Document 2J2oNdrwQpyN0n3X49M68qYmr
sll I pprroodduuccttEssaaCffeettyy llaabbssI Sette 725 Cranbury Road East Brunswick, New Jersey 08816-3206 908-254-9200 800-425-0002 * Fax-908-254-6736 on pz2t2 PPRROODDUUCCTT
Lot #22L-2
J-- SSTTUUDDYY TTIITTLLEE
Primary Eye Irritation
~[__= crn 158, Guten #314] DDAATTA RREEQQUUIIRREEMMENT 40 CFR 158, Guideline #81-4--~ Co aroma, 84 AAUTTHOR Gary Wnorowski, B.A. Novombe2r, 1095 SSTTUUDDYY CCOOMMPPLLEETTEEDD OONN November 3, 1995 PPEERRFFOORRMMIINNGG LLAABBOORRAATTOORRYY radu Sater Le Product Safety Labs
ot Sranata2t% core 725 Cranbury Road
East Brunswick, New Jersey 08816
sem LLAABBOORRAATTOORRYY PPRROOJJEECCTT IIDDEENNTTIIFFIICCAATTIIOONN NNUUMMBBEERR 3871
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Trro) ou oroszses SSttuuddyy NNuummbbeerr 3388771!
Exhibit 2791
3M_MN01062303
]
srle le--ee-- pprroodd-- uucctt-- ssaaffee-- ttyy lla-- abbss --------------------
SSTTAATTEEMMEENNTT OOFF NNOO DDAATTAA CCOONNFFIIDDEENNTTIIAALLIITTYY CCLLAAIIMMS
Noo ccllaaimm ooff ccoonnffiiddeenntitiaalliittyy iiss mmaaddee orfor aannyy iinnffoorrmmaattiioonn ccoonnttaaiinneedd iinn tthhiiss ssttuuddyy oonn tthhee bbaassiiss of iits ffaalllliinngg wwiitthhiinn tthhee ssccooppee ooff FFIIFFRRAA 1100 d](d) (1(1) A1(A), ((B8)} oorr ((CC1)..
PPaaaqee 22 ooff 2233
173
22779911..00000022
auMNo1062304 Study Number 3871
StLJdv Number 3871 3M MN01062304
psi product safety labs product safety labs
GGOOOODD LLAABBOORRAATTOORRYY PPRRAACCTTIICCEE SSTTAATTEEMMEENNTT
J Lot #22L-2
Rn El Pr ps This study meets the requirements off40 CFR Part 16,0~vith the following exception: The
stability, characterization, identity anc~verification of ~1% test substance concentration as received and tested are the responsibility of the study sponsor.
sp hon Study Director:
-- Submitter: -- Sponsor:
[ Eae-- Gary Wnorowski, B.A.
Moo 3.1976
Date
a I= 16-7
Date
Date
4 22779911..000003
f-- Study N[~mher "~,71 3M MN01062305
msl
ca
pprroodduucctt ssaaffeettyy llaabbss
TTAABBLLEE OOFF CCOONNTTEENNTTSS
section
SECTION
PAGE NO.
PAGE NO.
CO SNBTNE Cover Sheet
eee
Confidentiality CIM... eee 2 Confidentiality Claim ............................................ 2 GLP SEEMENt Loe 3 GLP Statement ................................................ 3 TaOfbCOlMeETS... .veeeseeeeeeee 4 Table of Contents .............................................. 4
Purpose ..................................................... 5
Summary .................................................... 5-7
SGNANEPBGE Lee Signature Page : ............................................. 8 Materials Lee Materials .................................................... 9 MGtROdS LLL .e10 Methods ..................................................... 9-1 0
PProrocceedduurree ...t.r.r.e.v.e.s.s.......r.e.e.....e.e......a.e......- ...........r.e.e.. 11 00-111
Stuy Conduct. ..ooi Be om Study Conduct .................................... ............ 1 1 Quality Assurance Lo... a BT Quality Assurance .............................................. 1 1 Protocol Deviations ooo. ee n2 Protocol Deviations ............................................. 1 2 Rectoboe Mraindtaisned . ............. Le cz Records to be Maintained ......................................... 1 2 Resuts....... 2 Results ...................................................... 1 2
Conclusion ................................................... 1 2
Tables orien 1320 Tables ...................................................... 1 3-20 Appendix A (Feed andWater Analyses) .................. cm Appendix A (Feed and Water Analyses) ............................... 21 Appendix B (Certificateof Analysis) 22 Appendix B (Certificate of Analysis) .................................. 22 Quality Assurance Statemen: 23 Quality Assurance Statement ...................................... 23
Page 4 of 23
22779911..00000044
aW_MNo1062306 Study NlJmber 3871 3M MN01062306
psE l pprroodduucctt ssaaffeettyy llaabbss t SBPatougndeys5eNoiufmn2sb3ers3e87nA1
PPRRIIMMAARRYY EEYYEE IIRRRRIITTAATTIIOONN
acer: PROTOCOL NO: PROTOCOL NO.: AGENCY: STUDY NUMBER: STUDY NUMBER: seonsoR: SPONSOR:
Pazs P324
(em) ~__EPA (FIFRA) ~
PRODUCT IDENTIFICATION:
PRODUCT IDENTIFICATION:
PRODUCT DESCRIPTION:
PRODUCT DESCRIPTION:
DATE RECEIVED:
DATE RECEIVED:
PSL REFERENCE NO.
