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EC number: 300-340-2 | CAS number: 93925-38-3
Preliminary Screening Test
Clinical observations, body weight and mortality data are given in the attached Table 1 and local skin irritation is given in the attached Table 2. The ear thickness measurements and mean ear thickness changes are given in the attached Table 3.
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.
Based on this information the undiluted test item and the test item at concentrations of 10% and 1% v/v in acetone/olive oil 4: 1 were selected for the main test.
Estimation of the Proliferative Response of Lymph Node Cells
The radioactive disintegrations per minute per animal and the stimulation index are given in the attached Table 4.
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
acetone/olive oil 4:1
acetone/olive oil 4:1
Clinical Observations and Mortality Data
Individual clinical observations and mortality data for test and control animals are given in Table 5 and local skin irritation is given in Table 6. The ear thickness measurements and mean ear thickness changes are given in the attached Table 7.
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
Individual body weights and body weight change for test and control animals are given in the attached Table 8.
Body weight change of the test animals between Day 1 and Day 6 were comparable to that observed in the corresponding control group animals over the same period.
Calculation of EC3 Value
EC3 = c + [[(3-d)/(b-d)] x (a-c)]
EC3 = 10 + [[(3-2.27)/(3.20-2.27)] x (100-10)] = 81
The concentration of test item expected to cause a 3 fold increase in 3HTdR incorporation (EC3 value) was calculated to be 81%. However, this result was not adopted because an alternative and more sophisticated statistical analysis of the data provided an overall SI index of 2.54, giving the conclusion that the substance is not a sensitizer.
a = lowest concentration giving stimulation index>3b = actual stimulation index caused by 'a'
c = highest concentration failing to produce a stimulation index of3d = actual stimulation index caused by 'c'
A study was performed to assess the skin sensitization potential of the test item in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear.
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100%, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of five animals, were treated with 50 µL (25 µL per ear) of the undiluted test item or the test item as a solution in acetone/olive oil 4: 1 at concentrations of 10% or 1% v/v. A further group of five animals was treated with acetone/olive oil 4: 1 alone. A concurrent positive control test, using a group of five animals, was also performed with the known sensitizer, a-Hexylcinnamaldehyde tech., 85%, at a concentration of 25% v/v in acetone/olive oil 4: 1
The concentration of test item expected to cause a 3 fold increase in 3HTdR incorporation (EC3 value) was calculated to be 81%.
A standard preliminary statistical evaluation performed on the data calculated the SI to be 3.2, which is of sufficient magnitude to suggest that the substance be characterized as a sensitizer. However, a more detailed and appropriate ANOVA of properly transformed data shows that all treatment data are similar. Given these results, it is appropriate to pool the SI data from the all treatments. In so doing the average SI for the substance is 2.54 and therefore, the substance should not be considered a sensitizer.
a-Hexylcinnamaldehyde, tech., 85% gave a Stimulation Index of greater than 3 when tested at a concentration of 25% v/v in acetone/olive oil 4: 1 thus demonstrating the sensitivity and reliability of the test system.
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