Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There is no skin sensitisation data available for C16-22-(even numbered)alkylamines (CAS no 68037-92-3). In accordance with column 2 of 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. Due to the high pH and the skin corrosive nature of C16-22-(even numbered)alkylamines (CAS no 68037-92-3), it is also not considered scientifically justified to perform such a study on animal welfare grounds. The corrosive classification of the substance and the required risk management methods minimise the potential for skin contact. Based on the pH, the substance is classified as corrosive to skin Category 1 and on animal welfare grounds it is not considered relevant to perform an animal test.

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 as the substance is classified as corrosive to the skin.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

C16-22-(even numbered)alkylamines (CAS no 68037-92-3) is a handled as a liquid and has a low vapour pressure of 0.022 Pa at 20°C. Its use is limited to industrial and professional users and does not include formation of aerosols, particles or droplets of inhalable size. Exposure to humans via the inhalation route is therefore considered to be unlikely.

Justification for classification or non-classification

Based on limited exposures by dermal route (substance is corrosive) or by inhalation (low vapour pressure and no generation of aerosols, dust or droplets of inhalable size), sensitisation is expected to be unlikely. However, as a firm conclusion from a study with this compound is lacking, no definite conclusion might be drawn for classification purposes.