Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

DBMC is considered to be persistent and fulfils the criteria for toxicity according to Annex XIII of Regulation 1907/2006EC, but since DBMC does neither meet all three criteria for a classification as persistent and bioaccumulative and toxic nor all two criteria as very persistent and very bioaccumulative, DBMC is not considered to be a PBT- or vPvB-substance.

Likely routes of exposure:

Persistence Assessment

Taking into account that 6,6’-Di-tert-butyl-2,2’-methylenedi-p-cresol (DBMC) was not readily biodegradable in an OECD compliant ready-biodegradability test and hydrolysis is not a significant degradation process, DBMC is considered to be persistent according to screening criteria.

Bioaccumulation Assessment

DBMC has a measured bioaccumulation factor of 840. The value is well below the threshold (> 2000 L/kg PBT-criteria and > 5000 L/kg vPvB-criteria) for bioaccumulation. Therefore, DBMC is not considered to be bioaccumulative.

Toxicity Assessment

DMBC is neither included in Annex I to the Dangerous Substances Directive (67/548/EC) nor in Annex VI, Table 3.2 to the CLP-Regulation ((EC) No 1272/2008). Based on the available toxicity and ecotoxicity data and considering the provisions of the Dangerous Substances Directive (67/548/EEC) and of the CLP-Regulation ((EC) No 1272/2008), classification as a Cat. 2 reprotoxic (H361 fertility) under CLP is proposed. Thus DBMC fulfils the criteria for toxicity according to Annex XIII of Regulation 1907/2006/EC.

Conclusion:

DMBC is neither PBT nor vBvP.