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EC number: - | CAS number: -
No signs of systemic toxicity, visual local skin irritation or irritation indicated by an equal to or greater than 25% increase in mean ear thickness were noted. White residual test substance on the ears was noted after dosing on days 1 to 3. Based on this information, the dose levels selected for the main test were 10%, 25% and 50% w/w in ethanol/distilled water (7:3).
Clinical observations and mortality data
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the study. White residual test substance was noted on the ears after dosing on days 1 and 2 in all animals treated at the 50% w/w concentration and after dosing on day 3 in all animals treated at the 25% and 50% w/w concentrations.
Bodyweight gains of the animals between days 1 and 6 were comparable to those observed in the control group over the same period.
Table 1: Indiviual bodyweights and bodyweight gains
Disintegrations per minute and Stimulation Index
Table 2: Disintegrations per minute, Disintegrations per minute/node and Stimulation Index
* dpm/Node is calculcated by dividing dpm by 8 (total number of lymph nodes)
In a GLP compliant skin sensitisation study conducted in line with OECD Guideline 429 and EU Method B.42, the skin sensitisation of the test substance was investigated. The Stimulation Index scores for 3HTdR incorporation into lymph node cells were less than three at all test concentrations and the substance was therefore considered to be a non-sensitiser.
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