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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 fatty acids, coco, esters with 1,3-butanediol (CAS 73138-39-3) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

Persistence

Fatty acids, coco, esters with 1,3-butanediol CAS 73138-39-3 is readily biodegradable (60.1% biodegradation after 28 d), as shown in a study conducted according to OECD guideline 301F. Thus, the substance does not meet the screening criterion for persistency and it is not considered to be P or vP.

Bioaccumulation

The bioaccumulation assessment was not conducted for the substance since it is not persistent and according to ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (2017) further generation of information on bioaccumulation is only necessary, if the P/vP criterion is fulfilled for the substance.

Toxicity

Experimental toxicity data are available for aquatic organisms of three trophic levels. All acute and chronic effect values were > 0.01 mg/L. Moreover, fatty acids, coco, esters with 1,3-butanediol (CAS 73138-39-3) is not classified as carcinogenic, mutagenic, toxic for reproduction, germ cell mutagenic or toxic for reproduction and does not bear specific target organ toxicity after repeated exposure according to the consolidated version of Regulation (EC) No. 1272/2008 (and further ATPs). Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the test substance is not considered to meet the T criterion.

In conclusion fatty acids, coco, esters with 1,3-butanediol CAS 73138-39-3 is not considered to be PBT/vPvB.