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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:

The PBT Assessment for Alcohols, C6 -24, distn. residues (CAS 102242-49-9) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).

Persistence

Alcohols, C6 -24, distn. residues (CAS 102242-49-9) is readily biodegradable in one study according to OECD 301B (77% (CO2 production) after 28 d). Thus, the test substance does not meet the screening criterion for persistence and it is not considered to be P or vP.

Bioaccumulation

The bioaccumulation potential of Alcohols, C6 -24, distn. residues (CAS 102242-49-9) is expected to be low to moderate. For the main constituent octadecan-1-ol, a BCF of 1501 L/kg wet weight has been calculated using the BCFBAF-module (version 3.0) of EpiSuite4.0, while the module calculates lower BCF for molecules with longer C-chains, e.g. tetracosanol (CAS 506-51-4: BCF = 54.03 L/kg wet weight) or Lanolin wax (CAS 68200-49-0: BCF = 7.48 L/kg wet weight). Thus the substance is not considered to be B or vB.

Toxicity

Alcohols, C6-24, distn. residues (CAS 102242-49-9) is considered as not toxic. The substance is not acutely toxic to aquatic organisms. Chronic toxicity is not expected since the substance is not persistent and has a low potential for bioaccumulation. Furthermore the substance is not classified for specific target organ toxicity, carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals (see Section 5.9). The criteria for “T” based on mammalian effects are therefore not met. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the substance is considered to be not T.

References:

ECHA. 2012. Guidance on information requirements and chemical safety assessment – Chapter 11: PBT assessment. Version 1.1 November 2012. European Chemicals Agency, Helsinki