ECHA calls for information to avoid unneccessary animal testing

11-Aug-2009 - Finland

The European Chemicals Agency (ECHA) is calling for health effects information on the reproductive toxicity of a specific chemical substance by 24 September 2009. This is the first time that this type of public consultation - foreseen by the REACH Regulation - is made, and ECHA expects to make many such calls about different substances over the coming years. Anyone with relevant information is invited to send it to ECHA by the deadline. Organisations that may have testing reports on the substance (or scientifically valid equivalent information) include academic institutions, individual companies and NGOs. The aim of the call is to give anyone the opportunity to submit relevant data with a view to make sure that animal testing is only conducted as a last resort when the available information is not sufficient to assess the potentially harmful effects of this chemical on human health or the environment.

In this case, the registration dossier concerns a new substance with a complex and variable composition manufactured or imported into the EU in considerable volumes. The registrant has, as permitted by the legislation, claimed many of the details of the registration dossier confidential and so they cannot be made public by ECHA. However, this UVCB1 substance has the generic chemical name of “hydrogenated oligomerisation product including dimers and trimers, of tetradec-1-ene and alkene”. The substance is a component in lubricants used by professionals and consumers. Based on the available data the registrant has not classified the substance as dangerous either for physical-chemical properties, health effects or for the effects on the environment. The testing proposal from the registrant concerns information on reproductive toxicity: i.e. requiring two experimental tests involving vertebrate laboratory animals.

The testing proposal will then be evaluated by ECHA in the coming months, together with any information resulting from this call. On the basis of this evaluation ECHA will propose a decision to accept, amend or to reject the testing proposal. The dossier, like any other registration dossier, may in addition be put through a further check by ECHA also on other parts than for information on reproductive toxicity. Non-compliance with the REACH requirements may inter alia lead to a need for further studies to complete any identified data gaps.

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