Registration Dossier
Registration Dossier
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EC number: 947-121-3 | CAS number: -
Endpoint summary
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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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