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EC number: 229-904-5
CAS number: 6829-22-7
The results show that the test item (Macrolex Rot E2G Gran.) has a weak
sensitizing potential in mice after dermal application. There was an
increase compared to vehicle treated animals regarding the cell counts
and the weight of the draining lymph nodes in all dose groups.
Thus, a hint for a substance specific activation of the cells of the
immune system via dermal application was found by the method used, i.e.
the test item has a weak skin sensitizing potential.
An irritating potential at the same doses measured by acute ear swelling
or ear weights, however, could not be determined.
Macrolex Rot E2G was examined for sensitization according to OECD TG 429
under GLP conditions. The modification refer to the measurement of cell
proliferation by cell counting instead of radioactive labelling. In
addition, the acute inflammatory skin reaction is determined to
discriminate specific from non-specific activation of immun system, as
also recommended in the update of OECD TG 429. NMRI mice were treated
dermally with 0% (vehicle control); 1%, 10% and 25 % as suspension in
polyethylene glycol 400 once per day on 3 consecutive days. One day
later the evaluation was done: cell count index of draining lymph nodes,
ear swelling and ear weight.
Compared to vehicle treated animals, the measured cell counts in the
test substance groups reached or exceeded the 'positive level' defined
for this assay;1.25. The cell count indices were determined 1.0
(vehicle), 1.53, 1.63, 1.48 Thus, the positive level was reached or
exceeded. The positive level which is 2x10[exp-2]mm increase of ear
swelling has not been reached in all dose groups. In addition, there was
no significant increase in the ear weights
Thus, the results show that Macrolex Rot E2G has a weak sensitising
potential in mice after dermal application.
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