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EC number: 406-040-9 | CAS number: 125643-61-0
Following the topical application of 0.5 mg/cm2 14C-labeled test substance in PEG to mice under occlusive conditions, approximately 29% of the radioactivity applied was detected in the swabs used to clean the treated skin after 6 h. Another 65.4% of the applied radioactivity was extracted from the protective dressing.
The dose recovered from the treated skin (0.07%) and in the first two tape strips (0.27%) accounted for 0.34% of applied radioactivity. The mean total amount of non-absorbed (sum of the dose removed during the washing procedure and the dose remaining on the skin surface) accounted for 94.32% of applied radioactivity.
Radioactivity detected in the stratum corneum corresponded to 0.26 % of the applied radioactivity. Radioactivity in urine, feces and cage washes accounted for 0.90%, 0.71% and 0.20% of applied radioactivity, respectively.
Radioactivity recovered in the gastrointestinal tract (including contents) accounted for 0.03% while 2.26% of applied radioactivity was detected in the carcass. The mean concentrations of radioactivity in carcass, treated skin, and gastrointestinal tract were 0.085, 0.021 and 0.006 µg equivalents/g wet weight, respectively.
The overall mean absorbable proportion of 14C-labelled test substance (sum of direct absorption [excreta, tissues], treated skin and stratum corneum) was 4.42% of applied radioactivity.
Table 1: Distribution of radioactivity detected after topical application of 14C-labelled test substance to male mice in percent of applied radioactive dose.
Time point/interval (hours after dosing)
0 - 168 h
28.95 +/- 5.62
59.62 +/- 5.60
5.75 +/- 2.17
Dose on surface (Strips1,2)
94.59 +/- 2.50
DIRECT ABSORPTION (Tissues & Excreta)
0.90 +/- 0.21
0.71 +/- 0.22
2.26 +/- 2.06
0.03 +/- 0.02
0.20 +/- 0.03
4.09 +/- 2.33
Skin (after stripping)
0.07 +/- 0.02
0.26 +/- 0.16
Direct Absorption + treated skin + Stratum corneum
4.42 +/- 2.40
99.01 +/- 1.95
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