Contract No. DAMD17-79-C-9161 I ITRI Project No. L6121 Study … · 2018. 8. 22. · contract no....
Transcript of Contract No. DAMD17-79-C-9161 I ITRI Project No. L6121 Study … · 2018. 8. 22. · contract no....
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Contract No. DAMD17-79-C-9161 I ITRI Project No. L6121 Study No. 6
DETERMINATION OF THE CHRONIC MAMMALIAN TOXICOLOGICAL EFFECTS OF ROX
TWENTY-FOUR MONTH CHRONIC TOXICITY/CARCINOGENICITY STUDY OF HEXAHYDR0-1,3,5-TRINITR0-1,3,5-TRIAZINE CRDXJ IN THE
FISCHER 344 RAT
PHASE V FINAL REPORT Volume 2
Prepared by:
Barry S. Levine E. Marianna Furedt Donovan E. Gordon John M. Burns Paul M. Lish
I IT Research Institute 10 West 35th Street Chicago, IL 60616
Supported by:
U.S. Army Medtcal Research and Development Command
Fort Detrick, Fredertck, MD 21701
Project Officer: Jesse J. Barkley, Jr.
November 1983
Approved for pub I le release: Distribution Uni lmlted
The findings In thls report are not to be construed as an official Department of the Army position unless so designated by other authorized documents.
IIT RESEARCH INSTITUTE
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Disclaimer: The findings in this report are not to be construed as an official Department of the Army position unless so designated by other authorized documents.
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APPENDIX X
OPHTHALMOLOGY REPORT
IIT RESEARCH INSTITUTE
339
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340
S?UDY Iit:i,''.3~R: ~EST Arl.TICLE: SPECIES, RAT
L6121-6 R!JX
KEY NO'?E: ·rhe figure "X" ·;;2.s used to denote an ar.imal exa:-:1.i:1ed without any abnormal cli::!ical finjings ai: the desisnated test week.
su;:;.-:ARY OF OFHTHALr1iIC FINDINGS
Ocula!' conjunctivitis and discharge were observeC. in all test groups throughout the study and probably v,'ere a result of chronic external irritation. Throughout the study, there appeared to be a correlation between orbi~al bleeding and cataracts, phthisis, enophthalmia, iritis, and retinal and choroidal vascular attenuation. Since it ·::as not recorded which eye was bled, it is difficult to sa~e a definitive assessment, but ocular trauma or penetra~ion could cause the aforementioned abnormalities. Prominent lens nuclei and suture lines and vitreal strands are ~ormal aging changes that were observed in all groups, espec.:ally at Test ~eek lOJ.
Two animals (602, 603) were examined on 2-26-81 in addition to che scheduled examination weeks because of morbidity observed by IITRI Staff. Data Sheets are so labelled.
The high dose (40 mg/kg/day) female group, at Test ~foek 103, showed a definite increased incidence in c2.--:;aracts 1 luxated lenses, phthisis, buphthalmia, iritis, hyphe~a, and retinal degenerative changes which may be related to test article toxicity. Scleral icterus was also observed, and was probably related to disorders or tumors else·,·;here in the body (liver). The high nortality rate of the high dose (L:-o rng;/kg/day) mflles, at Test ':Jeek 103, makes useful interpr0tation of that data difficult.
C, Sue West, D.V.~. Diplornate, American College of Veteri~ary Ophthalmologists
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Study Number L6121-6 Test Artich: '"
LESION
Lid Laceration Ocular Discharge Con June ti vi tis Buphthalmia l'ieratitis Corneal Scar Iritl~/Anterior Uveitis Anterior Synechia Posterior Sgnechia Iris Bombe Cataract Retinal Folds Vascular Attenuation: Retinal
Choroidal Retinal Hgperreflectlvity
Males
Q.,_Q Q...2 .L..1!. B.O
0/7'J 0/75 0/7'J 0/75 0/7'J 2/73 0/75 1/7'J 0/75 2/7:;I 0/7'J 1/7'J 0/75 0/7'J 0/7'J 0/75 0175 0/7'J 0175 0/7::1 0175 0175 0175 017S 0/7::1 0/75 0175 0/75 117'J 0175 017S 0175 1/75 0/75 0175 0/75 0/75 0/75 0l7S 0/7'J 2175 0175 0/75 1/75 0/75 0/75 0/7'J 0/75 l/75 0/75 0/75 0/75 0/75 0/7'J 1175 0/75 1/7'J 0/7'J 1/7S 0175
OPHTHALMIC INCIDENCE TADLE SUMMARY - TEST WEEK 25
Dose Smq/kq/dau)
Erma1e1
40. 0 Q.,_Q o..;, w, !LQ ~ 1/72 0/75 0/75 0/75 0/7'J 0/7'J 1/72 717'J l/7'J 5/7'J 2/T'J 2/7'J J/72 7/7'J 1/7'J 6/7'J 2/7'J 2/75 l/72 0/75 0/75 0/75 0/75 0175 2172 017'J 0175 017'J 0/75 0175 0172 0/75 0/75 0175 1175 0/75 0/72 0/75 0175 0/75 0175 0175 2172 0/75 0/75 0/75 1175 0175 2/72 0/75 0/75 0/75 0/75 0/75 1172 0/75 0/75 0/75 0/75 0/75 2172 0175 0/75 0/75 0/75 0/75 0/72 0175 0/75 0/75 0/75 1/75 0/72 0/75 0/75 0/75 0/75 0175 0/72 0/75 0/75 0/75 0/75 0175 0/72 0/75 0/7:l l/7'J 0/75 1/75
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Studq Number L6121-6 Test Article: "'
....,_,,,. Lid Scarring Ocular Discharga Ccn J unc ti vi tis Buphthalmia Phthisis Enophthalmia Keratiti1, Corneal Edema Cot-neat Scat-Hyphema Iritis/Anteriol' Uveitis Antet-iot- Synechia Posterior Svnechia Cataract Retinal Folds V•scular Attenuation: Retinal
Choroldal Retinal Hyparreflactivity Papllledema Orbit;,! Man Nystagmus
t:!lill
0. 0 .... w,_ 0/54 0/52 0/47 4/54 1/52 1/47 1/54 0/52 0/47 0/54 0/52 1/47 1/54 0/52 0/47 0/54 0/52 0/47 0/54 0/52 0/47 0/54 1/52 0/47 1/54 1/52 0/47 0/54 0/52 1/47 2/54 0/52 1/47 2/54 1/52 0/47 2/::!4 1/52 0/47 5/::!4 11:,2 0/47 0/54 0/52 0/47 0/54 0/:12 0/47 0/54 0/52 1/47 0/54 0/52 1/47 0/54 0/52 0/47 0/54 0/52 0/47 0/54 0/52 0/47
OPHTHALMIC INCIDENCE TABLE SUMMARY - TEST ~EEK 76
R.2il (mg/kg/day)
Etm•le!i
~ ...._. Q,_Q_ .... W! B. 0 ..... 0/53 l/ 19 0/:12 0/54 0/53 2/04 0/47 1153 1/19 5/02 7/54 14/53 0/:14 3/47 0/53 0/1'? 0/52 0/54 0/53 0/54 0/49 0/53 0/19 0/52 0/54 0/53 o,~ 0/47 0/53 2/19 1152 0/54 1/53 3/54 2/47 0/53 0/19 0/52 0/54 0/53 0/54 0/47 0/53 0/19 0/52 0/54 0/53 1/54 0/47 1/::;3 0/19 01:,2 0/54 1/53 0/54 1/47 0/53 0/19 0/52 0/54 0/53 0/54 0147 1/53 0/19 0/52 0/54 0/53 0/54 l/49 2/53 1/19 1/52 0/54 2/53 0/54 4/47 0/53 1/ 19 0/52 0/54 0/53 1/54 0/47 0/53 1/19 0/52 0/54 0/53 l/54 1/47 8/53 1/19 31:,2 0/54 3/53 l/54 11147 0/:13 0/19 0/52 01:,4 0/53 0/54 1/47 0/53 0/29 1/52 01:,4 1/:13 1/54 0/47 0/53 0/19 0/52 0/04 0/53 0/54 0/47 0/5:J 0/19 3/52 0/04 1/53 l/54 0/47 0/:J:] Oil'>' 0/52 0/54 1/53 0/54 0/47 0/53 0/19 0/52 0/54 0/53 0/54 t/47 01:,3 0/19 1/52 0/54 0/53 0/54 0/47
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-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0-0 ,,,,,,,,,,,,,,,,,,,,,,,,,,, OOOOOOOOOOOOOONOOONNOOOO-oo
nnnnnnnnnnnnnnnnnnnnnnnnnnn nnnnnnnnnnnnnnnnnnnnnnnnnnn ,,,,,,,,,,,,,,,,,,,,,,,,,,, 0-0000000-000-mo-onnooooru-o
---------------------------nnnnnnnnnnnnnnnnnnnnnnnnnnn ,,,,,,,,,,,,,,,,,,,,,,,,,,, 0~0000000-00-0-0000-noo-oruoo
• • • " • J
" • • • • " ' • • •• > • • 0
• :, ..... ::> ::>
.,. .c Ill Z
• " ' • • ... ...... ... '° • "" . • 0 .. ,:: ::,, .. 0:: u .....
• 0 •• •• • •
"" ,, "" •• 0. ., .
a 1-.CU \/1.C::> • •••
OH 1- "' o u o, "' \II -., ~ ................... +'ll+>..C+> .. -"'" u .... P:lll;o..,.,Ca;
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STUDY IWI-IBER L6121-6
TEST ARTICLE ROX - --- ---
DOSE mg/kg/day 0.0
SEX Male -' "' "' ~ ,: "' ,._,:::: z~ - N "' z M .,,. m
W'ithin normal limits X X X X X
Lid Laceration
Lid scarring
Ocular discharge
Co,njunctivitis
"Chernosis
cluphthalmia ~-
Ptithis is
Er.ophthalmia
Keratitis Corneal Edema
Corneal scar
Hv~hema
Iritis/Anterior Uveitis
Anterior Svnechia Posterior Svnechia
Iris Bombe Prominent Lens Suture Lines
Prominent Lens Nucleus KEY.
L = 1 eft ~
~ R = right ~ U = both
Sl= suture line A "' anterior
ltlCIDENCE OF OPHTHALMIC LESIONS
TEST I/EEK 25
0 - N M .,,. m w ~ OJ w ~ OJ "' - - - - - - - - -X X X X X X X X X X X - -
f--
-
~ - ~
---
-
L
L
-
C = capsular I = immature S = sector N = nucleus
"' C - N - N N N X X X X
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Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles .. - -~
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w ~
"' STUDY IIUMBER L6121-6
TEST ARTICLE ROX
DOSE mq/kg/day O.O
--' "' SEX Male ~~
INCIDENCE OF OPHTIIALMIC LESIONS
TEST !!EEK 125
--:z::S -· Or-1NMtj-l.()
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STUDY IIUI-IBER L6121-6
TEST ARTICLE ROX
DOSE mq/kg/day ....Q.:.Q
SEX Ma] e
Within normal limits
Lid Laceration
Lid scarring Ocular discharge
Conjunctivitis
Chemosis
I ..., "' "" w
'"" I .._.. Z lO Z => N «z X
" 00 "' 0 N N N M
X X X X
IIICIDENCE or OPHTIIALMIC LESIONS TEST I/EEK 25
- N M .,. "' ~ " 00 0-, 0 M M M M M M M M M .,. -.,. X X X X X X X X X X X
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N M .,. "' ~ " 00 ~ 01 .,. " .,. .,.
" .,. .,. .,. "',
X X X X X X X X X
I Buphthalmia I I I I \-l--l--Phth1s1s
-t--1 I I I I I I I I I I I ! 1-1-1-Enophthalmia
Keratitis
Corneal Edema
Corneal scar
Hyphema
iri tis/ An_t_~rior Uvei_t_i s
Anterior S_ynechia Posterior Synechia
Prominent Lens Suture Lines I I I I I I \ I I I f--f--~1-1---J-1 I I I l--I Iris Born be 1 1 1
~· ~--,
Prominent Lens Nucleus I I I I I I I I I I I I I I '--1---'----'--'---'-_J'--'-J_...L_j__l KEY:
L = R = u = Sl= A =
left right both suture line anterior ___ .. __ : __
C = capsular I = immature S = sector N = nucleus Co= cortical *~previously died or B = brunescent sacrificed V = vacuoles ,.1 = m::1t1,rP
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~ .,,. 00
STUDY IIUIIBER L6121-6
TEST ARTICLE ROX -
HICIDENCE OF OPHTIIAU\l C LES IONS
TEST i,EEK 25 --- --·-- ------- - . -~-- ---·- ---,-
DOSE mq/kg/day 0.0
SEX Male ~ °'
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STUDY NUMBER L6121-6
TEST ARTICLE ROX -DOSE mg/kg/day 0.0
SEX Male --"" ""' w :;: "' ,.....z
~ E M st ~ z => ""'z
~ ~ ~ ~
Within normal limits X X X X X
lid Laceration
Lid scarring
' Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
•Phthisis
Enophtha lmi a
Kera ti tis .
