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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 accordance with the screening criteria of the ECHA Guidance on information requirements and chemical safety assessment (Part C and Chapter R.11: PBT assessment):

 

4-TBC is not readily biodegradable but inherently biodegradable with more than 70% of degradation reached in less than 7 days including the log and lag phases (OECD 302B). In addition an abiotic degradation test (OECD 111) showed that 4-TBC was stable in freshwater at pH 4, but unstable at higher pHs 7 and 9, with half-lives of 6 days and < 3.5 days respectively, the underlining phenomenon seemed to be oxidation instead of hydrolysis; and no major degradation products (>10%) were likely to be produced. Therefore, it is considered that 4-TBC does not comply with the P and vP criteria, that is the compound should not be Persistent in the environment.

 

As 4-TBC presents a Log Kow ≤ 4.5, it is assumed that the affinity for the lipids of an organism is insufficient to exceed the B criterion (i.e. BCF value > 2000).

 

4-TBC is neither classified as carcinogenic (cat. 1 or 2), mutagenic (cat. 1 or 2), or toxic to reproduction (cat. 1, 2 or 3), nor classified as T, R48 or Xn, R48. In acute aquatic toxicity tests, theE/LC50 for fish, daphnidsand algae are upper 0.1 mg/L. Furthermore, based on Log Kow ≤ 4.5 and ready degrability, 4-TBC fulfils neither P criteria, nor B criteria. As a result, the PBT assessment can be stopped, the substance being presumably not T.