Registration Dossier
Registration Dossier
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EC number: 500-311-6 | CAS number: 120498-03-5
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Test results are expressed in terms of Stimulation Indices, the ratios of the mean scintillation count per group obtained from the test groups relative to the corresponding mean scintillation count from controls. The threshold level for the Stimulation Index to be considered a positive indicator of the potential to cause skin sensitisation is 3.0.
Main study 1
Concentration of test article in applied formulation (% w/v)
10%
25%
50%
Stimulation Index
5.3
5.5
8.5
Main study 2
Concentration of test article in applied formulation (% w/v)
10%
25%
50%
Stimulation Index
3.1
5.4
3.2
Migrated from Short description of key information:
The skin sensitisation was investigated following OECD Guideline 429 and EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay).
The study was performed under GLP conditions.
Justification for classification or non-classification
The Local Lymph Node Assay demonstrated that Uvasorb HA 88 has the potential to cause skin sensitisation. The test article was classified as a Category 1 sensitiser according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Basing on the results above reported, REGULATION (EC) No 1272/2008 (EU Regulation on Classification, Labelling and Packaging of substances and mixtures) would indicate the following:
Skin sensitisation:
Classification : Skin sensitiser - Category 1
Signal word : Warning
Hazard statement (Oral) : H317: May cause an allergic skin reaction.
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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