Registration Dossier
Registration Dossier
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EC number: 406-690-3 | CAS number: 43136-14-7 MDI/ODA
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
A ready biodegradation study demonstrated 7.8 % degradation after 28 days in a study performed according to the European Union method C.5 (Degradation: Biochemical Oxygen Demand) (1991). The substance is therefore considered to not be readily biodegradable and is potentially persistent or very persistent based on the screening criteria.
Two calculated partition coefficient values ranged from 19.07 to 21. Log Kow values above 10 show that the uptake of the substance may be hindered in organisms. Both predicted log Kow values are greater than 10, indicating that the uptake and therefore bioaccumulation of the substance may be limited. The substance has a low water solubility of <0.9 mg/L at 20⁰C. Based on the very low solubility and very high partition coefficient of the isolated substance, limited uptake in the aquatic environment is expected. Additionally, the substance is manufactured and used in base oil which will further reduce the bioavailability of the substance and its bioaccumulation potential. It can therefore be concluded that the substance is not bioaccumulative based on a Weight-of-Evidence approach using expert judgement.
Three acute toxicity studies were performed (Daphnia sp. Acute immobilisation test; acute toxicity to fish test andFreshwater Alga and Cyanobacteria, Growth Inhibition Test). The results from all the studies showed that no acute toxicity occurred at the maximum solubility limit or at the highest tested concentration of the test item. Therefore, no evidence of toxicity was observed in the available studies and the substance is considered to be unlikely to be toxic, but chronic ecotoxicity data are not available to compare against the definitive toxicity criteria.
Overall, as the substance is not bioaccumulative and unlikely to be toxic, the substance is not considered to be PBT or vP/vB.
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