Document MMJrGX3wekdgzbbX14zYroLZj
B105EARCH INCORPORATED
P.O. OX 9598, PHILADELPHIA. PENNSYLVANIA 18101 TtLEPHONE; <21S) 730-4499
AR226-2907
Project Number;
SUMMARY OP RESULTS OF AN ACDTE ORAL TOXICITy LD STUDY
Conducted for; Date of Report;
E. I. du Font de Neoours & Company
Bukeil Laboratory
Jtily 26. 1982
Acute Oral Toxic! ty LD - Male JRats. Ihe LD-Q and 19/20 Confidence Limits -
2^150 (1,961 -
2,358) agAg.
Company Sanitized. Doss not contain TSCA CBI
B10SEARCH INCORPORATED
P.O. BOX asa|B. PHILADELPHIA. PENNSYLVANIA laioi tELEPHONE; (21S> 739-4499
Page i at 3
Project Number; Submitted te
Material:
Sample Received:
Study Initiated; Pate of Reportt
Test; Object of Teat; Procedure:
I. E.
d^ Font de Hemoura s Company
Haakell Laboratory
j SUtton Road ,
Newftjek, Oelawra
19711
E. X. dd Font d Xemours fi Company - H-14,53
4/30/821
5/18/82
Study Completed: 6/29/82
7/26/82
Acute Otal Toxicity LD - Rats
To study the acute oral tozicity in rats of the subject
materiaie
'
!
.
.
I
fl-oe groups of ben Wi''<s albino rats of the outbred SpeagueOawley iltraia weighing between 200 and 300 OB each were
enployeil in ^his atHdye 'Sks rats were deprived of food bat
not wat<r overnight prior to dosing. Each anioal was weighed and dbs^jd by direct administration of the experimental materia;, into the stomach by means of a syringe and dosing
needle. .'
Ibe animals wra housed and maintained in compliance with the Animal fjrelfare Act (Pub. L-94-279) 9 CFR Part 3.
Husbandry Conditions; Temperature - 72"B1 ^ 2? Relative Humidity " 45* + 5*
light -112 hour .Ught/darit cycle Diet - te^na Lab-Blox and tap water were provided ad libitu
Based on our current knowledge no contaminants were known to be in this diet or water that might be expecfte^ to interfere with the objectives of the study* Caging 4 Stainless stoel with elevated wire nesh flooring , "' osle rats/cage Bedding,- Techboard
Shepherd Products Company Kalamazoo, Michigan 49005
die sample was dosed as a 10 w/v suspension in water.
Company Sanitised. Does not contain TSCA CFA
Project Number:
Page 2 of 3
B. I. du Font de Nemours t, Company
Acute Oral Toxicity ID Stufly.
H-14,533
Procedure< (continued)
Ac following dosage levels were administered)
1,580 2,000 2,510 3,160 3,980
ng/kg og/k? g/kg ng/ko ogA?
rollqwing administration the animals were allowed food and
waten ad libitcm for the I'4 day observation period during which fciae the rats were observed for signs of toxicity and ortaj-ities.
AniiBajLs were observed frequently on the day of dosage, and twice'per day thereafter (morning and afternoon) Individual weights were recorded on the day of dosage, weekly thereafter, and CT-ior to sacrifice* The animals were euthanized at the concision of the observation period with carbon dioxide*
Gross autopsies were performed on all animals which died during the 14 di,' observation period and also on all survivor*
of thif 14 day observation period.
The LO-- was calculated employing the Thompson Moving Average Method as modified by Well, (Bioisetries, September, 1952, Vol. 9, Mo. 3, pp 249-263).
Results:
All the raw data ia on file in the archives of Biosearch,
Incorporated, Philade^ iia, Pennsylvania
See Table 1.
Conclusion:
The subject material when studied in male albino rats has an acute pral LD_- of 2,150 Bg/kg with 19/20 Confidence Limits of from 1 j,961 to 2,358 gA9*
1
This report is in compliance witn
ft GLP'l
Affrime^
y ^ _ tlity Assurance
Date /
Officer
^^^f\.^-tM^ Barbara A. Costello, M.Ag.
Laboratory Supervisor
^^L^M^ ^
Karl L. Gabriel, V.M.D., Ph.D. Study Oireetor
7.2^'r*-
Date
Company Sanitized. Does nol contain TSCA C3I
lOStAMCH INCOHPOWATtD
ra ox saa
PHILAOCLPHIA. PINNIYLVANIA 1B101
(21SI 73-4*9B
Project Number
TABLE 1
9tCUt e Onill Toxic Ity "^O -
5
I, ? Matariaill E.
du Pont de NeisouKB S Ccimjwny'
j Concentrabioni 10>0 ing/Ml
H-14 '533!
?
jj0
a Dosage
Level ng/kg 5 1,580
2,000
b 2,510 5 -B-- -3,-l60--
u
;. 3,890
Number
of Anima la
Dosed
10
10
10
IX). ....... 10
K101rtal.iti 08 Day'a 1 2 3 4 5 6 7 8 9 10 11 12 13 14
0 0 0 0 0 10 0 0
0
0
0
0
0
00 0 100 10 0
0
0
0
0
0
0 0 1 0 2 10 0 0
0
0
3
2 0
- 0 - 0----JWU-- --
-----0- --1- --0 --2-
3 2 'X: 1 0 2^.
Hales
Itotal
Dead 14 Days
1 2 9
-t0
10
I]" ^
Itotal Survive)J
14 Days
9
Avg.
initi
Heigh
go
259
8
270
1
239
"0
-
-
-
-af4W3*
0
247
Observational
nie Mg. and 19/20 <:dnfidenca LinitH 2,150 (1,961 - 2,358) Bg/kg.
1,586
2,000 ,;. '.
2,510
. ' . . . . , " gAg All of tho aniiialnai)pe<ared ruffled after 3 hours. Ihey appeared norral after 24
1 aniiiar-iin'tlayfi waa not precii&ded by any abnofBal clinical signe. 'Hie reuining
appear^flo^^^rougho!^ g/kg-- All of the.artiaiaia appeared^ruffled^
appeared
: -
nprual
aft.e.r.
24
'''anlaljB'c^iailjN':'^^
The re
.cont|^^
'^V-' '^:-
ngAg., - All of the animals appeared ruffled after 3 hours, they appeared norial after 24
subsequently occurred over several days as indicated. The aniBals appeared to slo
death occurred.
3,160 ng/kg 3,980 ng/kg -
All of the animals appeared ruffled after 3 hours. One aath occurred within the remaining animals appeared normal after 24 hours. Deaths subsequently occurred o indicated. The animals appeared to slowly waste away until death occurred. All of the animals appeared ruffled after 3 hours. Three deaths occurred within the surviving animals appeared to be in generally poor health after 24 hours. Th
on the dayo noted.
Note* All the animals surviving the observation period loafc weight*
Gross pathology< Oross pathologic examination revealed nothing remarkable.
The LD was calculated empJLoyina the Thompson Moving Averai, 1952. vol. 8, No. 3. pp 249-263).
Method an modified by Heil, (Biometr
.
Company Sanitized. Does not contain