Registration Dossier

Administrative data

Description of key information

As Oleyl tripropylenetetraamine is corrosive to skin, no in vivo sensitisation study needs to be performed. There are no structural concerns for sensitisation, and cross-reading to data from structurally related substances also do not show a concern. Due to use in industrial and professional setting only, with the application of adequate Personal Protection Measures related to the severe corrosive properties of the diamines, exposures are limited. There are no reports on incidents of sensitisation to diamines available.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There is no sensitisation data available for Oleyl dipropylene triaamine.

As indicated in REACH Annex VII, an in vivo skin sensitisation study does not need to be conducted as the substance is classified as corrosive to the skin. Available data indicate that Oleyl dipropylene triamine is corrosive to the skin. 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.

 

Additionally, the molecular structure of the Oleyl dipropylene triamine does not contain toxicophores indicating a concern for sensitization. Primary fatty amines are recognised as not sensitising. Available QSARs indicate possible sensitising properties based on structural similarities with ethylene amines known to have sensitising properties, and some other structural similar substances that actually do have protein binding properties, and as such are not considered to be predictive for the polyamines.

 

The profiling of alkyl-diamines (QSAR Toolbox v.3.0) 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 polyamines does not contain toxicophores indicating a concern for sensitization, and also read-across to data derived from animal testing available for the structurally related branched triamine (Dodecyl dipropylene triamine, branched) and primary amines in general do not indicate a concern.

There are noreports on incidences of sensitisation from industrial production and use of the substance.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There is no information on respiratory sensitisation. However, no concerns are expected.

As chemical respiratory sensitisers also elicit positive results in predictive tests for contact sensitisation, a negative prediction for dermal sensitisation would also be predictive for non-respiratory sensitisation of the substance. As indicated, the molecular structure of the polyamines does not contain toxicophores indicating a concern for sensitization, and also read across to data available on structurally related branched dipropylene triamines and primary amines in general do not indicate a concern. Consequently, respiratory sensitisation is not expected from polyamines.

 

Additionally, the likelihood for exposure via inhalation and thus becoming sensitised to polyamines, is very low, based on the high boiling point (> 300 °C) and very low vapour pressure (4.7 x 10-5 Pa at 20°C for the cocodipropylene triamine, with the shortest average alkyl chain length representing the highest vapour pressure for the group of polyamines)

Justification for classification or non-classification

Based on limited exposures by dermal route (substance is very corrosive) or by inhalation (very low vapour pressure) and results from a structurally related triamine showing no sensitisation, as well as lack of toxicophores in the structure of polyamines indicating a concern for sensitisation, there are no concerns for sensitisation expected.

However, as a firm conclusion from a study with this compound is lacking, no definite conclusion might be drawn for classification purposes.