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
- Additional information:
Sensitisation
A GLP-conducted local lymph node assay was performed to evaluate the sensitizing potential of the test substance according to OECD 429 in CBA/CaOlaHsD mice with 5 animals per group (Lütkenhaus, 2012b). Due to the low solubility of the test substance and the results of a preliminary test, the test animals were exposed to 25 µL of 6.25, 12.5 and 25% (w/v) concentrated test solutions. According to OECD 429, the test substance was applied topically to the entire dorsal surface of each ear of each mouse once daily for three consecutive days. The proliferative response of lymphocytes in the draining auricular lymph nodes was determined via3H-methyl thymidine incorporation, the stimulation index relative to the sham treated controls and the EC3 values were calculated. Neither mortality, clinical signs of toxicity or local effects at the application site were observed until the end of the study. Further, all animals showed the expected weight development including a weight loss of 2%. The test substance induced stimulation indices of 8.2, 9.8 and 16.9 for 6.25, 12.5 and 25% test substance, respectively, which result in an EC3 value of 0.64%. In compliance with the classification criteria given in the GHS, the test substance is classified as a skin sensitizer, Category 1A.
Migrated from Short description of key information:
skin sensitisation (OECD 429): sensitising (SI > 3)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VIII of Regulation (EC) No. 1907/2006.
Justification for classification or non-classification
The available data on skin sensitisation of the test substance meets the criteria for classification as Skin Sens. 1A (H317: May cause an allergic skin reaction) according to Regulation (EC) 1272/2008 and as Xi (R43: May cause sensitisation by skin contact) according to Directive 67/548/EEC.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