Corneal Edema
Corneal scar
H··-hema
Iritis'Anterior Uveitis Anterior Svnechia Posterior Svnechia
Iris Bombe Prominent Lens Suture Lines
Prominent Lens Nucleus KEY,
L = left w R = right ~ U = both ~ Sl= suture line
A = anterior P = posterior
INCIDENCE OF OPHTHALMIC LESIONS
TEST WEEK 25
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N n ~
!UDY IIUl·\BER L6 I 21-6
TEST ARTICLE ROX -OOSE mg/kg/day O.O
SEX Male
1 "0:: 1.-. ....
r;it,. .. ,.,..+
luxated Lens Vitreal Strands
Vitreal Hemorrhage Retinal Folds
Vascular Attenuation: .
Retina 1
Choroidal
Retinal Hyperreflectivity Sparse Choroidal Vascular Pattern
Retinal Hemorrhaqe
1 Retinal Degeneration
Papil ledema
Icterus
Orbital Mass
Mystagmus
'Bled - orbital sinus
_, _____________ .. KEY.
L = R = u = Sl= A = p =
~"' "" w ::: o:J ...... == - N M " z =, « z m m m m
left right both suture line anterior P.• s teri or
m m
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 25
"' ~ 00 ~ 0 - N M " m m m m m "' "' "' "' "' "'
- -B Bl 1
G ~ "' 00 "' "' "'
~ -
- -
·- -· -
-
~
C = capsular I = immature N = nucleus
0 - N ~ ~ ~
R
R
Bl
S = sector Co= cortical *=previously died or
sacrificed
M ~
B = brunescent V = vacuoles Bl= specific eye used not M = mature recorded
" m ~ ~
-
B - -
-
"' u C
" u ·-u C -2
1
1
10
'
,, •[
., ,,, I
I ·1l
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STUDY IIUMBER L6121-6
TEST ARTICLE ROX DOSE mg/kg/day -9.:.Q
SEX Female ~"' "" w :,: ro ...... ::::::: z~ "" z
INCIDENCE OF OPHTIIALl1IC LESIONS
TEST I/EEK 25 --.-~-
'°I " ~ " 001 ml 0 1 -1 NIMl•l~l'°I~ ~ ~ ro 00 OC1 00 00 00 00 00 001 ml 0 1 -1 NIMl"'"I~ 00 OCI O'\ cr-, O> c.n O'I en C
'°I ~1 "'I crl c c.nc.ncnc.n,-1
Within normal limits ~1-!'.--\_:
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~
n 0
STUDY IIUIIBER L6121-6
TEST ARTICLE ROX ----
INCIDENCE OF OPHTIIALMIC LESIONS
TEST 14EEK 25
DOSE mq/kg/day O.O --·- - ·-- -· -~-~ ------
SEX Female ~~
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~
~ ~
STUDY NUMBER L6!21-6
TEST ARTICLE ROX -DOSE mg/kg/day 0.0
SEX Female
Within normal limits
Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
Phthisis
Enophthalmia
Kera titi s
Corneal Edema
Corneal scar
Hvnhema
Iritis!Anterior Uveitis
Anterior Svnechia
Posterior Svnechia
Iris 13ombe Prominent Lens Suture Lines
Prominent Lens Nucleus KEY:
---,·- - .
..., "' ""' w :c "' ~ N M tj" m ...... == 0 0 0 0 0 z~ ""' z
~ ~ ~ ~ ~
X X X X
u u
-
- -
L = left R = right U = both 51= suture line A= anterior P .. posterior
INClDENCE OF OPHTHALMIC LESIONS
TEST 14EEK 25
"' ~ "' cr, 0 ~ N M tj" m 0 0 C" 0 ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ - - - ~ X X X X X X X X X X
"' ~ co cr,
~ ~ ~ ~
~ - - -X X X X
-- -
·-
·-
-
C = capsul a·r I = immature S = sector N = nucleus
0 ~ N N N N - - ~ X X X
Co= cortical * = previous1y died or B = brunescent sacrificed V = vacuoles t-1 = mature
M tj" m N N N - ~ ~ X X X
-
-
" n ~
STUDY IIUIIBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day __!l.Jl
SEX Female
1 Pdnn
r.r1tr1rnr.t
IrlCIOENCE OF OPHTIIAUIIC LESIONS
TEST HEEK 25 -·----·.-·· r- ----, r ---.-----,
__J "'
!~1~1NIMl"lml' -:3 O CG O C' C ~z:-r-1.-1....-1.-lr
~1 "'I °'I O 1 ~ 1 NIM Is, Im I , 0 C C' ,-, ,..... ,--1 ..-, .-1 ,....... , .-l ...--I ,-1 ,-1 ...... ...... r-1 r-1 ,--1 ...
~1 00 l°'l 0 1~1N1 Ml s,I m ,....;r-1.-lNNN NNN ....... ...... ...... ...... ...... ...... ,....; ,-1 .-,
~~::::~ ~~~:nds ~I I I I ttttttl I I I 1-t1=1=1-1jjjj---1 Vitreal Hemorrhage
Retinal Folds
Vascular A_ttenuation: Retinal
Choroidal
\ Retinal Hyperreflectivity \ 1--~ I I I I I I I I--I-S£arse Choro1dal Vascular Pattern
Retinal Hemorrhage
Retinal De~eneration
\ Papil 1 edema \ \ \ \ 1-1--1--f-l- I I i----1-1----l---1-+-t--+-+-Icterus
Orbital Mass
Nystagmus
\ Bled - orbital sinus J I f1 I +l-+-H-~f--~1-1 IB1 H I I -1--f \ f \ \ l-!1--+-+-l-l-l--l---1-I I I I 1-1-1--
KEY: L = left R = right U = both Sl= suture line A = anterior P =~ n.r,
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STUDY llUI-IBER L6121-6
TEST ARTICLE ROX ~--!NC!OENCE OF OPHTIIALM!C LESIONS
TEST I/EEK 25
DOSE mg/kg/day O.O ~ ~~ C
SEX Female ,::c I..LJ ~ ~~
-
I
STUDY llUMBER L6121-6 TEST ARTICLE ROX ---DOSE mq/kg/day O.O
SEX Female
1--~'"ln
.C:".. .
Lux a ted lens Vitreal Strands
Vitreal Hemorrhage
Retinal Folds
Vascular Attenuation: .
~"' "" w :,-: ro - ,c z~ ""z
Retinal Choro1dal
Retinal Hvoerreflect1vitv Sparse Choroidal Vascular Pattern
Retinal Hemorrhage
Retinal Degeneration
Papilledema lcterus
Orbital Mass
Nys tagmus
Bled - orbital sinus
- -~----- ---KEY:
L = left R = right U = both
- -· -
"' ~ N N - -
-
Sl= suture line A= anterior P = poc: tP,ri qr
--- -
00 "' 0 N N M - - --
-
Bl
INCIDENCE OF OPHTHALMIC LESIONS
TEST I/EEK 25
- N f ~ ~ "' ~ 00 "' 0 - N M M M M M M M M ST ST ST ST - - - - - - - - - - -- - -
-- -~ -
_,_
- - - - -
I- j__ I- - j__
,-,-
,_ - - I- -.
C = capsular I = immature S = sector H = nucleus
ST ~ "' ST ST ST - - -
---
-
- - I-
Co= cortical *=previously died or 8 = brunescent sacrificed
~ cc ST ST - -
~l
- -
V = vacuoles Bl= specific eye used not M = mature recorded
ru u C ru u --
"' 0 u ST ~ C - - -
-··-
C----1
,__
- I- 10
- I-'
-
STUDY llUMBER
TEST ARTICLE
L612!-6
RDX
DDSE mg/kg/day
SEX Male
0.3 -
Within normal limits Lid Laceration
Lid scarring
' .J "" -0: w ,: ro I ~ s: z C, -0: z
INCIDENCE OF DPHTHALMIC LESIONS
TEST l!EEK 25
' ' ' ' ' ' ' ' ' ' ' ' ' ' ' ' '
~~ ~ ~ ~ ~ 00 0 £ ~
-
., n p
STUDY 11urmrn L6121-6 TEST ARTICLE ROX
DOSE mq/kg/day ~ SEX Male
_J_c_s.1 nn
_cataract
INCIDENCE OF OPHTHALMIC LESIONS
TEST lffEK 25 ,-- - ... -----,----------.-----i- --,- --r-
~"' ~~1-1N1M1S,1~1 ~ ~I ~I ~I§\ ~l~\§\;\~l~I ~I §\§l~ISl~I Ml "'I ~ ,_. •- LO LC> LD LO LD ~ ~ ~ ~~ ..... -- ..... - - - -
-t-t-r--+-t-1-l-1-l-l-1-1-1-f-l-l--+--1--+----J-l_j
I Luxated Lens I l I I I 1-1-1-1-~ ! I I I 1-1-1-1-1-1-H I 1-1-1 Y.i tr_e__Qj Strands Vi trea l_ Hemorrhage
Ret1na1 Folds_
'lascular Atte11uation: Rttinal
Chor_oidal
I Retinal Hyperreflect1vity \ I I ! f \ I \ I I H I I f---1-1-l I I I I I I ~ I Sparse Choroidal Vascular Pattern I I I I I t-t-\-1--
Retinal Hemorrhage
I Retinal Degeneration r1
I I I I f-f-1-1--1-1-Papil ledema
1 lcterus Orbital Mass _,_ I
1
.
1
Nys tagmus Bled - orbital sinus Rl Bl Bl . - I-
KEY:
L = 1 e ft C = capsular I = inuna ture
R = right S = sector N = nucleus
U = both Co= cort i ca 1 S1= suture line B = brunescent
*=previously died or
A= anterior V = vacuoles sacrificed
Bl= specific eye used not P ,- -·1str- ... i"-r 1-1 = mature "'€.CQ:"'rl.P,:\
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STUDY IWMBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day 0.3
SEX Male
Within normnl limit.s
Lid Laceration
lid scarring
Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
-Phthisis
~"' «w ,: "' I ,_.. :::C::: lD z co ~ « z -
X
~ 00 '" 0 ~ ~ ~ 00 - - - _, X X X X
INCIDENCE OF OPHTHALMIC LESIONS
TEST \!EEK 25
~ C - N ;;' ~ "' ~ 00 '" 00 00 00 00 00 co 00 '" - - - - - - - --
X X X X X X X X X X
- N M "" ~ "' ~ 00 '" < '" ~- '" ~ '" '" '" ~- '" < - - - - - - - - - < X X X X X X X X X X
--· --
LI_ I I I I I I --
Enophthalmia I ! I I I -J,-l-+-+--+-+-+--t--t--1-1-1 I I I I I I I Kera ti tis
Corneal Edema
I Hvnhema Corneal scar - - _J~
Iritis/Anterior Uveitis .
Anterior Synech i a -1 - • :
Posterior Synechia ----1--1-! _ i 1 1 1 1 J 1 , 1 : t 1 1 1......., Iris Bombe
I :~:;~:~~:~~:~::.Lines I I I I I ljj-!j-1 I I tt-t/j-1-1 I I \j I l w V,
"'
KEY: L a 1 eft Ra right U a both 51 = suture 1 ine A= anterior p a posterior
C = capsular 5 = sector Co= cortical 8 = brunescent V = vacuoles M = mature
I = immature N = nucleus *=previously died or
sacrificed
-
w
"' 0
STUDY IIUIIBER Lfil21-6
TEST ARTICLE ROX
DOSE mq/kg/day ~
SEX Male
1 oc inn
r ... ..... ~..,,. ..
INCIDENCE OF OPHTIIALll!C LESIONS
TEST I/EEK 25 -·1·-1--·r--.----1--r- 1 ·r----,·---,------,-~,- . .., -- ,--
~ °'
-
STUDY IHJMBER L6121-6
TEST ARTICLE ROX
DOSE mq/kg/day .2..:1 SEX Male -""
I NC !DENCE OF OPHTHALMIC LES JONS
TEST I/EEK 25
: ~ I~ IN IM I sc I ~ "'I "I "'I "'\ 0 \ ~,NIM I sc Im I"' z::JOCOO OOCQ,-
-
~
~
N
STUDY IWl·\BER L6!21-6
TEST ARTICLE ROX
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 25
DOSE mg/kg/day 0.3 ~ ~~ w SEX Male
-
STUDY NUMBER L6121-6 TEST ARTICLE ROX DOSE mg/kg/day o. 3 SEX Female_
Within Normnl I imitc;
Lid Laceration
Lid scarring Ocular discharge
Conjunctivitis
Chemosis
Buphthalmia -Phthisis
Enophtha lmi a
Keratitis Cornea 1 Edema
Corneal scar H11nhema
Iritis/Anterior Uveitis
Anterior Svnechia Posterior Synechia
Iris Bombe
Prominent Lens Suture Lines Prominent Lens Nucleus
KEY:
~
~
~
..J °' "" w :c"' ill
~ 00 O', 0 ...... :::::
z C, N N N M "' z
N N N N
X X X X X
L = left R = right U = both Sl= suture line A = anterior P = pas teri or
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 25
N M " ~ ill ~ lS ~ 0 N M - -M M M M M M M M "" " " " N N N N N N N N N N N N
-
X X X X X X X X X X X X X
-
->-
--
C = capsular I = founa ture S = sector N = nucleus
" ~ ill " .,,.
"" N N N
X X X
-
-
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
~ cc O' C, .,,. .,,. "" ~ N N N N
X X X X
'
,_
-
w ~ .,,.
