Table 5.

Template with minimum information on dermal absorption studies to be presented in assessment reports

In vitro and in vivo studies
Material/product tested (name/code number)
Type of formulation
Concentration of active substance in the formulation
Vehicle used (if any)
Dilution rates
Surface area dose in micrograms of active substance per cm2
Exposure time
Sampling duration (time of last sample)
Animal species/strain and skin sample source/application site
Group size/number of replicates/donor's ID for replicate
Total recovery (individual values for replicates, mean values ± SD)
Amount absorbed (individual values for replicates, mean values ± SD)
Samples contributing to the amount absorbed and samples removed as outliers (with justification)
Type of tape strip used
In vivo studies
Amount in excreta (individual values, mean values ± SD)
Amount in carcass (individual values, mean values ± SD)
Amount in exhaled volatiles/CO2 (individual values, mean values ± SD)
75% excreted in first half of study?
Amount in stripped application site (individual values, mean values ± SD)
Amount in tape strips 3 to ∞ (individual values, mean values ± SD)
Amount in tape strips 1 + 2 (individual values, mean values ± SD)
Amount in application site washes (individual values, mean values ± SD)
Swabbing
In vitro studies
Type of diffusion cell Receptor fluid composition
Specification of solubility in receptor fluid as recommended
t0.5 value
Amount in receptor fluid and chamber wash (individual values for replicates, mean values ± SD)
Amount in stripped skin sample (individual values for replicates, mean values ± SD)
Amount in tape strips 3 to ∞ (individual values for replicates, mean values ± SD)
Amount in tape strips 1 + 2 (individual values for replicates, mean values ± SD)
Amount in skin sample washes (individual values for replicates, mean values ± SD)
Swabbing

SD: standard deviation.