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EC number: 261-332-1 | CAS number: 58567-11-6
Skin sensitisation (OECD 429), mouse: Skin sensitising
The following results were obtained for (ethoxymethoxy)cyclododecane using acetone:olive oil (4:1 v/v) as vehicle:
Test item concentration % (w/v)
Number of lymph nodes isolated
dpm / lymph nodea)
BG = Background (1 mL 5 % trichloroacetic acid) in duplicates
SI = Stimulation Index (Ratio = dpm/lymph node test item treated group / dpm/lymph node Group 1)
a) = Since the lymph nodes of the animals of a dose group were pooled, dmp/lymph node was determined by dividing the measured value by the number of lymph nodes pooled.
Calculation of the EC3 Value
Test item concentration
EC3 = (a-c) [(3-d)/(b-d)] + c = 25.1 %
EC3 = Estimated concentration for a SI of 3
a, b, c, d = Co-ordinates of the two pairs of data lying immediately above and below the SI value of 3 on the LLNA dose response plot
In order to study the possible contact allergenic potential of the substance, three groups of four female mice each were treated daily with the test item at concentrations of 10%, 20% and 40% (w/v) in acetone:olive oil (4:1 v/v) by topical application to the dorsum of each ear lobe for three consecutive days. A control group of four female mice was treated with the vehicle acetone:olive oil (4:1 v/v) only.
Five days after the first topical application the mice were injected intravenously into a tail vein with radio-labelled thymidine (3H-methyl thymidine, 3HTdR). Approximately five hours after intravenous injection, the mice were sacrificed, the draining auricular lymph nodes were 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 of 3HTdR measured in a β-scintillation counter.
All treated animals survived the scheduled study period. Neither clinical signs on the ears of the animals nor systemic findings were observed during the study period.
The results obtained [Stimulation Index (S.I.)] are reported in the following table. The estimated concentration of test item required to produce a S.I. of 3 is referred to as the EC3 value.
EC3: 25.1 %
A dose-response relationship was observed. A calculation of the EC3 value was performed using the indicated concentrations (*).
In conclusion, the test item was found to be a skin sensitizer and an EC3 value of 25.1% (w/v) was derived.
One fully reliable study (2012a) in vivo is available that shows skin sensitisation potential of the substance. The test item was found to be a skin sensitizer and an EC3 value of 25.1% (w/v) was derived.
Study not required according to Annex VII-X of Regulation (EC) No. 1907/2006.
Referring to Table 3.4.4 of the 2nd Amendment to Regulation (EC) No. 1272/2008 (CLP, as implementation of UN-GHS in the EU), a substance needs to be classified as Category 1B "Warning - H317: May cause an allergic skin reaction", if a local lymph node assay reveals an EC3 value > 2%, which applies to the test item.
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