STUDY IIUMBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day .Q.,l
SEX Female
1 es ion
HICIOENCE OF OPHTHALMIC LESIONS
TEST HEEK 25
I --' "' ,'~I'° I ~1 00 I~ IO 1- IN I 61 ~I ~I ~ I fl I~ I 15 I~ I~ I ,_.~ N N N N M M M Z:=J N N N N N N N ""z ~ ~I ~I ml '°!~I'" I ~I
0
-
STUDY IIUl·IOER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day 0.3
SEX Female
Within normal limits
Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemosis l3uphthalmia
Phthisis
£naphtha lmia
Kera ti tis
Corneal Edema
Corneal scar
H·"--hema
lritis/Anterior Uveitis
Anterior Svnechia Posterior Svnechia
Iris Bombe
Prominent Lens Suture Lines
Prominent Lens Nucleus ·---~--KEY:
w
"' ~
--· ------
.J"'
-
w
"' "' STUDY IIUIIBER L6121-6
TE5T ARTICLE ROX
ItlCIDEMCE OF OPHTIIALIHC LESIDNS
TEST I/EEK 25 DOSE mg/kg/da-;D.3- - - - -- - - -- ·-- -•• - - -- --· 1 SEX Female ~ ~
:,::!;f' ,-, NM
-
STUDY IIUl·IOER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day o. 3
~ °' SEX Female "" w ,: ro ~ f ~ g_ a, - :c z co ,._ « z N N N
\,,1ithin normal limits X X X X x -Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemosis Guphthalmia -
.Phthisis
Enophthalmia
Keratitis
Corneal Edema
Corneal scar
H•,..,hema
Iritis/Anterior Uve1tis
Anterior Svnechia
Posterior Svnechia Iris Bombe
Prominent Lens Suture Lines
-Prominent_~en~_Nucleus KEY:
~ L • left m R a right ~
U a both Sl= suture line A = anterior p = posterior
INCIDENCE OF OPHTHALMIC LESIONS
TEST lsEEK 25
- N M .., ~ ~ ,._ 1 1 D ro a) ro co ro ro ro m N N N N N N N N ,_ X X X X X X X X X -
·-u
- ,_ - - -u
-
- N M .., ~ ~ m m m m m cr N N N N N N X X X X X X I- - - I- -- I- - - 1--
- - - --
- I-
,_ ,_ - - ,_ - 1--
1--
I- -
1-- - - - ,_ - ,_ - I- -
..
C = capsular I = inuua ture S = sector N = nucleus
,._ ro m m N N
X X - 1--
- -
- ,_
- ,_ ,_
Co= cart i cal *=previously died or 8 = brunescent sacrificed V = vacuoles M = mature
" _, C
" To ·-cr C m 0 u N M C -X X 74 - -
,_ -.
1
1
~-- -
-
-
--
- -- I-
-
~
"' 00 STUDY NUHOER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day Q.,J.
SEX Female
1 PS inn
-"''
INCIDENCE OF OPHTHALMIC LESIONS
TEST I/EEK 25
~~I '°I ,-.j "'I ~1 cl-lNIMl"'l~l'°l~l o;J zl 0 1-1 NI Ml"'l~l'°I ~1 "'I a,I 0 ~~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ N N ~ gJ R: gJ g:; R; R; ~ Ri gJ ~ \,--1..Jl."'1.L"'-"'--------------+---t----f-\ H-1--11-1-----1-----+--+--+--f-l-f-f-l I I I I I ·+-
I Luxa ted Lens 11 I I I I I I \-J--1__J--1----+--+--+----l-l-l-l-l-l-l I Vi trea_l Strands --l-l-+--1-+-+--l-·
I Vitreal Hemorrhage \ \ \ \ \ \ \ \ -1--\ I I I I I 11
f-f-1-1-H-I I I I
I I
Retinal f'
-
STUDY I/UMBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day 2:§. SEX Male
Within normal limits
..J "' « w ~ cc - ,: z "' « z
l--1T-
- N M "' m 0 0 0 0 0 M M M M M X X X X x·
INCIDENCE OF OPHTHALl1JC LESIONS
TEST HEEK 25
"' ~ co "' 0 - N M "'~
0 0 0 C - - - - - - -M M M M M M M M MM M X X X X X X X X X X X
~ co ~ 0 - N M "' m - - - N N N N N N M M M M M M M M M X X X X X X X X X
lid Laceration
I ~:~I :~a:~::~~rge ~U=1=ttttt=w=1=ttt1=tl=l=ljjjjjj ConJunct1v1t1s
Chemosis lluphthalrnia
Phthisis
Enophthalmia , 1-1-1 I I I I I --j,--,.-J-\--\-\-1 I I I I I I -l Kera ti tis
Corneal Edema
Corneal scar
IHyph~a --Iritis/Anterior Uveitis
1
~
"' co
Anterior Svnechia j Posterior Synechia ___ ----------------·---·---· ·--------. .----. ___________ .
Iris Bombe I I I 1--1-1 I I I I l-I I I ~1--1-1-1 I I I I I L-1 Prominent Lens Suture Lines
Prom in e1J_Llen1 __ N_!]c 1 eus i_L_L_J_.L.J_L..L-1_1-_1.-1_ 1-..L-1--'-....L-'---'-...J._.1........L-1_1 KEY:
L = R = u = SI= A = p =
left right both suture line anterior pas teri or
C = carsular I = immature S = sector N = nucleus Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
-
~
~
~
STUDY 11u1,mrn L6121-6 TEST ARTICLE ROX
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 25
DOSE rnq/kc1/day SEX Male
1.5 •T --••,--•r• --,.............- r--•,-----~ -r-'f"-r-"T 1-------r--,------.----,--,-'
~ °'
1no:;1--Iii~~~~~ ~1~1 001 ml 0 1-1N1M1q1~ C O O O r-< r-< r-< r-< r-< r-< M M M M M M M M M M ~1 ~1 ""l°'l 0 l-1N r-
-
STUDY IWMBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day 1. 5
SEX Male
Within normal limits Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemosis
Buphthalmia
Phthisis
Enophthalmia
Kera ti tis
Corneal Edema
Corneal scar H1mhema
Iritis/Anterior Uveitis
Anterior Svnechia
Posterior Svnechia
Iris Bombe
Prominent Lens Suture Lines
Prominent Lens Nucleus KEY:
w ~
- - ----·
-"'' ---,__ -
-
C = capsular I = immature S = sector N = nucleus
q ~ co q q q M M M
X X X
-
-,_ -
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
~ co C' ~ q q " M M M
X X X X
~ - -
-
,, ~ ~
STUDY NUMBER L6121-6
TEST ARTICLE ROX
DOSE mq/kg/day D SEX Male
lesinn
_Cataract
~~
~"' I ......... _ z~
-
STUDY llUMBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day Ll SEX Male ~""
-
'
~
~
~
STUDY NUMBER L6121-6
TEST ARTICLE ROX ~ -
DOSE mg/kg/day l .5
SEX Male
, __ , __
,.._._ ____ ~+-
Luxated I e--
Vi trea l Strands Vitreal Hemor~ha--
Retinal Folds
Vascular Attenuation:
__, ~ "" w :c ro - ,-: z~ «z
Retinal .. Choroidal '
Retinal Hvoerreflectivitv
Sparse Choroidal Vascular Pattern 1
Retinal Hemorrhaae
Retinal Degeneration
Papilledema
Icterus
Orbital Mass
. Nystagmus
I Bled - orbital sinus
I_ ~,~- ---~--KEY:
L = left R = right U = both
·-· --
~ N m m M M
Sl= suture line A= anterior P __ = rtos.t_eri o.r
M s,- m m m m M M M
II-ICIDEI-ICE OF OPHTHALMIC LESIONS
TEST \!EEK 25
-
STUDY IIUIIBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day .1.,2
SEX Female
INCIDENCE OF OPHTHALMIC LESIONS
TEST IJEEK 25 --·-,-r -~~~~,-
~"' ~~I '°I "I "'I ml 0 \ ~IN IM I" ,...... ~ r--.. r--- r--- r--- 00 CO OCI OCI OJ ~~ MM MM MM MM M ~1 "'\ "\ "'\ ~1c1~1N1M co co ro co co a, a, ~ a, M M M M M M M M M "\~\'°\"\'°\ml c a, a, O'> a, o-, a, C M M M M M M "
Within normal limits 1----------:f-+-Vl-~~l--~l--\-x Ix Ix Ix ~~l~~f:_\ x I x Ix \ x I ~~~ Lid Laceration
Lid scarring
~~:l~:::::::::ge ~ B=B=~tll I FI_I_EEl--1--1-!--l--ljj Buphthalmia
I :~~:::::,mia I I I i tttttt I I I I I ttjjj I I I I ~-1 Keratitis
Corneal Edema
Corneal scar
w ~
~
Hyphema
Iritis/Ant_er_i_o_r Uveitis
Anterior S.vnechia
Posterior Synechia
Iris Bombe Prominent Lens Suture Lines I I I I I I I f-j-j I I I I H 1--'--f--l-j I I I 1-f--Prominent Len~_Nucleus I I I I I I I I I I I I I I I
KEY: L = left R = right U = both Sl= suture line A= anterior P = posterior
C = capsular S = sector Co= cortical B = brunescent V = vacuoles M = mature
I = inm1a ture N = nucleus *=previously died or
sacrificed
-
'" ~ m
STUDY 11u1mrn L6121-6
TEST ARTICLE ROX
DOSE mq/kg/day J...5. SEX Female
lPe:inn
~~
INCIDENCE OF OPHTHAUIIC LESIONS
TEST HEEK 25 · - -, · .-- --1-- r·--,-- ,---,-
f \91 9 9 ~ 9 ~ 9 NI Ml sci m I ~ I " I 00 I m I O 1- I NI MI sc I m ~ " ao m c ,_. ·- co CD co ro co O'.l ro co cn O'I a, a-, o-, O'I cr, a, en cn o ~~ M M M M M M M M M M (V) M M M M M M M ~ - --
l_l.il='----------1-l-l-l-l-l-l-l-l-l-l,-+--+-I-I-I-I-I-I I I I I 1-l-t l-H-1-~ I I 1-1--H I I 1-1-1-1-1-+--+-_,_-1-1-
Luxa ted Lene;
I Vitreal Strands I I I I l-l-l-1-1-1-I I I I I l-l-l-l-+--1-\----j--l--~i treal Hemorrhage
Retina] Foldi
Vascular Attenuation: Retinal rt-t-t-ttl 11 \ H-[-j I i 1113 Retinal Hvoerreflectlvit~horoldal , t=l=l=-l=+--+-1--=1--~:~:_-_+-l---'r=l==-:~+--:_-:-::_-:=~·___;--l S~arse Choroidal Vascular Pattern
Retinal Hemorrhage
Retinal De1eneration
Papilledema j---1-1--1-1-•-'
Icterus I \jjj-Orbi tal Mass _ ___ . 1--1--1--1--->-+--l Nystagmus _\jjjjj L' Bled - orbital sinus Bl B Bl! Bl -1--
1 1-------------t I I I 1-1 I I I I 1-1-1-1-l-1-I-I I I I 1-1--
KEY:
L = left C = capsular I = immature
R = right S = sector N = nucleus
U = both Co= cortical *=previously died or Sl= suture line B = brunescent sacrificed A= anterior V = vacuoles Bl= specific eye used not p ~- oos ter_ior M = mature recorded '
-
STUDY IIUl·IBER L6121-6
TEST ARTICLE ROX -DOSE mq/kg/day 1.S
--- -
SEX Female --"" "" w "'00 - N M .,,. ~ ...... ::.:: 0 0 C' 0 0 z~ .,,. .,,. .,,. .,,. .,,. "" z
Within normal limits X X X X X
Lid Laceration
Lid scarring Ocular discharge Conjunctivitis
Chemosis Buphthalmia -Phthisis
Enophtha lmi a
Keratitis
Corneal Edema
Corneal scar H"nhema
Iritis/Anterior Uveitis
Anterior Svnechia Posterior Svnechia
Iris Bombe Prominent Lens Suture Lines
Promi nenJ_~_en~yuc 1 eus KEY:
~
"' L = left "' R = right U = both Sl = suture line A = anterior P • pos ter1or
INCIDENCE OF OPHTIIALMIC LESIONS
TEST HEEK 25
~ ~ 00 ~ 0 - N M .,,. ~ ~ ~ 00 0 0 0 0 - - - - - - - - -.,,. .,,. .,,. .,,. .,,. .,,. .,,. .,,. .,,. .,,. .,,. .,,. .,,. X X X X X X X X X X X X X
- - - -
~ ,_
--
,_ - - -
C = capsular I = immature S = sector N = nucleus
~ C -- N N " " " X X X
-
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
N M .,,. ~ N N N N
" .,,. .,,. .,,.
X X X
-
j I
--
-
' ~
STUDY IIUI-IBER L6121-6
TEST ARTICLE ROX
DOSE mq/kg/day 1. 5 --- -- -- . -- -- .
