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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:

Ready biodegradability and inherent biodegradability was investigated in well documented studies according to OECD guideline 301F and OECD 302C. The test item was found slightly biodegradable by 11.8% in OECD 301F test. Leuco sulphur Brown 37 has a high molecular weight (98.98% > 1000 Dalton). Under environmental conditions the substance will be oxidized to very big polymeric structures with a very high molecular weight. The bioavailability of the substance is negligible (low potential to cross biological membranes). Although the criteria for ready biodegradability are not fulfilled the results shows that the substance has the potential to biodegrade particularly in an environment.

The ‘P’ criterion according to Annex XIII is fulfilled for environmental compartments.

 

Due to the physico-chemical properties of the substance, it was not possible to specify the log Pow.

But a potential for bioaccumulation can be ruled out because the substance will be oxidized to very big polymeric structures with a very high molecular weight under environmental conditions. The bioavailability of the substance is negligible (low potential to cross biological membranes).

The ‘B’ criterion for Leuco Sulphur brown 37 is NOT fulfilled.

 

The substance is non toxic to mammalian and aquatic organisms.

 

The 'T' criterion for Leuco sulphur brown 37 is NOT fulfilled.

 

For Leuco sulphur brown 37 the ‘P’ criteria is fulfilled but the ‘B’ and ‘T’ criteria not. Nevertheless Leuco sulphur brown 37 is neither a 'PBT' nor a 'vPvB' substance.