Registration Dossier

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.