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TNPP (purity >99%) was tested in a local lymph node assay (LLNA) study (Sanders 2010) and none of the tested concentrations (25, 50, and 100%) produced a positive response (a three-fold increase in test/control ratio). These results are further supported by a OECD 406 Buehler assay of TNPP (purity >99%) conducted by Tay et al. (2001), which also found that TNPP is not a skin sensitiser.
The proposed Annex XV C&L harmonisation dossier for TNPP developed by France (December 2009) proposed that TNPP be classified as skin sensitiser based solely on the positive result in an older Guinea Pig Maximisation Test (GPMT) study conducted by Ciba-Geigy (Hagemann 1992). However, as discussed in the comments submitted by Dover Chemical (April 2010) during the consultation process, it has been well established that the GPMT can produce false positives and thusly the LLNA study was selected as primary study for the skin sensitisation endpoint under REACH. With the negative results of the LLNA study for TNPP now available, it clearly is inappropriate to classify TNPP as a skin sensitiser.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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