Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

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

Persistence Assessment:

The biodegradation of Tri -C18-22 (even numbered)-alkyl-2-hydroxypropane-1,2,3-tricarboxylate was not specifically determined. But the structural related substance Tri (hexyl, octyl, decyl) citrate with shorter chain esters was investigated. The criteria for vP requires a biodegradation half-life of > 60 days in freshwater. The criteria for P requires a biodegradation half-life of > 40 in freshwater. A study using freshwater with Tri (hexyl, octyl, decyl) citrate that followed an OECD ready biodegradation test guideline, 301B, resulted in it´s biodegrading to an extent of 67 % in 28 days, based on CO2-evolution, clearly showing that the half-life for Tri (hexyl, octyl, decyl) citrate was < 40 days,. Therefore the substance is not very persistent (vP) or persistent (P). It is expected read-across that also Tri -C18-22 (even numbered)-alkyl-2-hydroxypropane-1,2,3-tricarboxylate is not persistent. In addition Tri -C18-22 (even numbered)-alkyl-2-hydroxypropane-1,2,3-tricarboxylate is not toxic to organisms in the environment and is not expected to be bioaccumulative.

Bioaccumulation Assessment:

Tri -C18-22 (even numbered)-alkyl-2-hydroxypropane-1,2,3-tricarboxylate is not bioaccumulative (B) or very bioaccumulative (vB) based on results from a calculated bioconcentration (BCF) factor with EPISUITE software (EPIWEB 4.0).#Literatur angeben The calculated BCF was 3.16 L/kg (regression-based estimate) and 0.893 L/kg (Arnot-Gobas upper trophic estimate). Therefore the BCF is well below 2000 L/kg, which is the criterion for not being considered B, and well below 5000 L/kg, which is the criterion for not being considered vB.

Toxicity Assessment:

Tri -C18-22 (even numbered)-alkyl-2-hydroxypropane-1,2,3-tricarboxylate or it´s degradation products are not classified as toxic according to Directive 67/548/EEC and the data on toxicity provided herein.

Summary and overall Conclusions on PBT or vPvB Properties:

The data on the properties of Tri -C18-22 (even numbered)-alkyl-2-hydroxypropane-1,2,3-tricarboxylate do not meet the specific criteria detailed in Annex XIII and demonstrate that Tri -C18-22 (even numbered)-alkyl-2- hydroxypropane-1,2,3-tricarboxylate is not a PBT or vPvB.