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PBT assessment

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PBT assessment: overall result

Reference
Name:
T001141
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Related composition:
T001141
Reference substance:
T001141
PBT status:
the substance is not PBT / vPvB
Justification:

The persistency assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The biodegradation potential of the test substance has been assessed in a OECD 301B study (Desmares-Koopmans, 2016). The results reveal that the test substance is not readily biodegradable. It can therefore be concluded that based on the criteria mentioned above the substance is persistent in the environment. The substance is concluded to be P/vP.

The bioaccumulation assessment is based on the screening criteria in Annex XIII of the REACH Regulation. A measured Log Kow of <0.3 has been determined in an OECD 117 study (Reingruber, 2017) . Since the measured log Kow of the parent compound is below the criterium of log Kow 4.5 no further assessment on bioaccumulation is needed. The test substance is concluded to be not B/vB.

The toxicity assessment is based on the screening criteria in Annex XIII of the REACH Regulation. Based on an OECD 201 study (Migchielsen, 2016) it is concluded that the test item does not meet the Toxic (T) criteria since the ErC10 and NOEC values were 0.16 mg/L and 0.048 mg/L respectively. In addition, the test substance is not classified as carcinogenic or as a reproductive toxicant or as STOT RE category 1 or 2. It is classified as mutagenic Cat. 2 but not as a mutagenic Cat. 1A or 1B. Hence it does not fulfil the the Toxic (T) criteria.

As a conclusion, taking into account the conclusions that the substance is P/vP,  not B/vB and not T. Hence, the substance should not be considered as a PBT/vPvB substance.