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EC number: 260-135-8
CAS number: 56375-79-2
Both animals at a 50% test substance concentration were sacrificed
for ethical reasons or found dead on day 2. Clinical signs noted for the
sacrificed animal consisted of hunched posture, piloerection, lethargy
and ptosis. Slight erythema was noted on both ears of these animals on
Day 2. No signs of irritation were noted at a 25% test substance
concentration. Variations in ear thickness during the observation period
were less than 25% from Day 1 pre-dose values (no measurements were done
in both animals at 50% on Days 3 and 6).
Based on these results, the highest test substance concentration
selected for the main study was a 25% concentration.
An LLNA skin sensitisation assay was performed according to OECD/EC
guidelines and GLP principles. The test substance was applied at
concentrations of 5, 10 or 25%, however two of the three animals in the
highest exposure group had to be sacrificed due to severe systemic
toxicity. Data obtained at this concentration were not used for
In the other groups, no significant body weight loss was noted, and no
irritation of the ears was observed. The auricular lymph nodes of all
(surviving) animals treated with a 10% and 25% test substance
concentration appeared larger in size when compared to the other treated
groups, the auricular lymph nodes of animals at 5% test substance
concentration were considered normal in size. The SI values calculated
for the substance concentrations 5 and 10% were 0.5 and 1.1
respectively. Based on these data, TMAC is considered not to be a skin
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