Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

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.