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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Reaction Mass of Pentyl salicylate and 2-methylbutyl salicylate.
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence:


The substance is readily biodegradable. Hence, the substance is not considered to be persistent.


 


Bioaccumulation:


For the PBT and vPvB assessment a screening criterion has been established, which is log Kow greater than 4.5. Amyl salicylate has a measured log Kow of 4.4 to 4.5 (wieghted average of 4.47), which is just below this screening criterion. For organic substances with a log Kow below 4.5 it is assumed that the affinity for the lipids of an organism is insufficient to exceed the B criterion, i.e. a BCF value of 2000 L/kg. Since there is evidence that amyl salicylate is metabolised in fish, the aquatic BCF of amyl salicylate is expected to be lower than that predicted from log Kow. Indeed, the estimated BCF value for Amyl Salicylate based on read-across from analogue data is in the range of 380 to 570 L/kg. This is well below the B definitive criterion of BCF > 2000 L/kg. Therefore, amyl salicylate does not fulfil the B-criteria.


 


Toxicity:


E(L)C50 values for fish, daphnia and algae are > 0.1mg/L. Furthermore, there is no evidence of chronic toxicity, STOT RE or CMR effects.