Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Etherdiamine C13i/acetate 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.

 

Considering its structure, the substance is not considered to react with protein (OECD Toolbox profiling). The primary amine is likely the most determining substructure of the substance with respect to possible development of sensitisation.

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 then out of domain because of its high Pow value. (See attached document: OECD ToolBox-Sensitisation Etherdiamine 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 from sensitisation studies available. 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.

Justification for selection of skin sensitisation endpoint:
An in vivo skin sensitisation study does not need to be conducted as the substance is classified as corrosive to the skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
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, so adequate data is lacking. However, concerns for sensitisation are low as the potential for exposures are low as use is limited to industrial settings under controlled conditions. Furthermore, cross reading with primary alkylamines indicates that the substance would not be sensitising to skin.