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EC number: 298-791-2 | CAS number: 93839-21-5
Calculation and results of individual data; Vehicle: acetone/olive oil (4:1 v/v)
Test item concentration % (w/v)
number of lymph nodes
DPM per lymph node b)
BG = Background (1 mL 5% trichloroacetic acid) in duplicate
1 = Control group
2 -4 = Test groups
S.I. = Stimulation Index
a) = The mean value was taken from the figures BG I and BG II
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
The EC3 value could not be calculated since all S.I.'s are below the threshold value of 3.
VIABILITY / MORTALITY
No deaths occurred during the study period.
No symptoms of local toxicity at the ears of the animals and no systemic findings were observed during the study period.
The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
A significant increase in ear weights was observed in all treatment groups compared with the control group.
In this study the test item p-Nitrobenzoylaminobenzamid trocken dissolved in acetone/olive oil (4+1) was assessed for its possible contact allergenic potential. For this purpose a local lymph node assay according to OECD guideline 429 was performed using test item concentrations of 5, 10, and 25%. All treated animals survived the scheduled study period and no signs of systemic toxicity or local skin irritation were observed.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration results in a 3-fold or greater increase in incorporation of ³HTdR compared with concurrent controls, as indicated by the Stimulation Index (S.I.). The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.
In this study Stimulation Indices of 1.57, 1.22, and 0.85 were determined with the test item at concentrations of 5, 10, and 25% in acetone/olive oil (4+1). The EC3 value was not calculated since none of the tested concentrations induced an S.I. greater than 3. A significant increase in the ear punch biopsies was observed in all treatment groups compared with the control group. However, the data showed that the test item did not induce a relevant proliferation in the draining lymph nodes, thus the observed increase was not attributed to a sensitising effect. In conclusion, the test item p-Nitrobenzoylaminobenzamid trocken was not a skin sensitiser under the described conditions.
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