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EC number: 259-134-5
CAS number: 54381-16-7
was performed to determine the toxicity of
N,N-Bis-(2-hydroxyethyl)-p-phenylenediamine sulfate after repeated
dermal application by following methods similar to the OECD Guideline
411 (Subchronic Dermal Toxicity: 90-Day Study).
and female New Zealand White rabbits were used in the study. 6
animals/sex were used in each group. The hair at the site of application
on the back and sides of each animal was clipped short throughout the
study. The thoracic-lumbar area (one on each side of the midline) was re
alternated to minimize skin irritation. The application sites on three
animals of each sex in each group were abraded on the first treatment
day of each week.
mL/Kg bw of test substance formulation was applied. Animals were treated
for 13 weeks (twice/week). The treatment schedule was as follows:
1, 2 and 3: Animals were shaved, not treated.
1: Formulation 1 (P21) containing 1% of test substance was prepared.
Prior to treatment, the formulation was mixed with equal volume of 6%
2: Formulation 2 (P22) contained 0.5% of test substance
1 h of treatment, animals were shampooed, rinsed, dried, and returned to
were observed for clinical signs, dermal irritation and body weight
changes during the study period. Urine and blood samples were collected
at 0, 3, 7, and 13 weeks of the study to determine the various
parameters. Animals were sacrificed after 13 wk and examined for gross
abnormalities. Tissue samples were collected to perform histology.
Organ-body weight ratios were determined for liver, kidneys, adrenals,
heart, thyroid, spleen, and brain.
control and five test animals died during the study due to complications
resulting from cardiac puncture while collecting blood. Treated skin
showed slight thickening in some groups, particularly Group 1. This was
not unexpected, due to the frequency of dye application. No evidence of
test substance induced toxicity was observed. Body weight gain of all
test groups was at least equal to that of the controls.
were scattered statistically significant differences in the hematologic
and clinical chemistry values between test and control groups at the
various sampling intervals. However, these differences were not
considered to be of toxicological significance because of either the
trend or persistence of the differences or the fact that they fell
within the range of historical control values. The results of the
urinalyses were unremarkable.
gross abnormalities were seen at necropsy. No microscopic lesions were
seen that were judged to be due to the administration of the
on above, dermal application of P21 formulation containing 1%
N,N-Bis-(2-hydroxyethyl)-p-phenylenediamine sulfate mixed with
equal volume of hydrogen peroxide and dermal application of P22
formulation containing 0.5% of test substance to hair clipped skin of
rabbits for 13 weeks (twice/week) did not induce any evidence of
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