## 90 DAY INHAlATION TOXICIT STUDY IN TIlE RAT 

## WITH RECOVER.Y PHASE 

# APPENDIX 6 .. INDIVIDUAL FUNCTIONAL OBSERVATIONAL BAnERY (LANDING FOOT SPLAY, TlME TO TAIL-FLICK, FORE· AND HIND-LIMB GRIP STRENGTH)

caour • 01 DOSII LII9IIL. 

### o W- 

## a_nu .... a.£

., CUll FIIIIUa'I IJO 

# _au. DJIW12

.. 6 61 600
• 6 " 310

.. 6 70 n!l



## RBGULATORY/REPOR.T

- 197

## 90 DAY INHALATION TOXICI'Y STUDY 

## IN TIlE RAT 

# wrm RECOVERY PHASE 

# APPENDIX 6 -INDIVIDUAL FUNCnONAL OBSERVATIONAL BATTERY (LANDING FOOT SPLAY, TIME TO TAiL-FUCI(, FORE
.. AND HIND-UMB GRIP STRENGTH)

GIIII9I, 01 B:I'I. CAR 

# ...



# - DOIDI Y'fJIL. IIJIIII: 100 PJi1II ..GIIU
...... If JIO
... Dar. 12 1 

# , 11 

### e211 

# , 12 5&0 

# , 13 500 1 

# , 14 100. 1 II lIS 510 :J 10 11 US 1 10 17 410 1 10 

### Ie 47!1 10 

### I' 57S 31 10 20 400 I'I:IIALII aBl:DL Z 11 71 450 

## a 11 12 450 Z 11 73 .50 1 11 74 325 11 11 675 

# , 12 450 

# , 

# " 12 77 450



## REOUtATORY!REPORT

- 198

## 90 DAY INHAlATION TOXIcrv STUDY IN THE RAT WITH RECOVER.Y PHASE 

# APPENDIX 6 -
.. DIVIDUAL FUNCTIONAL OBSERVATIONAL BATTERY (LANDING FOOT SPLAY, TIME TO TAIL-FLICK, FORE- AND HIND-UMB GRIP STRENGTH) 

# ..,1. GIIOCIP. 02 CIiGB J.....a D08II LInlIL.

_ 1110 PIlI
.. ClUJ'
........ 110 110 UlIQL 12 41 13 ,. 131

, 12 7t .50

, 12 10 1$00



## REGUlATORYIREPORT· 199

## 90 DAY INHALATION TOXICfY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 6 - INDIVIDUAL FUNCTIONAL OBSERVATIONAL BATTERY (LANDING FOOT SPLAY, TIME TO TAiL-FUCK, FORE- AND HIND-UMB GRIP STRENGTH)

a:ovP ,03 DOSa LIIV1Do. 300 lis­ 

### m.anaaD188 • IlDL .0 CUB...... 110 lUIDIUo .... 12 <I 11 II 500 " 11 I. <671 <I 111 90 1525



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## 90 DAY INHALATION TOXICTY STUDY IN nlERAT WIrH 

## RECOVERY PHASE 

# APPENDIX 6 -INDIVIDUAL FUNCTIONAL OBSERVATIONAL BATrERY (LANDING FOOT SPLAY, TIME TO TAiL-FUCK, 

# FORE· AND HIND-UNB GRIP STRENGTH)

a:H01'. 03 DOIIII JonB,. 

# - 300 ,.". .. al:l U .... S UK CUll IfUJI: 110 110 UIIIDL 12

1 

### n a1 110 13 2:1 421 1 U 

## a3 sas 13 :14 UI U 25 600 .3 14 II SSO II 14 

### 21 US 3 14 H 550 3 U 

### n 500 3 14 :SO 610 IIIIIaLII .llflJD£ 

## a 1$ 

### u &'71 3 U 82 32' 2 11 U SSO 2 

### IS 84 4l1l 

### 2 IS 

# ., 31' 111 II 

## iso 

# " 

# ., t 

### II 600



## RBOULATORY/REPORT • 200

## 90 DAY INHALATION rOXICIY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 8 - INDMDUAl.. FUNCTIONAL OBSERVATIONAL BATTERY (LANDING FOOT SPLAY, nUE TO TAIL-FUel<, FORE· AND HIND-LIMB GRIP STRENGTH)

G'IOUP. 04 DOG: LIIYIIl'o I 1000
.. GIlD UllIN PIll 

# •

..... CAGI**~** 

# ....... JIO JIO 

## .u:nar. 12

1 17 31 525 1 17 32 221 1 11 33 

## aoo 1 11 350 

# " 1 11 35 675 3 1$ 

### 3. 6.0 3 10 37 500 3 1. 3. 321 3 10 

### n SSO 3 11 625 

# "'0



# ....... .IiIIDII.r. 2 21 t1 

### US 2 21 

### n 

# ... 2 21 

### SSO 

# " 2 21 .4 375 2 21 

### .S 65. 4 22 .11 1111 4 2:1 

# ., .so



## fREGULATORY/REPORT

- 202

## 90 DAY INHALATION TOXICTY STIIDY IN TIlE RAT WITH RECOVERY FHASE 

# APPENDIX 6 -INDIVIDUAL FUNCTIONAL OBSERVAnONAL BATrERY (LANDING FOOT SPLAY, TIME TO TAIL-Fuel(, FORE- 

# AND HIND-UMB 

# GRIP STRENGTH)

6JIJOI'1 0" DOIIII LIYIILt 1000 :IiIs- lilt 

### all'''''' • IIDL 

# ... CIQ,.....,.

_ 110 AJDaL 1:1

• 22 ,. 350 

## • aa " 5715 • 22 100 1525



## 'REGULATORY/REPORT

- 203

## 90 

## DAY INHALATION TOXICl'Y 

## STUDY IN THE RAT WIllI 

## REroVERY PHASE 

# APPENDIX 6 • INDIVIDUAL FUNCTIONAL OBSERVATIONAL BATIERY (LANDING FOOT SPLAY, TIME TO TAIL-FLICK, FORE· AND HIND-UMB GRIP STRENGTH)

IIUL 

# .,**~.** 01 

## c:aa IIIl.II 

# ., 

# - IIOBI: LaSL. 

# ...

12 0**~** 

## no au.usua 

# •

1 1 1 1125 1 1 2 850 1 1 :I 700 ;I. 1 

# '" 780 1 1 5. 1400 :I 2 & 700 I :.J. 7 1575 J :.J. 

# • 10.0 :I :.J. 

# • 185 • 3 2 10 1175 I!'IIf.I.LII .IIJDIU, 2 5. 61 100. 2 5. ca 1350 a 5 13 700 2 5 U la5 2 5**~5** 675 

# , -4 ISO 

# , " C7 1471 

# '"

iREGULATORY/REPORT

- 204

## 90 DAY INHA.LATION TOXICfY STUDY IN TIm 

## RAT WITH RECOVERY PHASE 

# APPENDIX 6 - INDIVIJUAL FUNCTIONAL OBSERVATIONAL BAlTERY (LANDING FOOT SPLAY, TIME TO TAIL-FLICK, FORE- AND HIND-UIIB GRIP STRENGTH)

QIOUF. 01 D08II 1oIVJIL. 

## o filii 

## no 8'
....... II IIIDr. III) CAIa 

### rau.s 

# .,.:na.r. _12 4 , ,. 1100

, ,. .00 f , 70 671



## 'REGUlATORY/REPORT • 205

## 90 DAY INHALATION TOXICfY STUDY IN THE RAT WlTIf 

## RECOVERY PHASE 

# APPENDIX 6 • INDIVIDUAL FUNCTIONAL OBSERVATIONAL BATTERY (LANDING FOOT SPLAY, TIME TO TAil-FUel<, FORE· AND HIND-UMB GRIP STRENGTH)

CiIIOUP. 02 DCMm 

### r.nar.. 100 PPI 

### n.D..I
....... 

# • IIDL 

### c.a.ca: IAI'.I: IIIIIIIC 10 JIO AIIDIat. 12 1 

# , 1, 1125 1 

# , 12 750 1 

# • 13 02111 1 I It 1:100 1 I 15 121**~** 10 16 025 

# " 10 17 725 3 10 U 725 3 10 11 1:1211 3 10 20 12110 J'aALII: AIIDIIoL 2 11 71 650 2 11 72 1100 2 11 7J 121 2 11 121 7" 2 11 7$ '10 

# " 1:1 76 1100 12 

## no 

# " 

# "

'RBOUlATORY!REPORT
- 2O'i

## 90 DAY INHALATION TOXIcrY STUDY IN TIlE RAT WITH RECOVERY PHASE 

# APPENDIX 

# 8 -INDMDUAL FUNCTIONAL OBSERVATIONAL BATTERY (LANDING FOOT 

# SPLAY, TIME TO TAiL-FUCK,

. FORE· 

# AND HIND·LlMB GFlP 

# STRENGTH)

G1IllVJI. 02 DOUi 

## uvm.. 100**~** 

## rr. cal1'....... lJ

_. QQII.....u.B DB II) 110 AlIJMIL 12 12 7. 1075 12 

### n 1121 12 •• "5



## REGUlATORY/REPORT

- 200

## 90 DAY INHAlATION TOXICTY STUDY IN TEE RAT WITH RECOVERY PHASE 

# APPENDIX 6 - INDIVIDUAL FUNCTIONAL OBSERVATIONAL BATTERY (LANDING FOOT SPLAY, TIME TO TAiL-FUeK, FORE· AND HIND-UMB GRIP SlRENGTH)

1tID'r. 

# ., GIIOIIP. 03 CI8I IIlU.lI 

# ., lUIJIGL J)Otg 

## r.rnrr... 

# ...

12 300 ppa 

## rr. au U8aIIS I
1 13 

### :u liS 1 13 

## aa 700 1 13 U 1575 1 13 U 6'75 1 l! 

## as '1'25 3 14 16 .,0 3 14 27 UOO 3 14 all 1000 3 14 21 lta5 3 14 30 1375 J'IIIU.B MDIU. 

### :a 11 11 110 :I 15 12. 6110 

## :z 15 13 1300 I 15 If. 1100 2. 15 15 775



# .. 1. 16 1351



# .. 17 U5C l'



## REGULATOllY/REPORT

- 208

## 90 DAY INHALATION TDXICfY 

## sruDY IN THE RAT 

# wrm RECOVERY PHASE 

# APPENDIX 6 -INDIVIDUAL FUNCnONAL OBSERVATIONAL. BATTERY (lANDING FOOT SPLAY, TIME TO TAIL-FLICK, FORE- AND HIND-UMB GRIP STRENGTH)

cat!OVI'. OJ IlOIJB Ln1IL. 300 ,.. 

## no DIP
_ • IIlDL QID FIIIU.Ii
__ 110 IfO 

### -'11%..... 1:1 ;I 16 •• 13100 t 16 •• III. t 16 .0 1000



## IREGULATORY/REPORT

- 200

# •• 90 DAY lNHALATION TOXICI'Y STUDY IN THE RAT WllH RECOVERY PHASE 

# APPENDIX 6 -INDIVIDUAL FUNCTIONAL OBSERVATIONAL BAnERY (LANDING FOOT SPLAY, TIME TO TAiL-FLlCK, FORE· AND HIND-UMB GRIP STRENGTH)

un. 

# .. GIl(JUP, Ot CAR IIIU 110 JllDIAL DOIIII LIVIIL I 

# -

U JO •• ". 

### rr. an ...... g

17 :S1 1.0 

### n 32 121 1 11 311 110. 1 11 3t 77& 11 35 70. 10 U 700 II 37 12
.. 3 18 III 1200 3 II 

### n 10.0 3 11 .0 11.0 JIIIIUJI JmII&L 

## a 21 .1 521 

## a 21 

### .2 .21 2 21 

### n 97' lI:l 

## .as :I 

### :u 

# . , 117• 

# , 9. :n lUI



# .. 12 97 ISO



## lREGULATORY/REPORT • 210

## 90 DAY INHALATION TOXIcrY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 6 - INDIVIDUAL FUNCTIONAL OBSERVATIONAL BATTERY (LANDING FOOT SPLAY, TIME TO TAIL-FLICK, FORE· AND HIND-LIMB GRIP STRENGTH)

CIIOQr. ., DOIDI LIIYKL. 100. PI'II I'to 

### an UUU It IDI. eMil**~** ... 110 110 UDIlL 12

, 22 9' 675

, 22 '9 9'711

, 22 10. .all



## 'REOULATOllY/REPOllT

- 211

## 90 DAY INHAlATION TOXJCTY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 6 • 

# INDIVIDUAL FUNCTIONAL OBSERVATIONAL BAlTERY (LANDING FOOT SPLAY, 

# TillE TO TAIL-FLICK, FORE- AND HIND-UMB GRIP STRENGTH)

OIOVI'. 01 DOH 

# .rnn:.. o P1III 

## aa. au.. a'L 110 C&GIt 110 AIIIIIlIL 110 __ 110 -------------------------­ eo •• I: • 'I' I ------ •••••• --.-- •••••• - •• ­ 1 J t 12 'I'IIIIID OU'I'

... 2 '7 12 'I'tIIID OU'I'



## REGULAIDRY/REPORT • 212

## 90 DAY INHALATION TOXICI'Y STUDY IN THE RAT 1VITH RECOVERY PHASE 

# APPENDIX 6 .. INDIVIDUAL FUNCTIONAL OasERVA110NAL BATTERY 

# (LANDING FOOT SPLAY, TIME TO TAiL-FUeK, FORE .. AND HIND-UMB GRIP STRENGTH)

.... QlI DOIUlIdlftl.. 3QO
.... 

## sa. ..... "DIJ'l, CIGlI ..... IIDDt -------------- •. ------.-- 

## co 11 It
... 't I --_.- ••••• ---------.------­ ., ., 110 Il1O ;, ]A 26 

### la !n.D 

### 0IIIIt

.. U ,_ 0IIft'



## RE.OUI.ATDRY/tlEPORT

- 213

## 90 DAY INHAlAll0NTOXlCJY 

## STUDY IN THE RAT WITH 

## RECOVERY PHASE 

# APPENDIX 6 - INDIVIDUAL FUNCTIONAL OBSERVATIONAL BATTERY (LANDING FOOT SPLAY, TIME TO TAIL-FLICK, FORE· AND HIND-UMB GRIP STRENGTH)

iIi1IOD. 

### ot IXMlB LSftL. 1000
... lUI IIIIr.II IB1't. WI) CUll 110 AIr.JIAL

.. DIIJI: JIll ----.-.----------------- •• CO •• II • l' I
--------------------------­ 1 17 31 12 'llIIID 00'1'



## REGUlATOIlY/REPORT

- 214

## 90 DAY INHAlATION TOXICI'Y 

## STUDY IN 

## THE RAT WITH RECOVERY PHASE 

# APPENDIX 6 - INDIVIDUAL FUNCTIONAL OBSERVATIONAL BAlTERY (LANDING FOOT SPLAY, TIME TO TAiL-FUCK, FORE- AND HIND-UMB GRIP STRENGllt)

IIIOUP. OJ DOa LIIVIIr.. 

## o ... .Ilh
........ HP..

., CMlII 10 MDIAL 10 _ 110 ••• - •• - •••• ----.---------. COli
.. II • " • ---- •••• --- •• ---- •••••••••• 

## a I 63 1:1 fJlD:l) 

## on
, 6 66 1:1 fJlD:l) 

## on

REGUlATORY/REPORT • 215

## 90 DAY INHALATION TOXICl'Y STUDY IN THE RAT 

# wrm: RECOVERY PHASE 

# APPENDIX 8 - INDMDUAL FUNCTIONAL OBSERVATIONAL BAlTERV (LANDING FOOT SPLAy' TIME TO TAiL-FUCK, FORE-AND HIND-UMB GRIP STRENGTH)

CIlOID. 113 DOSIr 

### LIIYJIL. 

### sao**~** OZa rJIIIIN'dI: Dl'L
..,**~GII** ., AIIIJI:AL 110 _ 110 

## .---.-- .. ---.--- •• - .• -.-.- co ••••**~** 

## • - .• -­ •••- •••••.• -----.----­ 

# , " .7 12**~_OUT**



## IREGULATORY/RBPORT

- 216

## 90 DAY INHALO\TION TOXICfY 

## STUDY IN TIlE RAT WI11I RECOVERY PHASE

c' 

# APPENPIX 6 • INDIVIPUAL FUNCTIONAL OBSERVATIONAL BATTERY (LANDING FOOT SPLAY, TIME TO TAiL-FueK, FORE· AND HIND-UMB GRIP STRENGTH)

WIOVI' • 0.. IXl8JI IJIVIIL I 1000 ppa IU. I'IIIDJ,JI UI'L (l1.GII AJIDIaL
_ -------.--- •• ---.---.----- Co 0 •••• I' I .------ •• -------------. __ .­ ., 110 110 110 Z 21 U U 'fDIIII) OUI'

.. 22 " 11 'fDIIII) OUI'



## REGUlATORY/REPORT • 217

## 90 DAY INHAIATION TOXlCIY STUDY IN TIlE 

## RAT WITH RECOVERy PHASE 

# APPENDIX 7 - INDMDUAL FUNCTIONAL OBSERVATIONAL BATTERY (MOTOR ACTIVITY) Key: NO. - 

## number 

# MINS- minutes

IREGULATORY/REPORT

- 218

## 90 DAY INHALATION TOXICI'Y STUDY IN TIlE RAT Wl11I RECOVERY PHASE 

# APPENDIX 7 - 

# MOTOR ACTIVITY (MOVEMENTS /5 MINUTES) 

# -. 12 a<M!J'. 1 DOD: LI9IIL. 0
... 1IJIlI: • UL.D • DleD (IOD) 

## gnu. 110. 1-5 6-10 

### 11-15 16-20 21-25 2'-3' 31-35 31-10 

## 41·" '6-50 

# ., 1 71 101 17 51 11 10 

### n 7. 51 2 11 71 II 

### n 13 

# ". 

# . " 

# 'I 'I 

# , 

# . •• 3 U 73 .0 71 13 II 12 I 107 

# '" 111 111 111 

# " U7 120 10' 

### 11' S 12 71 75 71 67 15 11 77 11 17 21 27 75 

### '3 11 10 

# , 

# " '" "7 22 7 

# .,. 

# ,. 10 21 2. SI 15 

# " I' II II 73 II 32 $I 21 117 52 13 

# • , '1 

# " 73 ." 'I II 

# , 10 '6 

# .. 9$ II 

# I.

10 

### .5 t3 11 13 I 11 II I' I' 

# "

IREGULATORY/REPORT

- 219

## 90 DAY INHALATION TOXICI'Y STUDY IN 

## TIlE RAT WITH RECOVERY PHASE 

# APPENDIX 7· MOTOR ACTlVITY fMOYEMENTS /5 MINUTES) 

# -. 12 GIOUrr 2 DOell LllYllLr lOG
... 

## az. 1IUoII8 JDXOD (1IIJI8, Ular. 110. 1-5 '·10 11-11 U-:30 21-111 2'-30 11-35 31-"0 "·50 

# U-'" 

# ,. 11 

### .2 17 II 77 7. 13 11 

# .. 10 12 

# ., 12 13 51 U 51 <II 72
..0 22 13 

### 7' 71 13 72 77 

### lot II 

### II 

# ... l' 

# " 76 67 111 57 12 

## n 11 15 112 11 '7 77 

### II II '7 67 1011 11 

### .. I 452 10 

### n 453 745 51 U 17 77 71 71 11 

### I 1 10 '7 

# " " " ''I 

# ., 

# "
11 

### II II 

# ., n .1 5' 

# " 

# .. 12 

# " I 14 111 11 75 II 72 75 31 21 '7 

# • 2. 51 711 12 

### I. 

### n IS 71 71 

### II 

### n 

# "

RBGUlATORY..ttBPORT • 220

## 90 DAY lNHALATIONTOXICfY STUDY IN THE RAT WiTH RECOVER.Y PHASE 

# APPENDIX 7· MOTOR 

# ACTMTY (MOVEMENTS /5 MINUTES)



# ..... 12 

# ., GIIIOIIIJ' • IlOiID LIYBL. SOD HII 

## au. DLD 

# ,..:1_ {tmaI) AIIJIIAL 110. 1-5 6-10 11-U 16-20 

### 21-21 26·3\\ 31-35 3f-". 41
.... 11 

# ,,'.5. 21 51 64 70 416 IiIIi 51 

## 61 63 7 iii 22 73 12 

# ., I' U U 34 

# .... :17 15 

# ., 60 

# .S 

# .. .. 23 77 44 22 12 ,U .0 

### u 12 10 

# " 'f 7. 

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# ... 15
. 2' 16 70 1105 411 7l 1. 14 25 

# " 51 

# " flli 61 

# ., 77 

# " 77 71 

# .. 7Z 

# , .. Z7 II 71. '0 17 U 

# " 12 

# •• :ae 7G fa 12 21 4 12 36 f 7 :II 

# " 

# " " 

# ,. 2' 

### at 51 61 S6 67 I. 

### n 21 SO 70 

# .. " 75 

# .. 2. 

# " 

# , 17 

# • 62 75**~GULA10RY~PORT** 

## - 221

# I**~** 

# §

# ~ .. 

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# .. 

