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EC number: 701-230-0 | CAS number: -
Several studies on mouse were available on butane-1,4-diylbis(oxy-2-hydroxypropane-3,1-diyl) bisacrylate to evaluation the skin sensitization potential. Based on the data, butane-1,4-diylbis(oxy-2-hydroxypropane-3,1-diyl) bisacrylate is considered as a moderate skin sensitizer.
No signs of systemic toxicity were observed. The body weight increased as expected.
Moderate redness was noted between the ears in animals treated with 10% and 25% of the test substance.
A local lymph node assay in the mouse was performed on butane-1,4-diylbis(oxy-2-hydroxypropane-3,1-diyl) bisacrylate to assess the skin sensitization potential of the substance in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The study was performed according to the OECD guideline 429 (2002).
Following a preliminary screening test, three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a solution in acetone/olive oil 4:1 at concentrations of 5%, 10% and 25%. A further group of 4 animals was treated with acetone/olive oil 4:1 alone.
The stimulation index expressed as the mean incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are of 4.28, 4.14 and 7.32 respectively. All the SI were higher than 3, indicating positive results. In conclusion, the test material was considered to be a sensitizer under the conditions of the test.
Key study (2005) :
Supporting studies (2002):
In the first LLNA experiment, 1%, 3%, and 10% preparations of the test substance in propylene glycol were administered to the ears of 6 female CBA/Ca mice per group. A positive response (cell count index of 2.16 and lymph node weight increase of 78%) was observed in the 10% group only, but at the same time the ear weight was increased by 31%, which is considered a sign for excessive irritation. Therefore it was impossible to determine, if the effects were due to the sensitzing or irritating properties of the test substance.
To clarifiy the results, the second study was performed using a preparation of 6.5% in propylene glycol according to two different treatment regiments: either the mice were treated with 25µl on both ear on three consecutive days as in the previous experiment (induction phase group), or they were treated with 25µl on the flank for three consecutive days 14 days prior to exposure to 25µl on the ears on three consecutive days (challenge phase group). In both cases no increase in ear weight and thus no sign for local irritation was observed. The induction phase group only showed a slight and not significant increase in lymph node weights and cell count, while the challenge phase group exhibited an increase in lymph node weight of 80% and a cell count index of 2.06 when compared to control.
Based on the available data, butane-1,4-diylbis(oxy-2-hydroxypropane-3,1-diyl) bisacrylate should be classified as moderate skin sensitizer (Skin sens.1B, H317).
Justification: Excessive irritation was observed in all studies at and above a concentration of 10%, while at concentrations of 5% (2005) and 6.5% (2002) sensitization was observed without irritation. Since no sensitization occurred when using a 1% or 3% solution (2002), the threshold for sensitization is above 3% and below 5%.
There are no data available to classify the substance as a sensitizer of the respiratory tract.
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