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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
4-allylveratrole - lead
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

This substance is not PBT or vPvB because:

This substance is considered as readily degradable and not P/vP. This substance is not having bioaccumulation (not a B or vB) potential as the substance is readily biodagradable and have a low n-octanol / water partition coefficient (2.74) which indicates no potential for bioaccummulation.

This substance is not toxic (T).

The lowest measured aquatic toxicity value of Methyl Eugenol, the LC50 of 8.72 mg / L to Freshwater fish is 8.72 mg/l. The substance is not classified as mutagenic, toxic to reproduction and not possessing any target organ toxicity after repeated exposure. A critical effect for the characterization of risk to human health for methyl eugenol is carcinogenicity. In animal studies the substance has been shown to induce multiple types of tumours in the liver and glandular stomach in rat and mice. In male rats, tumours were also observed in the kidney, mammary gland, subcuteneous tissue and mesothelium. In the opinion of the WHO/FAO authors, the relevance of the critical effects observed in animal studies to the exposure scenario in humans was questionable and further assessment of methyl eugenol was recommended. While structured epidemiological research exploring possible associations between spice consumption and hepatic cancer in humans is lacking, there is an absence of any indications of human cancer associations noted in the scientific literature. As the carcinogenicity assessment is not needed at the tonnage band the substance is registered no classification for carcinogenicity is assigned.