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EC number: -
CAS number: -
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.
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
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