Assessment of an extended dataset of in vitro human dermal absorption studies on pesticides to determine default values, opportunities for read-across and influence of dilution on absorption

Regulatory Toxicology and Pharmacology : RTP
M AggarwalR Billington

Abstract

Dermal absorption is a key parameter in non-dietary human safety assessments for agrochemicals. Conservative default values and other criteria in the EFSA guidance have substantially increased generation of product-specific in vitro data and in some cases, in vivo data. Therefore, data from 190 GLP- and OECD guideline-compliant human in vitro dermal absorption studies were published, suggesting EFSA defaults and criteria should be revised (Aggarwal et al., 2014). This follow-up article presents data from an additional 171 studies and also the combined dataset. Collectively, the data provide consistent and compelling evidence for revision of EFSA's guidance. This assessment covers 152 agrochemicals, 19 formulation types and representative ranges of spray concentrations. The analysis used EFSA's worst-case dermal absorption definition (i.e., an entire skin residue, except for surface layers of stratum corneum, is absorbed). It confirmed previously proposed default values of 6% for liquid and 2% for solid concentrates, irrespective of active substance loading, and 30% for all spray dilutions, irrespective of formulation type. For concentrates, absorption from solvent-based formulations provided reliable read-across for other formu...Continue Reading

References

Mar 15, 1982·Toxicology and Applied Pharmacology·R L BronaughE R Congdon
Dec 31, 2003·International Journal of Pharmaceutics·Joaquín Borrás-BlascoMarina Herráez-Domínguez
Oct 23, 2004·Human & Experimental Toxicology·B van Ravenzwaay, E Leibold
Jan 21, 2006·Reviews on Environmental Health·Christopher J Gordon, Lisa R Leon
Dec 21, 2006·Journal of Pharmaceutical Sciences·Franklin K AkomeahMarc B Brown
Apr 2, 2011·Skin Pharmacology and Physiology·P A LehmanT J Franz

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Citations

Jun 30, 2017·EFSA Journal·UNKNOWN European Food Safety Authority (EFSA)Arianna Chiusolo
Jan 16, 2021·Regulatory Toxicology and Pharmacology : RTP·Felix M KluxenChristian J Kuster

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