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EC number: 303-085-5
CAS number: 94158-14-2
Exp. A, B, C:
Total recovery of the
applied radioactivity was good with recovery rates between 96.5 and 98.1
The majority of the
applied dose (95.9 to 97.1 % of the applied amount) was recovered in the
The amount of
radioactivity remaining at the application site (skin) for the water
solution represented 1.68 % of the applied dose. The respective figures
for formulations with and without hydrogen peroxide were 0.56 % and 0.34
0.314 %, 0.05 % and
0.345 % of the applied doses were eliminated via urine and faeces within
72 h in experiment A, B and C, respectively. The lowest absorption rate
was obtained in the formulation containing H2O2.
Radioactivity was mainly excreted via urine (84 – 99 % of the total
amount eliminated). Elimination was fast, as 82 - 93 % of the total
amount eliminated was excreted within the first 24 hours.
Excretion via faeces
was of less importance representing 8.5 to 16 % of the absorbed dose.
remaining in the carcass was very low 72 hours after administration
(0.005 % of the administered dose for exp. A and C, 0.002% of the
administered dose for exp. B). Residues in organs were mostly below the
detection limit, with highest concentrations noted for kidneys. No
relevant differences were noted between males and females.
Based on these results,
a cutaneous absorption rate of 3.5* µg/cm² (equal to 0.318 %), for the
formulation without H2O2, of 0.59 µg/cm² (equal to
0.053 %) for the formulation with H2O2and of 3.95
µg/cm² (equal to 0.351 %) for the pure dyestuff in aqueous solution were
obtained based on the bioavailable amounts (carcass, urine and faeces).
If, as a conservative
assumption, the mean amounts found in urine, faeces, residual carcass and in
the total skin including the application site were considered as
bioavailable, a cutaneous absorption of 6.74 µg/cm² (equal to 0.613 %)
was calculated for the commercial hair dye formulation with hydrogen
peroxide. The respective figure for the formulation without hydrogen
peroxide was 7.24 µg/cm² (equal to 0.658 %).
Remark: In the report a value of 2.9 µg/cm² was given by mistake
Exp. D and E
of the test compound in the blood was observed after 35 min, the first
time point of sampling, after dermal as well as after oral application
of the test substance (experiment D and E) and declined with an initial
half-life of 1 h after cutaneous and about 1.5 h after per-oral
administration. The highest concentration observed in the blood after
oral application was about 70-fold higher than the highest value
observed after dermal application.
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