SEX Female ..J ~
-
STUDY llUMBER L6121-6
TEST ARTICLE ROX ---
INCIDENCE DF OPHTl~LMIC LESIONS
TEST WEEK 25
DOSE mg/kg/day LS [ ~ SEX Female i E5 -~ ,:'.:; ~ l : C cr, C ,..... N M q Lfl lD r--. CO cr, 0 ,- N M tj- Lfl \.0 r--. OJ cr-, c .;.... :z:5 C N f" MM MM MM MM M
-
~
00 G
STUDY NUMBER L6121-6 TEST ARTICLE ROX DOSE rnq/kg/day l. 5
SEX Female
1 - - , -. ""
__c;:,'-•··-~f-
Luxated Lens Vitreal Strands
Vitreal HemorrhaN~
Retinal Folds Vascular Attenuation:
.
--' "' "" w :Coo ,._. == z co "" z
Retinal
Choroidal Retinal Hvnerreflectivitv Sparse Choroida1 Vascular Pattern
Retinal Hemorrhane
Retinal Degeneration
Papil ledema
Icterus
Orbital Mass Nystagmus
ed - orbital sinus
··-------- --~- .. E KEY:
L = left R = right U = both
. -
"' ~ N N tj tj
81
Sl= suture line A = anterior P = p_si~t_eri~r
·--· -- --
00 ~- 0 N N M tj tj tj
-
INCIDENCE OF OPHTHALMIC LESIDNS
TEST liEEK 25 ..
; N M tj "' "' ~ 00 "' 0 - N M M M M M M M M M tj tj tj tj tj tj tj tj tj " tj tj tj tj tj tj tj - . ~ - - -
- - - - - - -
- - - -,_ -
I- - -
-Bl ,1 1 Bl ,_ - - - - -
C = capsular I = irrnua ture S = sector N = nucleus
tj "' ~ tj tj tj tj tj tj
- - --
-
-
Co= cortical *=previously died or 8 = brunescent sacrificed
~ 00 tj tj tj tj
,_
V = vacuoles Bl= specific eye used not M = mature recorded
" u C
" u ·-"' 0 u tj "' C tj· tj -
.
1
'
,_
I- 10 -
-
STUDY NUMBER
TEST ARTICLE
DOSE mg/kg/day
SEX Male
L6121-6 ROX
8.0
Within normal limits Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemosis
.J °'
-
'~ QO
'" INCIDENCE OF OPHTHALMIC LESIONS
TEST I/EEK 25 STUDY 11u1mrn L6121-6
TEST ARTICLE _..BQ._X_
DOSE mq/kg/day JL..Q. SEX Male
-- -, ··.,. --,--r--.-------.-,-- i- ·T----i-,---1-,-,--r--r~
1 "
-
STUDY NUl·\BER L6121-6
TEST ARTICLE RDX
DOSE mg/kg/day 8.0 --- -.
SEX Male _,~
-
~
°" ~
I
STUDY rrurmrn L6121-6 TEST ARTICLE ROX
UUJL Ill{!/ r.~!f u,,.y - . .,
SEX Male
ln
-
STUDY IIUl·IBER L6!21-6
TEST ARTICLE ROX
DOSE mq/kg/day !:,9_ SEX Male ~"' «w z: ro ,_..z
z~ « z ~ ~ M " m 0 0 C m m m
INCIDENCE OF DPHTIIALMIC LESIONS
TEST HEEK 25
~ ~
-
w a,
"' STUDY HUMBER L6!21-6
TEST ARTICLE ROX
DOSE mg/kg/day .§.:.Q SEX Male
l~r~~-
r-~+-"'""'"t
-~yxated Lens.
~ °'
-
STUDY IIUl·IBER L6121-6
TEST ARTICLE ROX --
DOSE mg/kg/day 8.0
SEX Fema 1 e ~ °" "" w :c "' w ~ co m 0 ...... :::: N N N N M z co m m m m m "" z
Within normal limits X X X X X -Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
-Phthisis Enophthalmia
Keratitis
Corneal Edema
Corneal scar
Hvrhema
Iritis/Anterior Uveitis
Anterior Svnechia
Posterior Svnechia
Iris Bombe
Prominent Lens Suture Lines
Prominent Lens Nucleus --·--KEY:
~
w L = left ..., R = right U = both Sl = suture line A= anterior P = posterior
INCIDENCE OF OPHTHALMIC LESIONS
TEST I/EEK 25
- N M st m w ~ co m 0 M M M M M M M M M st m m m m m m m m m m X X X X X X X X X X
+-- - -
I-
--
- - I-
I-
,_
- -
- N M st st "' m m m X X
I- -
,_ L
- +-- --L
-- -
-
- - --
-,_ -
- +---
.
st m w st st st m m m
X X X
- - --
- - +--
1-
-
- ,_
+--
- - ,_
C = capsular I = irnma ture S = sector N = nucleus
~ co m C st st st m m m m m
X X X X - f-- - ,_
-
I
-
- ,- -- +--- +--
- - - -
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
-
~
00 00
STUDY llUM8ER L6121-6 TEST ARTICLE ROX DOSE mq/kg/day .!h.Q SEX Female
l p_s_jnn
INCIDENCE OF OPHTHALMIC LESIONS
TEST I/EEK 25 --.----,- ·-1-r r- r---i · -
___, °' ~te 1~1~1ao1m I ~ ~I ~I al ~l~l~l~\~\~I~\ ~ ~l ~l~l~l~l~I ,_..:... N N N N Z: ::, lJ") U") LO Ln "" z
O'I ~I 0 ~- w w ~ \1__l.---+--+-+-l-t--,
Luxated I""' \--H ttttt1-1--H-1---J-H-Vitreal Strands -~~i- - -- -H-----4-+--l~-i Vitreal Hemorrhane t--Retinal Folds f--f-1-- I I 1-1-1-1-1-I I I I 1-+-I Vascular Attenuatio_~ R .!'_ti _!l__._j
_(;_hor_o!dal
\ Retinal Hyperreflectivity \ \ \ \ \-1-1-1-1-\ I I I I 1-1--1-1-1-H I I 1-1--1 I Sparse Choroidal Vascular Pattern f-1-- \ I \ I I l-l--1-\-\-1~f-l-H-l-l--1--
-
STUDY NUMBER L612J-6 TEST ARTICLE ROX
ay 8.0
--··
Within normal limits
lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
-Phthisis
Enophthalmia
Kera ti tis
Corneal Edema
Corneal scar
H11 nhema
Iritis/Anterior Uveitis
Anterior Svnechia
Posterior Svnechia Iris Bombe
Prominent Lens Suture Lines
Prominent Lens Nucleus KEY:
w
"" "'
-"" "" w t ,: "' - M ..- m ~:c m m m m z~ m m m m
"" z
X X X X X
L = left R = right U = both Sl = suture line A= anterior P = posterior
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 25
"' ~ ro °' 0 - N M ..- m "' ~ "' m m m m "' "' "' "' "' "' "' "' "' m m m m m m m m m m m m m X X X X X X X X X X X X
-
-
- - -L
L
-
C = capsular I = immature S = sector N = nucleus
~ cr, 0 -"' ~ ~ m m m X X X X
-
Co= cortical B = brunescent
*=previously died or
V = vacuoles sacrificed
M = mature
M ..- m ~ ~ ~ m m m
X X X
- I-
,_ --
- -
·--
-
~
"" 0
STUDY IIUIIBER L6121-6
TEST ARTICLE RDX - -
DOSE mq/kg/day 8 0
SEX Female _, °' "" w :,, t ,: 00 ._. == w z =, 1 odnn
-
STUDY I/UMBER L612!-6
TEST ARTICLE RDX
DOSE mg/kg/day 8.0
SEX Female
Within normal limits Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemos is
[3uphthalmia
-Phthisis
Enophtha lmi a
Kera ti tis
Corneal Edema
Corneal scar
Hvohema
Iritis/Anterior Uveitis
Anterior Svnechia Paster ior Synechi a
Iris Bombe Prominent Lens Suture Lines
Prominent Lens Nucleus ·-·--·- . KEY:
~
~
__, ~
-
~
-
STUDY NUMBER L612!-6
TEST ARTICLE RDX
DOSE mg/kg/day 4o.O
SEX Male
Within normal limits Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemosis lluphthalmia
.Phthisis
Enophthalmia
Kera tit is
Corneal Edema
Corneal scar
Hvohema
lritis/Anterior Uveitis Anterior Svnechia
Posterior Svnechia Iris Bombe
__ ,,,,
-
~
w ~
' '
STUDY 11u1mrn L6121-6 TEST ~RTICLE ROX
- -
DOSE 111q/hJ/di1y 10.0
SEX Male _J rr:: ,n:: tJJ - 1 ;::: cc ...... ::::::: cl z~
l nc>L-.n
-
STUDY NUMBER L6121-6
TEST ARTICLE RDX
DOSE mg/kg/day 4o.o SEX Male
Within normal limits
lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
-Phthi sis
Enophthalmia
Keratitis
Corneal Edema
Corneal scar
H""hema
Jrit1s/Anterior Uveitis
Anterior Svnechia Posterior Svnechia Iris Bombe
Prominent Lens Suture Lines
Prominent Len1_~ucleus KEY:
w
"' ~
-' "'
-
~
co m
; I
STUDY IWl·IOER L6121-6
TEST ARTICLE ROX -
DOSE mq/kq/day 4o.O
SEX Male
1~.-_inn
r:it-.--.--1-
luxated 11'1~'"
Vitreal Strands Vitreal Hemorrhane
Retinal Fo 1 ds
Vascular Attenuation:
--
~"' "' w w :,:: o:! ...... ::: N z~ w ""' z
Retinal
Choroldal
Retinal Hvnerreflectlvitv
Sparse Choroidal Vascular Pattern
Retinal Hemorrhaqe
Retinal Degeneration
Papil ledema
Icterus
Orbital Mass
Nys tagmus
Bled - orbital sinus
-·-----KEY:
L = left R = right U = both S1= suture line A= anterior
---Pr- n,:iste-.... ""'"
f a) "' N N w w
- -
-
INCIDENCE OF OPHTIIALMIC LESIONS
TEST l,EEK 25 -- -- --,-
0 ~ N M "' m w ~ a) "' 0 ~ N M "' m w ~ a) "' 0 M M M M M M M M M M "' "' "' "' "' "' "' "' "' "' m w w w w w "' "' "' "' "' "' "' w "' w "' "' "' "' w co
- - - - - -·- - -
- -
- - - - - -- - I- - "- - - j
I - - C- -- - - - - - --
-- - --
' - - - - - -- - - - --
- - -- -- I
- - - - - - - - - - - _I 1 Bl Bl ll -
- - - - - - - -
C = capsular I = irrn11a ture S = sector N = nucleus Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles Bl= specific eye used not t-1 =_.r!l.a turP recorded
-
STUDY IWMBER L6121-6
TEST ARTICLE ROX 40.0 -
INCIDENCE OF OPHTHALMIC LESIONS
TEST I/EEK 25
DOSE mg/kg/day
SEX Male ~ °' "" w :::::: ro -z z co "" z
~~~~~~ ~1 00! ml 0 1~1N1M1~1m1~ ~ ~ ~ lD lD
-
~
"' 00
STUDY IIUMBER L6121-6
TEST ARTICLE ROX
DOSE mq/kq/day
SEX Male
1 p,;; inn
10.0
~ °' "" w ::::: CC! -,: z~ "" z
INC!OENCE OF OPHTHALMIC LESIONS
TEST HEEK25 -----,-------,-.--r-1···~------.~~--~~~-.~~--~~-.---.-,
st ~1~ I~ I tii[ §[ [§ I ~I ~I :;[ t; I~ I - N M m -1NIMl"lml"'l~1oo " m m m m m I.O t.O lO \0
-
STUDY IIUMBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day !£.:..9. SEX Female
Within normal limits
Lid Laceration
Lid scarring
~ °' « w ,: 00 ..... ;.:::: z~ « z
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 25
wl ~ "'I "'I • 1-1 NI Ml •1 mlw 1~ I' r--. ...... t-- r--.. co co co OJ OJ co OJ OJ ( lO lO lO lO lO \D lO lO lO lO
-
c-o 0
ItlCIDENCE OF OPHTIIALIIIC LESIONS
TEST I/EEK 25 STUDY IIUIIBER L6121-6
TEST ARTICLE ROX
DOSE mq/kg/day 4o.O
SEX Female
--- -,-- -,-- ·-,-,- ,--1 -----,-T-a-,-r- ,--T-
... HX
i~ \ r;;I ~ t;I r:;t ~l ii ~lililffil~lil ~I ii ~I -1 N1M1sr1=1~ I ~I "'lmlo o-, cr, °' en m "' m m o
-
STUDY NUMBER L612!-6
TEST ARTICLE ROX DOSE mg/kg/day 4o.O
SEX Female
Within normal limits
Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemosis
Buphtha lmi a
-Phthisis
-
--"'' ""' w ,: co ....... ::::: z~ ""' z
" g: - M D ~ 0 0 ~ 0 ~ ~ ~
X X X X X
INCIDENCE OF OPHTHALMIC LESIONS
TEST I/EEK 25
~ I ~ ~ ~I ~I ~I 21 ~I;: I~ I ~ ~I ~I ~I ~ '° ~ co ~ 0 0 0 0 0 -~ ~ ~ ~ ~ X X X X X xix lxlx !xi xlxl xix I I xix\ x Ix ]x
u u
I ~:~~~:~::mia I I I I jtt1jj=!-jffl==l=ttl=1J I ljJ Corneal Edema
Corneal scat
H hema Jritis/8nterior l!veitis I I I I I I I I --1--1 I I I I I I l-1-1-- I I I I ! I I An t_eri or Synech i a
I Posterior Synechia I I l---l--\-1--1--1--1-1-l--+-1---'I-I-I-I I 1-1-1--l--l--l-'-Iris Bombe Prominent Lens Suture Lines
Prominent Lens_Nucleus I I I I I I I I I I I I I L I I I I I I I I I I I I - . ~
a
KEY:
L = R = u = Sl= A = p =
left right both suture line anterior posterior
C = capsular I = inuua ture S = sector N = nucleus Co= cart ica l * - previously died or B = brunescent sacrificed V = vacuoles M = mature
-
= 0 N
STUDY NUl·IBER L6121-6
TEST ARTICLE ROX DOSE mg/f,g/day 4o.O
SEX Female
lesinn
r;i f",)r;tc..t_
Luxa ted I Pnc:
__, "' « w ~ cc ...... :::: z~ « z
IMCIDENCE OF OPHTHALMIC LESIONS
TEST I/EEK 25 ------,-...-··--1-1 --,- I -;
-1 NI Ml q1~1~1~1 00 1~1c1-o O O D O O O O O r-< ,...., r-- r-- r-- r-- r-- r-- r-- r-- r-- r-- r-- NI Ml qi ml ~1~1 00 ,~, .............................. r-1 ............ r-- r-- r-- r-- r-- r-- r-- r-- 0 I -1 NI Mlqlm NNNNNN r-- r- r-- r-- r-- r--
~: :~::~ ~::~~~age I tt1-ttttttttttttt t_)j=n-jj=t Retinal Folds
Vascular_litt~nuation: Retinal
C_horoi d_e_l
I Retinal Hyperreflectivity I , l-f--.1---1-f---+- I I 1 1----1---f-l I I I I 1-'-.
