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EC number: 222-720-6
CAS number: 3586-55-8
study is conducted according to OECD guideline 408 with GLP. 10 male and
10 female Sprague-Dawley rats received via gavage once daily, 7 days per
week for 90 days 0, 30, 90, 270 mg/kg bw in corn oil (concentration 0,
0.6, 1.8, 5.4%). The
test substance induced local effects in the stomach at a dose level of ≥
90 mg/kg bw. Such effect is expected of a substance releasing
formaldehyde in situ. Other reported effects like reduced body weight
gain and some decrease in motor activity in the high dose groups and
alteration in haematology like increased leucocyte counts, shift in the
differential blood count at the high dose level are considered to be a
consequence of the chronic ulcerative gastritis & peritonitis. The
reduced pupil size detected in males and females and the negative pupil
response in males of the mid and high dose group (detected in functional
observation battery at week 13) might be a systemic effect of the test
substance but the toxicological relevance is unclear.
clinical chemistry parameters in the high dose group are recognized but
evaluation is limited without historical control data of the same
higher LOAELs can be expected if the test substance is applied via
drinking water or diet and not via gavage (bolus effect).
deficiencies include no data about the purity of the test substance
(responsibility of the sponsor, minor restriction); blood urea nitrogen
not determined in clinical chemistry and no data on significance at the
level p<0.05 (minor deficiencies).
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