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## 90 DAY INHALATION TOXlCI'Y STUDY IN TIlE RAT WITH RECOVERY PHASE 

# APPENDIX 7 - MOTOR ACTIVITY (MOVEMENTS /5 MINUTES)

..a. GIlOIIIl'I 12 1 DOIR 

# 10_. o .IM BU. I'IIICI.LJIII HlIOU (IIDII) UlDIU 110. 1-5 '-10 

### 11-111 16-210 21-21 2'-3. 

# 31-. "-'0 

### 41-45 ',"'0 

### '1 62 63 73 12 6. 

### 104 

# ,. ,. 7!1 71 111 71 17 

# .. .5 

# ,. 66 77 

# .. n 1<1 .2 1<1 

### 0 .'7 77 

### 1 15 62 71 

### n 15 6fo 

### .0 7. 

# " n 17 73 72 62 lit '70 

# " " " 

# ,. 6. 7. II 76 lit 

### n 113 75 76 ta Ia .0 IS 

# ., 17 13 

# " 

# ,. 77 77 a7 

# " 66 '2 

# " 71 t. 16 II. U 

### .3



# , 32 • 1 

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# " 52 

# • 

# ,. 0 

# .. " .0 

# • 6' 

### 1 71 

# " .2 1 

# " 0 a7 102 

### 73 61 aa 2. 

## n 72



## REGUlATORY/REPORT

- 223

# •• 90 DAY**INHALATIO~** 

## TOXICTY STUDY IN 

# nm RAT wmI 

## RECOVERY PHASE 

# APPENDIX 7 - 

# MOTOR ACTIVITY (MOVEMENTS /5 MINUTES) 

# -. 12 IilaCUJ'f a 

### D08II 

## r.n:u.. 100 nil SU. J'IIII.U8 PlUOD (JIXIII) 

# ....... .,. 1-' 1-10 11-11 u-ao aI-21 21-30 

## n-JI "-40 41-45 45-'0 71 .0 13 t4 

### I' 10 

### IS 

# .. I 

# .... 72 7S 7. !IIi .1 37 20 14 71 

# " " 7S 

# .. 74 

# ,. 731 

### n 74 

# " II 12 

# '" '" II 113 

### 111 10' 121 12' 

# " 114 

# " lU 711 

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# ,. 102 7:1 71 7S 

### '5 71 16 153 IS 

# ". 41 I 12 1 0 7S 

# •• 

# • 14 70 47 III 74 77 II 411 12 71 It 

### II II 

# ., 7a 

# " ztI 

### :u 41 

# " " 

# ., .. " 

# •• "t 14 731 72 40 34 15 II 72 

### I. II II 

# ... 50 1 31 17 4 

### I. II



## 'BEGULATORY/REPORT

- 224

## 90 DAY INHALATIO:'ll TOXICfY STUDY 1N THE RAT WITH lECOYERY PHASE 

# APPENDIX 7 - MOTOR AC11V1TV**~OVEMENTS** 

# I 5
.. NUTES)

I11III:, 12 4iIIOU1' • 3 DOIII:
.......... 30
..... 80, I'IIIIUoII8 iIIIllOD (IIIU) UIIIU. 110. 1-5 '-10 11-15 16·a 21-1a :I'-H 31-3S 31-40 41-45 "-SO 11 

## n n 

# •• IS II 17 

# •• It 

# 'II .1 61 17 !II 70 511 to .1 57 72 

# •• 75 11 14 I' 

# " 13 

# " 16 75 71 70 II 73 II 

### n 71 II 

# " 

# .. 61 10 71 

# " II 

# .,. .2 

# .2 70 

### n 5. 37 

# .1 as 

# .. 51 77 

# .. " 1 23 50 U If 

# •• U 51 71 76 4. 11 

# ... 13 10 76 61 11 61 7. :10 

# " S, 73 42 

# ,. 73 7 77 74 2S 

# " 51 .0 

### 5. .2 83 

# .. 51 67 1 72 

# , 

# . 13 14 

# ", 6a ." .1 U 16



## REGULt\TORYAtEPOR1



## - 225

## 90 DAY INHAlATION TOXKTY STUDY IN THE RAT wrrH 

## RECOVERY PHASE 

# APPENDIX 7· MOTOR ACTIVITY (MOVEMENTS /15 MINUTES)
.



# ...... 12 D08II UVIDo. 1000.1'11 BU • ....aLlIS 

# -. ..

.. IOD (1IDl8) .IoIIDIlIL 110. 1-5 6-10 11-11 

## lI-n U-U 21-30 31·3& 3.-<10 41-"1 41-110 91 100 

## n 16 31 '3 21 1 20 10 97 92 17 70 611 119 Sol <It 59 55 ..0 72 93 17 11 71 71 62 611 ". 70 

# .. 77 15 17 76 76 

## n 70 

### n 

# '4 6' 

# " ,. 15 62 60 6. 

### n 10 70 

### II '2 

### I. 

# ,. '7 

# •• 19 72 .2 

# " II 71 .7 

# " 711 13 

### S
.. 

# " 22 .3 60 116 

# " to 10 

# ... ,. 'I 611 73 62 117 U 117 

### 'I 61 

# ,. '2 

# •• 

# ,. 67 11 

### 113 100 10<1 10
.. 100 

# " 76 71 SI 2 <I 6 <It 13 13 

### n 

# "**~GULATORY~RT** 

## - 226

## 90 DAY 1NHALAIlON TOXICTY 

## STUDY IN THE RAT 

## WITH RECOVERY PHASE 

# APPENDIX 8 • INDIVIDUAL HAEMATOLOGY Key: 

# The 

# following abbreviations may appear in this 

# Appendix. M 

# F 

# NO HB RBC 

# Her MCV MCH MCHC 

# PLT 

# wac NEUT 

# LYMP 

# MONO EOSI BASO 

# LUC PT APPTS 

# RETICS sec male female number haemoglobin red blood cell COlBlt 

# haematocrit (packed 

# cell volume) mean cell volume mean cell haemoglobin mean cell haemoglobin concentration platelet count white blood cell rount neatrophil count lymphocyte count monocyte count eosinophil count

. basophil rount
.



# large unclassified 

# cells prothrombin time 

# activated partial 

# thromboplastin time reticulocytes count seconds 

# Blood ceO morphology comments ANIS MICR 

# MACR HYPO HYPR 

# VAR LEFT BLAS 

# ATYP 1 

# 2 3 aniscytosis 

# microcytosis maaocytosis hypochromasis hyperchromasis varichromasis increased left shift blastocytes atypical slight moderate marked 

# Only positive findings 

# are presented. If**~ere** 

# are 

# any text comments describing blood cell morphology 

# they will appear at the end of this Appendi"(.

'REGULATORY/REPORT

- 227

## 90 DAY INHALATION TOXICfY STUDY IN TJIB 

## RAT WITH REroVEI.Y PHASE 

# APPENDIX 8 

# -INDIVIDUAL HAEMATOLOGY

QIlOVl>, 

### 1 

### ooa Lll'fJlLI 

### 0 ppa lID' IGLI 

# .. IIIIC 

### -.v 1M2 

# -=**~** 

# ....

.. DIU. lID 

# ... ....... 110 Sl/U 

### U·U/I J!1 Sl/U 

### 111 dO·'/l PII· 

### 1 II 141 

### 16.0 7.'2 53 •• 

# 36.' 0.'06 IOU I
.. ' 

### 2 II it 

### 11.1 I.U 

### 52.4 17.' 34.0 0.'4' 127 :I II 

### 14 14.9 I.U 

### 110.' 17.' ".0 0.&:1. nl 

### 4 II 14 

### 11.0 1.'3 

### 51.' 1 •• 1 '4.' O.UI 102.1 

# • II 

### 14 1&.1 

# 7." 53.0 1'.2 

# ".3 

# .. ,

# .. .,0 

# , K it U., 

### 1.70 50.7 17.1 n.1 0.'&1 103:' 7 U 

### 1&.& 1.31 

# ".5 1'1'.' 3'.3 0.'" 

# ... • I I( U 

### U.I •• 15 112.' 11.1 34.7 •• 12. 

### 71& 

# , • U 14.2 

# '.31 50.5 17.1 

### 33 •• 

## •. no '50 

### 10 II 

### 14 U.7 

# '.1Il 50.7 

## 11.a ,13.' 

### 0.432 10"



## IREGULATORY/REPORT • 228

## 90 DAY INHAI..ATION TOXICI'Y STUDY IN THB RAT WITH RECOVERY PHASE 

# APPENDIX 8· 

# INDMDUAL HAEMATOLOGY
IiIioII:P • 1 flU, IIUoII lI08II 

## uv:a.. 0 

# .,.. UDAL JrDBD lID 

# ... ., 'IIIC 

### dO-'/l KIIft**ZJJI-"~** :r.'I1IP ><10·,/1 HOleD dO-"l l1l:I81 z10·"l BAllO 

### alO-'/l loUt: .10·./L 1 2 3 

# • • • 14 U 14 5.n 6.31 6.311 1.10 1.30 2.03 

# 3." 

# .... •• 00 0.11 0.20 0.11 0.13 0.22 0.11 0.0) 0.0) 0.0) 0.0' 0.01 0."


# .. II 14 5." 1.312 

### •. 1. 0.11 0.21 

### O.OJ 0.12 

# , 6 

# • II 14 14 6.21 

# 3." 1.64 1.11 

### 4.01 2.82 0.15 

# 0." •• 231 0.12 0.02 0.01 0.01 0.05 7 II 101 '.75 1.21 3.20 0." 0.11 0.01 0.04 

# • II U 5.13 1.3' 3.21 O.Z' 0.11 O.OJ 0.00 t II 101 

# '.:11 1,17 3.01 O.tO 0.11 0.01 0.0' 10 II U 

## 6.sa 1.101 '.15 0.10 0.17 0.01 0.06



## REGULATORY/REPORT

- 229

## 90 DAY INHALATIONTOXlCfY 

## STUDY IN 

## mE RAT WfI'H RECOVERY PHASE 

# APPENDIX 8 -INDIVIDUAL HAEMATOLOGY

iIIIOG'I' • 

### 1 Ia • .IfALII DOQ 

# L""', 0 

# ..... IIIIDIU. 

# ..... 1 l1li: 

# • 

# ... , 110 14 

# .,.


# . " It.' Aft'!' 

# - 25.1 JIII'l'ICIJ 

# •

a.7 a 

# • 14 

## 16.a a'.7 

## a.2 3 I( U U •• 

## as.o .1.0 t 

# • 141 

### 16.1 

### :u •• 1.7 II I( 14 11.1 24.7 1.1 6 II It 111.3 

## a_.'**~.a** 7 

# • 

# , • II I( It 

### 14 U 14.7 

## 16.a 16.' 1'.6 aa.7 

## 14.a 

# 1.' a.s a.4 10 

# • 14 

# 15.' as.3 1.6



## REGUlATORY/REPORT

- 230

## 90 DAY INHALATIONTOXICTY 

## STUDY IN THE RAT 

## WJI1I 

## RECOVERY PHASE 

# APPENDIX 8 .. INDIVIDUAL HAEMATOLOGY

GIIOUJI. 1 D08S LII9III.. 0 

# .... SIII:. I'IIIIUdI lDI )ICY DC IICII 

### -=ac IIIC'I'**.L~** lmI
.... 

# .. 1IIIIU: 

# ...... 110 a/lU 10-12/1 fl N· 

### Il'lIU 111 "'1-"1 61 

## r 16 16.6 7.51 113.1 

### It.S 3 •• 4 0.600 K3 112 

## r 14 13.' 7.31 54.2 1I.t 0.3111 tn 

# !C., 

# , 153 16 U.t 

# 7." 53.6 U.t 35.3 0.6al 170 Ie 

## r Ie It.6 7.'2 113.0 l'.t 311.6 0.60t 'III 65 J' 14 

### U.t 7.17 113 •• 20.1 37.6 0.3'2 '0' .6 J' 141 U.5 113.3 

### It.t 36.3 0.311 7.3 7 •• ' 

# , 141 16.4 7.56 U.3 It.l 1I7 .2 0.3" 

### .,1 

# " , 6. It 13.7 7.11 11.2 11.2 35.6 0.301 .4. 6t 

### r 141 U.t 7.17 n.2 it. I lIS.t 0.t21 

### Ion 

# , 70 It 16.3 &3.2 It.! lI6.0 0.3ta t71 7 •• '**~GULATORY~PORT** 

## - 231

## 90 DAY INHALATION TOXICIY STUDY IN THE RAT WITH REOJVERY PHASE 

# APPENDIX 8 .. INDIVIDUAL HAEMATOLOGV
GIIOOP, 1 II&'ItI nIIoUiIi DOIIII 

# .:rI&. 0 lisAIIDW. 

# ..... 61 

# ... 

# ... 110 

# • 14 DC

.. 10-./1



# .... DU'I'

.. 10'./1 I •• 

### "WI'

.. 10-./1 2.14 

# ..,

.. 10'./1 0.11 Il0l1**dO~./l** 

### D.O' BI.IIO 

### dO·./l O.Ot 

## r.vc: dO-./l 0 •• 1 C2. 

### r 1& 6.71 

### 1.SS 4.7' 0.12 0.13 0.06 ' •• 7 13 

### r 1<1 3.'4 0.70 2.03 0.'7 

### D.O. 0 •• 4 

# 0." 

# •• r 14 5.lIt 

### l.z:r. •• 50 

### •. U D.O • 0.'1 0.0' IS 'I 14 ... 15 •• 67 1.2' 0.'7 0.05 0.02 0 •• ' 16 'I 14 

### 3.31 0 •• 2.:17 

# • ••• D.l. 0.01 •• 04 17 

# ., 14 2 •• 3 •• 71 2.'7 0.01 0.07 0.01 0 ••• 10 

### r 1. 4.36 1.:12 2 •• 2 0.14 0.10 0.0. •• 0' 

# •• 70 

# • 

# • 14 It ••• 7 '.'0 0.11 

# ••• 2.12 3." 0.07 0." d ••• 

### D.07 0." 0.03 ' •• 5 0.01



# REGUlATORY/REPORT

- 232

## 90 DAY INHAlATION TOXICfY STUDY IN TIm 

## RAT WlTIi RECOVERY PHASE 

# APPENDIX 8 -INDIVIDUAL HAEMATOLOGY

CIiCIIIl'. J SID'.. PIilIDLJI IlOIIJI LJIVR.. 0 ftIII
AllDII.L II1JIIIIIDl lID: 

# -­ lfO 

### ''1'


# -­ Io1'ft 

# - D'l'IC' 

# , 61 

### n 

# • 

# ., 16 

## u 15.3 11.2 

## :n. , 2J.0 J •• 

### 31.1 

### n 

# ., 16 

# II.' 2a.3 

### 1.1 

### u 

# ., 16 

### U ... 21.1 2.'7 II 

# ., 1<1 16
... 

# ai.' a.o iii 

# ., U 11.' 2'.' 2 •• 

# ., 

# .. r 

### r 1<1 11 15 •• U •• 

### al.1 2'. '7 

# 1." 1.3 

# " ., 16 11.2 :U.7 2.1 70 

# ., 16 

# 15.' 15.2 

### a ...



## RBGULATORY/REPORT 

# • 233

## 90 DAY INHALATION rOXlCfY STUDY IN THE RAT 

# wrrn RECOVERY PHASE

IIUIIaL 

# ...... 11 12 13 It 15 11 17 1. 11 20 GIIOUP. 2 

## sa. IIUdI 

### ax 

# ., 

# .... • It 

# • 14 

# • it 

# • it III 14 )I 14 III 14 II 1.& II 

### 14 Ie 14 IXI8J
....... D fl/4l.



### 14.5 14 •• It., 1t.!I 15 • .& 14 •• H.' U •• 

# 111.' H • .& 100 PPI DC

10-12/1



## '.27 '.32



### •• 71



# .. 7.11



# " 1.11 

# ....

•• 31 

# '.13 '.14 

# APPENDIX 8 -INDIVIDUAL HAEMATOLOGY

IIICY at:B .. C IIC1' 1'10'**~1** P9. fl/4l. III 

### &10·'/1



# 51.'. 17.s 

## » .• 0.41' 

# 'I' SO.I n.4 34.S 0.411 '75 4'_1 1'.1 34.4 

## o.oa '34 52.1 11.7 311.3 ..... 11 

### In 52.0 17.5 33 •• 0 •• 7 11.&0

... 1 

### 17-' 31.0 0
.... 0 

### 'IS 

# •••• U.l 311.0 O.G' 

# '" 10.7 17 •• 34.1 0.0122 

### '07 S2.1 

### U .• 33.' 0."" 

## ,n SO.o 

# 1'7.' !III •• 0
.... ' 

### lU2



# 'REGULATORY/REPORT

- 234

## 90 DAY 

## INHAlATION TOXICIY 

## STUDY IN THE 

## RAT 

# wrrn RECOVERY PHASE 

## APPENDIX 8 -INDIVIDUAL HAEMATOLOGY

MDIAL 

# - aou.. 2 lID: I IIlIIdI lID: IIIDII: D08I Lna,.. IIBC 100**~** 

## on LDIP 

# .., 

# _I

IWIO 

### LUC 110 alO-'/l zlO-'/l z10-'11 zIO-'/l z10-'11 alO-'/l z10-'/l 11 II 16 5.71 1.'0 6.02 0.16 0.10 0.03 0.01 12 II 16 5.06 1.0e 3 •. 

### n 0.0' 0.11 0.03 0.0' U II 16 5.20 1.36 3." 0.13 0.1' 0.02 0.11 16 II 16 5." 1.51 3." o.oe 0.26 0.01 o.oe 15 II 16 5.67 1.21 6.16 o.oe 0.14 0.03 0.06 16 II 16 6.U 0.'5 2." 0.07 0.21 0.01 0.03 17 II 16 6.It 1.06 31.17 0.07 0.11 0.01 0.01 1. 

# .. 16 6.67 1.26 3.06 0.11 0.10 0.01 0.01 It 

# .. 14 7.n 

# 1." 5.11 0.15 0.16 0.02 0.07 20 

# .. 16 

### S.ts 1." 3.77 0.11 0.16 0.01 0.06**~GULAjORY~ORT** 

## - n5

# -- 

# - -- 90 DAY 

# INHALATION TOXlCI'Y STUDY IN THE. 

## RAT WITH RECOVERY PHASE 

# APPENDIX 8 - .. DMDUAL HAEMATOLOGV

GIOVI'. 2 II08S 10
..... 110 

# ... lisa 

## sa ..... PI 

### un DlICB .uDAL 

## sa aD 

# • 11 10& 11 •• 2 •• 

# • at.' 12 1« 111 •• 2'.1Ii I •• 

# • 13 11 15.& 

# 211.' 2.2 

# • 11 11 IMI IMI 2.1 

# • 111 It 22 .• 2.1 

# • 11." 11 1
.. 14.7 24.11 

# • 1.' 17 14 22.' 2.1 

# • 15.' 1. It 111.3 2
.... 2.2 

# • 1. 11 15 •• 2.1 2
... ' 

# • 20 14 11.0 21.11 I.' 

# •

'REGUlATORY/REPORT

- 236

## 90 

# DAY INHALATION TOXICI'Y STUDY IN TIlE RAT WITH 

# RECOVERY PHASE 

# APPENDIX 8 .. INDIVIDUAL HAEMATOLOGY

aoaP. 2 IXS1I LBY.U., 100 

# .. lis- BIll[ I t'IIIIIIr.JI DC JICY lICK IICIIC IIC'I' Jr.! 

# .... U:na.r. BIll[ JIVIIIIIIIl 110 ./40. 10"12/1 t'1 .,40. 1/1 

### dG"./l 

# ., 

# "" 71 14 14.3 7.'1 83.4 11.1 31.3 0.401 1&53 

# ., 72 14 1$.5 1.10 113.1 11.1 31.1 0.433 "2 

# ., 73 14 

# 13.' 7.32 51.4 

## Uu 11.' 3'.2 0."7 

# ., 74 U 14.1 7.2' 53.4 11.4 3'.3 

### O.lIl .00 

# ., 7S 14 

### 15.41 7." 11.1 11 •• 3'.5 0.412 612 

# ., 76 14 

### U.S T.U 52.4 241.2 

# H.' 0.317 ,.4 

# ., ,,. 77 14
.. 14.4 7.38 12.1 11.5 37.4 0.,.4 71 

# ., 14 

# 13.' T.U 52.1 

# U., 33.7 0.413 

# '" n 

## r 14 14.7 52.' 11.3 ".7 •• 4411 1142 

# '.'2 141 

## r 14 14.$ ',341 52.1 

# 11.' 

# :17.' 41.3" 

### 'OS**~GULArORY~ORT** 

## - '137

## 90 DAY INHALATION TOXICTY STUDY IN THE RAT WITH .lECOVERY P.HASE 

# APPENDIX 8 • INDMDUAL 

# HAEMATOLOGY

GIIOUI'I Z 81m. I'IIIIItoLB DCJIim LK1'IL I . 100 lJIIII UDWo 

# ..... au 1IIIIIiJ[ 

# ., II1IC _U-'/l IIBO'f z10-I/l L1ID' _10-,/1 

# .­ :dO-"l :1081 a10',/1 IIUO 

### _10-'/1 

## r.vc :dO"9/1 71 71 

### r r 

## a 14 

## a.,o


# .... , 0.$1 0 •• ' 2.15 

# '.f;!I 0.0' 0.13 0.011 0.12 1.0.1 0.04 0.06 0.04 

### n p 14 .... 1 1.13 3.410 0.01 0.11 0.03 0.011 74 p 14 

# 5." 1.73 3.73 0.11 0.10 0.03 0.011 75 p 1
.. 3.73 0.'" 

# I." 0.0. 0.04 0.04 0.011 7' P 1<1 5.01 0 •• ' 3 •• 0.0' 0.1<& 4).0" 0.0' 77 

### r 

## a 3.97 1.U 

## z.... 0.0. 0.01 1).02 0.011 7B 

### r 14 11.30 1.10 

## s .... 0.131 0.11 C.O" 0.07 

# 7' r 1
... 3.12 1.07 

## a.sa 0.1:1 0.07 t.02 0.04 10 p 1
.. 

### ... U 0 •• 2 3.10 0.0'**0.~** 1).0" 0.011**~GUL~TORY~R1** 

## - 238

## 90 DAY INHALATION TOXlCfY STUDY IN THE RAT WlTIf 

## RECOVERY PHASE 

# APPENDIX 8 .. INDIVIDUAL HAEMATOLOGY

GIIGIIJ'. 2 

### sa:r • .....,.. DOSI: LIWJIL. 100 PPI Maar. 

# - 11 

## sa: r 

# ... 110 U 

### n 

### _eo 16.2 I.I"ft' 

# - U.l 1III'I'1C.l 

# •31.' n r 14 15.6 

### :&4
.. , 1 •• 'J3 

### r 14, 111.6 

### 22.1 2.5 7. 

### r U 15.' 22.7 1 •• 75 

### r 14 

### 16.' 25.' 1.' '6 I' U 15.' 22.1 

### 1.7 '7'7 p U 

### U .• 23.5 2.1 '71 

### r U 15.' 23.0 2 •• 1t 

# , 14 16.11 

# 23.' 3.1 .0 

### r 14 111 •• 21.3 1.'



## REGULATORY/RE?ORT

-**23~**

## 90 DAY INHALATION TOXICIY SIUDY IN 1lIE RAT 

## WTIH RECOVERY PHASE 

# APPENDIX 8 -INDIVIDUAL HAEMATOLOGY

UDAL 

# ..... 21 22 U U 25 26 27 

# a. a. 30 CIOVI'. 

### 3 lID' 

### u:r.s lID 

# ... 110 II 

### 14 III 16 III 

### 14 

# ." It III 14 III 14 III 14 III 14 III 16 III 14 DOSB LJIftL I 

# ..

./41 14.1 

### 14.' 

# n.' 14.1 15.1 

## 15.a 14.2 14.6 14.3 

### U.O ::seO Jjpa DC

10'12/1 

### •. :n 

# '.37 

# '.1' Y.,.

•• $0 

# ..... 7." 

# '.16 '.22 

### '.3' IICY el. 

### !ll.a 51 ••



# .. 

# ". 10 • .11 12. !I 5 •• 1 

# ... ., 6 ••• 5'.S 

# 52.' 

# ..

..... 11.1 11.7 17.1 1'.1 18.1 

# n.' 1'.1 

# 17.' u .• 

# 17.' lIaR: 

### ./41 36.1 

### n.a :14

.. 2 

# ..... 340.7 :11.5 

### U ... 3'.0 SC,C 33.' IICr 111

0.'%6 0.633 0."17 

## o.n.'l 0.646 0.62' 0.3t1. 0.6" •• 4015 0."" 

# Plio" alo·"l 1011 

### I., 1013 717 

# "'7 

# .. ., 

# ... 

# ... 1102 

### N,



## fREGULATORY/REPORT • 240

## 90 DAY 

# INHALATION TOXIcrY S11JDY IN TIm 

## RAT WJfH 

## RECOVER.Y PHASE 

# APPENOIX 8 • INDIVIDUAL HAEMATOLOGY

UOUl'. 3 lUI DLI DOlI! 

