Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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:
A K1, GLP study is conducted in accordance with OECD guideline 429 is available (Sanders, 2014b). The study examined the skin sensitising effect of the 49.8% solution on mouse. Positive, solvent and negative controls were included in the study, and showed expected results, resulting in a valid assay.
Stimulation index (based on active ingredient) is determined as 1.38 (12.5%), 1.86 (25%) and 3.07 (50% solution).
Based on this study it was concluded that the substance is considered sensitizing to the skin.
Migrated from Short description of key information:
Based on the local lymph node assay in female mice according to OECD guideline 429 and EU Method B.42, performed in 2014, it is concluded that the substance is sensitising to the skin (category 1B).
Justification for selection of skin sensitisation endpoint:
Only reliable study available
Justification for classification or non-classification
Based on the available information and the criteria of the CLP Regulation, the test item (49.8% solution) is classified as a skin sensitizing substance, skin sensitising category1B. The 12.5% and 25% solution of the test item is considered not sensitizing to the skin.
No data are reliable available on respiratory sensitization. Therefore, no conclusion can be made on the classification for this endpoint.
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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