PSL REFERENCE NO.:
SPONSOR REFERENCE NO.:
SPONSOR REFERENCE NO.:
DATE OF PROTOCOL APPROVAL:
DATE OF PROTOCOL APPROVAL:
DATES OF TEST:
DATES OF TEST:
NOTEBOOK NO:
NOTEBOOK NO.:
Lowzatz Lot #22L-2 ht yellow power Light yellow powder June 30, 1995 June 30, 1995 Es0620-18 ES0630-1R GPesoe GP95-046 au 28,1995 July 24, 1995 Sey 27 August 17, 1995 July 27 - August 17, 1995. 95.29;pages 217-228
95-29; pages 217-228
1. eumpose: 1.
PURPOSE:
To provid information on health ozards ikely to arise from single intlaton of "Fo provide information on health hazards likely to arise from a single instillation of Lot 2212 no he eyes of rabbis. Dats from the Stuy may bo used 6 a bois for Lot #22L-2 into the eyes of rabbits. Data from this study may be used as a.basis for classiicaton and lsboing. classification and labeling.
2 summany: 2.
SUMMARY:
A Primary Eye rittion test was conducted with rabbis 1 determine th potential for A Primary Eye Irritation test was conducted with rabbits to determine the potential for Lot #2212t produce miaion andor conosion via the ocular fore. Based an the Lot #22L-2 to produce irritation and/or corrosion via the ocular route. Based on the
resus of testing, the wt Substance is Casali 28 severely Jiang 10 the oye. The results of testing, the test substance is classified as severely irritating to the eye. The lasaficaion was iso from modoratey to severely iting cue to he presence of score classification was raised from moderately to severely irritating due to the presence of a score greater han 30. all abbiaa the 26 hour evaluation inteas (See Table 31. greater than 30 in all rabbits at the 24 hour evaluation interval (See Table 3).
Onetanth of a gram of the tes substance was insted no the ight aye of six heathy One-tenth of a gram of the test substance was instilled into the right eye of six healthy rabbit. The lft oye remained unireated and served 9 convo. Ocular mation nas rabbits. The left eye remained untreated and served as a control. Ocular irritation was
17
22779911..00000055
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Stay umber 3871 Page 6 of 23
Study Number 3871
NevS liated by te mained of Drs ot of. The eye sores ware utees cwasieby the evaluated by the method of Draize et alI. The eye scores were further classified by the Sete of Kay and Canin (modi system of Kay and Calandra (modified)=.
One hour after test substance instillation, all treated eyes exhibited conjunctival irritation.
From 24 to 72 hous comes: ashy and 1s war ka avdent in 9 ama. The From 24 to 72 hours corneal opacity and iritis were also evident in all 6 animals. The incidence ard sevety of corn apscy and is hceseed rear. Contocivns incidence and severity of corneal opacity and iritis decreased thereafter. Conjunctivitis rise ini ror aves ough dy 10. Fans was ered in 2 anol bowen dove persisted in all treated eyes through day 10. Pannus was noted in 2 animals between days ivoush 21. Although cornet andlor comes acy arias nw awsne noun 7 through 21. Although conjunctivitis and/or corneal opacity persisted in two rabbits through Sy tamination, a other snmls wae es om ose ationb ao 31 study termination, all other animals were free from ocular irritation by day 21.
"Dre J, WonamardG. and Calvry HO. Methods for testy aan and toi of 1 Draize JH, Woodward G, and Calvery HO. Methods for the study of irritation and toxicity of
substances applied topically to the skin and mucous membranes. JPharmaco/Exp Ther 1944;
Sao, 82:377-390.
# MMaaxxiimmuumm MMeeaann TToottaall SSccoorree-- KKaayy JJHH,, aanndd CCaallaannddrraa JJCC.. IInntteerrpprreettaattiioonn ooff eeyyee iirrrriitatattioionn tteessttss..
Soc Co.~ Chem 1962: 13:281-289. See Table 3 for the, c/a_ssification system.
au unorozane 3M MN01062308
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The incidence, severity and reversibilitv of irritation are detailed below:
remem] Time Post | Gormeat Time Post
| station| Opacity Instillation
Incidence of Irritation
Corneal Opacity
Iritis
Conjunctivitis
[ror [os | on | oo | 1 hour
0/6
0/6
6/6
[ror [oe| oo| oo | 24 hours
6/6
6/6
6/6
[Cro [oo | on | oo | 48 hours
6/6
6/6
6/6
[Faron [a we|e] 72 hours
6/6
6/6
6/6
Day 4
4/6
4/6
6/6
Day 7
3/6
1/6
6/6
[Cowie[se [we | en] Day 10
3/6
1/6
6/6
oer Tse Day 14
3/6
0/6
3/6
[Como[oe | oe | an | CE ET CT Day 17
3/6
0/6
2/6
Day 21
2/6
0/6
1/6
[rime Pest 1 Time Post nstlaton Instillation
Ce me 1 hour
[imo [7 24 hours [sorsT7 weeas 7] 48 hours
Sever of ration:travian | Severity of Irritation: Maximum Mean Total Score (MATS) Mean Total Score (MMTS~)
15.0 39.5 35.2
72 hours
[oor | wea Day 4 [oo ws Day 7 [oni | ae | Day 10 Tove|e Day 14 T oe e| Day I 7
33.5
24.3
18.2
12.0
i
7.8
5.2
Day 21
2.8
* Maximum Mean Total Score - Kay JH, and Calandra JC. Iterpresation of ev ration tts Maximum Mean Total Score - Kay JH, and Calandra JC. Interpretation of eye irritation tests. Soc Cos Cham 1962: 15:281-283. See Table3 for tha classification syerem Soc Cos Chem 1962; 13:281-289. See Table 3 for the classification system.