### r.wv.r. I 3.0 

# ....

.. DIAL 

# ...... sa: 

# - 110 pc xlO'''l IIJIU'I' :dO·l/l L'IID' 1110·1/1 .-0 1110'1/1 

### _I: xlO'l/l JIMO :al"I/I 

## r.ue 1110'0/1 21 

# .. 14 lI.3" l.ao 

### I.U 0.01 0.2.2 '.02 0.07 22 

# .. 14 5.21 l.12 1.01 0.07 0.17 0.'1 0.0" a:J 

# .. 1<1 6.1' l.14 ".lIl 0.16 0.11 '.03 0.13 2
.. 

# .. 14 S.55 l.2.2
... OS 0.07 

## O.u. 0.03 0." 25 

# .. 14 5.U**~.12** 

# ".n 0.01 0.15 0.03 0.01 26 

# .. 14 1.25 1.70 S.U 

# '.11 O.lS 0.011 0.13 27 

### ze 

# .. 

# .. 14 1<1 

# '.11 ".12 l.U l." ... 36 

# 2." 0." 0.10 0.36 

# .... 0.12 0.12 0 •• ' 0.0' 21 

# .. 16 7.11 

### L.U 5.05 0.16 0.2.0 

## o.oa •• 01 30 

# .. 14 5.1<1 t.I" 3." 0.11 0.01 0.01 0.06**~GULATORY~ORT** 

### • 241

## 90 DAY 

# INHALATION TOXICTY STUDY IN TIlE RAT 

# wrm RECOVERY PHASE 

# APPENDIX 8 .. INDIVIDUAL HA!MATOLOGY

&IlOUI'. 3 DZ
...... DOIIlI LII'nIL. 300 ppa



# -­ .!I An'! D'llCS .IIIDIlU. 

# ..... BIt 110 

# -­ .. It 

### t 

## :n. 

# • 16 11.6 :U.3 2.3 22 I 14 1'.1 24.5 2.' 33 I It 11 •• U.4I 2.7 It I It 15.2 21.7 2.0 211 I It 

### III.Z In.l 2.0 26 I 16 16 •• 

### :U., Z.' 

### n 

# • It 

### u .• 31.! 

### Z.O 2! I U 111.0 U.S I.! 

### 2. I U 16.7 24.6

### 2~' 30 I 11 1'.2 2'.2 2.0**~ULATORY~ORT** 

## • 242

## 90 DAY INHAlATION TOXICI'Y STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 8 • 

# INDIVIDUAL HAEMATOLOGY

GIIOUJI. 3 D08JI 1aBYSL. 500 fill**ID.~**



## ... ow:. ID 

# - n UC IICII' IICII NC:IK IIC'I' 

### r''I IIUlIIID JIG 

### ./41**10~.u/l** III PII· ./41 

### 1/l.**.1e~'/1** 

### II 

### r 140 140.7 7.41 

### SS.O 19.7 

## sa.1 0.411 

### .12 82 

### r U U.3 7.60 5'.4 11.1 3&.5 0.'13 

# as, IS 

### r 140 14..5 7.40 &:1.2 

### 1'.1 ».1 0.$9" 7'3 II 

## r 14 1'.' 7.13 

### n.1 11.' 301.2 0.121 1.1 

## as 

## r 14. 140.7 7." 

## n.l 19.2­ •• 2 0.4" 124 II 

# ,. 14 1'.1 7.12 

### 12.1 II.' 

### 36.2 0.'01 1013 .7 

## r 14 14..' 7.41 

### !IS.' 20.0 3'.4 

## o.sn 174 II 

## r 14 

# 14.' 7.12 

# 55.' 11.' !I.' 0.413 

### '1' 

### n 

# .. 14 14..5 7.'1 54.2 19.7 3'.4 0.40G 113 

# •• r 14 11.7 7.n 12..7 19.1 37.11 0.411 771**~ULATORynuwORT** 

## . 243

## 90 DAY INHAlATION TOXICI'Y STUDY IN THE RAT WII'H 

## RECOVERY PHASE 

# APPENDIX 8 .. 

# INDMDUAL HAEMATOLOGY

GIIOUJI. :I JID I .I'IIA!.Ir DOD
......... 300 

# ... ""DUlL 

# ..... ID 

# ... ., PC lIlO-'/l IIJIIU'1I' .U-'/I IIPI' 1110-'/1**~** lIt"',1l 111M!

### Id'~"l. &UO :&10"/1. 

### Lac**~IO-'/l** U 

### r 14 2.15 

### O.SO 1.70 0.04 •• 0' 

### O.OJ O •• J IZ 

### r 14 3.00 0.57 2.28 

### O.OS 0.0. 0.01 0.01 IS 

# , 14 S.O& 0 ••• S.03**O.O~** •• 0' 0.02 O.OS 

### at l' U t.13 1.02 '.53 

### O.OS 0.00 O.OS 0.01 

### IS r 14 2.45 0.42 1 •• 5**O.O~** '.0' 0.02 0.01 

# ., 

# .7 r r 

## u 14 t.1'I' 3.11 1.01 0.111' 3.50 2 ••• 0.07

•• 01 

### •• 12 0.10 0.02 0.01 0.05

•• 0 • 

### I. I' 14 2.57 ••• 6 

# 1." 0.0' D.07 0.0.1 0 •• 5 

### .t to 

# ..


# .. 1<1 14 2.'2 

### :r.U O.fa 

# . .. , 2.12 2 • .,,, •• N 

# •••• '.N ) 

# ... •• 02 ..02 

### •. N 

### a.1S



# 'RE.GUlATOltY/RBPORT • 244

## 90 DAY INHALATION TOXICTY STUDY INTHB RAT WITH RECOVERY PHASE 

## APPENDIX 8
.. INDIVIDUAL HAEMATOLOGY

CIIIOUP. 3

... I'IIIGLII D08B LI¥ID'.. 30' 

# ,....
MDrAL 

# -­ 11 12. II.D: 

### r I' 

# ... 110 

### u U PI

# . ..., 11.3 

# Lt., un 

# - a6 •. 1 27.:1 IIII'l'.tCII 

# • 

# 1.'

l.a 13 I' 16 111.0 as.5 

# 1.' 

# ., 

# .. 14 

### 16,a 

### ao.6 l.a .5 

# .. If 

### 16.5 a:!i.fo 

### '.1 

# " 

# .. 140 15.6 

# 26.' l.3 11 P 16 It ... 

### aa •• l.1 

# •• I' 14 

### 16.1 U.S 

## z •• II I' 140 U.S 22.2 2.7 '0 

# .. U 

### 16.1 21.1 1.:1



## 'REGULATORY/REPORT - 245

## 90 DA,\, INHAI.All0N TOXlCfY STUDY TN THE RAT WITH RECOVERY PHASE

UDIU 

# ..... ::tl 32 

### n :U 

# ", n
"., 

# ,. 3. 40**~,** 

# • 111:. IIIJ.II l1li: 

# ., 

# - II 14 

# • 14 II 

## u. II U. II 14 II 14


# .. 14 

# • 14 

# • 14 

# • lol DOBII r.bIIL. 

# ..

.bU 1".2 

# l4.' 14.1 

# 13.' 11 •• 14.3 14
... 14.7 

### n . ..,. 15.2 1000 

# ... QC



### 10'1.1/1

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# '.3' '.:15 

# '.1., APPENDIX 8 -INDMDUAL HAEMATOLOGY

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# fO.' 11.0 311.4 

### 0.41' 131 

# .t., ".1 16.7 

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### "4**REGULATORY~ORT** 

# • 246

## 90 DAY INHALATION TOXICTY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 8 • INDIVIDUAL HAEMATOLOGY

IIIIOCI'I 4 

## sa. IIIALII D08II 1oIVZL. 1000 lis­ 

# _1 DC IIIIV!' Ii'llll' ...0 8UO U1'C UDIAL IIUIIID 

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­ 0.01 

# •• 15 

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# .. 14 It 6.52 11.11 

# 1.'. 1.S5 4.11 3.1. 0.17 0.15 C.lt 1.15 0.02 0.03 0.04 0.10 31 

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# 2." 0.01 

# '.01 0.02 0.02 !17 

# .. U 3.5' 1.4' 1 •• 1 O.OS t.OI 0.01 0.03 31 

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# 2.'" 0.11 t.11 0.0:1 0.07 3t 40 

# •


# .. U 14 S.l1 '.33 1.11 2.n 3.14 3.U 0." 0.10 t.1t f • .f.3 0.02 0.03 0.04 

# ....**REGULATORY~ORT** 

## - 247

## 90 DAY INHAlATION 'IOXICTY STUDY IN THE RAT WITH RECOVER"'i PHASE 

# APPENDIX 8 -INDMDUAL HAEMATOLOGY

GIIIOQI. 

### c 8D:
...... DOBI "
..... ". 1000 ppa
.IIIDW'o 

# .­ :u 

# .. ... 110 

# • 14 

### PI' 

# .­ 15 •• Dft 

# . 

# -

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# aI.' IIftICS 

# •2.2 32 M 14 16.2 23.7 2.' U 

# • If 14 •• 2S.' 2.' 34 H 14 15 •• 26.1 2.1i lIS H 14 15.2 25 •• 2.1i 31 

# • 14 14.7 2S •• 2.0 37 H 14 Iii.' 25 •• a.1i :tI H 14 15.6 

# 24.' 1." 3' M 14 

# l.Ii." 19.1 2.0 CO 

# • It 11.6 21.lI 1.'



## IllEGULATORY/RElORT 

## • 248

## 90 DAY INHALATION TOXICTY STUDY IN TIlE RAT WITH RECOVERY PHASE 

# APPENDIX 8 -INDIVIDUAL HAEMATOLOGY

GIIOOP. 4 IJCIiIII LIIftIo. 1800 

# .... lID. I'IIIIUoI 

# .. -­ DC IICY 

### -=a IICIIC IIC'I' 

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### Dr 110 

### ./dl. 10-1:1/1 fl ,/<11 111 

## >CIo·.Il. n r 

## u 14.0 

### 7.U 14.S 

### U.I '5.7 

### 0.3IP1 .70

- .2 

### r 14 14.3 

### 7.70 14.3 11.6 14.2 0.411 U4!

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### r 14 13.1 

### 7.fIJ 55.S U.I J5.2 

## o.na IN 14 

### r 14 14 •• - 

### 7.tO 53.2 1 •• 3 U.3 O.4U 11117 .S 

### r 14 II •• 7.93 5:1.3 II •• 

### .K.l 0.415 11M .1 

## r 14 

## u.s 7." 1:1.1 II •• .1.3 

### 0.40. 

# .. 

# . • 7 

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### 15.1 

# .,.n 14.1 U.I 11.1 •• 417 lOll 91 

### r 14 14.1 

# .,.$1 11.1 52.0 31.3 0.'01 9. 

### r 14 It •• 

# ., 

# ..• n.o 

# "'.1 

# •• •• 11.1 

### O.UL 100 

## r 14 15.0 1.15 1lI.1 11.7

- 11.1 0.,1t ,.2



## IREGULATORYIREPORT



## - 249

## 90 DAYINHALA110NTOXICTY STUDY [N 

## THE RAT 

# wrm RECOVERY PHASB 

## APPENDIX 8 

# -INDIVIDUAL HAEMATOLOGY



# , CIIOU1I'. 

### ooa LII'¥lIr.. 1000 ppa 

### ax ......... 

# ... .., Dc: L1'III' 11»1 IIAIIO IiIJC UlIIDoL I1IIt IIIIIB 

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# al.-"I lIl.-"l 111 

### r 14 2.51 

# .. ,. 1.11 0.0' •• )1 0.01 0 •• ' 

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# '.13 1." 0.05 0.07 •• )1 0.03 til 

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# '.'7 1.05 

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... '.15 2.71 0 •• 7 0.11 •• J! 0.04 1 •• I 14 4.20 ).71 :11.15 0.11 0.09 0.02 0
....



# IREGUlATORY/REPORT

- 250

## 90 DAY INHALATiONTOXICfY STUDY IN 

## TIm RAT WITH RECOVERY PHASE 

# APPENDIX 8 -INDMDUAL HAEMATOLOGY

GIlOVI'. of. 

## sa. J'IIIIGIoa DOBI LIn:IIL I 1000 

# ... .IIW'. 

# - u 

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# It., at.7 

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# D.' 2.1 100 

### r 141 1',. 1II3.' 1.6**~GULATORY~ORT** 

## - 251

# •• • 90 DAY INHALATION TOXICfY STUDY IN 11IE RAT Wl1lI RECOVERY PHASE

cmo1IIP, I 

## au, IDIoJ: AllOW; 

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# ° 

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### 10-1211

'.31 1.01 1.37 1.10 1.11 1.31 '1'.'6 1.11 7." I.sa 

# APPENDIX 8· INDMDUAL 

# HAEMATOLOGY

IICY IICII IICIIC 

### .C'I' JILl!

f1 PI­ 

### ./41. 1/1 

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## o.uo In 12.1 11.1 SI.1 0.617 7n 50.3 15 •• 3S.1 0.'21 Ito la.6 17.1 SI.I O.UO I'l'l 10.1 15.1 S3.a 

## o.'U '01 

# Sl.' 17.a 12.7 0.'11 101'1' $4.0 53.' 53.1 15.7 17.5 u.a 

# H.' S2.1 31.1 O.U' O.'SI 0.4021 '45 .11 

# It.

1t.0 1'.1 31.1 a.6Io 10'1'1



## IREGULATORY/REPORT • 252

## 90 DAY INHAlATION TOXICTY STUDY IN THE RAT WfnI RECOVERY PHASE 

# APPENDIX 8 -INDIVIDUAL HAEMATOLOGY

anw. 

# ....- GIOUl'. I SIX
...... IIBlI. 

# .... 110 IIOU LIJYllt.. II1IC**:dO~9/1** 0 

# ...


# -**xlO~9/1** ItDIP**xlO~./l.** 

# .., :all-"l 11081 .10-"1 BAllO xU-'ll. LUC :al0·"1 41 II 18 3
.... 0 .• 0 

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## o.oz**~.06**

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# '.21 a.22 3.'1 0.16 

### •• 1' 0.02 J.07 63 II 11 ' •• 7 3.al 1.91 0.21 •• al 0.03 1.11 44 II Ie 5.44 1-5'7 3.50 0.11 0.1. 

## o.oa ".07 

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# ,.ot 4' II 11 =1.16 1.'0 3.41 0.21 •• 25 0.01 '.03 

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# " II II 

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# .. , a.'o 0." a.u 3.st 0.12 0.10 •• 111 0.1. 0.01 0.01 '.13 

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# ".at 1·13 2.27 0.1' •• 12 0.00 

## ).oa 110 II 11 

# I." 1.22 4.40 0.11 0.1' 

## o.oa 1.01**~ULATORY~PORT** 

### • 253

## 90 DAY INHAlATION TOXICI'Y STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 8 - INDMDUAL 

# HAEMATOlOGY

CIIIOCI7 , 5 DOIIB LIYU.. 0 W- IlD. II'ALB AJ"J"I' UlrIca SJIl[ AIIIDL 

# "' _eo 

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# 2.' 41 11 16 •• 29.0 2.3 

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### l.'


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... 25.'7 2.1 

### ct 11 141.2 21.3 2.' 

# • ISO 11 16.8 26.2 2.5 

# •

REOULATORYfflEPORT • 254

## 90 DAY INHALo\TION TOXlCfY srUOY IN THE RAT 

## WITH RECOVERY PHASE 

# APPENDIX 8 • INDIVIDUAL HAEMATOLOGY**~.** 5 

## Sa:. I'IIIDI.S DOS:I t.ftI:L. 0 P.­
"DIAl'. 

### au: 

# ... BB DC IIe'I lICII EIIIC IlC'r 1'10'1' II1IIIIIIIIt 110 1J/4l. 10-12/1.**~1** N· 1/41 1/1 :K10-'/1 101 I' 

# I' U.S 7." 1111." 1 •• 2 :12 •• 0."42 1117 102 I' 18 14.1 7.76 14.3 1 •• 2 33.11 0.":1.2 

## 11m, 103 1M I' 

# • 11 

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•• 11.'1 n.6 53._ 

### 17.6 17. , 32.1 32.' O.S76 0.6&' "I 10'0 105 I' II 14.3 1.06 53." 

# 17.' 33.3 

## o.no .S6 106 I' 1. 14.6 •• 1' 1IS.4 

# 17.' 32." 0.4011 

### '17 107 I' 1_ 1t.1 7.73 14.3 11.2 33.11 0 •• 20 1002 10. I' 11 1t.6 7.01 M.7 

### 11.3 33.' 0.'33 

### .17 10. I' 1. 11 •• 7.711 

# U., 17.' 32.11 0 •• 17 

## loa. 110 

### r 11 141.7 •• 31 56.11 

### 17.1 SI.t 0 •• S6 "3



## REGUlATORY/REPORT

- 255

## 90 DAY INHALATION TOXlcrY STUDY IN THE RAT WITH REOOVERYPHASE 

# APPENDIX 8 -INDIVIDUAL HAEMATOLOGY

alUJ'. 5 DOH t.sn:L. 0 JIiIII. 

## sa:. naGU.1 

# ...., ftC IIlI1I'I' IoJlll' IIOII D80 

### love .llDIU. 

## sa: 

# ... IIOIIID' 110 

### :11:1'-'/1**XlD""/~** al0*'/l al0"tll alO-'/l 

### .10"'/1 XlD*'/1

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### e.o:I 

# • loa 11 2.n**0.5~** a.lI 0.11 0.01 0.'3 G.OI 

# • 103 P II 3.U 0.13 a.50 '.Of '.10 0.01 o •• a 10. II 3.31 0.53 2.13 0.05 

### 0.11 0.02 

### 0.'4 

# • lt1 II 3.2' 0.'0 2.31 0.0:1 0.10 0.0. 0.0" 

# • O.OT 107 1. •• 415 1.11 3.04 0." 0.14 0 ••• 0.07 10' 

# .. 1. 

# ..ot 0.'2 3.'1 0.0' 0.'3 0.01 

# • 

# ... , loa 11 3.4'7 a.57 0.01 0.01 0.01 0.05 

# • 101 10 3.a3 •• il 2.30 0.0' 0.11 0.03 0.01 

# • 110 P 0." 

### 1. 

# 4.'. 

# ..,. 3.51 0." 0.0' 0.04



## REGUIATORY/RBPORT

- 256

## 9QDAY INHAlATION TOXlCIY STUDY IN11iE RAT WITH RECOVERY PHASE!. 

# APPENDIX 8 -INDIVIDUAL HAEMATOLOGY

GJIOUl'. 

