Registration Dossier
Registration Dossier
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EC number: 284-943-5 | CAS number: 84989-53-7
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Justification for classification or non-classification
In vitro testing for skin sensitisation could not be performed because the test item was not sufficiently soluble in the recommended solvents. Instead an in vivo assay (LLNA) had to be performed.
In the LLNA study, Stimulation Indices of 23.7, 23.8 and 12.0 were determined for test concentrations 6.25, 12.5 and 25% respectively. As all of the tested concentrations exceeded the Simultion Index of 3, the EC3 value could not be calculated.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of 3HTdR compared with concurrent controls, as indicated by the S.I. Since this is the case, the substance should be classified for skin sensitisation category 1 according to EU N0 586/2011, Table 3.4.2. Given that the EC3 value could not be calculated, no further sub-categorization as 1A or 1B is possible.
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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