Division 5.1.2 Absorption, distribution, metabolism and excretion after exposure by other routes

Data on absorption, distribution, metabolism and excretion (ADME) following exposure by the dermal route shall be provided where toxicity following dermal exposure is of concern compared to that following oral exposure. Before investigating ADME in vivo following dermal exposure, an in vitro dermal penetration study shall be conducted to assess the likely magnitude and rate of dermal bioavailability.

Absorption, distribution, metabolism and excretion after exposure by the dermal route shall be considered on the basis of the above information, unless the active substance causes skin irritation that would compromise the outcome of the study.

Dermal absorption estimation from data generated in these studies on the active substance shall be critically assessed for relevance to humans. Dermal absorption measurement of the plant protection product is specifically considered under point 7.3 of Part A of the Annex to Regulation (EU) No 284/2013.

For volatile active substances (vapour pressure > 10^–2 Pascal) absorption, distribution, metabolism and excretion after exposure by inhalation may be useful in human risk assessments.