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EC number: 205-617-0 | CAS number: 144-15-0
Range Finding Test
Intradermal injection - No skin reactions were observed after the intradermal injection of the test article at a concentration of 5 %.
Table 1: Individual observations of skin reactions in the range finding test 48 h after intradermal injection
Dermal application - No skin reactions were observed after the dermal application of the undiluted test article.
Table 2: Individual observations of skin reactions in the range finding test 48 h after dermal application
m = male; f = female; E = erythema; Oe = oedema
There were no skin reactions after the dermal application in the induction phase and after challenge exposure. The sensitisation rate, i.e. the number of animals showing an allergic response expressed as a percentage of the total number of animals, was determined at 24 and 48 h after the patch removal and was 0 % in each case.
Table 3: Individual values of responses in the main test after challenge exposure in the test group (test article concentration: 100 %)
Reaction rate at 24 h and at 48 h: 0 %; m = male; f = female; E = erythema; Oe = oedema
Table 4: Individual values of responses in the main test after challenge exposure in the control group (test article concentration: 100 %)
Reaction rate at 24 h and at 48 h: 0 %; m = male; f = female; BW = body weight; E = erythema; Oe = oedema
The potential skin sensitising properties of the test article tris(2-ethylhexyl) 2-(acetyloxy)propane-1,2,3-tricarboxylate (ATEHC, CAS 144 -15¬0) were assessed in a guinea pig maximisation sensitisation test according to OECD 406 and EU method B.6 and in compliance with GLP (Bien, 2000) using 10 test and 5 control animals. Following the induction exposure to the test article or the vehicle (control article) aqua ad iniectabilia, the animals of both groups were subjected two weeks later to a challenge exposure with the test article and the control article. Responses to the challenge procedure were evaluated 24 and 48 h after the end of the exposure period. No allergic skin reactions were observed at 24 and 48 h after the end of the challenge procedure; the sensitisation rate was 0 %.
There is no indication that ATEHC may cause respiratory sensitisation.
According to the European regulation (EC) No. 1272/2008, the test material does not meet the criteria for classification and will not require labelling as sensitising to the skin.
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