Registration Dossier

Administrative data

Description of key information

No test data available. Profiling and QSARs indicate a low risk for sensitisation, and due to use in industrial and professional setting only, with the application of adequate PPE related to the severe corrosive properties of the etheramine, exposures are limited. There are no reports on incidents of sensitisation to etheramines available.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The profiling (QSAR Toolbox v.4.1) of3-((C9-11-iso,C10-rich)alkyloxy)propan-1-amine(Etheramine C10i) indicates that no alerts are found for protein binding, thiol reactivity is not expected, and that the structure is not represented among the categories of high, moderate or low reactivity in DPRA (direct peptide reactivity assays) for either cysteine or lysine depletion. Additionally, the molecular structure of the diamines does not contain toxicophores indicating a concern for sensitization, and also read across to data available on structurally related branched triamine (Dodecyl dipropylene triamine) and primary amines in general do not indicate a concern.

(The automated workflow in QSAR Toolbox for sensitisation results to a positive prediction, which is based on cross-reading to a single positive GPMT result from Isooctanol. As this is not even an amine structure, this prediction is not considered valid).

Information from QSARs:

- VEGA (Skin Sensitisation model (CAESAR) version 2.1.6): Predicts sensitizer, even with high validity: However, when checking the structures in the domain, they show little resemblance to alkyletheramine, and therefore the validity of the prediction is questionable.

- DEREK (Derek Nexus: 5.0.2, Nexus: 2.1.1): does not predict sensitisation

- TOPKAT (Accelrys ADMET Toxicity Prediction (Extensible)) predicts non-sensitizer.

 

There are no reports on incidences of sensitisation from industrial production and use of the substance.

 

Discussion: dermal

There is no data on sensitisation available for Etheramine C10i. Available studies indicate that the substance is highly corrosive. There are no consumer exposures, only industrial/professional use under circumstances involving the use of PPM following the classification as corrosive cat. 1B. Consequently, due to limited exposures, animal testing is not required.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Etheramine C10i has a low vp pressure and its use is limited to industrial settings that do not involve the forming of aerosols, particles or droplets of an inhalable size. So exposure to humans via the inhalation route will be unlikely to occur.

Additionally, information from profiling for expected protein interaction and QSARs for sensitisation result to a low concern.

Justification for classification or non-classification

There is no information available from testing. Available data is not robust enough to derive a definite conclusion. Cross reading with primary alkylamines indicates that the substance would not be sensitising to skin.