Document DMrgE4vyYOBXvNXV9vNJL43b4
ST-351 Final Report
ToxDoes 11-340
Final Report
28-Day Oral Study in Rats
(ToxDocs Study Number 11-340, MTDID 8391)
Study Director:
Jill Hart, AAS, LATg
3M Toxicology Assessment& Compliance Assurance, 270-2A-08 Saint Paul, MN 55144
Phone: 651-733-8586
Principle Investigator: John Butenhoff, Ph.D., CIH, DABT 3M Medical Department, 220-6W-08 Saint Paul, MN 55144 Phone: 651-733-1962
`Testing Facility:
3M Strategic Toxicology Laboratory, 3M Center, 270-35-06 St. Paul, MN 55144
Experiment In-Life Start Date: ~~ 9-1-2011 Experiment In-Life End Date: 10-12-2011
"ONFIDENTIALITY STATEMENT
`This report contains the unpublished results of research sponsored by 3M. These results may not be published, either wholly or in part, or reviewed or quoted in any other publication without the prior authorizationof 3M.
1.
ST-351 Final Report
"ToxDocs 11-340
Study Summary
`The objective of this study (ToxDocs Study Number 11-340) was to investigate the bilateral pupillary reflex responses in male Sprague Dawley rats (n=12/dose group) during 28 daily oral
NdoHsye'sPwFiBthA,ei3t0heranvdeh1i5cl0emcgo/nktgr/odla(yD)I. water) or MTDID 8391 (ammonium perfluorobutyrate,
All rats survived until scheduled necropsy. Twenty-four hours after the last treatment, ocular
tissues (n=12/dose group) were removed and processed accordingly for Western blot and retina
`whole-mount evaluation performed in the laboratory ofDr. Don Fox at University of Houston,
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and
port
histology
and will be
appended to this report when they become available.
Study Objective
"The objectiveofthis study was to investigate the bilateral pupillary reflex responses in male
Sprague Dawley rats during a 28-day oral dose study with either vehicle control (DI water) or
'MTDID 8391 (ammonium perfluorobutyrate). Rats received 28 consecutive daily dosesofeither
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treatment, ocular tissues from all rats were removedandprocessed accordingly for Western blot
aOpntdormeettirnay.whole-mount histology evaluation by Dr. Don Fox, Universityof Houston, School of
Experimental Procedures & Observation
`Test Material:
[emi |momssor
Other Identifiers
`Ammonium perfluorobutyrate, E-19895, NHyPFBA
Lot/Batch Number
3M NB# 140499-10/11
CFC CF-CONH,
98.8% pure, 28.9% in water
[swt
foam
Species Selection:
a.
ST-351 Final Report
ToxDocs 11-340
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theyare commonly assessment.
used
in
oral
toxicitytestingto
generate
data
for
human
health
risk
Animal Husbandry:
Hbootutsoimngca--gReastesxcferpotmdtuhreimnagidnossitnugdywhgircohuprewqeurieriinngditvheiidruarlelmyohvoaulsferdoimncsatgaensd.ard solidD10ieatll/Waantiemral--scaodmmleibrictiuamltlhyraovuagihloaubtlethceersttiufideyd. rodent chow and tap water were provided tEenmvpierraotnumreeno--tf 7E2nv&ir3onFm,ehnutmaildicotnytorfol3s0f-o7r0t%h,e aanmiimnalimruomomofwe1r0eesxecthtaongmeasiontfairnooam air pdearyhoofurp,upainlldaray1r2e-fhloexurexlaigmhitn/adtairoknc,ycilne.whTichhet1h2e-hroouormlwigahst/kdeaprtk dcayrckleiwnathseamltoerrneidnognutnhteil the pupillary reflex examination was completed. Exposure:
Daily Dose | Dose
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me[7324 hourdsospeost last 24 hours post last
* Dose refers to the sat form ofthe main componentofthe test atc.
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Observation: Each animal was observed daily for morbidity/mortalty.
Body Weights: dAalillyradtsoswienrgevwoeliugmheesdfwoeretkhley.subTsheequbeondty7wdeaiygshtunitniflonremxattisocnhewdausleudsewdeitgohicnalgc.ulaAtlel tahtes were also weighed prior to necropsy.
a
ST-351 Final Report
ToxDocs 11-340
Pupillary Reflex Evaluation (PRE): Pre-dosing and interim pupillary reflex evaluations were performed on all rats throughout the study based on methods provided by Dr. Don Fox.
Necropsy and Specimen Collection: All the rats were euthanized by decapitation 24 hours after last dose. Immediately after decapitation, ocular tissues were removed and processed accordingly for either Western bolts or retina whole-mount histology.
Results & Discussion All rats survived until scheduled necropsy. Data for body weights are summarizedin Table 1. All MTDID 8391-dosed rats gain weight similar to control rats. Bilateral pupillary reflex evaluation results are presented in Table 2. The corresponding ocular Wester blots and histology data are pending, and they will be appended to this report when they become available.
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ST-351 Final Report
Signatures
ReportPreparedBy:
7 easo t
Jill Hart Study Director
Reviewed By:
A lots
John Butenhoff, Ph.D., DABT, CIH Principle Investigator
ToxDocs 11-340
27 NAR. 26/3
Date
24 war 20/2.
Date
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ST-351 Final Report
ToxDocs 11-340
Table 1: Data for body weights and liver weights
iy
Pre-Doso| Week2| Wee3k| Weeks|Po
Gaoew | oDoese | Anima#l|Tail Mark BWoediygh| SWeoigyht| SWooiygt| WSeaigyht| B(oBd0y.9
9)
(9)
9
9)
a
[[ooroaors||uT|| o2e6s0|| 2086|| os2w0 || osaart|| s3e6r5 ||
[[RrsatooTTww|| 605 ||2201 || 2s0o6r||santa||oas0||
[[RCaiRtotz1T | vvi |225003||2s0008 ||s30r2|| 33820|| seas ||
[[oCirRsottsa||vwwn||226667||220060|| 332256|| 3s0a2s|| ssse0 ||
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[[RoraazzztT| w || 20665 ||a2024||a15|| ss5626|| osrais ||
[[CCioRRaazzeo| [vv i [22604 ||20151 || s3s0s0|| s1s8||sourss ||
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"6.
ST-351 Final Report
ToxDoes 11-340
Table 2: Bilateral pupillary reflex evaluation (PRE) data
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