# , IIIZ ......... IlOIB LIYIIL. 0 lisJIWI&L 

# ...... ID 

# ... 110 JI'I' 

# - API'! 

### _eo 

### ...,IC. t 181 7 11 liIl.1 :.14.1 3.0 102 I' 11 17.6 :14.7 2.' 103 I' 11 16.2 

## :U., 2.0 104 

### r 11 17.6 :h.1 2.1 105 I' 11 17.6 :n.1 1.7 106 

### r 11 15.1 :12.1 2.3 107 

### r 11 16.6 2'.2 1.7 181 P 11 

# 1'.' 2I.1i 1.1 1 •• I' 11 1'.1 

### :at., 2.1 110 

### r 11 11.7 23.1 1.6**ffiEGULAjORY~RT** 

## - 257

## 90 DAY INHALATION TOXICI'Y STUDY IN 1HE RATWrrH RECOVER.Y PHASE 

# APPENDIX 8
.. INDMDUAL 

# HAEMATOLOGV

aout. , 1I08S ...,...,. 1100 

# .. Ps­ 

## au, IIILI IIBe IIC'I IICII 1ICBC JIC'I' PL'I 

# ... .. uw. AS 

# ..... 110 

### lI/eU 10-12/1. 11 pt. 

### ./41 1/1 

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### 14 •• 

# . ... M .• 1".4 :I
..... 

# ..," .3. sa II 

### 1. 14.' 

# '.21 51.0 17.4 :14.2 0.41' 

# '"'' 113 1. 

# 14.' 

# '.1. U., :\4..1 •• 4$'7 

### Ule 4 •• ' 54 II 

### 1. 14.0 1.17 $2.:1 

## n.2 u .• 0.U7 

# • 

# '" sa II 11 

# 1'.' •• '1'1 H.1 

# 1',' n.ll 0.«2 

### It, 56 II 

### 1. 140 •• ' •• 0 

### "3.1 U •• 

## 31.' 0.417 

# '" S'J II 

# I' 14.:1. 

# '.53 

# 11.' 14 • ., 

## n.a 0.4062 LOal III 

# • 1. U •• '.30 1.1.1 U •• 31.4 0.4:12 til lit 11 1<1.1 

# ..... 51 •• 

## u.? 

## aa.3 0.41' 

# ... • f. II JI 106 •• 

# .... 110.7 16 •• 32.' 0.411 1061



# 'REGULATORY/REPORT

- 2.'58

## 90 DAY INHAlATION TOXICIY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 8 • INDIVIDUAL HAEMATOLOGY

GlOVP. 6 J:IOSt LnJIL. 1000 W­ SUI IIUJI 

### nc IIIPJ! r.DIP l1OlIO
.. I IWIO LVC UDIM. 

## sa: 110 xlO-"l xlO-'/l :d0-'/1 :dO-'ll xlo-"1 :dO-til :dO·,/I 

# - -- 51 

# .. 11 !I.07 1.00 3.73 O.lO 0.16 

### O.OJ 0.05 1.:1. 

# .. 11 C •• O 0." 3.31 0.37 0.16 O.Ol 0.03 1.40C 3.60 0.'1 0.30 •• 01 0.71 54 II 11 1.11 1.21 3.22 

## o.n •• 17 0.01 0 ••• 

# '3 

# .. 11 

# '.15

It!! 11 C.20 1.14, 2.11 0.11 0.13 •• 01 0.03 

# • 16 11 3.16 0.'0 2.01 O.tll 0.1:1 0.01 0.02 

# • 117 

# .. 11 5.11 1.n 3.311 O.tl 0.111 •• OD 0.05 II 8 11 

### •. n 1.33 3.01 

## o.a, O.U '.01 0.03 !It 8 U •• 71 1.31 2." I.Dt 0.17 0.01 0." 60 iii U •• 00 1.06 2 •• 3 

## o.a. 0.140 0.01 0.03**~GULATORY~RT** 

## - 259

## 90 DAY INHAlATION TOXICIY STUDY IN THE 

## RAT 

# wrm RECOVERY PHASE 

# APPENDIX 8 - INDIVIDUAL HAEMATOLOGY

GIOUP
... lID. IIlILJI DOIIII r..B'flI:L • 1000 

# ..... AII':IIGlo 

# ..... 51 IIU 

# • 

# - 110 II 1"1' Il41O 

### 15
... 

### un .eo. 

### 2
..... U'l'ICS 

# • 2.3 S2 II 11 

### 16.1 

### IT. 2 2.5 53 II II 16.1 

### 2a
... i.:I 

# It" • 18 

# 16." i3.7 

### 2
... 15 II 11 17.7 

### 2110.5 2.7 56 11 18 16.1 

### 23.7 2.1 57 

# .. II 16.1 

### 26.5 2.1 II II 11 16.1 23." 

### 2." 

# " II II 11.1 i6.1 

### 1 •• 60 II 18 

# 111.' 25.' 2.1



## 'REGULATORY/REPORT - 260

## 90 DAY INHALATIONTOXICTY STUDY IN TIlE RAT WITH RECOVERY PHASE 

# APPENDIX 8 -INDIVIDUAL HAEMATOLOGY

GIIOOPa I IIOR LIIYIIL. lOGO 

# .. PPI 

## au, I!'lDIiILK IIJIC MeV tICIlC IICI' 

### FLY )JI1tUIoL DZ 

# .... ** 

# ., g/tU 

### U-12/1 f1 pg. 

### ./dl. 1/1 "'0-'/1 

# -

111 

### r II 

### IS.' '.12 53.1 U.2 34.3 0.414 ,27 112 

### r 18 

# 13.' 

# 7." 111.1 18.2 32 •• '.42t. 1011 113 

### r II 

# 14.' 

# '.25 54.2 17.7 32.7 0.4407 

### US 114 

### r II 15.3 1.01 11.3 11.1 34.5 

# D."" '17 115 l' 18 

# 13.' i.U 55.2 11.7 33.' 0.410 721 116 

### :r 11 13.1 7.31 54.' 18 .• 33.1 0.401 

# .,. 117 l' 1. 

# 13.' 

# '.Z3 5111.1 18 .• 33.' 0.402 11111 

### 11. '1 11 

### IS.1 i •• 5 16.2 

# II.' U.I 0."04 UZI 11. 7 II U.l 1.00 14.1 1'1.1 32.' O.4U 1031 120 

### r 18 14.2 

# '.11 54.1 11.0 33.2 0.427 101'



# REGULATORyauwORT

- 261

## 90 DAY lNHALATION fOXIClY STUDY 

## IN THE RAT 

# wrm RECOVERY PHASE 

# APPENDIX 8 • INDIVIDUAL HAEMATOLOGY

GlOIW. I SUr 

## ......u: 1lOIII LJIY1Pi,. 1000 PIIII
AII1ltAL 

# ...... Sa: 

# -­ 110 1IBC :111'-"1 lID! :11lO-'n L'I1IIP :dO-'/l HOllO 

### z18-'JI mal: :1110-"1 IWIO 

### z18-"l 

## La: alO"'/l 

### 111 

# , 11 

## 3.a. 0.17 

## a.14 0.0' 

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## lla 

# , 11 

## a.'. 0.11' :Z.U 0.01 

# '.n 0.0' 0.05 113 P 11 3.U 

## o.n 2.7a 0.11 0.11 

### O.OL 0.0. 11<1. 

### r 11 3.'" 0.711 

## a.'4 o.ml 0.10 0.0' O.Ot 

### 111 

### r 11 2.74 0.'0 

## a.lI**0.~3** 0.07 O.OJ 0.01 111 

## r 1. 3.'1 0.71 2.'1 O.lO 0.07 0.01 0.04 117 P 1. 3.14 0.13 :Z.U 

## 0." 0.11 

### '.Ol 0.01 11. P 11 4.73 

### 1.11 

## a." 0.12 0.07 0.01 0.04 

### U, p 11 2.32 0.5' 1.57 

# ... , 

# .... 0.'. 

# '.03 120 P 11 3.57 0." 2.11 0.01 0.07 0." 0."



# 'ROOUlATORYIREPORT 262

## 90 DAY INHAlATION TOXlCI'Y STUDY IN THE 

# RAT 

# wrrn RECOVERY PHASE 

# APPENDIX 8 -INDMDUAL 

# HAEMATOLOGY

GII(Ift. 

# , lID. PIIIGLB DOSII 

### r. .... r.. 1000 PIIII
UDlUt JIUIIBD 

### au: 

# - 110 

# ." .40 AI'ft


### • .c 

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# , 111 P 11 17.1 241.3 2.' 112 J' 18 17.1 2 •• ' 2.:1 113 I' 11 17.0 26 •• 

# 1.' 11-1 I' 

### 1. 17.1 23.1 2.1 1111 I' 11 17.3 2!I.t 2.2 III I' 11 15.2 

# 241.' 1.' 

### 117 P 11 It.1 23.2 1.41 

### 111 P 11 1t.2 21.41 2.3 111 I' 11 16 •• 23.7 2.1 12. I' 11 17.1 31 •• 2.2

### REGULATORY~ORT 

## • 263

## 90 DAY INHALATION TOXICfY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 8 

# -INDIVIDUAL HAEMATOLOGY

1ItCMII'. 1 00II1 LIIYIn'o. 0 ppe IID.. IlUlJ.B _11IIIi 

# - lID. 

# - ., ... IS lIIet 1A<2 

### .0 aDO 

### un r.D"r
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# .. 14 1 

### a II 14 1 3 

# .. 1 • 1 1 

# • 

# .. 14 1 5 II 14 1 :I 1 

# , II 140 1 7 

# .. 140 

### a a :I 

# • 

# .. 1 • 1 

# • II 14 1 10 II 140 1



# 'REOULATORY/REPORT

- 264

# w

# ~**~**

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# Ii s -. 

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## SU DAY INHALATION TOXICfY STUDY IN THE RAT 

# wrm RECOVERY PHASE 

# APPENDIX 8 ·INDMDUAL HAEMATOLOGV

GI:01I7. 2 81m. IIALIt DOIR ....,.L. lOG PIlI


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# wrm RECOVERY PHASE 

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## 90 DAY INHAlATION TOXICI'Y STUDY IN TIlE RAT WITH RECOVERY PHASB 

# APPENDIX 8 - INDIVIDUAL HAEMATOLOGY Summary Of 

# Data Not Entered Onto ARTEMIS From Manual VerlftcaUon of Blood Films 

# No Fla 

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REGULATORY/RBPORT

- 277

## 90 DAY INHAI..A.TIONTOXICl'Y STUDY IN THE RAT WITH REroVERY PHASE 

# APPENDIX 9 - WDIVIDUAL BLOOD CLINICAL CHEMISTRY Key: The following abbreviations may appear in this 

# Appendix. NO 

# · number**G~GT** 

# - gamma glutamyl transferase M 

# • male POTIlUM



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# • female 

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# NGRATIO

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# AST



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# PCoA • palmitoyl coenzyme A CK 

# .. creatine kinase If 

# there are any text comments they 

# will appear at the 

# end of this Appendix.

'REGULAroRY/REPORT . - 218

# •• 90 DAY INHALATION rOXICIY STUDY IN THE RAT WITH RECOVERY PHASE 

## APPENDIX 9 - INDIVIDUAL BLOOD CUNICAL CHEMISTRY

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# - 281

## 90 DAY INHAlATION TOXICfY STUDY IN TIm RAT WITH RECOVERY PHASE 

# APPENDIX 9 - INDIVIDUAL BLOOD CUNICAL CHEMISTRY

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# ••• •••• 90 DAY INHALA.TION TOXICTY STIJDY IN TIlE RAT \\TfH 

## RECOVERY PHASE 

# APPENDIX 9 - INDIVIDUAL BLOOD CUNICAL CHEMISTRY

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# RAT WITH 

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# APPENDIX 9 • INDIVIDUAL BLOOD CUNICAL CHEMISTRY

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## • 285

# - 

# - 90 DAY INHALATIONTOXICTY Sl'UDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 9**·~DIVIDUAL** 

# BLOOD CUNICAL 

# CHEMISTRY

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RBGULATORY/REPORT • 286

## 90 DAY INHALJI\.TION TOXICfY STUDY IN THE RAT WITH RECOVERY PHASE 

# APF'ENDIX 9 - INDIVIDUAL BLOOD CUNICAL CHEMISfRY 

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REGULATORY/REPORT - 287

## 90 DAY INHALATION TOXICTY STUDY IN 

## TI;JE RAT WITH RECOVERY PHASE 

# APPENDIX 9 - INDIVIDUAL BLOOD CUNICAL CHEMISTRY

raoa:I'. :I 

### DOl. Lavu.. 100 II
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### au 

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### Clt/.DIII I.e) 

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# " IIUII8D 

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### nIl _1/1 p 71 11 100 63 71 2.75 2.11 

### n 17 72 P U 12. 

### UI 131 2.7. 1." U 31 

### 7' P U II I' 77 2.7' 1.,1 57 U 

### n p 1. '2 

## 2.n 1.73 77 U 

# ,. P 1. 

# " .D 

# " 61 2.75 2.0' a4 

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# " 76 14 141 N 

### IS 

# 2." 1.72 104 

### 3' 77 P U '7 II IS 2.12 1.'3 111 .t 71 P U 122 .4 2.17 2.73 7a 

### J. 

# • 7t 14 120 ID .1 2.t. 1.17 

### I. 50 

# • 10 14 112 11$ 2.17 1.17 III Ii 

# • 

# "

'REOULATORY/REPORT



## - 288

# ••• 90 DAY INHALATIONTOXlCl'Y STUDY IN THE 

# RAT WITII RECOVERY PHASE! 

# APPENDIX 9 • INDIVIDUAL BLOOD CUNICAL CHEMISTRY

1PIlOVI'. 2 11081 LrIm.. .00 PPI 

## a:z. I'IIIGLI: I'LUIIA I'LIII8IIUI. HAIIIA 

### .LAJaIIo.**.~** l'LUIa .LUM& .III1:IAL lID 

### ....: GLUcon e/lUIB I'O'l/IIJII toDJ.1III PIIOB/1I8 BIGS 

# ., _1/1 _Ill**~/l** _111**~/l** _111**~/l** 

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# - 11 

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# '.7 10' 5.:17 ... 4 1.62 

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# .. , 13 

### r 14 14.7 101 6,07 144 1.'6 •• 71 7.13 

### n 

### r 14 13.2 101 4.33 142 1.1' '.1$ 75 

## r loll '.0 105 

### •. M U3 

### 1.9$ ".30 0 •• ' 7 U •• 2 

### lin 0.72 71 l' 14 11.3 10' 3 ••• 1013 1.30 1 •• 

# 7' 3.'" 142 

# I.'" 7." ' •• 4 7. l' U 12.11 102 3.72 143 1." 0.13 6.:11 

## n l' 14 10.' 4.0' 

## ua 1.63 0.111 " •• 4 

# " 10 l' 14 1 •. 2 

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# '.112

REGUlATORY/REPORT

- 289

## 90 DAY INHAlATION TOXIcrY STIJDY 

## IN TIlE RAT WITH RECOVERY 

## PHASE 

# APPENDIX 9 • INDIVIDUAL BLOOD CUNICAL CHEMISTRY

CiIJIOIIIf • 2 D08lI 1'dYIIL. 100 ppa 

## sa. raI.LII PLAIDG I'LIIIID. I'LUIII. I'LIoIID 

### 1.1. IILOOD tI08J1I­ UDI&L 8111: 100II: 

### ALIIUIIn 'l'.J'IIOt' 8-ft' ".UIoI UftO 

### VIDl. 101,1'" tnIIIHJI 110 

### III Oil. mil _1/l. _l./l _/DL 71 I' 1-11 

# n.' '.7. 3.0J 1.03 3." 

### 1l5r.n ' •• 1 72 14 

## aa.l 

# ... , '.711 3." 1.01 3.se p 14.1 •• ' 73 P 14. 32:.2 51.' •• 5'7 2.7S 1.21 3 •• 2 1151.31 

# ,. f' 14. 30.' 61 •• 7.71 2.:11 1.00 2:.'7 12:1.35 

# " P 14 31.1 5'.1 12.12 3.11 1.11 3.U 14.7 •• 7. I' 14 

# n .• 5 ••• · 6.1' 2." 1.2. 3." 125.7& 

# .... 77 f' 14 33 •• 6.03 3.31 1.21 •• 13 1151." 

# ... ., 71 f' 14. 33.S 67.1- 2.6 1.00 2." III." 79 I' 14. 32.' 63." '.23 3.&' 1.05 3.71 137.5'7 10 14. 32.3 

### 61.t 

## I.n 3.29 2 •• 1 14.1." 

# • 1."**~GULATORYnrn'ORT** 

## - 290

# -- 90 DAY INHALATION rOXICIY STUDY 

## IN THB RAT 

## WITH RECOVERY 

## PHASE 

# APPENDIX 9 - INDIVIDUAL BLOOD CUNICAL CHEMISTRY

GllOUJI. 3 D08I LIMAi. 300 .". BU. IGLI: PLaIIIIa PLUIII.**P~** .LJJIIa. 

### .L.UD .LABA IL&IIIIa IIIDfAL 

## ax AL. AU' AlII' c:ar.e:I1M CII/8nL 

## a: CIIt/llUII 

# ...- RO 

### XVII nil IV/1 

### -.LIt _1/1 xvil _1/1 

# ,. 21 I! U 16G 

### il 2 •• 

## a••• 131 4. 2:;1 I! 1.e 1115 10 

### .3 2 •• 2.GO 10. 

## n 23 I! 1<1 204 

### 11J., 1.2 2.7' 2.10 lOS D 

### :u I! 1t 110 11 2.12 1 • .,7 

### IS U 

# " 25 I! 11 111 54 ." 

### a.77 2.U 10. U 26 11 112 181 1U 2.73 

### 2.U 173 311 

# • 21 I! 11 1to 17 1110 2.11 

## a.a7 111 A 21 I! 1<1 18' U2 154 2." 2.32 II., 4). 

# 2' 11 192 15 82 2.11 

# 2." 100 4. 

# • 30 II 1. 171 172 111 

# 2." 3.11 U4 IS**REGULATORY~ORT** 

## - 291

## 90 DAY 

# 1NHAlA110NTOXICTY S11IDY IN THE RAT WITH RECOVERY PHASE

DDIUo lIIIHBIIII 21 

## :u :z:J 24 25 21 27 

## .al :at 30 CIlOIIIP. J IID:
....... 

## au 

# ., 

# - I( 14 I( 14 I( U 

# • 14 

# • 14 I( 14 

# • 14 I( 14 

# • 14 

# • 1. IIOIIl 

### r.avm. r**~** GLUC8IIJ: _Ill 10.1 10.2 7.4 '.4 

## 10.' '.0 '.4 '.2 7.' 20.2 

# APPENDIX 9 -INDIVIDUAL BLOOD 

# CLiNCAL CHEMISTRY

3410 

# .,.. ....,. fLUIII, 

# ......... nasa. 

# ......... I'LaSICIL 

# ..... e/.IDII: 

### ",,1m. IODlUII ftl_ URA 

### _111 _1/1 

### _111 _111 _1/1 _1/1 10L 

# '.14 142 1.71 

### 1.7fo 

## '.01 1., 5.31 140 1.11 

### 1.0' '.OJ 

### 101 

# '.71 UJ 2.11 

### 1.01 1.75 

### 10L 

# '.N 142 

### 2.12 1.1I0 I." 10& lU 1.11 7.11 

# '.11 0." 10J 4.'3 lU 

### 1." 1.10 

# '.15 10.1 4.30 lU 1.$7 1.CI '.12 101 '.30 

## In 1.12 1.JI 1.52 10) 4.55 141 

### 1.n 

## I.e, 1.17 101 7.11 

### In l.'1 1.0. I •• 

## a



# lREOUlATORY/REPORT • 292

## 90 DAY INHALATION TOXICTY STUDY 

## IN THE RAT WITH RECOVERY PHASE

D_ 

# - 21 22 23 24 25 2' 27 21 U 

### 3.**~I** 3 IDI III.LII ID liliiii. 110 

# • 14 

# • 14 

# • 14 

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### 14 

# • 14 I 14 

# • 14 

# • 1.4 DO&II LIIVBL. Pr.AIIIa

u.a8IIl. 

### ell 

# 32.' 2'.1 31.' 30.5 32.7 32.3 33.0 32.4 32.4 31.' 

# APPENDIX 9 - INDIVIDUAL BLOOD CUNJCAL CHEMISTRY

SOG 

# .... l'L.I8Im**~.nor** 

### .11 I'Iio.UIIa 

### III-err 10/1 Hr.IIIID 'I ••

### X.I _1/1 

### AlG IIA'IIO BLOOD 

# -­ _1/1 

# ...... - 1.11'1'" ./IIL ' •• 5 1'.99 3.34 1.'4 3.11 

### l'S.I' S'.I 1.22 3." 1.'2 3.15 133.1Ii0 ' •• 3 

# '.37 s.:n 

# •••• 3.15 1".13 'Z.3 

# '.U 3.53 

### 0.16 3.lS 121.!! 12.2 7.19 3." 1.07 3.e. 141.72 ".0 10.15 4.1.3 0." •• 27 L47.711i 

### 'J.t 

### lIi.n 3.57 1.07 •• 03 15' •• 5 ' •• 2 7.2. 3.0S 1.02 3.0. 151." ' •• 0 

# '.12 3 .• ' 1.03 3.a. 1".13 II.' 11.:1' 2." 1.02 3.U L".10

### ~GULATORY~RT 

## - 293

# ••


# •• 90 DAY INHAlATION TOXICl'Y STUDY IN THB RAT 

# wrm RECOVERY PHASE 

# APPENDIX 9 - INDIVIDUAL BLOOD CUNICAL CHEMISTRY

QIIOUP. 3 DOD LIMU.. 300 

# ... sa .......... l'UIIIIA 

# .ro .... I'IioAIIHI. .L&SA 

## ,wuaa 

## n.ua 

# .ua. MIIIU. 

## au an: HJI UP UI' 

### c:.u.c:n. C1118'1!1& ClII: Cll/1IlD 

# ..... 110 mil. 

### tv/l tv/l -Vl.**~/l.** 

### mil _l./l. 11 

# .. 14, leI 

## .a UI 2.72 

## 1.a. 214 43 12 

## :r It 47 

### '0 2.'. 1.711 

### 18, 41 

# " 13 

## :r 14 

### 102 71 

### .2 2." 1.U 131 

## .u u 

# .. 14. 

### 10' 71 

### 104 2." 1.12 17 41 IS 

## :r 14 111. 106 2.74 2.04 10$ 

# '" 16 

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### n 7t 2.7! 

### 2.alI 

## a. 42 17 

# .. 14. 113 91 II 

## 2.a1 2.16 112 41 II 

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### 1.18 1.07 

### n It 

# .. 14 101 70 

### 2.1' 1.'1'3 

### n 

### so to 

# .. 14 1145 77 

# ., 2
... 2.02 53 tlt



# REGULATORY/REPORT . 294

## 90 DAY**INHAL~TION** 

## TOXIcrY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 9 - INDIVIDUAL BLOOD CLINICAL CHEMISTRY

GIOUJ'. 

### 3 D08II L_. 3DO 

# .... sa. I'IIIALI PLliSIII. PLAIIIIA Ho.UaA PLliSIII. PL&IIID. I'LUIII. n.a.tIIII. AIIJIDL IIU IIDII: 

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# 7.'. u P 14 

### 10.2 102 

### US 0.72 6," 

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### 2.0t 0.71 '1'.0. 

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# • I., 14 •• 1 

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## '.70 Itl 

### 1.111 0.611 

### T.'l 17 14 

### U.2 10' 

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### 14.' 100 

# '.t? 140 1.79 

### 0.'2 '1'.47 

# , to 14 

### 111.7 102 

# , 

# .... In 

### 1.61 0.'2 5.21



## REGULATORYflUWORT

- 295

# -- 

# -- 90 DAY 

# INHAIATION TOXICIY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 9 - INDIVIDUAL BLOOD 

# CUNICAL CHEMISTRY

GIOGl'. 3 D08I Lnu.. 300 JISlIl SD:. PIIIIAr.II



# ....... I'LUID 

### .LA8III. Ir.a&IA "/8 :ar.tJOe lIIOSH- UDI&L 

### so: AJ.BOJmI 

### '!'.nor 8-111" ,;.:aXLI &';10 LJ.IDiI 

# ..... 110 

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# 31." 5I.t S.II ',)3 1.21 ".Oil 18
..... 12 U n.7 

### n .• 7.n 2.11 1.1. 

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# • , as It 31.2 61.1 6. lit 2.r6 1.011 '.21 U7.S. 

