Document dQZnr4Xkp3K9609OnrwE3oRJ6
AR226-2981
DU FONT HLR 879-92
HASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE
STATIC, ACUTE 96-HOUR SCREENING TEST OF H-19913 TO FATHEAD MINNOWS, Pimepftales promelas
DISCLAIMER; THIS STUDY WAS NOT CONDUCTED ACCORDING TO FORMAL REGULATORY GOOD LABORATORY PRACTICE STANDARDS.
GENERAL INFORMATION MR: H:
TEST CODE: MATERIAL TESTED:
PURITY: COMPOSITION:
Poly(difiuoromethylene), alpha-fluoro-omega-[2((2-methy-1-oxo-2-propenyl)oxy}ethyll-, polymer with
2-ethyihexyl 2-propenoate, 1,1-dichloroetFiene,
2-hydroxyethyl 2-methyl-2-propenoate. N-
(hydroxymethyl)-2-propenamide, and alpha-(2methyl-1 -oxo-2-propenyl)poly(oxy-1,2-etrianediyi)
Sponsor: Notebook SO:
SUMMARY
H-19913 toxidty was low (96-hour LC50 between 500 to 5000 mg/L) in a 9ff-hour unaerated, static, acute test using fathead minnows, Pimephales promelas. Nominal concentrations of H-19913 tested were 0.0.50,1.0, 50, 500, and 5000 mg/L-
Mortalities of 0. 0.0,0,0. and 100%, respectively, were observed. Based on visual
observations, the test substance was soluble in well water at 0.5 and 1.0 mg/L. The
three highest test concentrations appeared cloudy. Dissolved oxygen and pH were
measured in 0,0.5, 50 and 5000 mg/L nominal concentrations. The dissolved oxygen at 0 and 96 hours or at total mortality were 8.5,8.5,8.6 and 8.5 mg/L and 9.0, 8.7,8.4 and 0.7 mg/L, respectively. The lowest dissolved oxygen value resulted froin the
decomposition of dead fish at 5000 mg/L. The pH values at 0 and 96 hours or at total
mortality were 7.0. 7.1, 7.2 and 7.2 mg/L and 7.5. 7.7, 7.7 and 7.0 mg/L, resp^ctwely-
Page I of 2
DU PONT HLR 879-92
WORKBY:
j.-------^ -
LYNNS.FORD,/ TOXICOLOGY ASSOCIATE
^ ^^
MO^AY/YEAR
^ ^ APPROVED BY-
6^-Aft^ C fCftou^r-
GUAT-UANC.KREAMER RESEARCH TOXICOLOGIST
^//6/^2.
Mdo/^'YEAR
DiSTRJBUTION:
KDASTURd)
W. J. BROCK (1)
ELHOLLOWAY(I)
"y-0^14!1^
G. C. KREAMER (1)
^
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SAkH Ls^i
isSisLijsyBffi^"^^^
Thi iudy vc C9ndufd
8tndrdt (40 CPU 799). Any tudy rcord. (to dvlCi9M tudy.
Ito font mA 9^19
iy*"*TOiff'-jt
Good Uiboratory rretlc r dou--Kfd In th
th* vlldity f tlw
Subwitm K. I. du Font d Nmour* and Coxpuy
SpoiKori
IJH root Chiel
It* I. du font 4 Nourc md CoBpimy
^j^^ Study Dir.ctcr, ' /J
,Q,.^fl- ,
8Bffli rvr P<Klccl<Bit
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-ampap^.Sanitized. Does not contain TSCA CBI
_j-jg913
. -wy Sanitized,
not contain TSC;A
c^jtggijm^gjte,;
MM{M.lMroIATICl(g^g.j
^
Ite gent HUt 28^3
Speasori
Study Zaigiateg - CeBplatgd; In Life Phsse
jfaijiafd,.,- toapleud s
!hi Pons ai--iealu
B. I. 4u Pone 4 Nigsemra md GOMPSM
iiliRin|[ton, Dlsre 12/7/92 - 2/2/93
12/8/92 - 12/11/92
Du font HLX 28-93
Skin Xrrif^ion ft vithH-WU in Rabbita
SUMMARY
f t 9.19913 vaa evaluafd for aeuf kin irritation potential in 6 !
rabbif. The
ubitanca produced Mild or odaraf erythema end no or
light du by 24 hour* foljlovinf appUcctlon. By 48 hour* licht to
odrf ryth-- nd no to ulld dR vra obfrvd. By 72 hour* the
rabbit* exhibited licht or lid ryth--a and no or Mild d--.
