Registration Dossier
Registration Dossier
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EC number: 947-849-1 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters
- Reference substance:
- Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters
- Reference substance:
- Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters
- Reference substance:
- Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters
- Reference substance:
- Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters
- Reference substance:
- Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters
- Reference substance:
- Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters
- Reference substance:
- Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters
- Reference substance:
- Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters
- Reference substance:
- Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment of Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), estersis 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, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters is readily biodegradable in one study according to OECD 301B (89.9% after 28 d). Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be P or vP.
Bioaccumulation
Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters has an estimated log Kow of > 10.0 (QSAR models VEGA and EPI Suite), which may indicate a potential for bioaccumulation. However, a significant uptake and bioaccumulation of the substance in aquatic organisms is not expected based on the very low water solubility (< 6.57 µg/L at 20 °C, pH 6.3, OECD 105), rapid biodegradation and metabolization via enzymatic hydrolysis into free fatty acids and alcohols. It is well known from literature that the hydrolysis products will be effectively metabolized and excreted by fish (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990; Sand et al., 1973). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the substance. Overall, the substance is not considered to be B or vB based on the available data.
Toxicity
Neither long-term nor short-term toxicity tests resulted in any toxic effects to aquatic organisms up to the limit of water solubility (< 6.57 µg/L at 20 °C, pH 6.3, OECD 105) of Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters. Furthermore, the substance is not classified according to the consolidated Regulation (EC) No 1272/2008 and further amendments (ATPs). Therefore, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and it is concluded that the substance is not T.
In conclusion, the substance is not PBT/vPvB.
Reference
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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