# .. , 14 

# 31.' n.1I t.Ot 3;12 

### 1.17 3.31 "'0.13 

# ., p 

### 1. 30.1 57.7 5.0' 3." 1.13 3.31 152 •• ' 

# , .1 U 30.' 10.' 6.50 

## a.s. 1.02 3.51 157.11 

# , 17 U n.7 60 •• '1'.37 

## a.n l.a. ..01 1117.11
. II U 31 •• 61.7 •• '3 .,'2 1.00 3.Ia 152.20 

# • , II 14 

## 3a
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# n.' 5.27 

### n 1.10 UI.11' 3 •• ' 10 

# • 14 32.' 63 •• •• 55 2." 

# I." 2 •• ' "'3.1'1



# RWUlATORY/REPORT

- 296

## 90 DAY INHALAnON TOXlCfY STUDY IN TEE RAT WITH RECOVERY PHASE



# , GIIOUFI lID. IlAJoII AllIIIaL OJ: 

# ., .­ 

# - 1I1 14 

# • :sa 14 

# • 33 14 

# • 3' 14 

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# • 36 14 

# • 37 14 

# • JI 16 

# • 3t 

# • l' to 14 

# • D08I LDIUo. 

### 'LUIa



## u.1' lUll 1" 201 UJ 147 

### 17. III lU U6 176 151 

# APPENDIX 9· 

# INDIVIDUAL BLOOD CUNICAL CHEMISTRY

1000 ppa l'LIIiIIIIIa l'J'.IJIIII.
.... !IIIl. l'J'.IJIIII. I'w..a. :n..II8IIII**J.L~** aft c:.AICDM Cll/a'l'Jll. CIt call1'Dlll

GIl 

### IVII -u/l _1/1 IV!l _1/1 7S 

### n 2.U 

### 2.17 140 J. .S 131 2.tO 1.61 111 al 

# " 2.11 2.11 :r7 

# '!I 

# " 6S 103 2.67 1.65 1111 3. 

# ,. 106 2.t6 2.71 111 II 103 1" 2.1' 2.02 212 

# '" 7. 101 2." 2.21 US '2 7G IS 2." 2.It 137 40 

# ., 103 

### 2." 1.U 164 

# " 

# .. " 71 t7 

### 2.1" 2.37



## REGULATORynuwORT

- 297

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## 90 DAY 

## INHALATION TOXIClY 

## STUDY IN THE RAT WITH 

## ROCOVERY PHASE 

# APPENDIX 9 • INDIVIDUAL BLOOD CUNICAL CHEMISTRY

GIOal'I 

# .. DO
.. L ...... 1000 ppa BIZ. 

## xu. I'L.UIID. I'LIIIG Ir.IIaIII. PLll.8llll. I/il 

## Br.oou 

# ...... ­ 

# ... lIIIDL BIZ Af.8UJIJII 

## :r .• 1ICW 80ft**~.IU.t _~JO**  UJII& • LlnDII 110 

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### _111 III/IIL 

# -- 31 11 14 

## a'.7 

## n.1 7.'6 3.1:t 0." 3.lIt 141.51 U II 14 

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# ".3 '.61 ',Ja 1.02**~.61** 1101.51 

## .u II 14 33.1 63.7 7.25 

### •• ell 1.01 

### 3.oa 1116.17 

# 3. II U 10.' 6'.5 3.l1li 0.'1 3.'" In.55 10 •• ' IS II 14 33.2 63.6 4.10 

### 3.12 

# 1." 3.4.1 :&'71.72 56 14 29.5 60 •• 5.11 U •• 51 

# • 5 •• ' 

# •••• 3." 37 II It 

### u .• 65.6 6.11 2.44 

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... 131.65 31 16 12.6 

### tla.a 

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# • 31 I( 14 aI.5 .2.0 6.51 .... 07 

# 0." 3.'7 131.2.1

... 0 14 U.6 62 •• 7.20 3.17 1.01 2.'3 111.403 

# •**~GULATORY~ORT** 

## - 299

# •• 90 DAY INHALATIONTOXICIY 

## STUDY IN THE RAT WITH 

## RECOVERY PHASE 

# APPENDIX 9 - INDMDUAL BLOOD 

# CLiNCAL CHEMISTRY

&OVI'. 

### e DOIIK LJIVU.. 

### 1000 

# .... IID:. l'IIIILII pLll.lllQ. Pr..LIIID. I'W8IIlo PLISIA l'LUBI. n.&8IQ. 

# ...... 

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# ... AlIDIU. SU 

## u.P &'1' Aft C&IoCI
... at/8ft1 CI: CIl/mlll 110 

### mil lV/I 

### lUll _1/.1 -0111 

### 1Ut'1 _Ill U 

### 143 

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# '3 r 14 1$ 

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### 40 

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### Ie n M 111 

## a.'5 a.0'7 

## la 44 17 

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### Ie e1 72 

### a.'" a.a4 13 

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# , 14 11' 

# " .7 

# .3 2.ta 

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# ., M 

### a.n 2.431 I. :It 

# " 100 

### r 14 

### .e .1 100 .1.77 

### a.ao '71 

### .a**RBGULATORY~ORT** 

## - 300

## 90 DAY 1NHAlATION TOXICI'Y STUDY IN THE RAT WITH RBOOVElY PHASE 

# APPENDIX 9 -INDIVIDUAL BLOOD 

# CUNICAL CHEMISTRY

GIIOOP. DOI1I LIIVBL. 1000**~** SID: I I'BII&LIr 

# "



# ..**~** PLIUIIII. PLABIIl 

# . ..- .. LUIIa 

## .. r.aaa 

# .. .- JIIIIXll,L SIIlI: 

## au GLUCO!R 

### C/alDII J'O'I'/IUII 1OD:n.I JIIIOII,IIS 1UG8 UIIQ. 

# ...... 110 _1/1**~/1** _1/1 

### _1/1 _1/1 _1/1**~/J** 91 

### r 1
.. 10.1 116 5.0' 161 1.92 0.&1 1.91 '2 

### r 1
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# ., lUI 16 10.3 1
.. 

# 4." 164 2 ••• 0.17 7.6' 

# ,. .,
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# I.'• ., 4.,. 'S U- 11.2 113 1
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## o.ts 1.21 ' •• 7 

# ., 

# " '7 14 9.1 US 3.'2 143 1.21 1.65 7.93 II P 16 11.2 III 3.70 1ft. 

### 2.U 0.12 7.1:1 P It 13.3 113 

### 3.1' 1
.. 1 1.3. 

## o.n 6.61 100 P 14 16.1 1f3 3.5' 143 1.'4 0.15 5.'5



# ltEGULATORY/REPORT • 301

## 90 DAY INHAlATION TOXIC::Y STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 9
.. INDIVIDUAL BLOOD CUNICAL CHEMISTRY

1DtOVP. t IIOdIII LIIvm:.. 1000 dlt. J'IIID.I'oI: 1'L.UIIA l't.UIIa l'LUIf& l'LlaI. &/8 lloOID PIID8l'II­ 

# ...**~** IIIDIlL 

### aD UBIIIIl.**~.1'IIm** G-Ift 

### '.SILI 

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### ,/l. IO/l _l./l _Ill. 

### ./M. "I 

# - 91 

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# 32.' a.t 6.tO 

### 1.11 t.lI 16•• 32 

# Zo" 92 I' U 33.0 a.3 6.'7. :It. 62 

### 1.12 3.313 151.82 '3 II 14 

### :s .... 117.5 6.10 :S.U 1.11 3.$t 

### 151.12 

# ,. 

# ... It 32.3 42:.1 6.62 3.51 1.0' 3.70 116.19 IS I' U 31.5 ,.,1 5.22 

# 2." 1.11 3.46 131.76 I' 14 32,' 11.1 6.U 

# J." 1.16 

### 111. 

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# ., I' U 31.7 63.1 7.93 3." o •• t :1.70 1$7.'3 II 33.0 6.10 1.01 U'7.02 

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# ., I' U 31.1 n.t I.:tl 3.12 1.0' 3.13 1'72." 100 I' U 32.1 1.35 3.2'7 1.12 2.71 111."2 

# M.'

RBGULATORY/REPORT - 302

## 90 DAY INHALATIONTOXIcrYSTUDY IN THE RAT WITH 

# REO>VERY PHASE 

# APPENDIX 9
.. INDIVIDUAL BLOOD CLINICAL CHEMISTRY

IIIOUJ'. 5 IU. III\LII DOI1I LKYIIL. 0 PPI
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# ... ., J'LAIlIID. I.LlI' lUll J'LUIIA 11.'1' lVll J'LlUIIA Aft 

### rull Ir..I8IIA c::IloC:I:WI _111 I'L.t.II\III. 

### CIlI­ _1/1 

### :ruaa. 

## a 18/1 l'f.UIa c:a/llIIIII**~/l** U II 11 170 

# I. to 2.71 2.411 '71 17 U II 11 210 201 166 2.1t 2.11 .0 3!J 43 II 11 1'" 115 It 2." 2.'3 It 

# I' 

# , .. II 1. 

### Ut 115 141 2.7' 2." 72 3t 

# '15 II 1. 227 116 13' 2.'2 3.211 .0 3t U II II 202 laO 1
.... 2.10 

# 2." 113 

### 3. 47 

# .. 1. 1" I. 2lS 2." 3.10 10. 411


# ... II 11 170 101 tI 2.'0 2." 

# •• ,. It 

# .. 11 IISJ III 142 I
.... 2.71 100 47 50 II 11 111 I. I" l.tI 2.2' 101 

# ,.**~OULAroRY~ORT** 

# - 303

# •• • 90 DAY INHALATION TOXICl'Y STUDY IN THE RAT WITH RECOVERY PHASE

I\lIIOIJI' • IS 

### sa ..... JJlDIAL 

### sa RID: 

# ...... 110 U 11 

# • ta 11 

# • 61 18 

# • U 11 

# • .5 11 

# • 18


# .. n 11 

# • 

# • II 'II 11 

# • 50 11 

# • DOIII LrI&.**P~** ar.VCC81 

### _Ill

7.' '.2 

# '.6 7.7 7.' 11.11 '.1 1.1 1'.4 '.3 

# APPENDIX 9 - 

# INDMDUAL BLOOD CLINICAL CHEMISTRY

0 

# ,.. :I'LAIIB. 

# ........ 

# _x. I'LUIIIa 

# ........ PLUIa 

# -

C/JU:DS .ar/11lll 

### "'/H 

# .:rea 

# .... _111 _111 

### _111 -UI**~Il ~/I**  102 4.'0 lU 1." 1.31 1.'3 101 4.31 1t3 1." 1.U 7.13 100 4.n 142 1.'7 1.37 '.57 

# ,. '.n lU 1.114 D
... 1.11 

# " •. n lU 2.2. I.U 1.6' 101 •• SS 161 1.55 1.71 7.73 104 I." 142 1." 

### O.t., •. U lOt '.65 143 

# 1." 

# 0." 

# '.5' lOt 11.24 140 2.2' 0." 

# '.12 10f 11.77 lU 2." 1.25 I,ll



## IREGUlATORY/REPORT

- 304

## 90 DAY 

# INHALATION TOXICI'Y STUDY IN THE 

# RAT WITII RECOVERY PHASE 

# APPENDIX 9
.. INDIVIDUAL BLOOD CUNICAL CHEMISTRY



# ...... 5 IU, IIIILII DOIIII r&¥IIL • 0 WJIIIIDL 

# -­ SJDI. IIIIU 110 .1oiUIIm ALIIUIIDI 

### gil I'LUID. 

### r • PIlOt'**,,~** rw.IIa 8-B 18/1**.~** 

### ' •• ILI**_~/l** All;, 

### uuo IILOGD VUllo­**-1I~** 

# ..... - LI.IDI 

### ./DL 

## n II 11 32 •• 6'.2 1.15 3.:17 0." 3.14 

# 'I'.n u II II 31.1 6'.0 6.S6 3.13 0." 3.13 tlO.57

.. 3 

### u II II 11 II 31.3 31.1 

# 61.' 

# , 

# ... 6.31 7.'6 3.11 3.21 0.'1 

# 1." 3.n 2.111 tll.27 l70." t5 II II 31.1 61.1 1.5:1. 

### 4.31 0.,6 3.L2 '
.... 1 .6 II 11 33.0 67.7 6 •• ' 3.67 0.1111 3.n 

### 1403 ••• 

## n U II II 11 11 31
... 33.1 61 •• 65.1 6.62, 7.n 3.'" 3.'3 0.'. 1.'2, 3.U 

# .. ,. 1'0.11 111.'3 

# .., II II 

## :u.o 61.1 6." 2, •• 1 1
.... 3.7. 161.26 50 II II 32.0 6&.3 1'.11 3.10 0." 3.03 1117.11



# REGULATORYAWPORT

- 305

# -- •• ••

•• 90 DAY INHAlATION TOXICTY STLl>Y IN TIlE RAT WDlI RECOVERY PHASE 

# APPENDIX 9 • INDIVIDUAL BLOOD CUNICAL CHEMISTRY

cmou.. 5 D08JI UYIIIo. 0 

# ... SUI PaHoB .LAIIII. .r..IIIIIII. .LABIII II.UMI. I'L.lI8A .a8IIA**~** 

### .urJllAL lID ALl' 

### AliI' .a8'I' ct.r.C11III 

### Cl/.I'IL. ell: 

# ...... ... 111/1 

### 111'11 111'/1 .01./1**~/.1** 

### lV/l 

### _1/1 101 p 1. 77 

# ,. 3.01 2.54 

### n 3. 192 11 1. 

### n r1 

### n 2.113 2.61 

### .5 U 103 

### r 1. 

### n 13 10. 3.01 

### :l.u III to 104 

### r 18 SI 70 2: ••• 1.111 

# .. .. 105 11 18 115 17 

### n 3.03 2.U 62 42 10. 

### r 1. 1111 104 

### l.'75 1.01 13 U 

# " 107 11 18 

### 164 

### .7 11. 

### l ••• 2.01 17 4. 10. 

### r 1. 117 77 1115 3.01 2.2l1 

## as .0 

### let 

### r 1. 77 11 .• 7 

### :a.U 2.33 40 

# " 110 

### r 1. 110 

## n 131 3.00 2.00 lit



## IREGULATORY/REPORT • 306

## 90 DAY INHAlATION TOXICl'Y STUDY IN THE 

# RAT 

# wrm RECOVERY PHASE 

# APPENDIX 9 • INDIVIDUAL BLOOD CUNICAL CHEMISTRY

GIOUP. 5 lI08II r..vIIL. 0 PJIIIl IU.I J'lIIIlU'.Ii**p~** 1'L.IiIIIA I'LUIA**l'~** l'LUIII. PL&IIDo I'LMIIIIl AIIIIDJ'e 

## sa: DB GLUCOI!II CfttUill 1Om/I'llil HDIW 

### QOS/. 'I'IXU JIUIDIIIII 110 _loll. _l/l. _111**~/l** _111 .ol/l _1/1 

# - 101 I' II 12.6 103 •• 32 U3 1.0' 1.0. '.00 102 I' 11 15 •• 105 U7 l..l1 1.11 7.2.6 

# '.!II!! 103 I' II 16.3 

# .... lU 2.0' 

### o.,tI 1.56 '7 101 I' 11 11.0 101 •• 2' U2 1.13 0.74 7 •• ' 

# ., 105 II 17 •• 102 •• 43 1U 2.2.6 

### O.lIt '.03 101 I' 11 

### tI.O 

## loa '.36 lU 1.11 0.97 7.2' 107 I' II 15.3 101 6.21 1405 1.111 1.21 •• 75 101 I' II 11.1 lOG 3.71 US 2.22 0.'. 

### tI •• 3 10' I' 11 12.' 101 4.ot 1U 1.40 1.:11 7.n 110 I' II ',I ttl 6.16 UO 2.'3 0.67 

### •. U



# IREGUlATORY/REPORT

- 307

## 90 DAY 1NHALATION TOXICI'Y STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 9 • INDIVIDUAL BLOOD CLINICAL CHEMISTRY

GIIIOD. a DOSI 1II91IL. 0 

### p,. 

## so:. J'IIIlUdI 

# ....... 1'1'.loIII). 1'1oASa 

# ....... IIJG BLOOD 

# ....... MJJD.I'. IIBlI: 

# ., AU8IWf 

# ".ftO'J.' G-n ".BU.! ...,,!O r.UIH 

# .... 

# - _1/1 _1/1 

# -­ ell ell 

## mIl _iDr. 101 l' U 311.11 67.0 7.46 3.SIl 1.12 :l.U 171.99 102 l' 11 33.' 61 •• 7 •• 7 3." 1.11 

### S.39 1".11 103 U 31.1 7.26 3.0' 1.11 3." 1'2.21 

# ., 

# " 

# .. , 10"' 1. 33.'**n.~** 7.40 3.27 

### I.U 3.n 11".70 

# , 1011 U 33 •• 61.1 '.Ui :t.'7:I 1.06 

### 1.11 172.30 

# , 106 U 32.1 ".2 I.U 2
... 

## l.as 3.60 1114.112 

# , 10' 11 33.1 63.J I." 3.71 1.11 1.111 U4.19 

# ., 101 11 !f.. II 61 •• 7.11 :J.U 1.22. 4.10 

### 164." 

# ., lOt U :11.7 ".1 1.10 3." 1.16 3.a. II!." 

# .... 110 l' 11 3:1.1 6.U 3.10 1.11 3.'3 164.11



## IREGUlATOllY/RBPORT
- 308

# • •• 90 DAY INHALATION 1'OXICIT STUDY IN THE RA1' WITH RECOVERY PHASE 

# APPENDIX 9
.. INDIVIDUAL BL.OOD 

# CUNICAL CHEMISTRY

aOUP. I IlOfIJI IoI"I'IU. • 

### loeo PIll

.... IIBLS l'LUID I'1ioaIIU. 'J.UIII, PLAIDIA 

# ......... 'L&Sa I'foAIIKII. AIIIlLUa SSI[ a:JIJC ArJ**~** 

### AS"**~** 

### Clt/_ CII: 

### ta/1DJa Nil IVll. 

### lUll**~!).** -.1/), 

### XVIl .ol}l 

# - 

# -- 51 1a 194 10' 91 2.U 

## a.:u· II 31 

# • 52 X 11 201 101 2.15 

### S.I' .to 

# .. ,. 53 11 232 132 

### 1" 2.14 

### a.ll 

# u, 3' 

# • U l' 1411 U I' 2.11 l.'3 163 U 

# • SII X 11 

## no 16 101 Z.?I 2.U 12. 36 SII 11 1'7' 12 10. 

## a.u 2.17 

# ., • '1 

# :I..,. n Ie 110 lOT 130 

### Z.U 113 41 

# • 

# ,. S. 11 116 2 •••**~.lU.** 60 

# 3' 

# • ,., S' 11 

### 1'" It t1 2.13 I.U 711 10 X 11 U7 

# ,5 I.n l.U IT 

# 3' 

# "**KEGULATORY~PORT** 

## - 309

## 90 DAY INHALATION TOXICTY STUDY IN THE RAT WITH RECOVERY PHASB 

# APPENDIX 9 • INDIVIDUAL BLOOD CLINICAL CHEMISTRY

GaaU'I'. 1\ DOIAI UQI,. 1000 lisPI, ....... Pr.UIIk I'LA8IIiIo 'IoAIIIIl ,....". 

### .....-a. 

# ...... I'!oI8IA



## .. aar. tAlI 

# .... GIoVCOSII CIUU J'OI' n;UIoI 'IIOI/UII WIllG& 

### vua 

# "l11li 

# ...... 110 _1/1 _l/1 _1/1 _1/1 _1/1 

### _lIl -.1/1 ,II 

# .. 11 1.2 100 

## •. n 141 L.IO 1.314 1 •• 4 

## sa 

# .. II 

# I.' 101 4,111 143 L.'4 

### 1.21 7.00 

## on II II 10.lf 101 4.01 US 

### J.H 0." '.4111 

# , .. II 11 

### 12.5 

# ,. 143 :1.11 1.0' 

# ,.03 4. " .IS 11 1.3 100 4.n 143 Z.SI 1.03 

# '.11 

# " 116 

# .. II 11.6 102 '.61 143 1.60 1.17 '.311 51 11 

# '.1 100 •• 01 1
... 

# L." 20,00 

### 7,21 

# • II 

# .. 11 11.' 

### too 131 1.14 0." 

# . .. , II ••" III II II 100 4.'0 1'102 0.71 6.7' 

# ••• 

# I." 10 II II 7.3 101 4.02 143 •• U 7.n 

# I."

fRIDUlATOltYIREPORT

- 310

## 90 DAY INHAlATION TOXICTY STUDY 

## IN THE RAT 

## WITH RECOVERY 

## PHASE 

# APPENDIX 9 • INDIVIDUAL BLOOD CUNICAL CHEMISTRY



# , CIlOUI'. DOSI LIrVJIL. 1000 

# P'­ BU. BLI: PLIUIIII. I'LIIID PL&BIIIr. PLIIIIII. 

## AI. IILO(D notmIUlJ1III.L 

## au wac .l.LlJ'lD(U '!' .1'IlO'r 

### G-ft '.BUI UlJ:O UUA • LIPIDa IJO 

### gIl 

### ,11 IV/l**~/J.** _1'1 IIIiI/DL 

# - 51 :II II 

# 33." ".0 

### 2.41 3 ••• 1.02 3.71 111.'. 52 :II 11 

# n." 

# , 

# .... '.37 3.10 i.Ol 3.17 1'
..... 0 13 II II 30 •• 

### 'I.a 7." ".07 0.13 3.'3 111.11 I
.. II 11 30.3 3.0. 1.07 3.11 13'.3' 

# II.' '.n III II 11 

# 31.' ".3 ' •• 1 ... 14 1.10 2.1. 11:l.12 

# ., It., 

# a.', II la 32.' '.01 3.'0 0." 1
.... 17 57 II 11 :12.1 

# , 

# .... 5.'" 3.13 0." 3.37 1' •• 42 &I II II 't.1 

# '.71 3.011 0
.... 3.11 1.0 •• 7 2 •• " 51 I( 11 3:1.7**,~** 

# ... 7.0' 

# ".31 1.03 3.15 11 •• :11 10 I( 11 30.1 !I'.l 7.31 3.'" 1.01 3. 

### sa 117.'"**~GULATORYnrnPORT** 

### - 311

## 90 DAY INHAlATION TOXlcrY SIUDY IN 11IE RAT WITH RECOVERY PHASE 

# APPENDIX 9 • INDIVIDUAL BLOOD CUNICAL CHEMISTRY

_ DIll. 