17%
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TEER PPaaggee 88 ooff 2233
Study Number 3871
LLoott##2222L1-22 PRIMARY EVE IRRITATION
PRIMARY EYE IRRITATION
WfWaeiethftthuhleelyuurnneddfelerercsstiiggtnnheeeddprddoeecccellaadrureerettshhaaatnt dtthhreeawmmedetaththoaoddusss,,edrreeossruullcttsosllaaanntddedddaadttuaariccnoognnttthaaeiinnesetddudyiin.n tthhiiss rreeppoorrtt
faithfully reflect the procedures and raw data used or collected during the study.
= R Gary Vinorowski,y BA. SGtuadyry Director Wnorowski, B.A.
Stud )irector
CRalpa h St hapiro, Phh .D. RLaablpohratorypiDrior,ePctho.rD.
Laboratory Director
4
Tod} MCOchatski, D0VfMe
Frinchal ST J.
Ochalski, D.V.M.
Technician
Tabor Zawa, 85. JAasss~isi/traBntawTao,xiBc.oSl.ogy Teapmician
Assistant Toxicolog~~ician
LOH RAKseesnninmseteatihntBBTaarorexri"c/alogy Technician
Assistant Toxicology Technician
Moo 2,91 -- Bare
Date
Bateete 3 18a
Date
Gare
50.1995
Date
Swe 8 3, 13pm
Date
Gly 3 m0
Bae
Date
171 22779911..00000088
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psl pprroodduucctt ssaaffeettyy llaabbss
b Page 9.t of 23 Page 9 of 23
Study Number 3871
3. mata:
o
MATERIALS:
A Tostsubstance:
A.
Test Substance:
TaTanhnhidedeghvwttteioaastyssteffssluuuulrrobbtthwsshettpararonnidwdccodeeeneniidrtdfiefeiiaenennddttdifwwieveiididttahhssasPPs,sSStLoL.rCCeododdaeet ,NNLoLuouoommtmtbb##ete2r2er2m2EELp1S5e-0220rBa6wwt33aua00rss--e11.rrR,ee.ccTeeTThiihhveveeeesddttaeeoomssnnpttlJsJseuuuubnbwnseseattsa33an0n0i,cc,nees11wwt99ae99aed5s5
a light yellow powder and was stored at room temperature. The sample
515 retcoetivesdu.bstDaonccuemeintraettaiionnedofbtyntehmeestphoonsdosr,of synthesis, fabrication, of as received. Documentation of the methods of synthesis, fabrication, or
derivation of was instilled
derivation of
the test substance is retained by the sponsor.
CCshphaoarnrasacoctrtreiwrziazasattii(ooSnnesooffAptthhpeeettneedsstt6ss1uubbssttaannccee aass pprroovviiddeedd ttoo PPrroodduucctt SSaaffeettyy LLaabbss bbyy tthhee
sponsor was (See Appendix B):
Composition:
Composition:
Related
c- o99m33p..o33u%%nds
-
4.3%
Related compounds - 4.3%
opHH:: NNoott aapppplliiccaabbllee
Sola: Soluble in acetone, ethanol and methanol
Solubility: Soluble in acetone, ethanol and methanol
Suit: Stabe
Stability: Stable
EExxppiirraattiioonn DDaattee:: JJuunnee 2288,, 11999977
5 Animals:
B.
Animals:
5.8.1 Numberof Animals:
3.B.1 Number of Animals: 6
38.2 Sex: 3 mals and 3 famates
3.B.2 Sex: 3malesand 3females
3.8.3
3.B.3
Species/Suain:
Species/Strain:
RabbitNew
Rabbit/New
ZZaesallaanndd
iba albino
38.4 Age: Adult
3.B.4 Age: Adult
J33a..B8n.e.5530SS,oouJururlccyee7::
RRaenecdceei1ivv4ee,dd1ff9rro9om5m
Davidson's
Davidson's
MilMill
FFaarrmm,,
SSoouutthh
BBrruunnsswwiicckk,,
NNJJ
oonn
June 30, July 7 and 14, 1995
a. memos:
o
METHODS:
A Husbandry:
A.
Husbandry:
G44cc.uaa.A0glg.ii.in11naggfHHioworotiutuhsthsihinenmmggoCe::sashhrTTehhffleeloaonoaaedrrnnssiimUmwwasahlhelissiccawwhhfeecrcLreoooabnnsosffioironnarrggmtmlloyyrttyohhoooAtuuthhnsseieemddssaiiliiznznseessDrruueessHccppooeeEmmnnmddmeeee(nddNndEsdsa)taataitiiNinonoolennessssss8i15nss.tttte2ehhee3eoll
Guide for the Care and Use of
pLeircweepeakpa was placed beneath Litter paper was placed beneath
he cage and was charged ot eget Laboratory Animals DHEW (NIH)
the cage and was changed at least
trae times No. 86.23.
three times
per week.
