Registration Dossier

Administrative data

Description of key information

in vitro, hCLAT: positive

in vivo, LLNA: negative

Key value for chemical safety assessment

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Category 1

Substances shall be classified as skin sensitizers in category 1 where data are not sufficient for sub-categorisation in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test.

In case local lymph node assay, a stimulation index of 3 or more is considered as positive response.

Subcategorisation is done as follows:

Sub-category 1A

Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.

Specific criteria for local lymph node assay: EC => 2 %

Sub-category 1B

Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.

Specific criteria for local lymph node assay: EC3 value > 2 %

Based on available data, the substance is not classified according to the CLP Regulation (EC 1272/2008).