Document 7O148ZDOgpa67E57x34dw1jz6
AR226-2820
Material Tested:
Submitted by:
E. I. du Font de Nemours and Company
Haskell Laboratory for Toxicology and Industrial Medicine
HASKELL LABORATORY REPORT NO. 11-64
ganic Chemicals Department, Jackson Laboratory
Haskell No Other Code
ACOTE ORAL TEST
Procedure; The material was administered, as received, by stomach tube to young adult Call-CD male rats Survivors were sacrificed 14-15 daya later.
Result 8;
Dose*
fa>B^)
11,000 1,500 5,000 2,250
Mortality**
S - 15 d. S - 15 d. S - 14 d. S - 14 d.
Toxic Signs
Slight initial weight loaa
Weight When Killed Body (an) Liver (gm)
345
23.2
334
18.9
314
15.3
305
15.7
^y" wt-
Body Wt.
x 100 --
6.7
5.7
4.9
5.1
*
**
Baaed S- (
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n
a
d.
c
=
t
i
ve Sa
ci
nri
gfi
cree
dd
i
e(
n)th,
i]a_y_s_
____
after
______
dosing
TEN-DOSE SUBACuTE ORAL TEST
Procedure; The test material, as received, was administered daily by stomach tube to each of six youn rats, five times a week for one or two weeks. Where animals survived, groups of three teat rats, along sacrificed four hours and 14 days after the last treatment.
^conta
Comp^S^28'-30857
Results:
Dose* fmgyke/day)
5,000
2,250
Mortally
6/6
0/6
Toxic Signs
Death after 3-5 doses, weight loss, diarrhea, discoloration of
perineal area.
First Week: slight
weight loss
Second Week; slightly depressed rate of
weight gain. Reeovegy Period; none;
weight gain parallel that of. controls
* Based on active ingredient
2 -
Individual Liver Weights (a)
4 hours after 14 days after
10th dogse
10th doge
Control Teat Cootrol Test
13.9 16.6 17.4
29.8 35.2 30.2
16.8 16.6 18.6
24.2 25.0 23.9
Individual Liv
4 hours after
10th doae Control Test
4.5 11.5 5.0 11.6 5.0 11.8
r i L male rac, its Appuxiiate Lethal Doee (ALD) being greater thanTT,000 mg/kg of bodywiight, based on
The compound produced an increase in the liver weight of the animal doaed at 11,000 ing/kg, and possib
'Bosed at 7,500 mg/kg.
\ji^f^SIhouB high cumulative oral toxic&ty. When administered to each of six rats at a d day, all1. died after thaving received three to five doses. Two of the animals examined hietologically
terminal lung damage, in addition, their stomach contents were in the form of a firm core that waaBO the digestive tract in a normal Bander., When administered to rats at a dose of 2,250 mg/kg/day,|||||^ extremely heavy livers in animals sacrificed after the tenth dose, with evidence of some recovery' me sacrificed after a 14-day recovery period. Microscopically, the heavy livers contained some enlarged enlarged nuclei which had prominent nucleoli or an uneven distribution of chromatin material. The le were not those usually indicative of deg<aerative changes.
o
;sn'
.Sa^^00"
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3 -
oJ||B|BIHHHHIBHHBgupon Because of the effect
the liver of rats after high le
their use as a component of food wrappi'-" "tterlal would require (a) that studies be conducted to determ
if any, to which they migrate from wrappiu\ " foods and (b) that additional feeding studies of longer
ated to determine a "no-effect'" level as ? r- Liminary to securing Food and Drug Administration approva
Report by: Approved by:
enry Sherm Toxicologis
.^/- ^z . D. B. Hood
Chief, Toxicology
HS/ujd Oste: February 3. 19f4
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