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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The measured data for Cashew Nutshell Extract, Decarboxylated (“Technical Grade”) indicates that the substance meets the specific criteria detailed in Annex XIII for B, but not P. It was not possible to come to a definitive view as to whether the T criterion was fulfilled given the available data. On this basis Cashew Nutshell Extract, Decarboxylated (“Technical Grade”) is not a PBT and is not considered to be a vPvB substance. Therefore, an exposure assessment and risk characterisation does not need to be conducted.

 

To address the issues identified concerning the persistence and bioaccumulation potential of the test substance the following studies are on-going or proposed:

 

1.         The ready biodegradability of Technical Grade has been assessed in an OECD TG 310 (CO2 in sealed vessels (Headspace Test)) with and without enhancement measures to address effective exposure of the test substance to the test micro-organisms.  In this type of screening test, substances are considered to be readily biodegradable if CO2 production is equal to or greater than 60% of the theoretical value within ten days of the level achieving 10%.  The profile of the biodegradation for Technical grade with enhanced exposure measures was similar to that for the test substance without enhancement measures.  With enhancement measures the measured evolution of CO2 after 28 days was 69.3%, but this rate of degradation did not satisfy the 10-day window criterion. As a result Technical grade cannot be considered to be readily biodegradable, with or without enhancement measures, but  is considered to be potentially ultimately biodegradable given that a high overall level of degradation was recorded. It should also be noted that as the test substance is a mixture, different rates of degradation may occur under realistic environmental conditions.  

 

2.        It is proposed that the potential for bioaccumulation in aquatic biota is clarified by the conduct of an OECD Test Guideline 305 “Bioconcentration: Flow through Fish Test” on Distilled and Distillation Residue grades with read-across to Technical grade by interpolation.