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EC number: 203-794-9
CAS number: 110-71-4
Test item concentration % (w/v)
number of lymph nodes
DPM per lymph nodeb)
BG = Background (1 ml 5% trichloroacetic acid) in duplicate 1 =
Control Group 2-4 = Test Group 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
deaths occurred during the study period.
Clinical Signs: No
symptoms of local toxicity at the ears of the animals and no systemic
findings were observed during the study period.
Body Weights: The
body weight of the animals, recorded prior
to the first application and prior to treatment with3HTdR,
was within the range commonly recorded for animals of this strain and
Ethylene glycol dimethyl ether and Diethylene glycol methyl ethyl ether, which is tested for its sensitising potential, belong to the glycol ether family. These substances have been demonstrated to be very similar in structure, physical/chemical properties and the toxicological profile. Due to the fact that Ethylene glycol dimethyl ether and Diethylene glycol methyl ethyl ether have nearly the same chemical structure (especialy with reference to the functional groups):
1. Ethylene glycol dimethyl ether: H3C-O-CH2-CH2-O-CH3
2. Diethylene glycol methyl ethyl ether: H3C-O-CH2-CH2-O-CH2-CH2-O-CH2-CH3
the same mode of interaction with living cells and tissue is expected due to their similar metabolism to the toxic metobolite 2-Methoxyethanol. Therefore, a read-across from Ethylene glycol dimethyl ether to data obtained with Diethylene glycol methyl ethyl ether is scientifically justified.
The present study (Vogel 2010) analyses the sensitising potential of Diethylenglycol EM
Three groups each of four female mice were treated daily with the test item at concentrations of 25, 50, and 100% (w/v) in acetone:olive oil (4+1) by topical application to the dorsum of each ear (left and right) for three consecutive days. A control group of four mice was treated with the vehicle (acetone:olive oil (4+1)) only. Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes, which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by the incorporation of3H-methyl thymidine measured in ab-scintillation counter.
All treated animals survived the scheduled study period and no signs of toxicity were observed.
A test item is regarded as a sensitiser in the LLNA if the exposure to one or more test concentration resulted in 3-fold or greater increase in incorporation of3HTdR 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 0.73, 1.03, and 0.69 were determined with the test item at concentrations of 25, 50, and 100% in acetone:olive oil (4+1). The EC3 value could not be calculated, since none of the tested concentrations induced an S.I. greater than 3.
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