4A.2 Animal Room Temperature Range: 67.71F
4.A.2 Animal Room Temperature Range: 67-71 F
22779911..00000099
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4.A.3 Photoperiod: 12 hour lightJdark cycle
sSeIReEssn Page lOof 23 Study Number 3871
4.A.4 Acclimation Period: 13, 20 or 27 days
44..AA..55 FFoooodd:: PPeelllleetteedd PPuurriinnaa RRaabbbbiitt CChhooww ##55332266
-
4.A.6 Water: Filtered tap water was supplied ad libiturn by automatic water dispensing system.
4.A.7 Contaminants: There were no known contaminants reasonably expected to be found in the food or water which interfered with the results of this study. Results of the analysis of the food and water are kept on file at Produc~ Safe~y Labs. The dates of the most recent analyses are presented in Appendix A.
B.
Identification:
4.B.1 Cage: Each cage was identified with a cage card indicating at least the study number and identification and sex of the animals.
4.B.2 Animal: A number was allocated to each rabbit on receipt and a stainless steel ear tag bearing this number was attached to the animal. This number, together with the sequential animal number assigned to study 3871, constituted unique identification.
5.
PROCEDURE:
A.
Preparation and Selection of Animals:
Prior to instillation, both eyes of a number of animals were examined using a fluorescein dye procedure. One drop of 2% ophthalmic fluorescein sodium was instilled into both eyes of each rabbit. The eyes were irrigated with physiological saline (0.9% NaCI) approximately 30 seconds after instillation of the fluorescein. Using a Blak-Ray Lamp (compact 4 watt UV Lamp), the eyes were checked for gross abnormalities according to the "Scale for Scoring Ocular Lesions" (Table 2). Only healthy animals without pre-existing ocular irritation were selected for test.
B.
Instillation:
One-tenth of a gram of the test substance was instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about 1 second before releasing, to prevent loss of the test substance. The other eye of each rabbit remained untreated with the test substance and served as a control. Elizabethan collars were placed on each rabbit and they were returned to their designated cages.
14
22779911..00001100
3M MN01062312
pIpsOIiroprodductusact lats s~t~eyEiSLAaeE nns product safety labs
Page 11 of 23 Study Number 3871
Ocular Scoring:
Ocular irritation was evaluated usin~o a high-intensity white light (Mag Lite) in accordance with Draize et al. (Table 2)I at 1, 24, 48 and 72 hours and 4, 7, 10, 14, 1 7 and 21 days post-instillation. Twenty-four hours after instillation, the collars were removed. The fluorescein dye evaluation procedure described in Section 5.A was used at 24 hours and as needed to evaluate the extent of corneal damage or to verify reversal of effects. Individual scores were recorded for each animal, in addition to the observation of the cornea, iris and conjunctivae, any other observed lesions were noted. The average score for all rabbits at each scoring period was calculated to aid in data interpretation.
D.
Classification of Eye Scores:
The average 24-hour score (MMTS) of the rabbits was determined to further classify
tthhee tteesstt ssuubbssttaannccee bbyy tthhee ssyysstteemm ooff KKaayy aanndd CCaallaannddrraa ((TTaabbllee 33))2..
E.
Cage-Side Observations:
The animals were observed for signs of gross toxicity, behavioral changes and mortality at least once daily during the test period. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.
6. o
SSTTUUDDYY CCOONNDDUUCCT:T:
-
This study was conducted at Product Safety Labs, 725 Cranbury Road, East Brunswick, New Jersey 08816to comply with Good Laboratory Practices as defined in 40 CFR 160: U.S. EPA Good Laboratory Practice Standards: Pesticide Programs (FIFRA) and in accordance with Pesticide Assessment Guidelines, Subdivision F: Hazard Evaluation: Human and Domestic Animals, Section 81-4.
7.
QUALITY ASSURANCE:
The draft final report was audited for agreement with the raw data records and for compliance with the protocol, Product Safety Labs Standard Operating Procedures and appropriate Good Laboratory Practice Standards. Dates of inspections and audits performed during the study, and the dates of reporting of the inspection and audit findings to the Study Director and Facility Management are presented in the Quality Assurance Statement.
~ Draize JH, Woodward G, and Calvery HO. Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. JPharmaco/Exp Ther 1 944; 82:377-390.
Kay JH, and Calandra JC. Interpretation of eye irritation tests. J Soc Cos Chem 1962; 3:281-289.
2
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Study Number 3871
J ---- 8.
DEVIATIONS FROM FINAL PROTOCOL: None
5. necToeoemnanToAIEsD: 9.
RECORDS TO BE MAINTAINED:
coyote sgn sp, toga ith rts 30 i ts ant rues A copy of this signed report, together with the protocol and all raw data generated at Product Ce Con nana nh Bods Sory Ls er Safety Labs, is retained in the Product Safety Labs Archives.
To. nests: 10. RESULTS:
ET ------ All animals appeared active and healthy. Apart from the eye irritation noted below, there were Tom oF tn ares POSS Horsf sr Sha no signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.
ro hur sts tet sutra ina, al ste ays xsd concn rtin One hour after test substance instillation, all treated eyes exhibited conjunctival irritation. Fo 4 tn 2 nov. somes pay ns. nda a8 ae From 24 to 72 hours corneal opacity and iritis were also evident in all 6 animals. The Incase ra soiy of caro psy nd i decreed rer, Com incidence and severity of corneal opacity and iritis decreased thereafter. Conjunctivitis priser imi tubeepeiehi pei persisted in all treated eyes through day 10. Pannus was noted in 2 animals between days
7 through 21. Although conjunctivitis and/or corneal opacity persisted in two rabbits through
study termination, all other animals were free from ocular irritation by day 21.
