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EC number: 915-179-9 | CAS number: -
Five concentrations (the undiluted test item and 50, 25, 10, 5% w/w) were selected to be used in the preliminary phase.
No signs of toxicity (clinical signs or toxicologically relevant body weight losses) were observed at any of the tested concentrations.
The evaluation of visible reactions showed no erythema at any of the concentrations investigated.
The evaluation of ear thickness indicated that the reaction was acceptable (increase of less than 25% compared to Day 1) at the concentration of 100% (undiluted test item).
The evaluation of ear punch weight indicated that the reaction was acceptable (increase of less than 25% with respect to the negative control) at all the investigated concentrations.
According to the results described above, the undiluted test item was the highest concentration selected for the main phase.
Main Assay - In vivo phase
No mortality nor significant clinical signs were recorded in animals treated at all dose levels.
Body weight decreases/reduced body weight gains observed in some animals from all groups (including controls) were considered of low entity and/or incidental and thus not toxicologically relevant.
The undiluted test item and four concentrations (50, 25, 10, 5% w/w) in acetone:olive oil 4:1 v/v were selected to be used in the preliminary phase, in order to identify a non toxic and minimally irritant concentration and avoid false positive results.
No signs of toxicity (clinical signs or body weight losses) were observed at the tested concentrations.
According to the results of the irritation screening, the undiluted test item was judged to be not irritant.
In the main assay, the test item was topically administered at the concentrations of 100, 50 and 25% w/w, in acetone:olive oil 4:1 v/v.
No mortality or clinical signs were recorded in any animal.
Changes in body weight observed during the study were within the expected range for this strain and age of animals.
No increase in cell proliferation of draining lymph nodes was observed in any treatment group. The calculated stimulation indices (SI) were 0.93, 0.79 and 0.77, respectively at low, mid- and high dose levels.
In the group treated with the positive control item, a stimulation index (SI) of 2.96 was calculated. As it was greater than 2, the test study was regarded as valid.
The results obtained in this study indicate that the test item does not elicit any sensitisation response in mice following dermal exposure.
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