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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-Butenedioic acid (E)-, di-C12-14-alkyl esters (List No 938-575-3) 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

2-Butenedioic acid (E)-, di-C12-14-alkyl esters (List No 938-575-3) is considered to be readily biodegradable based on read across to the structurally related analogue substances Didodecyl fumarate (CAS 2402-58-6), Ditetradecyl fumarate (CAS 10341-03-4) and 2-Butenedioic acid (E)-, di-C18-22-alkyl esters (CAS 68921-53-9). 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 2-Butenedioic acid (E)-, di-C12-14-alkyl esters (List No 938-575-3) is expected to be low. This assumption is based on the environmental fate and on the high molecular weight of the substance. Due to the ready biodegradability, high adsorption potential and low water solubility a low bioavailability of the substance is assumed. Furthermore the molecular weight, size and structural complexity of the substance hamper uptake and bioaccumulation. This is supported by calculated low BCF/BAF values (BCF: 0.90 - 0.89 L/kg, BAF: 1.55 - 0.89 L/kg; Arnot-Gobas estimate, upper trophic). The accumulation potential of the substance is also diminished by a rapid metabolisation and excretion by organisms. Thus the substance is not considered to be B or vB.

Toxicity

2-Butenedioic acid (E)-, di-C12-14-alkyl esters (List No 938-575-3) is considered to be not toxic. Studies on the acute toxicity of the read across substances Didodecyl fumarate (CAS 2402-58-6), Ditetradecyl fumarate (CAS 10341-03-4) and 2-Butenedioic acid (E)-, di-C18-22-alkyl esters (CAS 68921-53-9) determined no effects in the range of water solubility. A chronic exposure of aquatic organisms is considered as unlikely due to the low bioavailability of the substance as a consequence of the ready biodegradability, high adsorption potential and low water solubility of the substance. Thus bioaccumulation and chronic toxicity of the substance are not expected. 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.