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:

Persistence: o-tert-butylphenol can be considered to be inherently bioegradable based on reliable measured biodegradation studies. Consequently, in line with the detailed ECHA guidance, o-tert-butylphenol does not fulfil the criteria for Persistence (P).

Bioaccumulation:Based on reliable measured and modeled study results, it is concluded o-tert-butylphenol is neither bioaccumulative nor very bioaccumulative. Additional evidence is provided based on measured log Kow is less than 4.5 and modeled BCF results are less than 2000. It is concluded that there is a low potential for exposure and bioaccumulation in terrestrial organisms. O-tert-butylphenol does not fulfil the criteria “bioaccumulative (B)” or “very bioaccumulative (vB)”. According to ECHA Guidance on information requirements and chemical safety assessment (May 2008), Chapter R.11, Figure 11-2: Integrated testing strategy for B-assessment, no further testing is required to conclude on the bioaccumulation criterion.

Toxicity: Based on available reliable data for toxicity of o-tert-butylphenol short-term acute toxicity (LC50 or EC50) to aquatic organisms is >0.01 mg/L and does not meet the definitive toxicity criterion according to the ECHA guidance on PBT assessment (Part C). Chronic data on aquatic species showed no effect concentrations (expressed as NOEC) >0.01 mg/l and therefore the criteria of Annex XIII REACH for aquatic toxicity are not fulfilled. Therefore, it can be concluded that the substance does not fulfill the toxicity (T) criterion as laid down in Annex XIII of regulation (EC) No 1907/2006..

The overall conclusion is that o-tert-butylphenol does not meet the PBT or vPvB criteria. No further testing is required.