I ~::~~:lc~:::~~~:g~ascular Pattern I I I \_ltttH-1 I I I tt-ttHjj I I I j Retinal Oe1eneration
I Pa pi 77 edema I I ,, I 1-1----1----1----l-l---->-+---+---+--t--t--l----l----l--f---1-11->-+--+--·-I c terus
Orbital Mass
Nystagmus ! Bled - orbital sinus Bl IBl Bll
)----------------1-+-+--t---t-f--f--\ ) ) ) f-l-f---1-1-1---+---l-\-l,---+---l
KEY: L = left C = capsular I = immature R = right S = sector N = nucleus U = both , Co= cortical * = pre~iously died or Sl= suture line B = brunescent sacrificed A = anterior V = vacuoles Bl = specific eye used not p • posterior" M = mature recorded - . . . '
-
INCIDENCE OF OPHTIIALl1JC LESIONS STUDY IIUIIBER L6121-6
TEST ARTICLE ROX TEST Ii EEK 25
-----DOSE mq/kg/day .MW!
0, u C
SEX Ferna 1 e __, "'
~ 0,
-
.i:··
0 ~
STUDY IIIJIIBER L6121-6
TEST ARTICLE ROX DOSE mg/kg/day 40.0
SEX Female
1--•,o
,.~ .. ~-~- ..
Lux a ted 1 ....... ,.
Vitreal Strands
Vitreal Hemorrhage Retinal Folds
I Vascular Attenuation: ' i -
..J ~
"" w :c OJ -::::: z co '"' z
Retina 1
Choroidal 1 Retinal Hvnerreflectivitv
Sparse Choroidal Vascular Pattern
Retinal Hemorrhaoe
Retinal Degeneration
Papil l edema
Icterus Orbital Mass
Nys tagmus , Bled - orbital sinus
---~ ---~---- -- - --KEY:
L = 1 eft R = right U = both
~ ~ N N ~ ~
1
Sl= suture line A = anterior P "' r,.ns t_eri or
00 "' 0 N N M ~ ~ ~
-
INCIDENCE OF OPHTHALMIC LESIONS
TEST l,EEK 25
~ N M st ~ ~ ~ OJ "' 0 M M M M M M M M M st ~ ~ ~ ~ ~ ~ ~ ~ ~ ~
-~ -
- - -
,-
,_ - - - •-1 Bl
~ N M st st st st st ~ ~ ~ ~
1-- -
·-
-
-
_,__ -
,_
- ~ -
~ Bl
-
C = capsular I = inuna ture S = sector N = nucleus
~ ~ st st ~ ~
-
Co= cortical B = brunescent *=previously died or sacrificed
~
"' ~
V = vacuoles M = mature Bl= specific eye used not l"Pr-nrde~
.,.
"' u C 0,
V 00 "' 0 ·-
,, "' "' ~
u ~ ~ ~ C .. -
• " • ,,
'
1
1
Bl 1--
ID -
I
-
,,
STUOY 11111-llJEII
TEST ART! CLE
~-- .. ' , .... ' --
Within normal
Lid Laceration
lid scarring
L.6121-fi --·- --·--- --- ---ROX
ay 0.0
1 imi ts
Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
Phthisis
Enophthalmia
l
-
~
0
"' STUDY IIIJl,IBER L6121-6
TEST AllTICLE ROX
DOS[ mq/kq/day --11..:.Q
SEX Male_
lP
-
STUDY IIUIIBER L6121-6
TEST ARTICLE ROX -0.0 ·-- ·-·
.. -DOSE mq/kg/day SEX Male ~ °" "" w :;:: co
....... ::'.': "' ~ 0:, °' 0 z =, N N N N M
"" z
Within normal limits X X X X x Lid Laceration
lid scarring
Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
Phthisis
Enophthalmia
Kera ti tis
Corneal Edema
Corneal scar
Hvnhema
Iritis/Anterior Uveitis
Anterior Svnechia
Posterior Svnechia
Iris Bombe Prominent Lens Suture Lines
Promine~_U~~-N~cleus KEY:
~
0 L = 1 eft ~ R = right
U = both Sl= suture line A= anterior P = pas teri or
IIICIDENCE OF OPHTHALI\IC LESIONS
TEST 1'EEK 51
- N M st ~ "' ~ 0:, °' 0 - N M M M M M M M M M M st st st st X X X X * X X X X X X X
~ -- '--
~ -
~
R
I = immature C = capsular S = sector N = nucleus
·--st ~ "' ~ .,. .,. .,. .,.
X X X X
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
0:, O' 0 .,. .,. ~ '
X X *
-
•·-
~
-
STUDY IIUIIBER L5121-6
TEST ARTICLE ROX
DOSE mq/kq/day ..Q.,.Q
SEX Male
les1nn
_,"' "" w
- --, ---,- --, --
INCIDENCE OF OPHTHALMIC LESIONS
TEST 1,EEK 51 -..----i-r- ____.., .. -r---.- - , - ~ ---··, ·- -,--
; ~ I ~1 N "'I "'I 0 1 -1 NI MI "'I~ I~ ~z" N N N N M M M M M M M ~1 °'I "''I cl -1 ~ I MI"' I ~1 ~1 ~1 cc I rn I 0 M M C',
-
STUDY NUMBER L612!-6
TEST ARTICLE ROX
DOSE mg/kg/day -2..:.Q SEX Male ..J "' ""~ :;: co - "' z C, ""z ~1 0 m "
INCIDENCE OF OPHTIIALMIC LESIONS
TEST I/EEK 51
Ml ~1 ml "'I ~100\m\o[~I~ ~ ~ ~ ~ w ~ ~ w w_~ Ml ~1 ml "'I ~1oo\mlo1~ w ~ w w w w w r-- r-- NI M\~lm r-- r-- r-- r--
~Jithin normal limit.c; X X X X X X X X X X -ir X X X * X -ir X X X X X X X Lid Laceration Lid scarring - ---
Ocul_ar d~s~h~rge ·-- I ~==-,-ConJunct1v1t1s ,__ ~ ~ Chemosis - ' ,-
Buphthalmia H-+-l,-i--l-,-l-f-l-1-1-1-1 , 1-1-•-•Phthisis
I Enophthalmia I I I \ I I I I j \ I I I I I I j-j-j I I I I I I --1 Keratitis Cornea 1 Edema
Corneal scar:_
H hema Iritis/Anterior Uveitis 1-1 I I I 1'-'--H I I 1-\-\-1-1 I I I I Anter:jor Syn_echia
Posterior Synechia
I ~~~;~:~\ens Suture Lines I I I I I I ij-jj=ttttltLJ_j_j I l=t:=: Prom ine11 t LenL._~uc l eus
~
0
"'
KEY:
L = left R = right U = both 51= suture line A = anterior P = posterior
C = capsular S = sector Co= cortical B = brunescent V = vacuoles M = mature
I = immature N = nucleus *=previously died or
sacrificed
ru u C ru u u C -6!)
1
1
1
f-2-·-1 1 '
f--' 1 .I -·1
8
-
~ ~
0
STUDY IWMBER L6121-6
TEST ARTICLE ROX
DOS[
SEX
mq/k9/d,1y
Male
1 o
-
STUDY IIUl·IBER L6121-6
TEST ARTICLE ROX -DOSE mq/kg/day 0.0
·--
SEX Female _, °' -,: w ::r.: c:c -~ ~ ~ 00 "' 0 z co ~ ~ ~ 00 -,: z ~/ithin normal limits X X " X ;~ . -lid Laceration
Lid scarring Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
Phthisis
Enophthalmia
Kera ti tis
Corneal Edema
Corneal scar
H"nhema
Iritis/Anterior Uveitis Anterior Svnechia Posterior Svnechia Iris Bombe Prominent Lens Suture Lines Prom i ne_n_t Len~_N~c 1 eus
KEY: _.,. L = left
R = right U = both Sl= suture line A = anterior P = posterior
JtlCIOENCE OF OPHTIIALl1IC LESIONS
TEST HEEK 51
- N M .,. = ~ ,_ 00 "' 0 - N M 00 00 00 co 00 00 00 co 00 "' "' "' 0, * X X X X X X X X X X - - -
u L - -
~-~
-
C = capsular I= immature S = sector N = nucleus
.,. = ~ "' "' "' X X X
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
C ~ 00 " C "' "' "' -
X
L u
L ~ j -
-
STUDY IIUIIBER L6121-6
TEST ARTICLE ROX
DOSE mq/kg/da_y ..Q.:.Q SEX Female
l i:,.c: inn
""'"""'""t
---~--
~"'
INCIDENCE OF OPHTIIALMIC LESIONS
TEST I/EEK 51 -,--r-r- 1 --,--~
~ i I co\ ~I oo\ ml O 1-1 NI"'\.,-\ ~I col ~I ool "'I O 1-1 NIM \.,- I~ lco I~ I 00 I c I ~ ~ z r-- r-- r-- r--. co co ro co ro co co co ro co m m m m m m m a, m m ... L
R
M --t-t-1 I t-H-1 I I 1-1-f-/-i-H--\ I I I 4
I Luxated Lens \ \ \ I I \-1-\-f- I ! I I I I I I l-1-l-l-/-1--\-l-_Vilrea 1 Strands
Vi_trea_l Hemorrhage
Retinal Fo_l_cl_,_
; Vascular Attenuation: Retinal I ! I I l-f--+-I-H-f--l I I I I I 1-1-1 I ! I I \_I i Choroi da_l_ 1 Retinal Hyperreflectivity -'-'--\ I I I I 1-1--
Searse Choro1dal Vascular Pattern -e--l-1 I I I I I I I I I 1 I I 1---l-
Retina 1 Hemorrh_?_ge
Retinal De~enerat1on
Papilledema
Icterus
Orbital Mass
Nystagmus
Bled - orbital sinus
------ KEY: I I I I I I '
L = left R = right U = both Sl= suture line A = anterior P =: pqste_riqr
-
STUDY IWl·IBER L612!-6
TEST ARTICLE ROX -DOSE mq/kg/day 0.0
.~ - --
SEX Female .J ~ ...-c I.JJ -~-- :: rn _, ~, M tj ,n .... : ~ 0 c• 0 0 0 :;--:;:;:, - - - - --Posterior Svnechia
1--
Iris Bombe
Prominent Lens Suture Lines
Prominent Len1_N_uc1eus KEY:
~ L = left -w R = right
U = both S1 = suture line A = anterior P ,. posterior
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 51
-
-STUDY IIUIIBER L6121-6
TEST ARTICLE ROX ---/d;iy. Q,0
~·-" , '·""". C
loo.Joo
f':ii-e.----'-
Luxated Lens Vitreal Strands
Vitreal Hemorrhane
Retinal Folds
Vascular Attenuation:
___, ~ r( lJJ :,_ Cf:! ...... :.:..: z=:i
-
STUDY NUMBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day
SEX Male
0.3 --' ~
-
~
00
STUDY IIUIIBER L6121-6
TEST ARTICLE ROX
OOSE mq/kq/day _()__]_
SEX Male
1es1nn
~~
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 51 ------.--·, ----·r·--,--,-,-,--- ·i----i 1
~ ~ I~ IN IM Is,- Im I ~ ~1 "'I ml cl ~1 NI MI"' Im I'° I ~1 °"I
-
STUDY IWI-IBER L6!21-6
TEST ARTICLE ROX -DOSE mg/kg/day O.O
__, ~ SEX Female
-
"
STUDY tiUMBER L6121-6
TEST ARTICLE ROX ay 0.0
-' °'
-
STUDY NUI-IBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day JW. SEX Male
Within nornrnl limit_~
Lid Laceration
Lid scarring
Ocular discharge
J"' d'. w :;: 00
-
~
N 0
STUDY NUHBER L6121-6
TEST ARTICLE ROX
DOSE mq/kg/day .Q.,l
SEX Male
lP
-
J"' 1-
INCIDENCE OF OPHTHALMIC LESIONS
TEST IIEEK 51 STUDY Nlll-lBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day .Q..1.
