Registration Dossier
Registration Dossier
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EC number: 285-550-1 | CAS number: 85116-97-8
Endpoint summary
Administrative data
Description of key information
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 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.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
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 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.
Skin sensitisation
CAS 627-83-8
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
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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.
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