# - CIIOUF.**~** SQ, J'II8LI: SQ 

# ... 110 DOH
...... ,.. 

# .r..taIll

.u,p 011 

### 1000 ppa :tr.a.8III.

llo'I 1./1 l'I'oAIIla U'I 

### tvll tLMD Q1.C1'UII**~/l** PLaIIIG 

### c:.J
_ -.1/1 

# ........ ca: ofl ftoUIIA 

### CII/IIlIIII**~/l** 111 

# ., 18­ 

### 112 61 

# ,. 2.1' 

### 2.U 7 .. 

# .. 111 

## r II 'I 

# ... Ui 3.1' 2.77 1311**~.** 113 

# ., 18 107 166 210 3.01 2
.... 72.**~,** 114 

## r II 

### 12
.. 16& 1t2 

### 2." 2.2' U**~3** liS 

### r II 

### n 

# " 1!17 2.71 2."3 

# " 43 

### 11' P II 112 1_ 

# a., a••' 

# 1." 112 U 117 

# ., 11 

# " 17 7111 

### 2.T' 1.13 73 31 UI P 1. 117 71 12
.. 2.11 

### 2.73 

# " 4. 11' P 11 102 166 300 3.0" 2.4& 57 41 1:1141 P II 101 

# ... 73 

# 2.'" 2.13 66 41



## 'RBOUIATORY/REPORT**~** 

## JU

## 90 DAY INHALATION TOXICTY STIIDY IN TIlE RAT WJfH 

## REroVERY PHASE 

# APPENDIX 9
.. INDIVIDUAL BLOOD CUNICAL CHEMISTRY

CIIIClU1'. 6 DOS:I ::.II'f'Do. 1000 

### ua 1IIIa • 

### .-..s


# ........ I'r..ua .t.uD PLA8l, 

# ........ 

# ...... I'Io.UU. M'lIIU ID 

# ... .: GL1IC08B C/IUIII H'f/l1lll SIXlIW 

## :nos/_ ftD18 

# ..... 

# ....... 110 _1/1 _111 _111 

### -Ul _1.11 

### _1'1 _1/1 111 

### r 11 '.2 104. 4.ao U4 1.60 0.1'7 '7.n 112 

### r II 2C.2 10C 5.15 

## u. l.U O. '71 

# '.U'­ 113 

### r 1. 13.' 103 

### 3.11 US 0.'71 5.'2 l •• ' llC 

### r 1. •• 5 101 5.U "2 1.54 

## o.n 

# 6." 115 

### r II 13.1 6.13 131 I.U 0.6' '7.'. 11. p 18 12.2 101 4.U U3 l.U 0.'70 

# '.a. 117 r 11 

### '.7 100 4,27 143 1.26 1.35 I.IC 

### r II 12 •• 101 4.11 U2 l.tI 0.60 •• 50 

# ll. "



# ., 11 14 •• 100 4.61 144 0.6' 

# l.'" 

# .. ,' 11' 120 

### r 11 11.1 104 4.41 141 l.U 0.5. 5.11



## IREGUlATORY/REPORT

- 313

## 90 DAY INHALATION TOXICIY STUDY IN THE RAT WITH REOOVERY PHASE 

# APPENDIX 9 • INDIVIDUAL BLOOD CUNICAL CHEMISTRY

1i1IO'CQ', I D08I LKftL. 10" 

# .... SU
............ 

# .....,.**~.** 

# .......... 

# .......... 11./& BLOOI**JII08"~** AIIIUL lID: 

# .., AloIIUImI**".~** Qo4! "
.. UI "'''10 IOUIDII 

# ..... .... II/I _1/1 

# -- ., 

# . II/I 11111 _111 111 I' 11 II.! 16.6 7.21 3.11 1.13 3.71 

## a ••• u 11:1 

### r II 

# 31.' 'I.a: 7.4:1 

### 2.U 1.0' 1I.1S 

## no." ll! p 11 11'.1 

### 66. 

## a 1.30 1I.la 1.0' 2." 117.11 

# ., lit 11 :1'.0 ".! 7.66 2. ,. 1.12 

### 3.2S U7.:J2 115 

# .. 11 31.0 

## n.a 6.31 11.01 1.14 

### :I.n 111.27 

# ., 11 33.1 

## n.l 5.1' 11.'5 1.1:1 '.111 1".0:1 

# 11' 117 

# .. 11 ".1 ".11 I.IIS 3." I.U •• U Itl.21 111 P! 11 33.:1 13.11 

# '.'5 11.013 1.11 11.'1 ltO.1? 11' P! U 

# It.' II.' 6.10 

# 3.'" 1.0a 1I.2T 111." 1:1. P! II
.... 5 1.10 2.71 UlI.12 

# 3!.' ",I 

# '.n

IREGULATORY/RBPORT

- 314

# • • 90 DAY INHAIATION TOXICTY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 9 - INDIVIDUAL BLOOD CUNICAL CHEMISTRY

GI:01I:.. 

### 1 D08I LKYIIL. ppa 

# • SU:. KU.II LlYIDl AIIDfU. 

## sa: lPCGI. 

# -. • 

# - -,.,. 110 If 14 0.:186 

# , it 

# • •. n' 14 0.232 !Ii' If It 

# 0."'" 10 1. •• !PI 

# •**~GUlATORY/RE1ORT** 

## . 315

# ~ 

# i**~ ~** 

w 0\ 

# -**~** : : :: := 

# Ii

.. .. 

# .. .. .. 

# !

# ~I 

# .. .. 

# "" All • 

# ""
... .. 

# .. • 

# !II 

# i:

.. I
r

# ~ ~**~ ~ ~** 

# tiS 

# , .. Will...
... ... • 

# : t :: :: : ii' 

# •

# ~ I 'V 

# m Z C 

# X U) I 

# Z 

# c 

# -
- < 

# c c )It r" 

# 6 0 

# c n I: 

# z

# n

# ~ 

# n X 

# m I: 

# !i**~ ~** 

# ~ I<

# ~ d

# ~ 

# d

# ~**~** -< 

# i

# ~

# ~**~.**

# ~ "**~** 

# -<

# ~

## 90 DAY INHAlATION TOXICfY sruDY IN THE RAT WITH RECOVERY PHASE

GIIOVP. Z SUI IIALI: UDII.I. SIlt 

# ... 110 

# ...... 16 

# .. U. 17 

# .. 14 11 II 14 It 

# .. 14 

## zo 

# .. 14 

# APPENDIX 9 .. INDIVIDUAL BLOOD CLINICAL CHEMISTRY

DOa:I LPIIL. 100 ppa LI9D.



# - _laI.



### 0.154 0.30' 

### 0.U4 0.23:11 O.,Ot



## IREGULATORY/REPORT

- 317

## 90 DAY INHAlATION TOXICfY STUDY IN 

## nIB RATWlTH lWOOVERY PHASE 

# APPENDIX 9 -INDIVIDUAL 

# BLOOD CUMICAL CHEMISTRY

GIIOUI'. I IIOBIl LSYlIL. 100**~** 8:1][. FIIIDLII DlDL 

# -­ lID 

# - JI() LIYlIII**.~** 

# aa/.,. 7t F U. 0.309 77 

# ,. 14. 0.077 71 

# ,. 14. 

### o.ln 7t 

# ,. U 0.3.)2 10 F U, 0.232



## /REGULATORYIR.EPORT • 318

## 90 DAY INHALATION TOXICJY STIIDY IN THE RAT WlTIl RECOVERY PHASE 

# APPENDIX 9 • INDIVIDUAL BLOOD CUNICAL CHEMISTRY

4iaOUI'. 3 DOSI 

## r.n.u.. 31111 1iU.**~** LlYR illlIGL 

### lID: .c:oA 110 

### -.III/a 

# ... Pa­



# - 26 U 11.'77 

# • 27 U 0.617 

# • aa I 14 0.lt3 2' I 14 0.077 lit I 14 0.3011



## 2/REGUlATORY/REPORT • 31!)

# •• •• 90 DAY INHALATION TOXICI'Y STUDY IN TIlE RAT 

# wrrn RECOVEl.Y PHASE 

# APPENDIX 9 • INDIVIDUAL BLOOD CUNICAL CHEMISTRY

QaOOI'. 3 DOD LlIVBL. 3.0 

# ...**IID.~** LIYDI UDIAL lID .cal. 

# ... IIUIIIIJIIl 110 

# -'./8 

# ., r 14 0.30' 

### .7 r 14 0.017 

### r 14 O.lUo 

### r 14 1.15 • .0 

### r 14 0.017



# IREGUlATORY/REPORT

- 320

## 90 DAY INHALATION TOXIcrY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 9 - INDMDUAL BLOOD CLINICAL CHEMISTRY**~.** 4 DOh: .L1I'9IDo. 1000 

# .... SIIlI:. IIU.I 

### Lrna 

# ... 8lIfA£ BBa !'Col.. JIO**~.,u** 

# - 36 II 14 0.077 37 II 14 0.017 

## 3. 

# .. It 0.113 :It II 14 

## a.3e, 40 

# .. 14 0.077



## IftEGULATORY/REPORT • 321

## 90 DAY INHALATIONTOXICl'Y STUDY IN TIlE RAT WITH RECOVERY PHASE 

# APPENDIX 9 • t4DIVIDUAL BLOOD CLINICAL CHEMISTRY

GIlOVP • 

# • IIlUI: • I'II:IIIIiLS 110IIII LSUL. 10&0 SIsAIIDfAL 

# ..... . , IU 

# , 

# - 110 14 LIYU l'CoA 

## -'-/"

0.077 

### .7 

# , 14 O.lU 

# ,. r 14 0.15& 

# ,. , 14 11.30' 100 F 14 11.15'

### ~GUlATORY/R.EPORT 

## - 322

## 90 DAY 

# INHALC\TION TOXICI'Y STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 10 -INDIVIDUAL URINE CUNICAL CHEMISTRY Key: 

# The following abbreviations may appear in this 

# Appendix. M - 

# male F
- 

# fema:.e NO

- number Y - 

# yellow URO/GEN

- urobilinogen B/RUBIN

- bilirubin BLD - 

# blood B CELLS - 

# blood cells 

# E!IHIAL - epithelial**~** 

# - negative 

# + ) Represent an arbitrary scale 

# ++ ) of increasing presence of a +++) urinary parameter. If 

# there are text comments further desatbing the appearance of the urine they 

# are shown at the 

# back: of this Appendix.**~GULATORY~ORT** 

# - 3D

## 90 DAY INHAlATION TOXJClY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 10 .. 

# INDIVIDUAL URINE CUNICAL 

# CHEMISTRY

GlO1II'. 1 DOIII LCfBt.. Q 

# ... ..:. MI.II UhU- 

## uua VllDIII 11111. VIIJ.a 111101 

### _DIll Mnw:. .uKlJI ct£0lIIt 

## wr. ... 8(; 6lLI1COU**.~QJJI** 

# .. .... 

# .. 110 

### at 

# - 1 

# • 13 10..." !' 1'1.0 1.':U 

# •••• 

# .. .... 2 1.:1 IOIIIJlo Y 7.8 1.(3. ..36 JIlIQ 

# ... • 3 13 JOIIIIiI.Io I 1t.0 1.U. JI:IG II8S 

# • '.'7 

# , 

# .. 13 JOmw. Y 

## I.a 1 •• 11 7.17 

# .. .. !I 

### 13 

# ...... I 

## n.1I**l.~U** 7 .... 

# .. ... •


# .. 13 IIOIIIDI. Y 

# '.0 1 .• 1 7.18 

# .. .. • 

# ... 7 II 13**~** Y 7.0 1.01:1 7.03 DO 13 110....... Y 21\ •• 

## 1.«'" 'I'.U DC 

# • • 

# .. • 

# .. 13 IO&IIU. Y 

### 13.0 1 ••• 7.11 

# .... 

# .. 10 13 IIOJIDI. I 12 •• 

### l.U' 7.11 IllIG 

# ... •**~GULATORYnmrORT** 

### - 324

# • • 90 DAY INHAlATION TOXICfY SfUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 10· INDIVIDUAL URINE CUNICAL CHEMISTRY**~.** 1 D08II ...."..... 0 pa- SO:. IIU& DID 

## nnn RID DDII &IDIU. 

## so: WIlD**~** BLOOD PIIO'RD u.)/1ID 110 _1/1 

# ..... 1 II 13 

## mea IllIG +. 3.2 

## :a 

# .. 13 fIUI.ClI: ftactI +t 

### 3.1I 3 II 13 IIR IllIG + 

### 3.1I



# .. 

# .. 13 + 

# .. ++ 

### 3.2 5 

# .. 13 IIR + 

### 3.2 

# , 

# ­
.. 13 IllIG ++ 3.2 '7 II 13 IIJIG +t 

### 3.1I 13 UCI JIIIG + 3.2 t II 

### 13 DACII lin 

# ... 3.2 10 II 13 \'U.CII lin ++ 

### 3.2**~ULATORY~ORT** 

## - 325

## 90 DAY INHALATION TOXlC1Y STUDY IN THE RAT 

# wrm: RECOVERY PHASE 

# APPENDIX 10 • INDIVIDUAL URINE CUNICAL CHEMISTRY

GIIIOVI'. 1 D:I8lI LIfnIL. 0 PPI BU ........ :.uoJopa. 

# ..... IrJtJ:IG mil. 

# -- 8DU VIIDDI aIIllf.& 

### 8a. 

# ..- UI<:I 

## eor.ou YOL
.. BIiI JIll GLOClO8I .'
.... 1. 10 al 

# --- 6J U C£OOI)!" 

### r 15.0 1 .•

# ,3 •• S­ 

# ., 

# ... ... 1, •• 

# ... I' U 1IO'IMlI.t. 1 

### 1 .• 11 

### t.n mIG 

# " 

# .. 6" 7' U 110
....... 

### r L".'III t.OLS 

### t.U. dO


# ... p 

# '.11 

# .. u IIOI1111L 't 

## n .• 1.'111,6 dO 65 11 CLQIUD'r l' 

### I1.S 1 •• 17 6.73 11M IllIG 

# . , ., P 

# ...... 2,.0 

# .. lIN 1J l' 

### 1.01' 6." IT 

# ., U 

# ....... l' 

## n.o 1.013 

### 1.01 r.u.c:.& del 

# ., U 

# ....... l' 17 •• 1.011 1.12 

# ... ..­ 6' 

# .. P 11 IIOJIIW. l' LO •• 1.0:&$ 

# 5.'" IllIG 

# .. ,. ., 

# ., 

# .... 

# .. .. If IIOIIIIa.I'. ].f •• 

### .1.0'1_



# 2/REGULATORYIJ.tEPORT • 326

## 90 DAY INHAlATION TOXICTY STUDY IN-THE RAT WITH RECOVERY PHASE 

# APPENDIX 10· INDIVIDUAL URINE CUNICAL CHEMISTRY

GIOVl'. 1 D081I LIIYJIL. 0 

### lisa



# --**sa.~** 

# - vanr& 

## mun 'lJllDIII 'IJIIDII UIJII,L 

### sa D'rCJmIS BLOOD l'IIOUD' UiO/CIIIII 110 _Ill U 

### r 13 11M IIH 

### + 3.1 62 

### r 13 

### IIC KIIG Dac:JI 3.2 53 I' 13 01; KIIG IIH 3.1I 54 I' 13 IllIG lUG 'D&<3 :S.2 

# .. I' 13 lUG IU.ClI 3.2 

# " 

# .. I' 13 DC**~** 3.2 

# " 67 

### r 13 IIH ftM:I lid 3.2 

# 6. 

# ... 

# .. I' 13 'I'UCII 3.2 69 

### r 13 IllIG IIH 'I'UCII 3.2 70 

### r 13 IllIG JIJIC IllIG 3.2**~GULATORY~PORT** 

## • 3Zl

## 90 DAY INHAI.ATION TOXIClY S'IUDY IN THE RAT WITH 

# RECOVERY PHASE 

# APPENDIX 10 -INDIVIDUAL URINE CUNICAL CHEMISTRY

GIOOl'. % DOIII UYn. 100 ". lID I JIU.II, .uPUIl- VRI:D 

### .. :um .. u. IIIlIIIIi muD IJ2IR UDIAL lID IIIDJt AIIC3 CClLOVII 901._ M 

### J.III GIoUCOIQi a/IIUJlD 

# ., 111 

# -- 11 

# .. 13 IIOaI.I. Y 20.0 1.12.. 

# ... IIIICI 

# ".11 12 

# .. 13 IIO.ut.L Y 12.1 1.'27 1.40 IIBG 

# ... ... 13 II 13 IOIIIIAL Y 11.0 1.12.3 1.02 KIIiGI U 

# .. 13**~** 

### r '.0 1.C32 1." IllIG 

# ... 15 13 IIOaI.I. 

## r 11.0 1.'2% 1.%1 IIIIGI 

# ... • 11 

# .. 13 IIOIIIaL 

## r 12.0 1.'23 1.'7 

# ... 11M 17 13 IIOIIIaL 

## r 11.0 1.12.% 

# I." 

# .. .. • 18 13 IIOIIIIII.L Y •• 0**1.~31** 1
..... IIIIGI IIBG 

# • 19 

# .. 13 IIOIIIIII.L y 27.0 1.U3 1.'7 IIIIGI IIIIGI %0 

# .. 13 IIOIIIIII.L I' 42.0 1.UO 1.11 

# .. ...

IREGUI..ATORY/REPORT
- 328

## 90 DAY INHAIATION rOXICfY STUDY IN 'I'HE 

## RAT WlTIf RECOVERY PHASE 

# APPENDIX 10 -INDMDUAL URINE CUNICAL CHEMISTRY

GIIOUJ'. 2 D08I r..IIWL. 100 PPII IIIZ. BLJI VJlIb VJIllIIi VJlIb 

## Dr. InIIAIo sa; 

# .... D!'<IIII8 BLOOD I'IIO'l'IiUl DO/_ 1lO _lit 

# ..... 

# .. 11 

## x 13 'DACB 3.2. 12 X 13 !lIN 

## an 

# ....**3.~** 13 X 13 'DACB IllIG ++ 3.1 U X 13 ftt&CB ++ 3.% 

# .. 15 X 13 BACII + 3.2. 

# .. 16 X 13 ftACII :1.2 

# .. 17 X 13 ftACII ++ :1.2 

# .. 1. X 13 + JI1lG 

# •• 3.2: 19 13 IllIG 'DACI 

### 3.: 

# • 20 13 DG I'K DACII 

## 3.a 

# •**~ULATORY~PORT** 

## - 329

## 90 DAY INHAlATION TOXICfY STUDY IN DIE RAT WITH RECOVERY PHASE 

# APPENDIX 10 -INDMDUAL URINE CUNICAL CHEMISTRY

UlJIIIL 

# - 71 12 7S 

# ,. 15 

# " 11 1. 

# " aD GItOOt. 2 lID. l"IIIIU.B SD 

# - 110 J' 1lI J' 13 J' 13 

# ., 13 

# ., 13 

### r 13 

# • 13 

# ., 1:1 

### r 13 

### r 1:1 D081I UYIIL.



# ....... ­

It.IICZ IODJ,L IOaIIIlo IODJ,L IOIDL JOa'AI. JOa'AI. JOIU.L 

# .,..... lIOaUo lIOIIIIIL 100 

### .snIB

C«aOIft l' l' l' l' l' l' Y l' l' Y VUD 

# VOL_ III 15.1 13.0 40.0 17.1 111.0 11.0 12 •. 5 111.0 11.0 11.1 

### nUl 

# .. 1.019 1.011 

### 1.0407 1.017 1.UI 1.011 1.0ao 1.el9 1 •• :1:1 1.U' .. l1li: 

### aID 

# ,. GI'.UCDIIII '.55 DC: 

# •••• DC: '.23 DC: 

## •. s. 

# .. 1.03 

# ... 1.1.5 De 1.24 

# .. '.11
. 

# .. 7.00 DC: 

### 7.11 

# .. awrII 8/11UJ11l1 DC: DC: 

# .­ 

# ... ... ... 

# .. .. ... 

# -­

VREGULATORY/REPORT • 330

## 90 DAY INHALATION rOXICIY STUDY IN THE RAT WITH RECOVERY PHASB 

# APPENDIX 10 -INDMDUAL URINE CUNICAL CHEMISTRY

4aOUP. 

### a DOSII: LBYKL. leO 

# ... 111m • I'JIIIII.UI DDIlI 

## nra
.. DIll 

## na::. _DII.L lID DYOIRS IILOOD HOnm 

### no/_ 

# ....... _1/1 110 

# - 11 I 13 lUG 

# ..**~** -.; 3.2 72 I 13 IQIG IQIG tu.a 

## 3.a '73 I 13 IQIG DV <> 3.:1 

# - .. '74 

### r 13 IQIG 3.1 '75 

### r 13 IQIG IQIG 3.2 

# .. 

# ­ '76 I 13 lUG '!IllICIt S.l 1'7 

### r 13**O~** ftW:I 9ACII 

### 3.2 '78 

### r 13**O~** IQIG '!IllICIt 3.1 '79 

### r 13 OG 'IIIACII 3.1 

# .. .. 10 

### r 13 IllIG IllIG 3.2**mEGULATORY~PORT** 

## - 331

## 90 DAY INHALATION TOXICfY STUDY IN THE RAT 

# wrm RECOVERY PHASE 

# APPENDIX 10 -INDIVIDUAL URINE CUNICAL CHEMISTRY

1ItOUJI. 3 DOSJI LDIIli. 3DO JIlIII IllS. IIAU U1IlD VIUJI1r 'UUD U1IDUI VIIl:_ DDIII 

# ... AI'I''''- 

# 110._ "'IDL .IIX .uICII COLOR M pII GLUC08II ., ... 0 lIUIIIID BO Ill. 2.1 13 IIOI111U. 'I 10.11 1.0ao 

### 1.41 

# .. .. • 

# .. 

# .. 22 13 IIOIIIGL 'I 1.1 

### 1.otO 

### 1.11 

# • 23 II 13 WOD&L 'I 10.1 l.8al 7.21 

# .. .. ... ... 2C 13 IIOIIIIU. l' 1.1 1.033 

### 6.'4 

# • 211 II 13 .,IIIIIL 'I 16.0 1.023 1.12 

# ... ... 

# .. a. 13 BOIIIIU. 'I 21.0 1.011 1.38 JaN 

# • a7 II 13 

# ....... 'I 10.0 1.031 7.32 

# ... ... 28 II 13 JIOJIIIaL 'I 211 •• 1.011 7.11 DC! 

# ... 2. 

# .. 13 .,IIIIIL 'I 1'.0 l.oao 

### 1.69 

# ... JaN 30 

# .. 13 BOIIIIU. 'I 23.0 1.016 1.51 

# ... JaN



# llEGULATORY/REPORT • 332

# •• 90 DAYINH.ALATIONTOXIcrY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 10·
... DMDUAL URINE CUNICAL CHEMISTRY

caouJ'. :I 

## oos. LKYKL. 300 

# ... aBl
...... UIlDIJI 1IIlDII ftDII: UllIn aJlDIIIL 

## sa n:a KIftClIOSIl BIoOOD U1t;)/CDIf 

### noD" 

# ..... _1/1 110 21 II 13 ftloCi IlK +< 3.2 22 II 13 ftloCI + 1 •• 0 U II IS ftloCII 11M +i 3.2 2' 13 ftloCI IIJI& 3.:1 I( .i 

### as I( 13 ftloCI IIBG ++ 3.2 26 13 DG IIBG + 3.2 

# • 

# .. 27 II IS ++ 3.2 2. 13 

### DG 11M + 3.2 

# • 2t 13 ftloCI lin + 3.2 

# • 30 II 13 !DCI 11M 3.2 

# •**~OULATORYnuwORT** 

## • 333

## 90 DAY INHAlATION TOXIClY STUDY IN THE RAT 

## WITH RECOVERY PHASE 

# APPENDIX 10 -INDIVIlUAL URINE CLINICAL CHEMISTRY

GIIiaID'. 3 D08I
......... 300 ppa IJIZ. FIIIIUJI 

### unut- 

### Dro UItlID uaID 

### nlD 0l1li &.DIll '-DIU. 

## au 

# .... U'CII C1IJ,CRm 1'IIlILUIII IIG pM GliIlCOlUl a/_III 

# ....- 110 111 at J 13 8OaD.L Y 

### 23.5 1.U' 6." DQ DC 12 J 13 Y 12.1 1.tal 6.31 DQ DC 13 

# - DQ J 13 

# ....... 'I 16.1 1.U2 ' •• 1 DC 14 J 13 Y '.0 1.132 DQ IIIICI ' •• 3 

### II 

### r 13 

# - :r 11 •• 

## l.n. '.11 

# .. .. 

# - ... 

# .. I. I 13 110
..... 'I 

### II •• 1.UI 1.17 

# .., 

# .. 13 HIIlUIL Y 11.0 1.)27 

### 1.26 IIIICI 

### I. 

### r 13 JIQ1IIW'. Y 140.0 1.J22 

### 1.1t 

# ... 

# .. ., 

# .. .. r 13 Y 1'.0 

### 1.tU 6.1t 

### to 

### r 13 

# - IIOIIIaL Y 7.0 1 • .,1 

# .. .,., 

# .. ..

IREGULATORY/REPORT • 334

# •• 

# •• 90 DAY INHALATION TOXICfY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 10 .. INDMDUAL URINE CUNICAL CHEMISTRY

GIDUJ'. 3 DOBII r&vBL. 

