Registration Dossier

Administrative data

Description of key information

The substance has skin sensitisation properties as demonstrated in an in vivo test and reported in a case study for production workers.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Although a recent in vivo LLNA study is available indicating no skin sensitation properties, available human data on workers exposed to the substance as well as another in vivo study with guinea pigs indicate skin sensitation properties.


Justification for selection of skin sensitisation endpoint:
Two in vivo studies available. Additionally, one case report on sensitation in humans (production worker) is available.
The study by Thompson is selected due to the acceptable reliablity of the study and the observance of the precautionary principle.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

The presented substance has indication for skin sensitisation. The substance is not an Isocyanate and there are no structural alerts as mentioned in the flow chart (REACH technical guidance document IR/CSA: scheme of R.7a, Fig 7.3-2). The available Mouse Local Lymph Node assay indicates no sensitisation potential. Therefore, in a weight of evidence approach, the present data indicate no respiratory potential.

Justification for classification or non-classification

According to Regulation (EC) No 1272/2008 the substance is classified as skin sensitiser category 1. For this classification the substance has to be labelled with the signal word “Caution”.