Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

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. Additionally, the molecular structure of the polyamines does not contain toxicophores indicating a concern for sensitization.

The structure of the polyamines does not indicate protein binding which is considered a basic mechanism for sensitisation. Primary fatty amines are recognised as not sensitising. Available QSARs indicate possible sensitising properties based on structural similarities with ethylene amines with known 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.

There are also results from LLNA studies on related substances that point at possible sensitising properties. However, in recent years studies conducted and published show, that LLNA is not a suitable test system for certain categories of substances. Below is a list for which there is consensus that the LLNA provides false-positive results based on WoE (including hRIPT data).

- surfactants – mainly unsaturated fatty acids (via EFfCI)

- surfactants (Cesio)

- siloxanes/silanes (via CES) (Propylpiperidyl functionalized silicones and Polyamino functional Siloxanes).

For the above mentioned group for many years of handling and use have not led to signals on

possible sensitising properties.

As for the polyamines, the supplier indicates there is data from a Bühler study with a C12 triamine showing no indication of a sensitising potential, despite a LLNA was positive on this substance. In addition decades of use including as biocide in cleaning formulations, has not shown specific concerns for sensitisation.

Migrated from Short description of key information:
No study was performed since the substance is classified as corrosive.

Justification for classification or non-classification

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. Additionally, the molecular structure of the polyamines does not contain toxicophores indicating a concern for sensitization. Therefore the substance need not be classified for skin sensitisation.