N-(3-aminopropyl)-N- (C12-18 even numbered) alkyl-propane-1,3-diamine

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

There is no sensitisation data available for cocodipropylenetriamine.

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 cocodipropylenetriamine is highly corrosive. There are no consumer exposures, only industrial/professional use under SCC. Consequently, due to limited exposures, animal testing is not required.

 

Additionally, the molecular structure of the cocodipropylenetriamine 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 actuallydohave 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 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.

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

Migrated from Short description of key information:
As cocodipropylenetriamine is (very) corrosive to skin, no in vivo sensitisation 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. There are no reports on incidents of sensitisation to polyamines available.

Justification for selection of skin sensitisation endpoint:
In accordance with column 2 of REACH Annex VII, an in vivo skin sensitisation study does not need to be conducted if the available information indicates that the substance should be classified for skin corrosivity. Besides, no testing is required for on-site isolated intermediates handled under SCC.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Likelihood of exposures via inhalation is low considering that cocodipropylenetriamine is a liquid with a high boiling point (> 300 °C) and very low vapour pressure (4.7 x 10-5 Pa at 20°C). It is only used as on-site isolated intermediate and handled under SCC. 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.

Migrated from Short description of key information:
No information. No respiratory sensitisation is expected.

Justification for selection of respiratory sensitisation endpoint:
Exposure considerations: Low likelihood for exposure via inhalation

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.