Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

The PBT Assessment for 2-octyldodecan-1-ol is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012d).

Persistence

2 -Octyldodecan-1-ol

is readily biodegradable according to a study following OECD guideline 310. Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be P or vP.

Bioaccumulation

2 -Octyldodecan-1-ol

is neither bioaccumulative nor very bioaccumulative. Evidence is provided based on calculated BCF is less than 2,000. It is concluded that there is a low potential for exposure and bioaccumulation in aquatic and terrestrial organisms.

2-Octyldodecan-1-ol

does not fulfil the criteria “bioaccumulative (B)” or “very bioaccumulative (vB)”.

Toxicity

2 -Octyldodecan-1-ol

is considered to be not toxic. Studies on the acute aquatic toxicity determined on 2 -octyldodecan-1 -ol or structurally related substances show no acute toxicity to fish, algae and aquatic invertebrates up to the limit of water solubility. Furthermore the substance is not classified for specific target organ toxicity, carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals. 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.