expected to be toxic after an acute exposure. The substance is not classified for repeated dose toxicity, reproductive toxicity, carcinogenicity or mutagenicity. Thus the substance is not considered to be T(oxic)

Considering that the substance does not meet the criteria for Bioaccumulation (B) and Toxicity (T), even if it meets the criterion for Persistency (P), it is not considered as PBT as it does not meet the other two criteria (B, T)