### 380 PJIII 811:1. I"III&U.I UIlID
.. DIll aID 1JiII1D MIIIIL 

### aD ICft<lIIIB JniOOI) PIIOI'IIII 

# - RD," lItIIBa aD _Ill 11 l' 13 DG 11K 3.2 

# ... .2 p 13 DG IDG !'IIACII 3.a. 

# .3 

# ... p 13 lIN + l.2 p 13 lIN + 3.2 

# .. 

# ­ 

# - ... .5 P 13 JIIc:: 3.2 86 p 13 De 11K IIIICIi 3.:11 

# ., 

# ... p 13 lIN + 3.2 

# ... P 13 lIN ftACII l.:II 

# ... P 13 lIN IDCI 3.:1 

### .0 l' 13 DG + 3.:1 

# ...**~GULATORY~ORT** 

# - 335

## 90 DAY INHAlATION TOXICIY STUDY IN THE RAT WITH RECOVERY PHASE

_DIAL 

# -- :11 S2 33 3t 

# '5 

# 3. 37 Ja 

# " to GIOII'I'. t SlCI: I IIIIU 

## sa WIlD 110 

# • 13 

# • 13 )( 13 I! 13 

# • 1S I! 13 )( 13 

# • 13 

# • 13 

# • 13 DOSI 

## r.rnu..



# ......... ­

AIIC3 IJOIIDL 

## .oau.r. IIOaaL .OJIIIUU'. IIOIIIDL IIOaaL IIODIIIo IIOIIIDL IIOIIIDL IIOaaL 

# APPENDIX 10 -INDIVIDUAL URINE CUNICAL CHEMISTRY

1000 PPII RDJI UIIlJIII 

## au. RlJIII Willi ftDK

COLOUII 

## vor. ... 811 

### l1li GLO'COIII ./UIID 

### at 

# .. Y 11.15 1.Ut 7.02 IllIG 11.0 1."',2 

# III." 

# .. JaM! Y 37.0 I.UO '.01 

# ... y


# .. 

# ­ Y S.O 1.1ll0 111.58 11M y 12.S 1.UO IllIG 

# I." 

# .. Y 18 •• 1.12" 7.21 IllIG JaM! 

# ... Y 21.0 1.01' 7.73 IllIG 

# ... Y IS.O 1.016 '.!l0 IIJIO 

# .. Y '15.0 1.011 

## 7.n IllIG Y 11.5 

## l.ea. 7.17 

# .. IllIG



## RBGULATORY/REPORT

- 336

## 90 DAY INHAI.ATION TOXICfY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 10 -INDIVIDUAL URINE CLINICAL CHEMISTRY

GIIIOIIQI • 

# .. DOD L.vsL. 1000 PPII 

### am I IIALIl 

### "DIll: OlD 

### vannt 

### oua _ou. 8D 

# .... IIlI'l'Ca.S IILOOD noDDI ORO/CRIll 

# ., IIUIIUJt -.1./1 31 13 ftI.II.CII IdS +i' 3.1 

# • 3:& 13 ftI.II.CII ftACI: +. 3.:1 

# • 33 13 D8 IdS 

# .. 3.2 

# • 

# .. 34 13 ftI.II.CII DG 16.0 

# • 

# .. 35 13 + ++ 3.2 

# • 

# .. 36 I 13 ftI.II.CII + 3.:1 37 13 'I'IWlII Dc: 

# .. 3.:1 

# • 31 I 13 IllIG IllIG 

# .. 3.2 :It 13 DG 

# ... .. 3.2 

# • 40 13 

# .. 

# .. + 3.:1 

# •**~GULA70RYnuwORT** 

## - 337

# •• 90 DAY INHAlAnONTOXIcrY 

## STUDY IN TIlE RAT WITH RECOVERY PHASE 

# APPENDIX 10 -INDIVIDUAL URINE CLiNCAL CHEMISTRY
CIlOU.. I IJICIS LlIYIIL. 1000 PPI IU ........ 

# _DIll Uvu:&- UIlID ftDIII UUIIII ftDIII UUIIII AJlDIUo lID. 

# ... .urc:B 

### c:or.oua VOLUIII 

# .. 

# .. GLlIC08II B/IlVIID 110 -.l 

# - U 

### r 13 

### .OIlWi 

# , 20.' 1.011 

### I.SC ma; 

# .. .. " n p 13 IIOI1Wi I 20.0 1.017 '.0' 

## ao t3 

### r 13 IIOI1Wi 

### -r 11 •• 1.0U I.*, 

# ... IIIQ 

### r 13 IIOIIWi 

### -r S.' 1.03' 41.1' 

# .. 

# .. .5 r 13 IIII..aL 

### -r 2$.0 1.011 

# '.73 DC! 

# .. r 13 IIO.cJIL 

### -r SI.O 1.01:1 7.33 

# •• 

# .. .. u IIOIIWi 1.031 

## r 13 IIOIIWi 11 1 •• 0 1.017 

### I," DIll 

# ., r 11 

## t.O 

# ,.,,, 

# .. 

# .. .. •• ".5 

# '.3' 

# .. 

# .. F 13 

### 110_ 

### -r 1.033 

### leo 

## r 11 IIOIIWi I 

### 12.5 1 •• 

## a:a 

# '.It 

# .. ..

'REGULATORYIREPORT

- 338

# •• 90 DAY INHA1ATION TOXICTY srUOY IN 

## nIB RAT WITH RECOVERY PHASE 

# APPENDIX 10· INDIVIDUAL URINE CLINICAL CHEMISTRY

GI:OVJI. , 1000 DQh L
..... ' 

# ... sa. I'lIIIUoJI RUllI UlUIII UJtllIIi UIlDIII .utDQ.L 

### sa IIlIDI: JCII'1'tmI:B HOOD JIIIO'IBJII 

### uao/ga lit _1/1 

# --- .1 

### r 13 IllIG IllIG IllIG 3.2 .2 P 13 IDCI DC! IU.CII 1.2 13 

### r 13 Del 

### 'l'ILICI: '.2 

# - .4 P 13 IllIG DC + 3.2 P 13 IllIG IllIG IllIG '.2 

# 'Ii sa p 1J IDCI 11M IllIG :1.2 

# ., 

# .. .7 U + 3.2 

# ... ., 13 

# - Del IllIG •• 2 

# ., ., 13 IllIG DC + 3.2 100 p 13 IllIG DII 'l'DCIi 3.2



## IREGULATORY.'REPORT - 339

## 90 DAY INHAlATION TOXICIY sruDY IN THE RAT WITH RECOVERY PHASE

CIllOUl'I 15 

## su • 

## .u.. AII'lII&L ilia'. liliiii: 

# ....... 110 U III 17 

# '2 III 17 43 III 17 

# '" III 17 II 17 

# "II ", 

# • 17 

# '" 

# • 17



# .... 17 

# • 17 

# '" 

# • 50 17 

# • D08I LwaLlUPIAIIAIICS 

# - lIOaAL IIOJIIIU. IIOmIAL 

# - IIOJIIIU. IIOIIIIIUo 

# - IIOI11GU. IIOIIIGL 

# APPENDIX 10 -INDIVIDUAL URINE CUNICAL CHEMISTRY
0 1IPI

UJUR

CDLOVR UllIa YOLUIIII 111 UllDlil 8& UIIIIIII pH UIIIIIII GliIHlClflll 

### nllll 

# .,_:or
l' 

## n.o l.taO T.33 dIG IllIG l' 15 •• 1.J2S 7.111 IllIG IllIG l' 12.0 1.t3;t 6.11 IllIG II'1II l' 25.0 l.nT 7.22 IllIG Be l' l' 

### n.1I 27.S 1.1113 1.1117 7 •• 11 

### 1.12 IllIG IllIG IllIG 

# .. l' 15.5 1.02' 6.81 IllIG IllIG l' l' 'I lO.O 1".0 10.5 1.0. 1.02. 1.02. 

# '.IIS '.n 7.06 IllIG IllIG 

# .. ... ... ...

tRBOUlATORY/REPORT 

## • 3.0

## 90 DAY INHAlATION TOXICfY SI1IDY IN 

## TIlE. RAT wmI 

## lGCOVERY 

## PHASE 

# APPENDIX 10 -INDIVIDUAL URINE CUNICAL CHEMISTRY

QIlOUP. 5 lI08II LJIVIII,. 0 PPII lID. IOILII VRIa 8Ia DIa Dna 

## Uncu. an 

# ..... D'IOEIS Br.ooD HODU 

## no/_ 

# .- .0 

### _111 U II 17 IllIG + '.2 

# .. fa I( 11 'II'IUI.aI lIS ++ 3.2 

# .. 43 II 17 'II'IUI.aI ++ 3.1 U II 17 'I'ItACIr + 3.2 

# .. IS II 11 l1li8 'I'IlACS + 3.2 II 17 IllIG IIU :1.1 

# " 

# .. • n II 17 'II'IUI.aI 3.2 

# .. 

# .. • I( 17 'II'IUI.aI ++ 3.2 til II 17 11K + 

# .. ... '.2 

### 5. II 17 'l'IUoII3 + 3.2**~ULATORY~PORT** 

## - 341

## 90 DAY INHALATION TOXICrY STIJDY IN THE RAT WITH REroVERY PHASE 

# APPENDIX 10 • 

# INDIVIDUAL URINE CUNICAL CHEMISTRY

GJlOII'. S DOSB QVI:L. 0 

# ...

__ sa, PaIIl.B 

## » .... - UllIn 

### uu .. 01
.. 

### uaaa: UUJIII

.. DIU. 

## su 

# - NICS COLClIDI. '9'OLIIR 

# .. »II CIL'IICOID 

# .:a1IIIIII IIUIIIldt 110 III 

# .....,. 

# .. 101 

### r 11 11 11.0 1.011 '.23 11M 102 I' 11 IIOIID.L 11 11.5 1.023 

### 6.U 

# .. ... 183 I' 11 lIOIIWo 11 1 •• 1.0U •• 11 DIG 11M 

### :11:1, 

### r 11 lIOIIWo 11 10.0 1.021 

# '.n 

# .. Be 

# .. ., 

# .. .. 185 I' 1'7 IIOIIIIUo 1: l2.S 1.0U 101 

### r 11 IIOIID.L 11 D.O 1.024) 

### •. U 11M 

# .. ., 

# ..... 

# ... , 

# .... 

# .. 107 I' 11 1: U.S 

### 1 •• 25 101 

### r 11 

# ..,

# ..... 11 

### D .• 1.OZI 

# ... DC 

### '.1' 

### U. I' 11 IIOIIIAL 1: U •• 1.02l "It 

# ... ... .., 110 

### r 11 IIOtIIIL 1: 7.S 

### 1.0n 

## .... s DC



## REGULATORY/REPORT . 342

# - - 90 DAY INHALATIONTOXICI'Y SI1JDY IN TIlE RAT WITH RECOVERY PHASE 

# APPENDIX 10 .INDMDUAL URINE CUNCAL CHEMISTRY

tiIIlOlII' • 5 DCa LJrIBL. 0 Pili lID
....... 

# - UllDIIi OlD UIIDIIi VIlDS .unJaI. SJD[ IQI!'CEIS Jr.oGO 

### .. O'rlll. 1lIIO/GIIII 110 _1/1 

# --

101 F 17 .. 6 IIIKI nw:II 3.1 102 

# ., 17 

# .... lin 

# .. 3.2 103 11 D6 IIIKI ilia 

### 3.2 

# ., p 

# .. 1040 17 D6 IllIG 3.2 

# .. 105 

### r 17 D6 3.2 

# - .. 10' P 11
.. S 

### 3.2 107 

# ., 17 D8 

# - nw:II 3.2 

# .. 

# ­ 101 

### r 17 01; 3.2 109 

### r 11 I'MoCII 3.2 

# .. 

# ­
110 

### r 17 

# - 01; 3.2



## mEGULATORynmpORT • 343

## 90 DAY INHAlATION TOXlCl'Y STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 10 -INOIVI)UAL URINE CUNICAL CHEMISTRY

GIClCJ» I 6 DOIII LlI'fBL. 1000 PJIl 

## sa:. JIII.LII UHAlt- va1llll 

## ua:unr vaUII vaIB val
.. 1IRDB MDIAL 

# .. n:a AJICIl Ctr.CIID 'IOto1llGl 

# • JIll GliVCOllll 

# .'_111 110 III 

# -- III I 17 IIOIDIUo I' '1'.1 1.141 '1'.05 

# .. I11III 12 I 1'1' IIOIIDL I' 

# II.' 1.la7 7.46 DC 11M U II 17 1IOu:u. I' U.S 1.'24 '1'.10 IQIQ IUIII 54 II 17 IIOIIIDI. l' 7.!Ii 1.'41 7.14 I'M 

# ... 

# .. 

# .. 55 II 17 JIOBU, l' 14.1 l.t21 7.31 56 I! 17 IIOI1DL I' 12.1 1 •• :112 6.8. 

# .. 

# .. 57 I 1'1'**~** l' 11 •• 1,'32 6.67 

# .. .. sa II 17 IIOlIIIUo l' 10.0 1.t38 6.7' lIIIO 

# .. tit II 17 IIOIIIDI. l' 

### U.I 1.t31 7.n DC IUIII 60 I 17 IIOIIIDI. l' U.S 1.tal 7.27 

# .. ...

)2fREGUlATORYIREPORT • 344

# •• 90 DAY INHALATION TOXICIY SI'UDY IN THE RAT WITH RECOVERY PHASE 

## APPENDIX 10 • INDIVIDUAL URINE CLINICAL CHEMISTRY



# , CROUJI. DOIIIILnn. 1000 PPI 

## sa. IUILI 01
.. ftDIJI 1I1IDIIJ UltID M'1K1I:I. 

## sa IIDlt**D~** IIILOOI) 'U.O'III • 

### 801" 

# ....... ., _111 

## al II 17 + JIIIQ .+ 

### S.I 52 17 ftACIE IllIG ++ 3.2. 

# • 

# ... 53 17 !'IlACJ: ++ 3.a 

# • 540 

### n + JIIIQ .+ S.lI 

## as 17 ftACil 

# .- ++ :t.2 

# • 

# " II 17 'lU.C:I + 3.2 

# ... 57 II 17 DACI D$ + 3.2 

### n II 17 DACI IllIG ++ 3,2 17 JIIIQ JIIIQ + :t.2 

# " 

# • .0 

# .. 17 ft&CII IIl&CII + 1.2**~/REGULATORYIREPORT** 

# - 345

## 90 DAY INHALATION TOXICfY STUDY IN TIlE RAT WITH RECOVE1lY PHASE 

# APPENDIX 10 -INDIVIDUAL URINE CLINICAL CHEMISTRY



# , GIIOVI'. DOIII Lnm.. 100. 

### p.,. 

## au. J'IIIILIi VUIIII UJlDlK nlIIIi ftllQi VllEa nlIIIi

.... IKA.L 

## au 

# .... .... ua



# - eDLOU.'I 

## 9'Or._ IIIiI pH GLGCOa B/DliD 

# ., w.l 

# - 111 

### r 17 IIOIIIUIL I 17.1 1.020 6.10 .DC 111& 112 

### r 17 IIOIiIIAL I 13.0 I.OZO 6."1 IIZG 

# .. ... .. 113 

### r 17 110..." I 20.t J.OU 6.53 P 17 lIOMU. J;' 12.5 1.020 6.U 

## .nc 11M 111 P 17 IIOIIIIIIL J: a.5 1.031 '.30 .DC 

# .... 11"
P 17 IIOIIIaL I 1.0 1.021 6.10 .DC 1118 11' 

# ., 

# .. .. 117 17 JrOIIDL I 1.1 1.031 1.31 118 

### r 17 lIOMU. I 12.1 1 •• Z2 6.31 

## .nc 

# .. , 

# .. 

# .. 119 P 17 

## ....u. l' 1.030 6.t" 

# - .. lZ0 F 17 JrOIIDL I 1.0 J.040 6.S' IIIW**~GULATORY~PORT** 

## • 346

## 90 DAY INHAIATION TOXlC1Y STUDY IN THE RAT WITH 

# RECOVERY PHASE 

# APPENDIX 10 -INDMDUAL URINE CLINICAL CHEMISTRY

GROUI'. , DOB& LIIVJIL. 1001 PPI 

## sa:. I'aIa£.II UIlJD UIllD UUU QD1I 1II:Df.IIL 

## ax BIll DII.'QIIIS 

## Ir.ooo IPII:O'I'IIIlI IIUIIBD 110 

### _1/1 

# laO'" 111 

### r 17
.. 8 lin IN 

# ".2 112 7 17 IIIIC IllIG DI 3.2 

### 113 17 11K DC 3.2 p 

# .. 116 

### r 11 DG DG DIG 31.2 

### 115 

### r 1T DG IllIG !JI&CII 31.2 116 1'7 DC IllIG 3.2. 

# .. " 

# ... 117 

## r 17 JIBe 'I'IW3 3.2 

# ... 11. 

### r 17 

## :no DC 3.2 11" p 17 

## :no 

# ... 

# .. 'I'IW3 3.2 120 

### r 17 JaG 3.2**~GULATORYnwPORT** 

## - 347

# ~ 

# II

., I

# ~ 

# I ::: II 

# I :

+ 

# I + 

# I**~.**

... 

# I 

# , • 

# I 

# I i 

# 'II**~** !

# ~ I 

# i 0 

# I 

# II " •**~** 

# Ii**~** 

# &**~** ." 

# m**~** 0 

# Z 

# §2 "< 

# - S< 

# !

- 0 

# z • 

# e**~** 

# e .C



# 'I! c ::II 

# - z 

# m 0 

# I: 

# z 

# -**~** 0 

# :.:a: 

# m 

# - en


# ....**~** 

# il 

# § 

# 9**~** -< 

# - z

# ~

# ~

# ~

# ~**~**

# ~ trJ

## 90 DAY INHAlATION TOXIcrY STUDY IN TIlE RAT WITH RECOVERY PHASE 

# APPENDIX 10 -INDIVIDUAL URINE 

# CUNCAL CHEMISTRY



# ..... 1 !lila £DSI.. II pp. SID:. 1"IiI&LB 

### u .... CUB'I'AL CUH JIIID aD
.. nil • 

### a'BSK

.. DIAL Ult DB 

## cu.u CIILL. c:&L8 

### _1m 110 61 

### r 13 D(I IIIIGI DG IIIGI IIIIGI 

# .. U 

### r 13 IIIIGI IIIIGI IllIG IIIGI 

# ... ...

'REGULATORY/REPORT

- 349

## 90 DAY lNHALATJOlS TOXlCIY S'J'UD'Y 

## IN THE RAT WITH RECOVERY PHASE

...**~** 

# APPENDJX 11 • INDIVIDUAL ORGAN WEIGHTS (9) 

# Key: following comments may appear in 

# tbis Appendix. 

# NO WT w**~** 

# number weigbt 

# EPIDIMS 

# 'PrruIRY 

# . epididymis

- pituitary 

# WRR
­ LUND
­ right adrenal 

# lung both TESL**~** 

## testis 

## left 

# UT/CERV**~** 

# uterus with cervix 

# UT/CV­ uterus with 

# cervix


# COMMENTS Number 31

- TESL 

# reduced by 

# 50% ,'. 

# Number 79
- LUNB inflated prioir to 

# weighing (excluded from statistical 

# analysis) Numbet 86 • UTCV distended 

# Number 46

- ADRR abnormal 

# NwnbeJ 110

- mOHr ADRENAL GLAND redu<:ed 

# Nwnbel33

- PITIJrrARY damaged at necropsy 

# (excluded from statistical analysis)

JREOULATORY/REPORT 350 #

## 90 DAY INHALATION TOXICI'Y S1UDY IN TIlE RAT WITH RECOVERY PHASE 

# APPENDIX 11 • INDIVIDUAL ORGAN WEIGHTS (g)

aoaJI. 01 PIGL



# ... DOIIII r.JIQL. lIOII'lQI5In! (g) 0 ppa AIIU:IW. II:lMK'I' 1ft' BOn 1ft' 110ft LIYD 

# _I.,. UnIS 1ft' BOn: SlDh UDja 1ft' 80ft 

# ........ IIIAJ. 

### a:a'f 

# _I'

DZen 1 =60.0 0.065 3.$1$ If.587 

## :r.5" 1.301 2.121 1.6" 

## a .... 0 0.0l1li 3.012 lI.1Z7 3.727 1.431 

## a.Dl 1.253 3 .".0 0.071 3.146 11.713 3.637 1.367 2.130 1.367 4 C71.0 0.062 3.0e, 11.'19 3.3152 1.271 2.0&' 1.313 5 U2.0 0.065 3.3U 17.2'" 3.'91 1.511 2.111 1.tl5 

# , U6.0 0.072 3.212 11.017 3."0 1.231 2.CDO 1.667 '7 !17.0 0.0'3 3.ltt 1I.1n 3.69' 1.492 2.Ul 1.445 I**~2'.0** 0.0'11. 3.316 11.023 4.2<12 1.547 2.873 1.507 

# , $23.0 0.060 3.4c6 17.161 3.715 1.385 2.lI86 1.5S. 10 505.0 0.0" 3.05' 17.211 3.61' 1.2157 2.014 1.'0'



## IlEGULATORY/REPORT

- 351

## 90 DAY INHALATION TOXICTY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 11
.. INDMDUAL 

# ORGAN WEIGHTS (g)**~.** 01 DOIIII UVIIL. 

# • 

# ... BU. IWoI' 

## anmr.

110. 1IOO!DIGilft (II) 5 •• 0 SPUD dtG8'f



### 1.027 ft'IIIIII 

## al"



# . ... , ftDIOlD W'1' lIO'I'II O.Il:U 'J'.I'fI/U OIGld '.110 l.VW rt'I IIOIB 

# I.'" f •• O 1.05 • '.430 0.G2' '.01.0 1..71" I 

### ••• 0 1.Ul 

### O.t.1 

## o.au •• 000 

### 1.75' 

# , tn.o 0 • ..,' 0.310 0.019 •• 011 1.916 112 •• 0.153 0.'05 

## o.a:u '.012 1.611 

# , ••• D O.'fO 

### 0.41'. 

## o.au '.011 2.212 f 511 •• 0.'" 0.3411 O.OLa t.OJ.O 1.7'5 

# • 5211.0 1.3.3 

### O.U. 0.02' 0.009 2.091 

# , 5:U.0 1.0n 0.03 0.022 0.011 2 •• " U 105.0 •• "0 0.a111 •• C:12 

# '.01. 2.212



## :/REGULATORY/REPORT - 352

## 90 DAY INHAlATION TOXICI'Y sroDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 11 - INDIVIDUAL ORGAN WEIGHTS (g)

GI.'OVF. 02 DOB LIIY.I'L. 100 W- IDJI:, JDH UIMM. IIODTISIGIII' .&IIiUIDL lillIlID' LDD ftftIS DID/. IIIUoDI -!!