The 24 hour Maximum Mean Total Score of
, Lot #22L-2 is 39.5.
A. Idd Sere for curio: Se Tab A.
Individual Scores for Ocular Irritation: See Table 1
. Sel for Scaring Our Loins: Ses Tale 2 B.
Scale for Scoring Ocular Lesions: See Table 2
C.
Classification of Eye Irritation Scores: See Table 3
11. CONCLUSION:
Based on the scoring system used,
Lot #22L-2 is classified as severely irritating to
the eye when instilled as received. The classification was raised from moderately to severely
irritating due to the presence of a score greater than 30 in all rabbits at the 24 hour evaluation
interval (See Table 3).
153
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Study Number 3871
TABLE- 1
IINNDDIIVVIIDDUUAALLSSCCOORREESSFFOORROOCCUULLAARRIIRRRRIITTAATTIIOONN '
w ew e] e Hours
Rabbit No. 8191 Days
Jeefe] [7Jn w]w] u]ve ]a] 1
[I,CoC-- omrneeas |
I ll I I El CKK A. Opacity
0
Soe B. Area
4
CC Ci chI CK (AxB)x5
0
24
48
72
4
7
11
11
11
11
01
4
3
3
2
4
20
1 5
1 5
10
0
10
14
17
21
0
0
0
0
4
4
4
4
0
0
0
0
feem oeo eee] A. Values
0
1
1
1
1
0
0
0
0
0
[ m= elelieoeollese] Ax5
0
5
5
5
5
0
0
0
0
0
frm III. Conjunctivae
eS eee eT A. Hyperemia
3
3
3
3
2
0
0
0
0
0
eon| [|e [ao ee] B. Chemosis
2
3
3
3
2
0
0
0
0
0
we [3 [eo C. Discharge
3
3
3
3
3
1
1
0
0
0
een [ww[ww |e voo] (A+B+C)x2
16
18
18
18
14
2
2
0
0
0
EER CH 2EE EERERKRKK Total
1 6
43
38
38
29
2
2
0
0
0
1 2% fluorescein sodium used to evaluate the extent of corneal opacity.
184
22779911..00001133
3M MN01062315
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T TAA BLEB-1L 1 c(oE cnotn: .t.)) I INDIVN IDUAD LSSCCI OORREEV SSFFOOI RR OOCCD UULLAARU RIIRRRRA IITTAATTL IIOONN
|[wee[seoT ln]o e[o[w ou]r] ]=] I. Cornea [[emoewn1 [-- ------ -- -- ---- A. Opacity [ome [0[Tv[vo e]o]o e+] B. Area ree a [seTaL]eL ]a]r] (AxB)x5
Hours
Rabbit No. 8192 Days
1
24
48
72
4
7
10
14
17
21
O
11
1~
11
01
0
0
0
0
0
4
2
1
1
4
4
4
4
4
4
0
10
5
5
0
0
0
0
0
0
I1. Iris
EREN EE EE E EE EEEA A. Values
0
1
1
1
0
0
0
0
0
0
Et Ax5
0
5 .
5
5
0
0
0
0
0
0
e III. Conjunctivae
[[rFoemeel|SF-- [--F--o[Fo[ooo7] A. Hyperemia
3
3
3
3
2
0
0
0
0
0
[eoems [755[a 7 [ B. Chemosis
2
3
3
3
2
1
0
0
0
0
[comme[5[5[5Jo[5[77o[ooo]0] C. Discharge
3
3
3
3
3
1
1
0
0
0
Er eee ee eeo] (A+B+C)x2 [Toowlw[ala]w]lz]o]o]0] Total
16
18
18
18
14
4
2
0
0
0
16
33
28
28
14
4
2
0
0
0
~ 2% fluorescein sodium used to evaluate the extent of corneal opacity.
168
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Study Number
33887711
TABLE- 1 (cont.)
ININDDIVIVIIDDUUAALLSSCCOORREESS FFOORROOCCUULLAARRIIRRRRIITTAATTIIOONN
)
w e m T e] e Hours
Rabbit No. 8193 Days
e Lr [ewe] [oT] x] I. Cornea
24 48 72
4
7
10
14
17
21
Ccc ml ] A A A. Opacity
0
11
11
11
11
21
11
11
11
01
ECE I A A ANANENE B. Area Cc cA EA (AxB)x5 peII. Iris
4
3
3
2
1
1
1
1
1
4
0
15
15
10
5
5
5
5
5
0
= rer A. Values
0
1
1
1
1
0
0
0
0
0
CC ICeEK]K Ax5
0
5
5
5
5
0
0
0
0
0
r Ill. Conjunctivae
rem eme] o A. Hyperemia 2
3
3
3
3
2
2
0
0
0
EC a EAEE ENEA ENRA AK B. Chemosis
2
3
3
3
3
0
2
1
0
0
Feo SS ooTe] C. Discharge
2
3
3
3
3
2
1
0
0
0
[eres [ow [we[oo] (A+ B+C)x2
12
18
18
18
18
14
10
2
0
0
EEREE TT Total
12 38 38 33 28 24 15
7
5
0
~ 2% fluorescein sodium used to evaluate the extent of corneal opacity.
