Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

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

The substance is not readily biodegradable and also hydrolytically stable as determined in screening tests. No simulation biodegradation tests are available to finally conclude on the P/vP criterion. Thus, based on the available data the substance has to be treated as P/vP.

The n-octanol/water partition coefficient (log Pow) of 4 -OH Tempo was calculated to be 0.56 andthe bioaccumulation factor was estimated to be 3.162 L/kg wwt, therefore it is concluded that 4-OH TEMPO does not have the potential to bio accumulate. 4 -OH Tempo is considered to be not B/vB.

The lowest NOEC for freshwater organisms is >0.01 mg/L (Daphnia magna 1.5 mg/L) and the test item is not classified as carcinogenic, mutagenic or toxic for reproduction, however based on the 28-day repeat dose study the substance has been assigned the classification STOT RE Cat 2. The substance is therefore considered to fulfil the criteria to be 'Toxic'.

In overall conclusion, the substance could be considered persistent and toxic but not bio accumulative. In order to be considered PBT, all criteria must be met. This is not the case therefore the substance is not PBT.

The substance is not vP/VB due to not fulfilling the bio accumulative criteria.