UndT the condition! o thi tudy^ B-IMU w^ a odraf kin irritant.
^
^N1 Scott Karr
Toxicology Tochnleian
/yJohn^^f^_____A/a Etevievd and
Approved for
(\^fi
Iuci ^6^----' \J
L^\
<
John V. Sarvr
Study Dilreactor
/g^3
AcknovldcMnt> Tracy Pllllben and Bryan Croaaley alo partlclpafd in th
conduct of thia atudy. JVS/alv
'ofiapanjf SaniSIzed. Does not contaio TSCA <
Du Font HLR 28-93
mm^m Aasro^d pocuNBNrmoM
(-19913)
Oaf of 3ht&.tion;
Condn^t - 12/8/92 Record*, Rport(c) -
1/26/93
Dt?fi> FindiMg Rtporfd to>
tu4y Difetor - 1/26/93
ItaiMKHMnt - 2/1/93
J^ Rporfd by)';SD>^^
4b-l -f-
Donna R. Rolt
Qucllty Awurance Auditor
^t/^ 'Dif
6 -
eo^BpanySanitjzed.Does not contain TSCA CBj
INTRODUCTION
Du Font HLR 28-93
Th purpose of this study vaa to evaluate th skin irritation potential of H-19913 vhen applied to th<i shaved, intact kin of Hev Zealand White rabbits.
H^mMS WO HKTROPS
A. Animal Husbandry
Young adult fMl He^ Zealand White rabbits were received from Hr Narland, Havitt, Nev Jers<ty or Baxleton Research Product*, Denver, Pennsylvania. The rabbit* vere housed singly In suspended, stainless
steel, vire-meah cages* pReh rabbit y-- i|nd unique identification number which vac recorded on card affixed to the c(. The rabbif were offered approxiiwtely 125 (ra-- of Purina Certified Niyh Fiber
Rabbit Chov* 532S daily durini; th study and vafr vaa available ad
libitur except ae noted under Protocol. Rabbita vare quarantined,
velghed, and obaerved for Igeneral health for approxiBately 2 veekc. Aniiial rool-- were --infixed on a tiler-controlled, 12-hour light/12-hour dark cycle. Envtronient<4 conditions of the room were targeted for a tenperature of 20*C i 2*C and relative hunidlty of 50X * 10X. Any excurciona outalde theae faneec were of all MKnitude and/or brief duration and did not adversely affect the validity of the tudy.
B. Protocol
On the day prior to tteatent, the hair of 6 female Nev Zealand White
rabbits vaa closely shaved to expose the akin froi the scapular to the
lumbar region of the backf The body weights of the rabbits ranged from 2947 to 3320 gram on the: day of treatmnt,
Bach rabbit vas placet into stock which had been fitted vich a
piece of rubber sheeting, approximately S" x 16". The rabbits reaained in the stocks throughout he exposure period and during that time did not have access to food or wa ;er. In the absence of visible evidence to the contrary, the test aubstaiiee va assumed to b stable under the conditions of admlnlstrat:.on. Approximately 0,5 aL of H-19913 was applied directly to a 2-inch gauze square that was then placed on the test site. The patch vas,held in place vith non-irritating tape. The rubber sheeting vas then wrapped around the animal and secured vith clips to retard evaporation and to keep the test substance in contact vith the skin without undue pressure
7 -
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Sanitized. Does rm w^. ^ G81
Du Font HLR 2H-93
fur Approxli--fly 24 houn) affr Mlieation ftl th tent ubtftnc th
rub qu
ber r
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vith kin
Ivory*
v-- fnt
foa
ly
p
patted dry, and th nilwX*i-l vr rturnd to thlr cx.
Approxl--fly 24, 48, ftnd 72 hour* after q>pliction of the
f t substance, th
vr valuafd for rytha, d--, and other
f t lf vidnc of dcrmi ffef nd ver cord cording to th Draisc el
(Table I). Th adjaemt 4r of thd unUaftitfd kin
uwd for
ftl vf cocparicon. No othr
ubtncc vr ftod on th rabbits.