1&6
22779911..000015
3M MN01062317
pOpsiLroprdoducut sacfety tlabssafeSynAieEabs product safety labs
Page 16of23 Study Number 3871
T TABA LE-B - 11 (L (ccoonE ntt.))
IINNDDIIVVIIDDUUAALLSSCCOORREESSFFOORR OOCCUULLAARRIRIRRRIITAATTIIOONN
I == T-- w --] Hours
Rabbit No. 8194 Days
nDpon 24 48 72
4
7
10 14 17 21
om -------- Ennng I. Cornea
------ [Aowsw A. Opacity
To[wo] ooe oo] 0
11
11
11
01
0
0
0
0
0
Ee EE EE B. Area
4
2
1
1
4
4
4
4
4
4
[elTele e oos ov] (AxB)x5
0
10
5
5
0
0
0
0
0
0
II. Iris
vT w m] A. Values [frAvie Jo [aI]Jofoloo]o]o] Ax5
0
1
1
1
0
0
0
0
0
0
0
5
5
5
0
0
0
0
0
0
I III. Conjunctivae
Creee ees e A. Hyperemia
3
3
3
3
1
0
0
0
0
0
[om [TTee o foe] B. Chemosis
2
3
2
2
1
0
0
0
0
0
Fe EEE C. Discharge
3
3
3
3
3
EE 1
1
0
0
0
mes [eee Tele A + B+ C)x2
16
18
16
16
10
2
2
0
0
O
FTe elslwl=loasl]i]iv] Total
1 6 33 26 26 10
2
2
0
0
O
1 2% fluorescein sodium used to evaluate the extent of corneal opacity.
7
22779911..00001166
3M MN01062318
msl pprroodduucctt ssaaffeettyy Lbslabs
BE Page 17of23
Study Number .3871
T TABA LE-B -11 (L (ccoonE ntt.))
INDIVIDUAL SCORES FOR OCULAR IRRITATION
re T LETe eT I. Cornea
EC ll a Ea A. Opacity Se Ee B. Area
[ome |vJw[we[www Tw]w]w] (AxB)x5
= II. Iris
Hours
Rabbit No. 8195 Days
24 48 72
4
7
10
14
17
21
4
4
3
3
3
3
2
2
1
1
0
20
15
15
15
30
20
20
10
10
[|ave [ol TT A. Values
0
1
1
1
1
1
1
0
0
0
mers [i]o]o]o] Ax5
0
5
5.
5
5
5
5
0
0
0
a eseTee III. Conjunctivae
ee TE A. Hyperemia
3
3
3
3
3
2
2
1
1
0
oe B. Chemosis
2
4
3
3
3
3
2
2
1
1
on [SS TS TTL C. Discharge
3
3
3
3
3
2
1
1
0
0
CCE chEE (A + B + C)x2
16
20
18
18
18
14
10
8
4
2
fTe elesales] Total
16
45
38
38
38
49
35
28
14
1 2
~ 2% fluorescein sodium used to evaluate the extent of corneal opacity.
z PPaannnnuuss pprreesseenntt..
1%
22779911..00001177
3M MN01062319
pJsoil PpprrooPdduuccEtt ssaaftettyy lbslabs
sP uerti mesn Page 18of23
Study Number 3871
TABLE- 1 (cont.) INDIVIDUAL SCORES FOR OCULAR IRRITATION
Rabbit No. 8196
Hours
Days
[ee1[TeTaln[[olwlo]=] I. Cornea I ---- A. Opacity
dE a B. Area [[oros eTe o[mw wse wa]e[woe wvw]+] (AxB)x5
24 48 72
4
7
10 14 17 21
0
11
11
11
1~
21'2 2~,2
2~
21
4
4
4
3
2
2
1
1
1
1
0
20
20
15
10
20
10
10
10
5
II. Iris
[Ava A. Values T0 o 1 l 1 [I ] i1 0 e0]ef0 o]0 oo0] TAex5oolse0ls5 l5s]5 o5fe0 o0 ]o0 ]0 o]0
ree| III. Conjunctivae
EN ENHEEN IE EN IE CO ] A. Hyperemia
2
3
3
3
3
2
1
0
0
0
[ome So B. Chemosis
2
4
3
3
2
1
] [coer C. Discharge
[o3 le3
J3e3f
e] 1
1
[oe [ww[owww]o] (A+B+C)x2
14
20
18
18
12
8
1
1
1
0
1 o0lo0 r]0
6
2
2
0
[oo vimmm ow |mo]|w7]]ua]]+e0] Total
14
45
43
38
27
28
16
12
12
5
2% fluorescein sodium used to evaluate the extent of corneal opacity.
2 PPaannnnuuss pprreesseennt.t. ? CCoorrnneeaall ooppaacciittyy ssccoorree ddeetteerrmmiinneedd uusiinngg wwhhiittee lI ighhtt soouurrccee,.
