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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

Classification of Phenethyl isovalerate for effects in the environment

In determining the classification appropriate to Phenethyl isovalerate, it is necessary to consider all available evidence concerning its persistence, potential to accumulate and predicted or observed environmental fate and behaviour that may present a long-term and/or delayed danger to the structure and/or functioning of aquatic ecosystems. These points are considered below. 

 

Persistence

Available data indicates that Phenethyl isovalerate is not persistent in the aquatic and soil environment. Moreover, its persistent characteristics is only observed in the sediment compartment but its diffusion in sediment is very less, to the level of 0.927%. Hence it has been concluded that Phenethyl isovalerate is not persistent in nature.  

 

Thus, Phenethyl isovalerate is classified as a not persistent chemical. 

 

Potential to accumulate

The estimated log Kow values for Phenethyl isovalerate is less than 4 (mean Log Kow = 3.883). The potential for Phenethyl isovalerate to bioaccumulate in the tissues of organisms that inhabit aquatic or terrestrial matrices is negligible as the reported BCF value for the substance is less than 2000.  

 

The estimated BCF of Phenethyl isovalerate is highest 193.9 L/kg wet wt. and below the threshold of 2000. 

 

Thus, Phenethyl isovalerate does not satisfy the criterion for classification as bioaccumulative (B).

Toxicity

The toxicity values of invertebrates and algae are reported as EC50 = 1.956 mg/L and EC50 = 3.094 mg/L, respectively. These values suggest classification for aquatic toxicity in the Aquatic Chronic 2 category. But the BCF value of Phenethyl isovalerate reported was not >= 500.(Does not fullfill CLP criteria for toxic classification).Thus considering the CLP Criteria for aquatic classification of the substance , it is concluded that Phenethyl isovalerate is non hazardous to the aquatic environment.

In addition to aquatic toxicity, the substance, Phenethyl isovalerate, is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to CLP (Regulation (EC) No 1272/2008) and there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure) according to Regulation (EC) No 1272/2008.

Thus, Phenethyl isovalerate does not meet the criterion for classification as toxic (T).

 

Thus, in accordance with the requirements of Annex XIII; it can be inferred that Phenethyl isovalerate is a not a PBT (including vPvB) substance.