SEX Male
2S$1-1N1M1~1 ~3 ~ !-S~ -NM~[§_~~ 001 ~1 °1-1N1 Ml 71 ~ ~~ ~ ~ ~ ~ . ~ ~ ~ ~;::;;::;;::;;::; ;:/;::;;::; N;::;;::; ~ ~ ~ ~ ~ ~ \lithin normal limits Xx Xx xi xlx:1-2'._J Xl Ix I X[tj_:_L_:_j:_j_?'_~!_I XI* IX Lid Laceration -~-Lid scarring --- -- _,_,_ Ocular discharge ___ ·1 r-1-l--l-l-l-l-.;-,-•-•-Conjunctivitis ,_ 1-- -\-1-1-1-1-1 1 I I I Chemosis - -- _,_ -~·
Buphthalmia ---'- ul-1-l-t--•Phthisis _,_,_,_ _,_ - ,-1--t-•-
1~-•-
-•-•-•·-•-•-•-!--!-! I I-
Enophthalmia ·-· - - 1._
Keratitis 1- - 1--- - _j7 Corneal Edema - - - - - - -]-J
'--------------t-t-l-l-l-l-l-l-1--1.-H--1.-
-
~
N N
STUDY NUMBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day .lll SEX Male
, ,...,. ~ ""
---
I ~"' d'. w ;;§@1~1NIMl""l"'I z:=iOOCOO o::t:zNNNNN
I NC !DENCE OF OPHTHALMIC LES IONS
TEST HEEK 51
~ ~1~1~1~1~1z121~1~1 ~ ~I ;:1/ ~! ~1 ~I~! ~( ~! "' N N \ cataract I l-l-i-H-1--1 I I I I i-\-1--1----1---__,_-1_,_
luxated Len,
I ~::~::~ :::~~~age 1-t=1-t=1~=1=j-r I I ! l=l=w=l=1 I I I-I-I Retinal_ Fol~_,_
i Vascular _ _btt~nuat_ion; Rg_tina1 I I • rhor_o1dal
' · Retinal Hyperreflect1vitv Srarse Choro1dal Vascular Pattern
Retinal Hemorrhage
Retinal Oe_generation -1--1-1--!-t--l--t--;---,
I Papilledema I I ~1-1 I 1-1--1-1-H f I I l-l-l-1--1-1-1 , 1-. Icterus H-1- -1--!-+---l I I I-H-1--1--1--1--I-H--!-1-1-
0rbital Mass
Nys tagmus
I Bled - orbital sinus I I I I I 1 · I I -i--t-l-+-\1-+-l-+-t-l-l-t--l--! -•-in: B I I I I I --1-1 1-1---1 I I I-I-H-1-1---f-J
w u ~) ';
~ ·-u C -=:!J
-I I I
I I
10
\---
-- ---·-- ------ ... KEY:
--,,:,:------'-.L....J..--l_L...L-1._I_.L..J......J._L._..l_.L- --~--
L = left C = capsular R = right S = sector U = both Co= cortical Sl= suture line B = brunescent A = anterior V = vacuoles P = _posterior /.1 = mature
I = immature N = nucleus
*=previously died or sacrificed
Bl= specific eye used not recorded
-
STUDY NUMBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day .£.:2 SEX Female_
Within Norm~l I imit~ lid Laceration
--"" -0: w :c "' ~,: z C, -0: z
"' ~ °' 0
N N M N N N
* xix X X
INCIDENCE OF OPHTHALMIC LESIONS
TEST WEEK 51
~ N M rj" m "' ~ t ~ 0 M M M M M M M M tj N N N N N N N N N -
X X X X X X X * X X ----
~ N M rj" m "' ~ cc ~- 0 rj" rj" rj" rj" rj" rj" rj" rj" tj m N N N N N N N N N N
X X * X X X X X X X
I Lid scarring \ \ \ \ \ \ \ \ -1-1 . \-\- I \ I I l-l-1-1----1-1 I Ocular discharge
\ ~~:~~:~~ivitis 111 l~j I IJj-1-1 I tttttl=td=tljj Buphthalm,a
-Phthisis
I ~:~::~:~:mia I I I I I I I j_\j_\_\ I I I-1-lj=IJ_\j I 1-1 1 Corneal Edema
Corneal sea,:
I Hyphema lritis/Anterior Uveitis I I I \---I I I 1-\--\ I I f----1--1 I I I I I I I ! I _ Anterior Synechia Posterior Synechia I f--1 I I I I I I I 1--Iris Bombe
I :~::~:~~ ~:~: ~~~~::s Lines I I I I I I I Hj I I I ttt I I I I I I I I I -~
N ~
KEY:
L = R = u = Sl= A = p a
left right both suture line anterior posterior
C = capsular I = immature S = sector N = nucleus Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
-
~
N ~
I
STUDY NUMBER L6121-6
TEST ARTICLE ROX
IJU)t ll!!j/ t::lj/ u,1,y - • -
SEX Female
1--'on
C, • .
Luxated 1 ,..,.,,.
Vitreal Strands
Vitreal Hemorrhaae
Retinal Fo 1 ds
Vascular Attenuation:
~~ .-.i:: t,J ;:~ ~ ,_. ::::::: z cc,
-
STUDY IIUMBER L6121-6
TEST ARTICLE ROX -OOSE mg/kg/day 0.3
-- --,-.--
SEX Female ..J ~ « w :7- i:c ~ N M ST ~>= m m m m z => N N « z N N
Within normal limits X X X X
Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemosis Cuphthalmia
Phthisis
Enophthalmia
Kera tit is
Corneal Edema
Corneal scar
H1mhema
Iritis/Anterior Uveitis
Anterior Svnechia Posterior Synechia
Iris Bombe
Prominent Lens Suture Lines
Prominent Lens Nucleus KEY.
~ L = left N ~ R = right
U = both 51= suture line A = anterior P = posterior
INCIDENCE OF OPHTHALMIC LESIONS
TEST l!EEK 51
I
m '° ,-.. ro "' C ~ N M ST m m m m m m '° '° '° '° '° '° N N N,N N N N N N N N I I
' X X * " X X * X X
R L
- '---
- --
-
- - -
-
'° ,-.. ~ ~ '° '° N N
X X X X
- -
-
~ - --
-
- - -
-
-
C = capsular I = immature S = sector N = nucleus
0 ~ N ,-.. ,-.. ,-.. N N N
X X
R
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
M ST m ,-.. ,-.. ,-.. N N N
X X .,
-
-
--
-
.,-N
"'
i
STUDY 11u1mrn L6121-6 TEST ARTICLE ROX DOSE mg/kg/day 0.3
SEX Female
1,., .. ~.,n
,..~ .. ~-~- ..
Luxa ted 1 """
Vitreal Strands Vitreal Hemorrhage Retinal Folds
Vascular Attenuation:
---"'' '"' w :,: a, - ::: z co '"' z
Retinal
Choro1dal
Retinal Hvoerreflectivitv
Sparse Choro1dal Vascular Pattern
Retinal Hemorrhaqe
Retinal Degeneration
Papilledema
lcterus Orbital Mass
Nystagmus Bled - orbital sinus
-------· KEY:
L = left R = right U = both
--- ··- -
- N m m N N
Bl
S1= suture line A= anterior
-P "·"aster.inr
M m N
ST m m m N N
- -
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 51
"' ~ 00 "' 0 - N M ST m m m m m "' "' "' "' "' "' N N N N N N N N N N -
- - - ,__
"' ~ 00 "' 0 - N "' "' "' "' ~ ~ ~ N N N N N N N - ,__
- ,__ -
-
-- -- ,__ -
- -- - - - ~ -
- -- ~ - -
- - - - -Bl B Bl Bl B ,__ Bl - ,__ - - ,__ - - - - ,_ -
C =·capsular I = irrnna ture S = sector N = nucleus Co= cortical * = previous1y died or B = brunescent sacrificed V = vacuoles Bl= specific eye used not M = mature recorded
M ""' ; ~ ~ N N
-
=I j
' ,__ -l - ~
,__ - =I -- - ,__
-
STUDY fllJl,\BER L6121-6
TEST ARTlCLE ROX - -
DOSE mg/kg/day o. 3 . ' - . ----
Female ~ °" SEX
-
~ ~
'" STUDY IWl·\BER L6121-6 TEST ARTICLE ROX DOSE mg/kg/day 0.3
SEX Female
loo l no
r::11t----t
Luxated 1 ---,c:
Vi trea 1 Strands
Vitreal Hemorrhaae
Retinal Folds Vascular Attenuation:
I •
~"' ""w :,: ro - :c z =, «z
Retinal Choroidal
Retinal Hvoerreflectivitv Sparse Choroidal Vascular Pattern Retinal Hemorrhaoe Retinal Degeneration
Papilledema Icterus
Orbital Mass Nystagmus
: Bled - orbital sinus
- -.-----. ~ - ----KEY:
L = left R = right U = both
"' f ~ N
-
S1= suture line A= anterior P_ = p.ost.erio.r .
ro "' G ~ ~ ro N N N
INCIDENCE OF OPHTHALMIC LESIONS
TEST WEEK 51
~ N M "' m "' ~ I i 0 ro ro ro ro ro 00 00 O'-N N N N N N N N I
•-
Bl
~ N M "' "' "' "' "' N N N N
-
--
-
STUDY IIUI\BER L6121-6
TEST ARTICLE ROX -DOSE mq/kg/day 1. 5
---,------ -
SEX Male -"'' « w :c: "' - N M "' = ~ :c: 0 0 0 0 0 z~ M M M M M d;Z
Within normal limits * X X X * Lid Laceration -Lid scarring
Ocular discharge -
Conjunctivitis
Chemosis Ouphthalmia
Phthisis
Enoph tha l mi a
Kera titi s
Corneal Edema
Corneal scar H" .... hema
Iritis/Anterior Uveitis Anterior Svnechia Posterior Svnechia
Iris Bombe Prominent Lens Suture Lines
Prominen_Llen~_~Jcleus KEY:
L = left "'" R = right w '"'
U = both 51= suture line A = anterior P = posterior
INCIDENCE OF OPHTIIALMIC LESIONS
TEST HEEK 51
~ ~ "' °' 0 - N M "' ~ ~ ~ 00 "' 0 0 0 C - - - - - - - - - -M M M M M M M M M M M M M M X * X X X X X X X X X X X X
·-1--1-- - - 1-- - -
-
-
C = capsular I = immature S = sector N = nucleus
0 - N N N N M M M X X X
-
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
M "' ~ N N N M M M
X X X
1--
-
.r:-,, 0
STUDY 11u1mrn L6121-6 TEST ARTICLE ROX
--·- --·· -~ DOSE mq/kg/day 1.5
SEX Male ~"' "" w :::: cc ~ I ;; ,_,:::::: z cc,
1 odnn -0: z
,._ .. ____ ..
Lux a ted 1 ,:,.,c;
Vitreal Strands Vitreal Hernorrhan
-
STUDY NUMBER L6121-6
TEST ARTICLE RDX
DOSE mg/kg/day l,:i SEX Male
INCIDENCE OF OPIITIIAU11 C LES IONS
TEST HEEK 51 ----.~-.----.-r,---- -
~*I w I ~1 00 1 m IO 1-1N IM I "'I ml wl ~1 00 1 m I c 1-1 ~ Ml s,·1 ml w I~ I 00 1° I c .....,~ N N C"J N M M M M M MM M M M tj- rj-
-
~
~
N
STUDY IIUl·IBER L6121-6
TEST ARTICLE RDX
DOSE mq/kg/day Ll SEX Male
l oc, -T nn
J"' "" w :::: cc ,_.;;::: z C, .::CZ
INCIDENCE OF OPHTHALMIC LESIONS
TEST !- =I Bled - orbital sinus 31 Rl Bl B Bl .
