Registration Dossier
Registration Dossier
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EC number: 948-047-4 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Reaction mass of 2-hydroxyethyl oleate, oleic acid, and 2-hydroxyethyl palmitate
- Type of composition:
- legal entity composition of the substance
- Related composition:
- Reaction mass of 2-hydroxyethyl oleate, oleic acid, and 2-hydroxyethyl palmitate
- Reference substance:
- Reaction mass of 2-hydroxyethyl oleate, oleic acid, and 2-hydroxyethyl palmitate
- Reference substance:
- Reaction mass of 2-hydroxyethyl oleate, oleic acid, and 2-hydroxyethyl palmitate
- Reference substance:
- Reaction mass of 2-hydroxyethyl oleate, oleic acid, and 2-hydroxyethyl palmitate
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The substance is readily biodegradable and no evidence of toxicity has been found in aquatic organisms. QSAR has been used to predict Log Kow as an indicator of bioaccumulation potential, however the very high predicted Log Kow means there is uncertainty regarding the potential for bioaccumulation, however further testing is not required as the substance has not fulfilled the P or T criteria and the substance is not a PBT substance.
Persistence
A reliable study was available on the read-across substance, Fatty acids, C16-18, esters with ethylene glycol. At days 28 and 56 the percentage biodegradation was 61 and 75% fulfilling the 60% biodegradation criteria. In the case of a UVCB substance the pass level can be applied at 28 days and is therefore readily biodegradable (61% after 28 days).
Bioaccumulation
The Log Pow of 2-hydroxyethyl oleate has been calculated using SPARC SAR modelling. The Log Pow of the substance has been calculated to be 7.6. This high Log Kow is indicative of the substance being potentially bioaccumulative. However, it is stated in ECHA Guidance R.11 that at very high log Kow (>6), a decreasing relationship between the two parameters is observed. Apart from experimental errors in the determination of BCF values for these very hydrophobic substances, reduced uptake due to the increasing molecular size may play a role as well. It is uncertain whether the substance will bioaccumulate based on the Log Kow information, but the potential for rapid biodegradation will reduce the potential for bioaccumulation in aquatic organisms.
Toxicity
The lowest EC50 from the available fish, aquatic invertebrate and algae studies was determined for the invertebrate Daphnia magna. The key studied was carried out on the read-across substance Butylene Glycol Dicaprylate/Dicaprate and resulted in a 48 hour EC50 for Daphnia magna of >2.0 mg/L based on immobilisation. Although it is not possible to confirm 'not Toxic' based on acute data only, the substance is unlikely to meet criteria for toxicity based on the laboratory studies available and the ready biodegradability of the substance.
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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