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EC number: 241-749-5 | CAS number: 17766-26-6
The animals gained weight normally during the study.
Animal supplier: Charles River Laboratories, Kingston, NY, USA
TMT was examined for its skin sensitisation potential in a Guinea Pig Maximisation test (GPMT) which was conducted under GLP according to OECD Guideline 406 adopted in 1981 (93-0164-FGT).
A pilot study was performed to evaluate irritating effects after intradermal and topical application. Concentrations of 0.1%, 1%, 3% and 5% of TMT 55 each in water and in a 1:1 mixture (v/v) FCA/water were used in the primary irritation screen. The highest concentration that did not produce ulceration and/or necrosis was determined to be 0.1% in water and 1% in a 1:1 mixture (v/v) FCA/water. Moreover concentrations of 9.5%, 19%, 38% and 75% in water were selected to determine the topical dermal irritation threshold concentration of TMT 55. No signs of irritation were evident for any of these concentrations after a 24 h exposure period.
Therefore, in the main study 20 Crl:(HA)BR VAF/Plus guinea pigs received an intradermal application of 0.1% test material in water and 1% test material in a 1:1 mixture (v/v) FCA/water for induction at day 0 of the experimental period. A control group with 20 animals were treated with water and adjuvance only. On day 7 occlusive patches with 75% of the test substance were applied on the same site of the test animals for 48 h for topical induction, the control group were treated with water only. On day 21 test and control animals were challenged with 75% test material by occluded patch for 24 h on the right flank. 24 h and 48 h after removing the patches, no dermal reactions were recorded. Thus it is concluded, that based on the results of this GPMT test TMT 55 is not skin sensitising. This negative result on skin sensitisation can be transferred to anhydrous TMT.
The available data on skin sensitisation of TMT do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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