I I I I I I I 1-1- I I I 1-1 I I 1--1-1--------·--··
KEY:
L = left C = capsular I = immature R = right S = sector N = nucleus U = both Co= cortical *: previously died or Sl= suture line 8 = brunescent sacrificed A = anterior V = vacuoles Bl= specific eye used not P ."'- n.os teri or . - M = mature recorded ·- -- "
-
STUDY HUMBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day Ll SEX Male ~"' d'. w
:c"' - 0c z =, d'. z ~ ~ ~ "'I ~ ~ ~1 M M
INCIDENCE OF OPHTHALMIC LESIONS
TEST I/EEK 51
~I ~I ~I ~l ~\~l~l~l~\ ~ ~ ~ 1-
"'l°'lcl~INIM lO lO r-. r-. r-- r-. M M M r,; M M
"'I~ ~ ~ MM W. h' l l' 't " X X X ,X I ,t ,n norma 1m1 s -H !._J~l!._l~l~~~(_:\~Lll_l~l!._~j_~_J~~~l~ Lid Laceration 1 1-t--
Lid scarring L__ --•- ,-- ,--,--,--1--+--+--•--Ocul_ar discharge ___ L f---·jjj I I I ConJunct1v1t1s _ _ f- _ _ ,-l---1-1--Chemosis
Buphtha lmi a j I I R j 1-1-----1-l----1----1 I I I l--l--l-1--\-1-1--1 ! l-+-----1-, .Phth is is
i Enophthalmia I 11 i 1-ljjjj-1 I I ttt-1=1=\jjjjj_;--l Kerat1t1s 1 Cornea 1 Edema
Corneal scar I \ 1---1-J j I --l-\--1-l-+-+--l--+---1--1-1--I--J---+--+--+--I~. ---< ):ly_R._hema
lritis/Anterior_~_y~itis
Anterior Synechia R
Po~terior Synechia "' --- --~jj I I ~l Iris Bombe +-
'" u C
"' u u C
61
1
1
1
Prominent Lens Suture Lines --H·--1--1--1 1 Promine!lL~en~.N~cleus . I I J ,,,. w w
KEY:
L = left R = right U = both 51= suture line A = anterior P = pas teri or
C = capsular S = sector Co= cortical B = brunescent V = vacuoles t-1 = mature
I = immature N = nucleus *=previously died or
sacrificed
-
~ ~
~
STUDY NUMBER L6!21-6
TEST ARTICLE ROX
DOSE mg/kg/day ..1.,.5.
SEX Male
lesion
~ °' "" w ,: co -,c ~ z =, = "" z
M
N M tj" = m m m m M M M M
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 51
'° ~ co m 0 ~ N M .,,. = m m m m '° '° '° co co co M M M M M M M M M M J '° ~ co m 0 ~ N M tj" co co co co ~ ~ ~ ~ ~ M M M M M M M M M I f-\-L-H-1-1-1-1-1 I f-f-f-f-l-l-l-----1-1-1--1-•--~-----------------1---1---1----1-J I I I l I I I I I I 1-1-1-1-1-1-t-t-'--
I ~~:~::~ ;:~:nds ~I I I I I 1~=1=1=~\=!t=t=t=t=t=l=l=l--11 I I I Yitreal HemorrhaoP Retinal Folds_
Vascular Attenuation: Retina}
Choroidal
I Retinal Hyperreflectivity I \ \ I \ \ \ \ \ -1 I I I I I I -1-l-l Sparse Choroidal Vascular Pattern
Retinal Hemorrhage Retinal Degeneration R
Papilledema
Icterus Orbital Mass
'" u C
'" u --u C -
1
1
1 I
f.-..J •
. Nys tagmus , ,
i Bled - orbital sinus rt I I I I I111-~r=-~I IB1I I I I I1~-tl ~-·-·- -·-- --- ..
KEY:
L = left C = capsular I = immature R = right S = sector N = nucleus U = both Co= cortical *=previously died or S1= suture line B = brunescent sacrificed A = anterior V = vacuoles Bl= specific eye used not o = o.0c:teri.nr_ M = J.Da ture recorded
-
STUDY llUMBER L6121-6
TEST ARTICLE RDX --- ·-- - -OOSE mq/kg/day 1.S
SEX Female -' ~ < w :::: en ~ ~ 00 m 0 ...... ::-.:: ~ ~ ~ ~ ro z~ M M M M M < z
Within normal 1 imits X X X X - -lid Laceration Lid scarring
Ocular discharge L
Conjunctivitis
Chemosis
Buphthalmia
Phthisis Enophthalmia
Keratitis
Corneal Edema
Corneal scar
H" .... hema
Iritis/Anterior Uveitis Anterior Svnechia Posterior Stnechia
Iris Bombe
Prominent Lens Suture Lines
Prominent Lens Nucleus KEY:
~ L = left w V, R = right
U = both Sl = suture 1 ine A= anterior P = pas teri or
INCIDENCE OF OPHTHALMIC LESIONS
TEST l!EEK 51
~ N M tj· m ~ ~ ro m C ~ N M 00 ro 00 00 00 00 00 00 00 m m m m M M M M M M M M M M M M M
X X X * X X X X * X X '---
f--
u R - f-- -
- -
-- -
C = capsular I = immature S = sector N = nucleus
tj m ~ m m m M M M
X X X
-
-
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
~ 00 m 1 m m m M M M X X X X
---
-- j
-'
- f---
-
~
w
"' STUDY IIUIIBER L612!-6
TEST ARTICLE ROX -
DOSE mq/kq/day 1.5
SEX Female --' °' « w ~ cc
~ ~-1--J--
z =, CZ
- . -· Lux a ted Lens
Vitreal Strands Vitreal Hemorrhage Retinal Folds Vascular Attenuation: Retinal -
Choroidal Retinal Hvoerreflectivitv Sparse Choroidal Vascular Pattern
Retinal Hernorrhaae Retinal Degeneration
Papilledema lcterus
Orbital Mass Nystagmus
Bled orbital sinus 1
KEY:
L = left R = right U = both Sl= suture line A = anterior
~-P =.,r10
-
STUDY IIUMBER L6121-6
TEST ARTICLE ROX -DOSE mq/kg/day 1.S
--~~~
SEX Female __J "' «w ::-..: o:! - N M " ~ ,.....z 0 0 C 0 0 z~ " " " " " « z
Within normal limits X X
Lid Laceration
lid scarring
Ocular discharge L R R
Conjunct i vi tis
Chemosis Buphthalmia
Phthisis
Enophthalmia
Keratitis
Corneal Edema
Corneal scar
Hvnhema
Iritis!Anterior Uveitis
Anterior Svnechia Posterior Svnechia Iris Bombe Prominent Lens Suture Lines
Promi nen1-.1_en~_~uc l eus KEY:
.,,. L = left w ~ R = right
U = both Sl= suture line A= anterior P" posterior
INCIDENCE OF OPHTIIALMIC LESIONS
TEST HEEK 51
"' "- a) "' 0 -N M " ~ "' "- a) 0 0 0 0 --- - - - - - -" .,. " " " " " " " " " " " X X * * X X * * X X * - - -
L L - -
-
-
C = capsular I = immature S = sector N = nucleus
"' C - N - N N N " " "' " X X X
-
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
M " ~ N N N " " " X X X
r
-
-
~
w co
I
STUDY IIUl·IBER L6121-6
TEST ARTICLE ROX ----- ·-·- - -
/kg/day 1.5
.emale _, 0-C
- - " " lnc:i~~ CZ C,h .
Luxated Lens Vitreal Strands Vitreal Hemorrhane
Retinal Folds Vascular Attenuation: Retinal
Choroidal
Retinal Hyperreflectivitv
Sparse Choroidal Vascular Pattern Retinal Hemorrhaoe Retinal Degeneration Papilledema Icterus
Orbital Mass Nystagmus
Bled - orbital sinus
KEY:
L = left R = right U = both S1= suture line A= anterior
· P -::- -,..·-s te~ ~ ,.., ...
M 0
"
-·
" m D D " "
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 51
~ ~ co "' D -D D C, D - -" " " " " " -
- - -
-
C = capsular S = sector Co= cortical
-Bl -
8 = brunescent V = vacuoles M ;:_ m_.:1 ture
-
N M " - - -" " " ---
m ~ ~ co "' C - N M - - - - N N N N " rj " " " " " " " - - _,
-- -
- ,_ -f--
R ~,. - -
u -- -
-- - - - -,_
- - --
- - - - - ,_ - - -·
I = im111a ture N = nucleus
*=previously died or sacrificed
Bl= specific eye used not recorded ' .
" m N N " rj
I
-
'
,_
-j
- f--
-
STUDY IIUHOER L6121-6
TEST ARTICLE ROX
OOSE mg/kg/day .L§. SEX Female
INC!OENCE OF OPIITIIALMIC LESIONS
TEST HEEK 51
-"" "' w ,: 00 ,_..z z C, "' z
~ ~ t1 ~1 ~1 ;:;;I ~'1 ;:::I ;,;
-
~
~
0
STUDY NUMBER L6121-6 TEST ARTICLE ROX 005[ mg/kg/day !c.:i SEX Female
1 ac, ~ nn
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 51 -~r· ----.-.--,--,---,-~-,---,-,--,--,--,--~-,---,-,--,---,---,---,-,-,
~ °' ~ $ I ~ I ~ I 00 Io; IO [ ;;j NI Ml "'[ ~ I ~ I ~ I 00 I o; IO [ ~ ~~ ~ ~ ~ ~ ~' tj-1 ~ ~ !;? ~ !;;? ~ ~ ~:; :; NI Ml "'I ~1 "'l~l"' I"' IC tj"tj",::j"
-
STUDY IIUl·IBER L6121-6
TEST ARTICLE ROX 8.0 --- -. ···-DOSE mq/kg/day
SEX Male ..J "' '"'w "00 ~ N M s, m - :c m m m m m z~ s, s, .,,. .,,. .,,. '"'z
Within normal limits X X X X
Lid Laceration Lid scarring
Ocular discharge
Conjunctivitis
Chemosis
Buphthalm1a
Phthisis
Enophthalmia
Keratitis
Corneal Edema
Corneal scar
Hvnhema
Iritis/Anterior Uveitis Anterior Svnechia Posterior Svnechia Iris Bombe Prominent Lens Suture Lines
Prominent Lens Nucleus ·------KEY:
~ L = left ~ R = right
U = both Sl= suture line A = anterior P = posterior
IIICIDENCE OF OPHTIIALMIC LESIONS
TEST HEEK 51
"' ~ 00 "' 0 ~ N M s, m "' ~ 00 m m m m "' "' "' "' "' "' "' "' "' .,,. s, .,,. .,,. .,,. .,,. .,,. .,,. .,,. .,,. s, ST ST
X X X X X X * X X X X X X - f-- - -
-
f-- -
,_
-
f-- ..
-f--
·-
C = capsular I = immature S = sector N = nucleus
"' C ~ "' ~ ~ .,,. ST ST
X X X
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
N M .,,. l ~ ~ ~ ST ST ST X * X X
~ - ~
-
~ p N
STUDY IIUIIBER · L6121-6
TEST ARTICLE ROX
DOSE mq/kg/day b.Q. SEX Male
,~sinn
--' ~
lrlCIDENCE OF OPHTHALMIC LESIONS
TEST !!EEK 51 . ·-,--r .-.--r-.- ---,-~--,-,-,--,-·
~ :5 LO LO LO LO LO LO LO LO LO lD lD lD lD lD
-
STUDY NUMBER L6121-6
TEST ARTICLE ROX --- ---· --
OOSE mg/kg/day 8.0 SEX Male _, "'
-
~
-~ ~
STUDY IIUll8ER L612!--6
TEST ARTICLE ROX ------DOSE rnq/kq/day .Q.,Q
SEX Male
lcinn
-' "'
-
STUDY NUl•mER L612!-6
TEST ARTICLE ROX
DOSE mq/kg/day ~ SEX Male .J °'
-
"-~
O'
STUDY NUl1BER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day llJi. SEX Male
,~~~~~
~~ d'. w
;':; "' I z C, d'. z §I ~ ~1 ~1
INCIDENCE OF OPHTHALMIC LESIONS
TEST WEEK 51
~l~l§\5ll~l~l~\81 ~ ~ ~I ~[~]~\~!~\ 511 ~I Ml"I~ N N N ~ ~ ~ M
I Cataract L I l--l----1----H----1--1--1----1 I I I /----R
----1---- ----l----+---r-t--l-1--1--
Luxa ted Lens \ 11 11 I \ I \ \-t----1----\ I I H----1--- -Vi trea 1 Strands ri---t--\----\-j-----j-j----\----1-1-1-----J----V i t real Hemorrhage !--l---J-j----J--J----J----J-----1---- ---- ----f-----l--l-l-1-/----1-/----1----1---+--l----,----,--j
I I I 1-1----/--j--j---,----,,--1-1
Retinal Folds
Vascular Attenuation: R~tinal l;_horo1 de_! ----' I
Retinal H erreflectivit I , /----H-!--1--1----f--l I I f--1----Sparse Choroidal Vascular Pattern I I I I 1---1-1-1- ----1-+--+---H----I-Retinal Hemorrhage
\ Retinal Degeneration I I I I \-\-\-1-\ j \ I /----f----H-i----i I I I I I ! Papilledema
I c terus 1---1--1 J-----i-l-----l----l-l-l-1-----'--l---l--+-l-+--+--+---t--+---t---1 Orbital Mass
Nys tagmus
j Bled - orbital sinus H--IBl I I I I ~-H I I I + I I I /-~1 j j I I __,_,___ I I I I I I /----f--1-t-t I I I /-'-- -l--+-1-1-1---
'" u C
'" u ·-u C -
1
10
.1
I ---.\
I ., I '
I I
·---·-- ----- '-'---'---'---'----'--'---'---'--'--'-'----'--'--k--'-+--~-L.__.L~-+---~1-----KEY:
L = left R = right U = both 51= suture line A = anterior
_p =_pas. teri or
C = capsular S = sector Co= cortical 8 = brunescent V = vacuoles M = mature
I = immature N = nucleus
*=previously died or sacrificed
Bl= specific eye used not recorded
-
STUDY IIUMBER L6!21-6
TEST ARTICLE ROX
DOSE mq/kg/day 8.0 ---- - -
SEX Female ~ °' -0: w Zoo "'
-
.