C. Rcord XtfntiQn
All rv data md th llmil report vUl b ceord in th archfivc of
Hankell Laboratory for ToNicolocy Mid Indtpll Ndieln, dtt N--ourff Mid Coiipuny, Njmrk, blayr or In th Du Pout
K. I. du
Rcord
Pont
Hngmnt Ccnfr, Vllnington, 6lvr.
giB|yy "ffT[.yWw^y.*W-*'
^m H--19913 produced iN ryhM with no (iM in 5 rabbltc and iodrftf
rythM vith light (dM in !l rabbit by 24 hour folloving application. By
48 houra alight ti-yeh-- vith no dw vai ob<rrv<l in 1 rabbit. Mild
rythiBa vith no or li(ht dRft vft obrv4 in $ rabbits, nd nodrt
rythem vith light or mild
vu ob--rvd in 2 rabbita. By 72 hour 2
rabbits xhibifd alight eythJMMi vith no ((na nd 4 rabbi t xhibifd ild
rythana vith no or Mild dfljk^ Individual kin irritation acoras r
pranfd in Tabl II. A unwary of kin roflipOM-- i prnntd in the
follovinx fbl*
Sumiwry of Skin Xttponm to B-19913
Rpone
No R9ponse
Slight Nild Hodrf
"X'Hr ^^ff-^nr'1
0/6
0/$
0/6
0/6
1/6
2/6
5/6
3/6
4/6
1/6
2/6
0/6
24 hr
5/6 1/6 0/6 0/6
ST
3/6 2/6 1/6 0/6
72 hr
5/6 0/6 1/6 0/6
Undar th conditlona of th^c ctudy, H-19913 v a moderate skin irritant.
a ^anpaniSanifeed. Does noi coma.n i acA Cte
Do font am 29-^
ccorI<fliat(EhMto6t(l>wt|uCidOS-Mtoarthe tolcbSclwindi offpfiftetttCi^/WuCiiDcculbctcwieeicct^icia,
the Oftijm jeKc^l of Buroimn C8wSBttl^<lSDtrctlv.flS/*67;
VI), H-im3 protMlbly hottU If clawiflMi -- a "IKKITA.W until f data if avilbl.
.,^ll!l,i.(,ff.t, . ;ul.. .l.lJ'h'.l'll^
" ^mpm^.Smiiwd. Does noi coiraia^n TSC'A CBI
ri.-ffl-l-U -t-'t"*-.ltf3';l.. ..-.!-^.--;'h-t-ri-. -- >.....* . ...-.^--lAi ... 'i...- .!*; i.-.-t ^... ,_ . .^.l...... ..^l..t^.lfAl^-B"^^t!fc:^^;fe.-.^*P-llfr<.*. '-Bi.. -J-f
Du Font HLR 28-93
TAM^I
DRAXZB1 SCALE fpR SCORING PRIMARY SKIN IRRITATION
Evaluation of Skin Reactions
Erythem and char foroation*
No erythena
Very light erythema (barely perceptible)
Vell-defined erythexa Moderate to severe erythwftk
Severe !-ytha (bet rdhM) to flight char fornatlon (injuric in 4pth)
Value
1 (Slight) 2 (Mild)
3 (Hodrt<) 4 (Sever*)
Edema fornationi
No dcia
Very light d--a (barely perceptible) Slight edena (edge* of arfa veil defined by
definite releing) Moderate edena (raiaed approxluately 1.0 m) Severe edeia (raiaed more than 1.0 -- extending
beyond the area of expoaure)
0
(Slight)
2 (Mild) 3 (Hoderate)
4 (Severe)
Abbreviations of other
Abraded
Intact
Thickening
Eschar
No Bffect
Blanching
denial effects arei P pissuring
N Kecroaia
6 Piacuring vith
Bleeding
S epidermal
Scaling
L
Sloughing
R
Rav Areas
X
Compound Adhered
to Skin
SN Superficial
Necrosis
Draixe, J. H., "Denial ToxUlty." Appraisal ot the Safety of Chemicals in Poods, Drugs and COaieetica. The Editorial Coronittee of the Association of Pood and Drug Officials Of the United States, Austin, Texas, 1959, pp.
46-59.
10 "" ""s.pany Sanitized. Does not contain TSCA CBI
Du Font BLR 28-93
TABLB II
HTOIVIDUAL 8KIN IKMTATIW 8COR8S
SKIN RfiSPOKSES OBSSRVBO IN TEST BABBITS ?OLL(WINS TOPICAL IXPOSURB TO H-19913
Rabbit Hulh^r
ggyth--t
j^hg ^ hr ?S hi
U hr B^ dhMr a_H__h_r
27558
232 020 27659 2 9 2 27662 222 010 27663 322 010120 27664 222111 000000 27665
11 - fionipan^Sanitizea, uoesttUiculuain uAUrii