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EFSA publishes preliminary assessment of new scientific studies on human in vitro dermal absorption

Following the entry into force of the Scientific Opinion on Guidance on Dermal Absorption in 2012 the European Crop Protection Association (ECPA) requested that the Commission and EFSA consider new data on dermal absorption with the aim of refining the default dermal absorption values and conditions for read across between formulations. The request was accepted and comprehensive data sets comprising information from >350 human in vitro dermal absorption studies, from ECPA and BfR, along with the original study reports, were submitted to EFSA in October 2014.

As a first step EFSA have assessed the quality of the data sets from both sources in terms of plausibility, compliance with OECD test guidelines and completeness. A preliminary assessment of these data was published 12 November 2015[1] and whilst some deficiencies were noted, overall it was concluded that “there is sufficient information to support the revision of the current EFSA guidance/develop a new guidance on dermal absorption.” EFSA has recommended that deficiencies in the data sets are addressed, duplicates between the two data sets are removed and the data are analysed by “applying a model-based statistical protocol in order to revise the current guideline/develop a new EFSA guidance on dermal absorption”.

[1] EFSA Journal 2015, 13(11):4304

For information on how this may impact on your business, or further information on the registration of plant protection products, biocides or general chemicals, contact JSC on  +44 (0)1423 520245,

Published 4th December 2015
Categories Agrochemicals, News
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