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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

In determining the classification appropriate to losartan free acid, 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.

Reliable studies are available to demonstrate that losartan free acid, and its close analogue, losartan, does not readily biodegrade and therefore is considered to be persistent in the environment. However,losartan potassium, the read-across analogue for losartan free acid, has been observed to photodegrade rapidly in water (half life less than 18 hours) and therefore it can be inferred that losartan free acid is persistent, but not very persistent. Predicted and measured log Kow values for losartan free acid are less than 4 (Log Kow = 1.1). The potential for losartan free acid to bioaccumulate in the tissues of organisms that inhabit aquatic or terrestrial matrices is negligible as the BCF factor for the substance is less than 1000. Losartan free acid is not B.Therefore, the substance is not PBT/vPvB.