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EC number: 214-244-2
CAS number: 1117-31-3
Table 1 Mean Hematology Data for Male Rats following Repeated Dermal
Dosing in a 28-Day Study with PGDA
N = 6 for each value
Table 2 Summary of Hematology Historical Control Data from Male Rats at
Report titled "Charles River-Clinical laboratory Parameters for the CD
Rat (March 2006)" found at
Four groups of Sprague-Dawley rats, each comprising 6 males and 6
females, received daily (5 days/week) dermal doses of the test material
for 28 days at levels of 0 (control), 100, 300, and 1000 mg/kg body
weight, respectively. OECD test guideline 410 was followed, applying
good laboratory practice.
No test substance related mortality occurred moreover no evident signs
of systemic toxicity were observed in any of the treatment groups.
Temporary local eschar formation on the treated skin side of several
animals among all groups was induced ,by shaving in combination with the
way of bandaging and not by the test substance. No test substance
related effects on body weight gain and food consumption were found.
Organ weights, organ/body weight ratios, haematology and clinical
chemistry data, and gross and microscopic pathology revealed no test
substance related changes.
Based on these findings it was concluded that repeated dermal dosing of
the test substance for 28 days up to a level of 1000 mg/kg body weight
caused no adverse health problems. The no observed adverse effect level
is 1000 mg/kg/day.
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