9
22779911..00001188
3M MN01062320
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PSPtaauggdeey11N99u0om1fb2e2r333871
Study Number 3871
Tami2 TABLE- 2
SCALE FOR SCORING OCULAR LESIONS SCALE FOR SCORING OCULAR LESIONS~
+. Carmen 1. Cornea A Opacty-dcras of deny sea moss dense toon for reading) A. Opacity-degree of density (area most dense taken for reading)
No Opacity .......................................................... 0
ESacsayrredor ios aes, deals o is Ges vie || Scattered or diffuse area, details of iris clearly visible ............................. 1 Opalesdcionscal ansiucant arse, cots of i sonyobscured 1111.1 11} Easily discernible translucent areas, details of iris slightly obscured .................... 2 ress, no dota of is aioe, S26 of pup arly discribe Lng Opalescent areas, no details of iris visible, size of pupil barely discernible ............... 3 Opeisci,ve mE nnn Opaque, iris invisible ................................................... 4
8. Aro of corns involved Be Area of cornea involved One quarter (or ake bu not 20. i. a One quarter (or less) but not zero ........................................... 1 restr thanone auarer.but sethar ha 11111 nnn Greater than one quarter, but less than half .................................... 2 Greaor thn hl, tls thn vescunts Ls Greater than half, but less than three quarters .................................. 3 Greater than hee quarters, up 9 wns en LLL Greater than three quarters, up to whole area .................................. 4
axaxs Tote asimum = 80 AXBX5
Total Maximum = 80
2k 2. Iris
Xvaves A Values
Noa 0 Normal
Folds above normal. congestion, sling, Scumcornas scion any oro of hiss of Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or
camsination of any tere 1 sl 040% 1 Tot Sn escion poser... 1 combination of any thereof) iris still reacting to light (sluggish reaction is positive) ......... 1 Nore(a0igch, namorhage, 01s aesusion (nyo a1 of asl niin No reaction to light, hemorrhage, gross destruction (any or all of these) ................ 2
axs Tots Masimum = 10 AX5
Total Maximum = 10
3. Conjuncivae 3. Conjunctivae 2. Rene refers to ipsa an boas connie excluding cones and is A. Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris) esas normal wr no o Vessels normal Vosads ute ineced shove ronal | ns Vessels definitely injected above normal ...................................... ore dis, deapa crimson ed, indicus esse ot snsy asearbie 1111111 3 More diffuse, deeper crimson red, individual vessels not easily discernible ............... 2 Diss best od ! Ld Diffuse beefy red ...................................................... 3
8. Cramoss Chemosis No sweling SE . 0 No swelling .......................................................... 0 Pn sling sve na nclades cain iran) | cond Any swelling above normal (includes nictitating membrane) .......................... 1 Obviousswaling witpaca svarsonof Ws In Obvious swelling with partial eversion of lids ................................... 2 SwSawlatiinnggwwiithh kdiss aabboouutt hhotl clloosseeds 1 compisiaty GoLsoed sn nnn3 Swelling with lids about half-closed ......................................... 3
Swelling with lids about half-closed to completely closed .......................... 4
c. Discharge Discharge Nodichage . . 0 No discharge ......................................................... 0 on amo fren rom nl (600 no nts snl mons observa i nr nis of Any amount different from normal (does not include small amounts observed in inner canthus of orl AAR) ene * s normal animals) ...................................................... 1 Dischorge with maistoning of th is nd hac os sen 10105 || nn Discharge with moistening of the lids and hairs just adjacent to tids ................... 2 Discharge ih mtsenig of th ds nd has. and congas es icon he ve 3 Discharge with moistening of the lids and hairs, and considerable area around the eye ...... 3
Score (a+ 8+ C1 x2 Tots Mar=u20 Score (A + B + C)X 2
Total Maximum = 20
Tots Maximum Score: 110 represents te sum of al sores abtind or a corn, is on confine. Total Maximum Score: 110 represents the sum of all scores obtained for the cornea, iris and conjunctivae.
s*1 uDDbrrasaitizzaeencJJeHH,s, sWWpoooooddlwwatarorpddicGGa,l,layanntddo 82:377-390. substances applied topically to
CtChaallvvseekriryyn
the skin
HO.He. anand
mMMueecttohhuoodsdssmeffomorbrtrthhaeenseststu.uddyyoPofhfarirrirmittaarctiiooolnnEaaxnnpddTtthooexxriicc1iitt9yy44oo:ff
mucous membranes. J Pharmaco/Exp Ther 1944;
82:377-390.
112
SM_MNO1062321
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22779911..00001199
psDIiL
product
product
ssaaffeettyy
llaabbss
ro 20012 Page 20 of 23 sBeReEn Study Number 3871
MMMMTTSS!1
00-05 0.0- 0.5 0o-2s 0.6 - 2.5 26-150 2.6 - 1 5.0 or. m0 15.1 - 25.0 21.500 25.1 - 50.0 01-000 50.1 - 80.0 01-1000 80.1 - 100.0 01-1100 100.1 - 110.0
cssicatonor ve mamoscones TTAABBLLEE-- 33
CLASSIFICATION OF EYE IRRITATION SCORES
ClCalsassisfifiiccaattiioonn2'
Noricai Non-irritating rca soci Practically non-irritating ---- Minimally irritating [rorier Mildly irritating a Moderately irritating cov irs Severely irritating rev Extremely irritating i Maximally irritating
SSyymmbbooll
;N TMPN "M1
M2
"M3 .S `E "M
Se se ro Maximum Mean Total Score - Kay JH, and Calandra JC. Interpretation of eye irritation tests.
J Soc Cos Chem 1962; 13:281-289.
