Fatty acids, C16 and C18-20 (even numbered, unsaturated), 2-ethylhexyl esters

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

8 PBT AND VPVB ASSESSMENT

8.1 Assessment of PBT/vPvB Properties – Comparison with the Criteria of Annex XIII The relevant PBT (persistent, bioaccumulative, toxic) criteria according to the REACH regulation and the corresponding properties of Fatty acids, C12-20 and C12-20-unsatd., 2-ethylhexyl esters are compiled in the following Table: Table 35: PBT and vPvB criteria and the corresponding properties of Fatty acids, C12-20 and C12-20-unsatd., 2-ethylhexyl esters

Criterion	PBT criteria	vPvB criteria	Fatty acids, C12-20 and C12-20-unsatd., 2-ethylhexyl ester	Criterion fulfilled?
P	Half-life in marine water > 60 d, or half-life in fresh- or estuarine water > 40 d, or half-life in marine sediment > 180 d, or half-life in fresh- or estuarine water sediment > 120 d, or half-life in soil > 120 d	Half-life in marine, fresh or esturarine water > 60 d, or Half-life in marine, fresh or esturarine sediment > 180 d, or half-life in soil > 180 d	Fatty acids, C12-20 and C12-20-unsatd., 2-ethylhexyl estersisreadily biodegradable and therefore has no potential to persist.	No
B	BCF > 2000	BCF > 5000	Fatty acids, C12-20 and C12-20-unsatd., 2-ethylhexyl estershas potential to bioaccumulate based on a logKow of 8.5 <= Log Kow <= 12.6.	Yes
T	Long-term NOEC for marine or freshwater organisms < 0.01 mg/l		No long term data.	No
T	CMR	n.a.	On the basis of the hazard assessment,Fatty acids, C12-20 and C12-20-unsatd., 2-ethylhexyl estersis not expected to be carcinogenic, mutagenic or a reproductive toxicant.	No
T	Other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC	n.a.	Not classified as T, R48, or Xn, R48 according to Directive 67/548/EEC	No

8.1.1 Persistence Assessment

The table demonstrates that Fatty acids, C12-20 and C12-20-unsatd., 2-ethylhexyl esters does not fulfil the P or vP criteria.

8.1.2 Bioaccumulation Assessment

The table demonstrates that Fatty acids, C12-20 and C12-20-unsatd., 2-ethylhexyl esters does fulfil the B or vB criteria.

8.1.3 Toxicity Assessment

The table demonstrates that Fatty acids, C12-20 and C12-20-unsatd., 2-ethylhexyl esters does not fulfil the T criteria.

8.1.4 Summary and overall Conclusions on PBT or vPvB Properties

A substance is identified as a PBT substance if it fulfils all three PBT criteria described above. P and B criteria are not fulfilled, and therefore the substance cannot be classified as PBT. A substance is identified as a vPvB substance if it fulfils both vPvB criteria described above. The P and the B criterion are not fulfilled. Fatty acids, C12-20 and C12-20-unsatd., 2-ethylhexyl esters is neither a PBT nor a vPvB substance.