Registration Dossier
Registration Dossier
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EC number: 256-881-9 | CAS number: 50977-10-1
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
Etheramine C13i is corrosive. As indicated in REACH Annex VII, an in vivo skin sensitisation study does not need to be conducted if the substance is classified as corrosive to the skin.
When considering available information on all primary amines using OECD Toolbox (v.1.1.0) it shows that some are sensitising (generally diamines) and some are not:
Category of all primary amines
removing all that are dissimilar for:
- Protein binding: Arylcarboxylate aminolysis; Electrophilic substitution of arenesulfinic acids; Nucleophilic addition to ketones.
- OASIS Acute Toxicity MOA: Phenols & anilines; Reactive unspecified
However, the substance is out of domain because of its high Pow value. (See attached document: OECD ToolBox-Sensitisation Etheramine C13i.pdf)
For the category of primary alkylamines as presented in the EU RAR, all are evaluated as to be non sensitising. Cross-reading with the category primary alkylamines seems most appropriate for this substance. (Ref.EU risk assessment under 93/793/EEC as published by ECHA in the annex XV REACH transitional documents)
For corrosive substances, the use of protective gloves and other equipment, such as face shields, aprons and good work practices are mandatory. As a result, direct dermal contact occurs only occasionally. Therefore, repeated substantial daily dermal exposure is unlikely.
Migrated from Short description of key information:
No information. An in vivo skin sensitisation study does not need to be conducted as the substance is classified as corrosive to the skin. Cross reading with primary alkylamines indicates non-sensitising.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
Migrated from Short description of key information:
No information available.
Justification for classification or non-classification
There is no information available from testing. Cross reading with primary alkylamines indicates that the substance would not be sensitising to skin.
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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