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EC number: 285-550-1
CAS number: 85116-97-8
Skin sensitisation (OECD 406): not sensitising
The hazard assessment is based on the data currently available. New
studies with the registered substance and/or other member substances of
the glycol esters category 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
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
The skin sensitising potential of ethylene distearate (CAS
627-83-8) was tested according to a Buehler test protocol similar to
OECD guideline 406 in Hartley guinea pigs (IBR Forschungs GmbH, 1982).
The solid test material was mixed with a few drops of water and applied
at a concentration of 100% for epidermal induction and challenge. The
negative control group was treated with the vehicle only. No positive
control data was included in the study report for reliability check. At
challenge, the neat test substance induced no skin effects in the test
and negative control group. No further skin reactions after induction
and challenge were observed.
In summary, based on the available data, the analogue substance is
not considered to exhibit sensitizing properties. Therefore, based on
common functional groups, structural similarities and common breakdown
products, the target substance Fatty acids, C16-18, esters with
diethylene glycol (CAS 85116-97-8) is considered to be non-sensitizing
Based on the analogue read-across approach, the available data on skin
sensitisation do not meet the classification criteria according to
Regulation (EC) No. 1272/2008, and are therefore conclusive but not
sufficient for classification.
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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