Update on TOTM Substance Evaluation

Oxea is manufacturing Oxsoft TOTM for several uses including medical devices. The excellent migration properties of TOTM make this molecule highly suitable for this type of application. TOTM is already used for years in medical devices, mainly medical tubing, and we see an increased demand for TOTM in this area because of concerns regarding DOP.
TOTM is currently undergoing the Substance Evaluation process under the REACH program. Currently the REACH registration dossiers have been evaluated by the designated Member State and the draft report is currently being discussed by ECHA and the other Member States. A final verdict is expected in autumn 2013.
TOTM was placed on the CoRAP because of its suspected PBT-properties. Based on available data, the Competent Authority was satisfied, that there is no concern regarding the Toxicity criterion. Further studies have been proposed to provide further data on persistence in the environment.
Oxea is committed to support any necessary research for missing data and to work closely with the Competent Authorities and co-producers in the further investigation into the product properties.
TOTM is outperforming other plasticizers like DOP, DOTP and hydrogenated DINP with regard to migration profile and therefore it has a promising future in applications where migration is a concern. This does not mean those products are not safe, not at all, it only means that TOTM has a superior migration profile. However it is important that the molecule TOTM is researched well and any missing data will be provided in order to tackle any future concerns and prevent any misunderstanding.

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