Registration Dossier
Registration Dossier
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EC number: 467-070-6 | CAS number: 191226-98-9
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
An evaluation of the inherent properties of the substance is performed against the ANNEX XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2014) were applied.
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 301F study (Grutzner, 2006). The
results reveal that the test substance does not degrade and the substance is considered to be 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 3.9 at 25°C and pH 6.5 has been determined in an OECD 107 study (Weissenfeld, 2006). 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 (Voltz, 2006) it is concluded that the test item does not meet the Toxic (T) criteria since
the EC50 and NOEC were >100 and 100 mg/L respectively. The test substance is not classified as carcinogenic (Cat. 1 or 2), as mutagenic (Cat. 1 or 2), or as reproductive toxicant (Cat. 1, 2 or 3), nor as STOT RE Cat. 1 or 2 according to the Regulation EC N° 1272/2008. Hence, it does not fulfill the criteria to be considered as Toxic.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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