Registration Dossier
Registration Dossier
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EC number: 285-550-1 | CAS number: 85116-97-8
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment 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 Assessment
The substances of the glycol esters category are readily biodegradable. All available screening studies, investigating the ready biodegradability of the substances, demonstrated degradation rates ≥ 60% after 28 days. Thus, the test substances of the glycol esters category do not meet the screening criterion for persistency and are not considered to be P or vP.
Bioaccumulation Assessment
The bioaccumulation potential of Fatty acids, C16-18, esters with diethylene glycol is expected to be low. This assumption is based on a low bioavailability of the substances due to its ready biodegradability. Furthermore, the substance is rapidly metabolised and excreted by organisms and thus significant accumulation is not expected. This is supported by calculated low BCF/BAF values of 0.893 - 69.79 (BCF: Arnot-Gobas estimate, upper trophic) and 0.903 - 69.93 L/kg (BAF: Arnot-Gobas estimate, upper trophic), respectively. Please refer to IUCLID section 5.3 for a detailed overview on bioaccumulation of the substance. Thus, taking all information into account, the target substance is not considered to be B or vB.
Toxicity Assessment
The hazard assessment is based on the data currently available. New studies with the registered substance will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.
For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
Aquatic toxicity data for the assessment of Fatty acids, C16-18, esters with diethylene glycol were taken from structurally similar source substances. Long-term toxicity testing with aquatic algae and aquatic invertebrates resulted in no effects up to the limit of water solubility. All available short-term toxicity data did not result in any toxicity up to the water solubility limit as well. Moreover, the substance is not classified according to Regulation (EC) No 1272/2008 (CLP) considering Regulation (EU) No 605/2014 (6th ATP). Thus, given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment” (ECHA, 2014) are not met and the substance is not considered to meet the T criterion.
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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