"
STUDY IWI-IBER L6121-6 TEST ~RTICLE ROX DOSE mq/kg/day §_,.Q SEX Female
lac-I--
INCIDENCE OF OPHTl~LMIC LESIONS
TEST lffEK 51 - , - ,·"- .----r--T--r-~~--.--.-,-,-----,-.,. ---.---,----r --, -- 1 ---,--· --,--·
--l
-
STUDY NUMBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day !:.Q. SEX Female
Within normal limits
lid Laceration
lid scarring
--""
-
~
~
0
STUDY IIUl·IBER L612!-6
TEST ARTICLE ROX
DOSE mg/kg/day .JL..Q
SEX Female
7 oc,~rw
_, °'
-
STUDY IIUl·IBER L6121-6
TEST ARTICLE RDX ---DOSE mq/kg/day 8.0
SEX Female
Within normal limits Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
-Phthisis
Enophthalmia
Keratitis
1
1 Corneal Edema
Corneal scar
H··-hema
Iritis'Anterior Uveitis
Anterior Svnechia Posterior S11nechia
Iris Bombe
Prominent Lens Suture Lines
Prominent Lens Nucleus . ----- -KEY:
~
~
~"'
-
C
" J
STUDY IIUI-IBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day S.O
SEX Female
, ~~ ~
_( •- - . - ,
Luxated 1 e--
Vitreal Strands
Vitreal Hemorrha~~
I Retinal Folds ' 1 Vascular Attenuation: I . '
--' "'
-
STUDY NUIJBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day 4o.O
SEX Male ~ °' "'w l 1 ,: "' ~ r r -:::: z =,
"'z
Within normal limits * ,,
* Lid Laceration
lid scarring
Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
-Phthisis l,
Enophthalmia Kera ti tis
Cornea 1 Edema
Corneal scar
H•mhema
Iritis/Anterior Uveitis
Anterior Svnechia L
Posterior S_ynechia Iris Bombe
Prominent Lens Suture Lines Prominent Lens Nucleus ··-~-
KEY: ~
~ L = left w R = right
U = both S1 = suture line A= anterior P = posterior
INCIDENCE OF OPHTHALMIC LESIONS
TEST \!EEK 51
5 ~ 0) m 0 ~ N M " ~ '° ~ 0) 0 0 0 ~ ~ ~ ~ ~ ~ ~ ~ ~ '° '° '° '° '° '° '° '° '° '° '° '° * X * X X * * X * X X X
-~ -
L
C = carsular I = im111a ture S = sector N = nucleus
m C ~ ~ N N
'° '° '°
X X *
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
N M " ~ N N N ~ '° '° '° * *
R
R
-
e n ~
I '
S TUOY IIUI IC ER L6 l 21-6
TEST ARTICLE ROX --- -40.0 -DOSE mg/kg/day
SEX Male _, "' "" w ;; 1 :;:: o:J ~~
-
STUDY NUMBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day 4o.O
SEX Male
Within normal limits
Lid Laceration
Lid scarring
Ocular discharge
Conjunct i vi tis
Chemosis
Buphthalmia
-Phthisis
Enoph tha l mi a
Keratitis
Corneal Edema
Corneal scar
Hvohema
Iritis/Anterior Uveitis
Anterior Svnechia Posterior Svnechia Iris Bombe
Prominent Lens Suture Lines
Prominent Len~ . .N~cleus KEY:
~
V; V;
.., "'
-
C
n ~
STUDY IIUl·IBER L6121-6
TEST ARTICLE RDX
DOSE
SEX
111q/k9/d,1y j.2..:..Q
Male
1 r>sj nn
_J °' I ~I .,,.,. w
~ ~I ;;~ cc Z§
-
STUDY NUMBER L6121-6
TEST ARTICLE ROX
DOSE mg/kg/day 40.0
SEX Male ..J °' "" w ~ [ t ;;' :c co - :c z C, " ""z
Within norma 1 limits X * X Lid Laceration
Lid scarring u
Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
-Phthisis LJ Enophtha lmi a
Keratitis
Cornea 1 Edema
Corneal scar
Hvnhema
Tritis/Anterior Uveitis
Anterior Svnechia Posterior Synechia Iris Bombe
Prominent Lens Suture Lines
Prominent lens Nucleus ·-----·-· KEY:
~ L = left V, R = right ~
U = both S1= suture line A = anterior P = posterior
t
X
INCIDENCE OF DPHTHALMI C LES IONS
TEST I/EEK 51
~ ~ co "' M 0 ~ N st ~ ~ ~ ~ '° '° '° '° '° '° '° '° '° '° '° '° '° '° '° ,_
X * X * X X * * X
'° ~ '° '° '° '°
* X - - - - -
- - -· - - - -
- - - - - - - - -
1- - -L
- ,_ - - - - ,- - -- -- - -
-,_ - - - -1- - - -
L -·
co "' 0 ~ N M st ~ '° '° ~ ~ ~ ~ ~ ~ '° '° '° '° '° '° '° '°
* * X X X X * - - 1-- - - - - -- - - - - -- - - - - - - --- - - - - ·- - -
- -
j= - - - -- -
- -
-
1-L
f-- -
-
-L - - - - - ---
- - - - -- - f-- - - - - - - - -
..
C = capsular I = immature S = sector N = nucleus Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
ru u C ~
" ·-u C -
34
1
4
1
4
2
-·--
-
~
n ,,
STUDY IIUMBER L6!21-6
TEST ARTICLE ROX
DOSE mg/kg/day
SEX Male
1 os i ""
40.0 -
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 51
_, "' ~~1~1N1M1cy1~l"'l~l°'I §I IBI ~1N1M1cy1~1"'1~1ro1m ;'.:; """ Ln Ln Ln LO LO LC> ln Ln lO I.O I.O lO lO lO I.O lO lO :z:: :=j lO I.O
-
STUDY HUMBER L6121-6
TEST ARTICLE ROX -DOSE mg/kg/day 4o.o SEX Female
Within normal limits
Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
-Phthisis
Enophthalmia
Kera tit is
Corneal Edema
Corneal scar
Hvnhema
lritis/Anterior Uveitis
Anterior Svnechia Posterior Svnechia
Iris Bombe Prominent Lens Suture Lines
Prominent L'l!J_~_Nucl eus
~
~
co
KEY:
L = R = u = Sl= A = p =
..J °' "" w "' 5 ,:: co - ,: " z~ "' ""z
X X
left right both suture line anterior posterior
00 "" 0 " " 00 "' "' "'
X ;, * f--
INCIDENCE OF OPHTHALMIC LESIONS
TEST I/EEK 51 ; '
~ N M 7 ~ "' " 1 cr 0 00 co co co co 00 co ~ "' "' "' "' "' "' "' "' "' X X X X X X X * * ·>
- -
~ N M 7 ~
"' "' "' "' "' "' "' "' "' "'
X X X X
- -
-
C = capsular I = immature S = sector N = nucleus
"' " "' "' "' "'
X
-
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
00 "' 0 "' "' 0 "' "' "
X X X
--l-
--
! ,I
-
-
.-"' 0
IIIC!DENCE OF OPHTIIALl11C LESIONS
TEST HEEK 51 STUDY IIUI\BER L6121-6
TEST ARTICLE ROX DOSE mq/kq/da_y 4o.O SEX Female
--, -~~-,-- r-· ,--, r .,....-;·--,--·1·--,----.--..,. --1--1 -· ! - , -
~"' "'~ I ~I ~ !;[ ~I ~\ i:l[ ~lilffi\IB!f2!ffil ~I ffi\ ~I -1 N1M1~1=1
-
STUDY NUMBER L612!-6
TEST ARTICLE RDX --DOSE mg/kg/day 40.0
SEX Female
Within normal limits
Lid Laceration
lid scarring
Ocular discharge
Conjunctivitis
Chemosis Buphthalmia
-Phthisis
Enophthalrnia
Keratiti s
Corneal Edema
Corneal scar
H""hema
Iritis/Anterior Uveitis
Anterior Svnechia Posterior Svnechia Iris Bombe
Prominent Lens Suture Lines
Prominent Lens_~ucleus KEY:
~
~
J"'
-
L-
O' N
STUDY NUIIBER L6121-6 TEST ARTICLE ROX -DOSE mq/eg/day 4o.o SEX Female
1~-::i~~
C,h_,e,
Luxa ted 1 ~~ ..
Vitreal Strands Vitreal Hemorrhaae Retina 1 Folds Vascular Attenuation:
_, O' = 00 ...... ::::: z C,
-
STUDY IIUI-IBER L6121-6
TEST ARTICLE RDX
DOSE mg/kg/day 4o.O
SEX Female
Within normal 1 imits
Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chemos is
Buphthalmia
-Phthisis
Enophtha lmia
Keratitis
Cornea 1 Edema
Corneal scar
Hvnhema
Iritis!Anterior Uveitis
!interior Svnechia
Posterior Synechia
Iris Bombe Prominent Lens Suture Lines
Promin~rit_L_en§: _Nucleus KEY:
.,,.. ,,., ~
_, "' ~ ~ ~ ~
"" z
X X X X
C-- -
INCIDENCE OF OPHTIIAL11IC LESIOIIS
TEST I/EEK 51
0 - N M "' = ~ ~ co m 0 M M M ~ M M M M M M "' ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ * X X X * X X * - - -- - ,-
i _)_ - - - - - - ~
- - - - - - - --R
- -
- - - ·- - - -- ·- -
- - - -L
L R - -
- - - - - -R
- N M "' = ~ co ~- ~ ~ "' "' "' "' "' "' "' "' .,,. ~ ~ ~ ~ ~ ~ ~ ~ ~ ~
* * ~} X X X X X X X - - - - - C-- - -- ·- - - - ,_ - - - ~-
- - - - -- - - - -·- ·- ·- -- - - - - - -- - - - - ,_ - - - -
-
-- - - -- - - - - - -- - - - ,_ - - - - -
- - - - -- - - -
- - - - - - -·--
- - - - - - - - -- ·- - - - - - - - - - -- -· - - - - - - - - -
- - - - - - - - - - - - - - - -- - -
L = left C = capsular I = immature R = right S = sector N = nucleus U = both Co= cortical *: previously died or Sl= suture line 13 = brunescent A = anterior V = vacuoles
sacrificed
P = posterior M = mature
" u C
" u ·-u C -
50
3 ----1
1-1 -·--1
' I-·-'
1-1~
-i I
' '.!
1
3
1
' j __ ., _I
,,
-
~
~
~
STUDY IIIIIIBER L6121-6
TEST ARTICLE ROX
1)05[ mg/kg/day 40 ·0 --- . ·-
~~
SEX Female « w
-
STUDY IWI-IBER L6!2!-6
TEST ART! CLE ROX -DOSE mq/kg/day 0.0
SEX Male
Within normal limits
lid Laceration
Lid scarring
Ocular discharge
Conjuncti vi tis
Chemosis Buphthalmia
Phthisis
Enophthalmia
Keratitis
Corneal Edema
Corneal scar
H"nhema
Iritis/Anterior Uveitis Anterior Svnechia Posterior Svnechia
Iris Bombe Prominent Lens Suture Lines
Prominent Lens Nucleus KEY:
~ 0--~
--- -- -- -
-"'' "" w :c "' -:::: z co CZ
~ N M s,- m
X -r~ * X
I,
I,
L = 1 eft R = right U = both Sl= suture line A = anterior P = posterior
ltlCIDENCE OF OPHTHALl1IC LESIONS
TEST I/EEK ','6
0 ~ N M s,- ~ ~ ~ "' ""
~ ~ ~ ~ ~ ~
X X * * X X X ~
u u
~
u
-
I
I,
~ ~ "' O' ~ ~ ~ ~
X X * 1~
-
-'--
-
C = capsular I = immature S = sector N = nucleus
C ~ N N N N
X * X
Co= cortical *=previously died or B = brunescent sacrificed V = vacuoles M = mature
M s,- ~ N N N
* * X
j - ~
-
'
STUDY IIUt,tBER L6121-6
TEST AIHICLE ROX
DOSE mg/kg/day _Q,,_Q
SEX Male
1,:,cinn
--' ~ COO ...... z:
INCIDENCE OF OPHTHALMIC LESIONS
TEST HEEK 76
~~l.--1\N\ '"'1
-
STUDY IIUIIBER L6121-6
TEST ARTICLE ROX -DOSE mg/kg/day D.D
--- ·--- - -· --·
SEX Male .J °' "" w :z ~ ...... ::::: ~ ~ co "' 0 z C, ""z N N N N M
Within normal limits X X X X * -Lid Laceration
Lid scarring
Ocular discharge
Conjunctivitis
Chernosis
Buphthalmia
Phthisis
Enophthalmia
Kera titi s
Cornea 1 Edema
Corneal scar
H•mhema
lritis/Anterior Uveitis
Anterior Svnechia Posterior Svnechia
Iris Bombe Prominent Lens Suture Lines
Prominen.:L1_en~_N_!:lcl eus KEY:
~ L = left "' ~ R = right
U = both 51= suture line A = anterior P = pas teri or
IIICIDEHCE or DPIITIIALI\IC LESIONS TEST HEEK 76
- N M "' ~ ~ ~ co "' 0 M M M M M M M M M "' -
X X * X * X X * X X
- N M "' "' "' "' "' X
f-- -
f-- - --