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EC number: 285-550-1
CAS number: 85116-97-8
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)..
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.
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.
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
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
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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