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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is no sensitization study available forBranched triamine C16-18.

The molecular structure of the substance does not contain toxicophores indicating a concern for sensitization.

Additionally, a Buehler study was performed on a structurally similar branched triamine C12:

The study was performed in accordance with EU Method B.6 and under GLP, using 0.33% (recalculated for pure substance) aqueous solution for induction and 0.15% (recalculated for pure substance) aqueous solution for challenge, gave a negative outcome for sensitization (Huntingdon Life Sciences, 1996). Twenty guinea pigs were used in the test group and 10 in the control. The dose levels were chosen based on the results of a preliminary range-finding study. The higher concentration was the concentration that produced some irritation but did not give rise to adverse effects, while the lower was the maximum concentration not giving rise to irritating effects. Animals were induced epicutaneously under occlusive conditions, using a 6 hours exposure regime at Days 1, 8 and 15. Two weeks later, they were challenged epicutaneously once, using 6 hours exposure duration under occlusion, and skin reactions were scored 24 and 48 hours after the removal of the patches. None of the test animals displayed evidence of induced hypersensitivity.

This data based on read across from astructurally similar branched triamine C12 is also valid for branched triamine C16 -18. Branched triamine C16-18 only differs in the length of the alkyl chain, which is suspected to influence aspects related to bioavailability, but not aspects of chemical reactivity and route of metabolisation, aspects that determine specific mechanisms of toxicity relevant for sensitisation. For these reasons, many of the studies can best be performed on the substance with the shortest chain length within a group of structurally similar substances, as this is considered to represent the most sensitive species to show specific effects.

Migrated from Short description of key information:
There are no structural concerns for sensitisation, and cross-reading to data from structurally similar substance does not show sensitising properties.

Respiratory sensitisation

Endpoint conclusion
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 outcome for dermal sensitisation is also 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 same branched dipropylane 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 (1.4 x 10-4 Pa at 25°C for the branched triamine C12, with the shortest average alkyl chain length representing the highest vapour pressure for the group of branched polyamines)

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

Justification for classification or non-classification

Based on the available data, the substance does not need to be classified for skin sensitization in accordance with Directive 67/548/EEC and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

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