7 IIff mmoorree tthhaann 4400%% ooff tthhee rraabbbbiittss tteesstteedd hhaadd ttoottaall ssccoorreess >> 1100 oorr aann iinnddiivviidduuaall rraabbbbiitt ssccoorreedd
30, the preliminary classification is raised to the next highest level.
/9/
22779911..00002200
-- 3M MN01062322
JpIsiL ppprorooedduruccatssalafefvetytyilalbabbsss
SEer e Page 21 of 23 Study Number 3871
AAPPPPEENNDDIXIAXA
Animal feed analysis independently performed on October 7, 1994for presence of chlorinated insecticides:
Aldrin
a Dieldrin
Heptachlor Heptachlor Epoxide Chlordane Methoxychlor alpha, beta, delta &
gamma
BHC
DDE
2DDD
DDT Endosulfan I & II Endrin Endrin aldehyde Toxaphene Endosulfan Sulfate
and for the presence of organophosphate insecticides:
Malathion Methyl Parathion Diazinon
LABORATORY:
INDUSTRIAL LABORATORIES 1450 East 62nd Street Denver, CO 80216
Ethyl Parathion Ethion Parathion
STUDY NUMBERS: .IL94107971,1L94107972andlL94107973
Water analysis performed on October 21, 1994 for NJDEPE Safe Drinking Water Act parameters and percent fluoride content.
LABORATORY:
NEW JERSEY LABORATORIES DEPE #12660 A.A. Labs Division 222 Easton Avenue New Brunswick, NJ 08901
SAMPLEID: 23119-1
Results of feed and water analysis for possible contaminants: Acceptable; none detected or within regulatory standards.
192
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3M MN01062323
SPPtaauggdeey22N22u.0omffbe22r33 3871
Study Number 3871
}
ChemicAAaplPPPSEeENrNvDDeIsIXX:
B AB nyi
CERTIFICATE OF Chemical Services: ANALYSIS Analytical
_ou
CERTIFICATE OF ANALYSIS
-- s-- res ARTICLE IDENTIFICATION
-- smeny| Manugaemr~r: 3M
Ong rio Commi chix: Ley x Origin of Preduotion: Commercial
; Pilot Plant
" Laboratory X ;
Teo FoofTrtm oie smytsirt Teelmical Prodtmt X ; Pormuladoa of Te~lmieal Produm ~ ; Analytical Standard
Lomoo n ont [I Laboratory Project ID No.: P95-021
Bamh No.: 22L-2
ed a mn or Liquid.
; Solid
wary
[EO Recommended Storage Condifioas:
totete x rns im Ambient Temperature:
In refrigerator:
f fee -- ht ew tamd In deep fr~z~r. he em is o Additional
PHYSICAL PROPERTIES
. Color:
light yel|c~w
Explradon Date: 6/28/1997
TI~ article is stable at least 7_ years from date of
analysis when stored at recommended onditiom.
E Common Name. Sent O Masi Strucaa-al formula: cy by mt l~tity by means of:
ARTICLE INGREDIENT IDENTIFICATION
CAS No.: Not available
Molecular Weight:
Cr RoTt e XR 5 meets Chromatographic Re.tzntion Time ---X__ ; IR,
; OV __ ; MS __
; Other Methods:
[---- Content of Active Ingredient/Impurities:
mee ANALYTICAL DATA
-nams = 93.297 % i Rtn somos = 290% Related compounds = 4.290 %
Foren + 006% Fluoride ion = 0.036%
Ae eos er. Amly~ieal Method Nos.:
RE rer TM-1128.
by IC
TM-1140, Fluoride by
one ri Date of Aaalys~:
6/28/95
EE GLP - COMPLIANCE
3 22779911..00002222
33MW_MMNNO011006622332244
psT i pprroodduucctt ssaaffeee ttyy llaabbss m SSPPtaatuuggddeeyy22NN33.uu0ommffbbe22er33r 33887711
QQUAULAILITTYYAASSSSURUARNACNECIENSINPSEPCETCTIIOONNS
Intervals
Intervals
ffoorr
QQAA
Assurance Urit.
iinnssppeeccttiioonnss aarree rraannddoommllyy Records of the findings of
sselleecctteedd pprriioorr t1o0 these inspections
ssttuuddyy riniittiaattiioonn are kept on file.
bbyy tthhee Quay Quality The summary
Assurance Unit. Records of the findings of these inspections are kept on file. The summary
QbuealloiwtypArsosviudreasncveeriafuidcitast.ion of statements made in the final report section which addresses below provides verification of statements made in the final report section which addresses
Quality Assurance audits.
Inspections were mad of:
Inspections were made of:
lhe DADATTEE
7127198 7/27/95 127195 7/27/95 10/2195 10/2/95 1012085 10/2/95
PPRROOCCEEDDUURREE ININSSPPEECCTTEEDD
Test substance preparation Test substance preparation Initiation of dosing Initiation of dosing Row data Raw data Draft report Draft report
eosin Final report
Findings
Findings
rreeppoorrtteedd
ttoo::
SSttuuddyy DDiirreeccttoorr 77//2288,, 1100//221/9955
Wanagemen: 7128, laps"
Management 7/28, ~Z~
QFuraal lniktyFFiiAaelslddseeurr,r,z a5Bn..c5Se.. Super, visor
Quality Assurance Supervisor
22779911..00002233
a3MW_NMoN100160622332255