Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

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

The PBT Assessment for Hexanoic acid, 2-ethyl-, C16-18 alkyl esters (CAS No. 90411-68-0) 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

Hexanoic acid, 2-ethyl-, C16-18 alkyl esters (CAS No. 90411-68-0) is considered to be readily biodegradable. This assumption is based on a study conducted according to OECD 301B (90% CO2 evolution after 29 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 Hexanoic acid, 2-ethyl-, C16-18 alkyl esters (CAS No. 90411-68-0) is expected to be low. This assumption is based on a low bioavailability of the substance due to its ready biodegradability, high adsorption potential and low water solubility. Furthermore the substance is rapidly metabolised and excreted by organisms and thus an accumulation is not expected. This is supported by calculated low BCF/BAF values (< 130 L/kg; Arnot-Gobas estimate, upper trophic). Thus the substance is not considered to be B or vB.

Toxicity

Hexanoic acid, 2-ethyl-, C16-18 alkyl esters (CAS No. 90411-68-0) is considered to be not toxic. Studies on the long-term toxicity of the substance are not available, therefore the assessment is based on read across to the structurally related substances C8-16-Fatty acid-2-ethylhexyl ester (CAS No. 135800-37-2) and 2-Ethylhexyloleat (CAS No. 26399-02-0). The chronic toxicity of both substances was tested in studies conducted according to OECD guideline 202 with Daphnia magna as test organism. A NOEC (21 d) ≥ 1 mg/L was determined for C8-16-Fatty acid-2-ethylhexyl ester (CAS No. 135800-37-2) and 2-Ethylhexyloleat (CAS No. 26399-02-0) respectively. 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.