.-0. (t) .., JIOIIB 117 110ft UllIIft' .. JIOIIB 117 1lOIII UIaY QICIIft

11 101.0 0.012 3.nO 17.433 3.171 1.3" 2.013 1 •• 0. 12**"~.O** 0.072 2 •• 1. 17.2&2 3.61" 1.220 2.061 I.JlO 13 "".0 0.0'" 3.13' 11
.... 3 • .,1 1.377 2 •• 83 1.113 14 131 •• 0 •• 15 3."31 It ••• 

### 3.13. 1.170 1.302 1.621 15 

### UZ •• 2.177 11."" 3.011 1.atl 1.tl' 1.261 0 •• " 16 .U.O •• 018 2 •• 33 11."0 3.7'" 1.317 2.114 1.:13. l' 527.0 0.073 3 •• 0' It •• 7 l.n. 2.U. 1.71t 

# s.". U IU.O 0.011 3.367 17
..... 3.170 1.ln 1.116 1. Ita 11 .... 0 0.01S 3.011 17.1121 1.U' 1.181 1.J.0 

# , 

# ..... 2. 

## tI,.o 0.01. 2
.... 11.11' '.t.t**:a~01t** 1.134 1 •• "**JRBGULATORY~ORT** 

## • 353

## 90 DAY INHALATIONTOXICTY STUDY 

## IN nIB 

## RAT 

# wrm RECOVERY PHASE 

# APPENDIX 11 • INDIVIDUAL ORGAN WEIGHTS (9)

CIlOUJ' •• 2 DOA YYU.I 100 ppa 

## sa. DLII lIIIIDL

1m. IIOIII1IItXQU 

# [., III'UIIII RIG1ft' 'I'ftIIIIB RIC1lIII' 'mQIIID

.... IIO'IK PIn/a RIGII'I' 

### r..e .... JIOII'II 11 IUI.O o.'n. ' •• 01 '.011 0.00' 1.7" 12 401'.0 0.'70 0 •• " o.oao 0.'10 

### 1.60' 13 •••• 0 •••• a 0.41' 0.011 0.00' 1.'16 1. 

## "a.o 0.91' O •• U 0.023 0.011 1.'63 15 tllI.O 0."5 0.377 0.017 1.'11 1."" 

### l' "'''.0 '.1110 0.3'" 0.01'7 '.010 1.MI 17 

### !In.o 0.801 0 ••• 0.oa5 0.0" a •• " 11 ••• 0 0.1" 0.50'7 o.oal 0.'12 1."0 10 .'.0 1.0aa 0.614 0.022 0.00' a.n. 10 463.0 0.1.16 O.tH 0.017 0.00' 1.61'



## !/REGULATORY/lt.EPORT - 354

## 90 DAY INHAlATION 

## TOXIcrY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 11 • INDIVIDUAL ORGAN WEIGHTS (g)

SIIOOl'. 03 DOIIII r.JI9U,. 300 ps- 

## ax • 

# ..... AImIu. BOIlJDllm'r ADIIIIIUIo JtIDBI1: IUD RII'IIB DID!_ BDDI 

# <., 

# .... " 110. 1'1' IlOl'8' 1'1' JM)'IW 1rIIr.... .,. 110ft 1'1' 1lOIII 

### _:min' IllUfID

U .'7.0 0.051 3.2. 20.032 3.161 1.1112 2.1J1 I.S17 U '29.0 0.0'71 3.141 1'7, '733 3.902 1.2'IS 2.16' 1.111 U !lli1.0 0.064 3.7A 21.'05 

### 3.12" 1.35' 2 •• ''7 1.11' 

# '" "'1 •• 0.0156 3.0" 15."1 3.2" 1.511 2.04S 

### 1.321 111 !!:l0.0 0.010 1.91. 16,017 S."" 1.t.O 2.301 1.491 16 !llit.O 0.067 3.765 21.061 3.1&' 1.3'IS 2.014 1.'11 

### n .'.0 0.07' S.3Zl 21.375 3.'5.9 1.4U 2.U. 1.702 

# .. !IOO.O 

## o.on 3.322 1 •• ISI 3.91' 1.3'1 2.160 1."1 29 Q4.0 0.056 3."7 19.125 3.6"" 1.4" 2.1':11 

### 1.114 10 ..... 0 

## o .Ollt 1.76) 11.110 3.112 1.213 2."5 I •• "

### ~GULATORY~PORT 

# - 355

## 90 DAY INHAlATION TOXICfY snJDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 11 - INDMDUAL ORGAN WEIGHTS 

# (g)**~.** os D08I: wrv.L. 300 ppa 

## sa. ur.a

....nw.

110. BOPnII1811!' 

### (,) Ur.III:II 

## urClft**~** "1GB'l' DnlOID 11'1' 1lOIII lPr'I'IJ/llI' 1111
... IolJllll 1'l' JIO'I'II :U 1".0 1.005 0.'.7 0.01' G.OI0 2.032 :12 Sat. 0 1.0lt 

### O.U' 0.022 C.011 2.001 23 SSI.O 1.031 0.'13 0.0121 C.OO' 1.1'1' 24 

### "l.O 0.'11 0.'" D.CIlO 1).007 1."7 25 

### III •• O.87S O.U" 0.8'.16 

## c.on 1.'15 26 alt.O 1.147 0.'0' o.lI1a . 4).014 1.'01 2' 5".0 1.0n 0.'61 

### o.lIn G.Oll 1.114 21 5l1li.0 O.US 0.,1t 0 •.Q11 '.Oal 2.0" 21 IX.O· 

## o.,n 0.15' 0.e2' •• 011 1.,.11 

### S. ' •• 0 0.'" 0."'· 0.G21 '.00' 2. liS**~GULATORynuwORT** 

## • 3.56

# •• 90 DAY INHAlATION TOXlCfY STUDY IN THE RAT WITH 

# RECOVERY PHASE 

# APPENDIX 11
.. INDIVIDUAL ORGAN WEIGHTS 

# (g)

GIOVI'. 04 II08Ir LImIIi! 11'00 JIPI 

## -.:. l1l£I: 

# DUI,_ AIID1r. 8OO'IWI'r
... ADiUltU JtIIInJ' LIYD I'JIBI'rs IIIIUII aaJl'I (g) 11'1' BOft 11'1'_ nUlll'.l' 11'1' JIOItII DX
.... 

### _I .... " 1lO'III :U 5 •• 0 0.057 

### I.U. ,S.U'S l •• 

## a. 

# .. .,.. Z.O'" 1.150 

## .n .. 56.0 0.072 3.3" 17.1 •• 1 •• 01 1.310 2.026 1.531 31 5N.0 0.063 3.41:1 11.366 I •• 

### n 1.187 2.152 1.461 U "117.0 0.066 3.2." 16 .151 '.4.' 1.211 2.11.1 1.4sa U .Ila.O 0.072 3.S17 1'.121 '.4.5 1.3'76 a.12' 1.4n 

### :u 530.0 0.0'1 3.S46 1'."0 '
... 01 1.503 2.221 1.552 

### 3' 5».0 0.011 3.02:1 11."0 1.114 1.365 2.0U 1.501 

### St 

## .. a .• ••• .0 3.0U 111,UO J.1.5 1.:'" 2.1" 1.254 3t "".0 0.063 3.0!12 1.,. lilt
... 7'10 1.flO a •• '3 1.451 

### u 4 •• 0 0.06. a.'4' 14.S" 1.112 1.4n a.16. 1
....**~GULA10RYnrnPORT** 

# - 357

## 90 DAY INHALATION TOXIcrY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 11 -INDIVIDUAL ORGAN WEIGHTS (9)

IIIIOVP. 04. DOSII 1'dIYIII.. 1000 PPII SUI IIILJI .ur:rJIAL

E. JIOI):msI
..... (9') .. UD 

### or&'l' 

# - 01
... DDIOID

.... IICWII rJ'fUfm' DI ..... LUIIIQ WI IIO!IIl U 

### Sll'.O 1.004 0.37' 0.0" 0.00' 2.10'1' 12 4".0 0.'17 0.U4 0.024 0.00' 1.16' 13 !lI4.0 0.'" 0.433 0.0:ita 0.004 1.'75 

### ;u ".'7.0 1.015 0.311 

## o.O:Ie 0.011 1.'774 

# 3. n •• o 0 •• 6. 0.41:1 0.017 0.010 1 •• 341 16 37**~30.0** 526.0 0.'01 

## o.n. 0.114


### •• I!! •• 0:1" 

# . .... D.OIO O.Oit 1.'711 1.10 

### I. 'Ia •• G.'32 0.111 ••• 26 0.010 1.'23 It •••• 0 0.'71 0.420 0.011 0.00' 1.142 40 455.0 G.I"**O.I~I** 

### •• D17 0.005 1.1'7



# fREGULATORY/l.EPORT

- 358

## 90 DAY INHALATION TOXICI'Y S11JDY IN 

# nm RAT \lITH RECOVERY PHASE 

# APPENDIX 11 -INDIVlDUAL ORGAN WEIGHTS (9)

caovr. 0' DOBII: 

## urvu.. 0 

# ,.. SUI IQU 

# _:ow. BOO
..... IGII'l AIIIIJIDL 111_ LI .... ru'lI8
.. ID'
.... 

### lIJI&la 

# ........



# ... (t) 11'1' 

### eon: 

### rr BO:rI**_I~** ., JNI!'Jr

.... BOllI 

## axcan UlGll'l



### u au.o 0.011' 

## a.'Ol 1
..... 3.405 1.U3 2.070 1."1 '2 

### ta•• o o .on 

### 2 •••• 

## n ••a" 3.730 1.:14,' 2.011' 1.1110 U 11'.0 0.0111 3.20' 1'.211 1.1:12 2.1113 1.'57 

# ... ., U "0.0 0.073 •• 2110 

# 1'.1:1' •• 074 1.1611 2.111 1."" U all •• 0 O.Otl •• 112 17.71. 3."1 1.""1 2.172 1.SH 

# " '''''.0 0.0" 3.111 

### 17.11'**"'.2~O** 1.31' 2.1 •• 1.S14 47 

### a .... 0.071 3.13' .I •• ", 3.,01 I.S1'1 2.1n 1."1 

## n 511 •• 0 

# ... " 3.396 

## n.la 3.I7S 1.512 2.114. 1.",


# ... lIIt3.0 

# 0.'" 3.0'" 

# 11.'" 

# J.'" 1.'" 2.'11 1.UO 110 1122.0 O.OH 2.''4 17.14" 3.IU 1.2112 2.,12 1
....



# VREGUlATORY/RBPORT

- 359

## 90 DAY INHAI....\110N 1OXlCl'Y STUDY 

## IN THE KAT wrrH RECOVERY 

## PHASE 

# APPENDIX 11 • INDIVIDUAL ORGAN WEIGHTS (9)

GIOUP. O. DCA UVJ:I.. D PIlla 810:, DIoI rMIIG
_ PDfAI,



## .o. BOIDYlll:IGII.'I'.' (II' BJ'LJIa DZ..., ftDIU5 "1I11II'I' 'I'IQIlOW lit' B(IftI .Ift/In BIGU '10ft U 

### n 1511.0

..... 0 0 •• '" .1.074 

# '.:1" 0.4" 

### o.ou 

## o.ou •• 0" 

# '.'05 1."0 1 ••

# 4. 4., list. 0 t •• 

## a. 0.:117 O •• J. O.HII 2.011 4. !l'0.0 1.017 0.65' O •• UI 0.011 

# 1.'2. n !1M. 0 1.073 0.310 0.01' 0 •••• 1.71111 41i .7 

# !I" .• a .... 

## •. au 1.oall 0.'" 

# ..... •• 016 0.016 0.0"

•• 0011 

# 1.,..' 2.1'2



# .... 4. 5114 •• 5U.0 1.140 1.217 o.:lU 0.311 •• 02.

••**O~O** ••• 11 

# . .... 1.731 a •• 05 

### ao 1122.0 0.11111 0.4.11 0 •• 2' •. 0.7 1.'73



# :,tREGULATORY/RBPORT
- 360

# •• 90 

## DAY INHALATION TOXIcrY SnJDY IN 

## THE RAT WITH 

## RECOVERY PHASE 

# APPENDIX 11 • INDIVIDUAL ORGAN WEIGHTS (g)

GIItIUIr. 0' 001II: r.JI¥BIo. 1000 

# ,.. lIB. IIIir.& AllDII.Io**~IGIl'!** ADIIDUd. Itl_ r.I't'D 1'II81'l:& DID,.. UtADI IIIU'I' 

# _I..., MI. III' IIO'fB tn' JM)Ift Irt IIO'fB tn' IIO'fB Dlem'l' 

## urGe 

# '.l 11 521.0 0.077 3.3n 11
.... 3.31111 1."" :I.U' l.al 52 141.0 0.05' 3.'" U.I'" 3
.... 1.330 2.U5 1
.... ' 53 IIC.O 

## o.on 3.311 llt •• 

### n 3 •• 3. 1.111 :1.0" 1."" 5" 1147.0 0.075 3.110 17.'" .. 142 1.702 :II .:11:1**1.~83** 57t.O 

## o.on 3.315 11.412 3.'5' 1.IIU 2.100 lS'6 56 1117,0 0.010 3."" 11.11' 3.'01 

### 1.41" 2.115 1.'" II? 561.0 0.'62 3.061 

## u.nl 3.116 a.2011 1.31117 1 • ...,. 

### sa Sl4.0 0.0740 3.7401 17."4 3.IU 2.143 1 •• U I •• " 5. 503.0 1.063 3.10:1 11.120 3 •• 5. 1.UI a.15' 1.3'S 

# " 'IIt.O 0.056 2.122 It.ln 

# 3.'" 1.41. 2.051 1.412

### flrnOULA10RY~ORT 

## • 361

## 90 DAY lNHALATION TOXICfY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 11 • INDIVIDUAL ORGAN WEIGHTS (9)

6UU:t ... DOSII: 

## s.na.. 1000 p.- BIll. DLI MIIGIL

lIO. BOD11I'IIGIl'f (IJI 

# ....... "I81ft' 

# -­ DIGIII!' 'ftInODI ft_ 11'ItI/lI'I' .Xlllft' t.UIIII PJIO'III III II:aI.O l.llS 0.31. '.011 0.005 1.173 52 5
.... 0 t.tO. 0.335 0.02' 0.006 1.110 531 1110,0 t.0'5 0.S'4 0.021 0.005 1 •• " 5. 54'7.0 l.Oll 0.441 0.020 

## o.ooa 1 •• '1 55 lI7'.O 1.1'" 0.413 0.021 0.00. 2.005 U .517.0 •• "3 0.463 0.021 0
.... 1.'07 57 561,0 

# .... , 0.392 0.025 O.UOI 1.7311 .1 

# II. 56 •. 0 lIO'.O 1.173 1.013 0.421 0
..... 0 •• 21 0 •• 2' 0.'05 0.011 2.10. 1.IS' 

## ao 45 •• 0 

### ..115 0.'.&0 0.01* 

## o.ooa 1.101

### ~ULATORY~RT 

### - 362

## 90 DAY INHALATION roXICfY STUDY IN THE RAT WJI'H 

## REffiVERY PHASE 

# APPENDIX 11 - INDIVIDUAL ORGAN WEIGHTS (9)

GIIOUI'. 01 IXIII:S r.:I'9&. 0 JllII Ba. I'IIIDLII DDI.U lIOI)'IIIIIIG1ft ADIIIDIAL Ill...., 1oI'9D OY.UI'I IIUIJI IIDIII 

# ,;, 110. (I) H' IIOftI 11'1' DOI'II
.. taft WI 

### IIO'I!. Rl111n RlGln'

11 333.0 0.013 2.U7 12.611 0.102 2.0'0 1.030 

### n 312.0 0.011 2.3t! 13.2112 0.1'0 2.03111 1.250 2".0 0.011 2.070 10.1'71 0.117 1 •• 

### n 0.'32 It 3U.0 D.on 2.U7 10.100 O.Ollt 1.170 1.016 

# " 21'1.0 0.01t 

### 1 • .,5 0.103 2.0t. 0.lt03 

# , 

# ... " 316.0 0.011 l.nl l1.tl1 0.1111 1.n7 1.2131 17 322.0 0.011 

## l.no 11.'" 0.115 2.030 1.011 

# I.
329.0 0.0'0 2.173 11.1" 0.117 2.027 1 • .,5 

### ,to ·211.0 0.0" 1
.... •• 7. 0.101 1.". 1.010 7. 301.0 0.015 

# I.'" '.3'7 0.11' 1
.... 1.012



## /REGUlATORY/REPORT 

## • 363

# • • 

# • • 

# l:

# ~ a**~**

# ~**~** "i

# ~ 

# J

.. .. .. 

# .. 

# .. .. 

# .. 

# .. . 

# IE

... 0 

# .. 

# .. 

# .. 

# .. .. 

# .. 

# .. lot N 

# ..**~** 0 

# • 11; 

# • 0



# .. 0


# .. 0



# .. 

# .. 0 

# •

0 lit III 

# • !II' 

# .. .. .. 

# .. .. w 

## tI :" 0 

# .. 

# ..

.. 

# .. .. 

# .. .. 

# .. .. .. .. 

# .. lot 

# ..**~** Q 

## 0**~ ~**  

### ::0 

# .. .. .. ... 

# .. 

# .. .. • 

# .. 

# .. .. 

# .. 

# .. =

0 

# ..**~ ~**  :=0 

# .. !" 

# ·**~** 0 0 0

0:0 0**~**

0 

# .. 0 0 

# .. 0 

# .. 0 

# ... 

# .. 

# .. ... 

# .. .. • 

# .. • 

# .. lot N 

# .. .. 

# .. .. 

# .. 

# .. III N w 

# • 

# .. :.. 

# .. ... 

# .. 0 

# .. 0 

# .. 

# .. I 

# .. ..**~** 

# .. · · ...**~** 0 lit 

# .. • 

# ... :: ::: 

# - .. .. 

# .. 

# II

0 0 Q 0 0 0 0 

# .. W 

## ;.. lit 

## ;., 

# .. ... 0- w 

# .. .. 

# .. .. 0 0 N 0 

# ..**~** 

# .. 

# .. 

# .. !» w 

# ... 

# .. 

# .. 

# II III 

# •

0 0 

### co 

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# 9**~** I'( 

# z**~**

# ~

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•



# ••• 90 DAY INHALATION TOXlCfY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 11 -INDIVIDUAL ORGAN WEIGHTS 

# (g)

GROal'. 

### oa DOIII U'fD.. 100 

### pr.- IU. rau& AlfIDL BODrmlIGIft MJlIIIIW. .IJIIIIIY UVD 0VPr 

### .... u

110. 

### Clr) W"I IIOftI W"I 10IIII 

### a'GIft W"I 1lO'I'II 

### aran ar.,.

71 3:U.0 

### o.on 2.3" 11.084 0.112 1.127 1.0» 72 327 •• 0.117 

### :a.oo. 12.UI 0.077 1.166 0 • .,6 73 :Z.I.O 0.01' 2.011 10.13. 0.0'. 1.133 1.014. 

# 7. 311 •• 0.0" 1.r-n 10.2011 0.111 1 •• '3 

### o ••

## a 71 216.0 0.0'7' 1.121 1.10. 0.120 1.n, 0 •• " 

# ,. 322.0 0.017 :J.2n 11 •• 23 •• 107 2.01. 0.K1 77 211.0 0.010 1.711 10.666 0.111 1.'0. 71 31:1.0 O.oa. 2.151 11.6" 0.011 1 •• 12 1 •• " 7. 302.0 0.0" 

### 2 •••• 10.6t3 0.137 1.'U 1.ln II 303.0 0.016 

### :a.on 10.111 0.111 a.l01 1.039

l .



## lREGULATORY/REPORT • 365

### 90 DAY 

# INHALATION TOXICrY STUDY IN THE RAT WITH RECOVERY PHASE 

## APPENDIX 11 - INDIVIDUAL ORGAN WEIGHTS 

# (g)**~102** DOSB IoJIYIIL I 100 lis- BU. DIIIIIoIi UIIIAL BODYRIGII'I V'!I/CD.V SP
.....**~** mDIOID tI'I'D/1'!' r.UIII WI'

110. (5) HIGIlt' DJGII'I'**nI~** .,. 80ft Ul
.... BO'I'II

71 321.0 0.701 D.7U D.'" 0.011 0.011 1.170 72 327.0 0 • .,5 O.UI 0.017 0.011 1.3" 0 •• " 731 2".0 0.7117 O.ltO 0.022 0.012 1.311 0 •• " 7. Ul.O 0 •• 21 0.'11 0.3" 0.015 O.OlS 1.3" 711 21'.0 0.732 0.721 0.3n 0.017 O.OU 1.'" 7'**32~.0** 0.614 O.U' 0 •• 62 0.011 0.014 1.11211 77 211.0 0 ••• 2 0.U2 0.311 0.022 0.012 1.2U 71 313.0 D.IU 0.110 0.417 o.DU 0.016 1.'71 71 302.0 0.761 0.172 0.356 0.02' 0.016 3.Sn 10 303.0 0.500 0.7211 0.3" O.DU 0.013 1.8111**~GULATORY~ORT** 

### - 366

# •• 90 DAY INHALATION TOXICIY STIJDY IN THE RAT WITH RECOVERY PHASE 

## APPENDIX 11 • INDIVIDUAL ORGAN WEIGHTS (9)

GJIOI8P, 03 DOSII LBVI:L. 300 PIlI ID, 

# ........ 

# _1_



# -­ AIIIDL IIDDIRIGIl'J' AmUIUL I:JIIEIT LIVU O¥U'I' BRAD IIDft

110. 

### €I,) ftllOB ft Hft .I8!'l' 'ft 110ft

U 305.0 0.0" 1.121 11.121 0.15' 1.GlO 1 •• " .2 311.0 0.100 2.01' 12.16' 0.114 2.012 1.05. .3 301.0 0.079 :II.IlS6 11.556 0.103 2.02. 0.116 303.0 0.0'1 1.15' O.lIT 1."5 1.121 II •• " 

# •.•,1 .1 2455.0 1.113 '.611 0 •••• 1.U' 0."0 

# 1.,., 326.0 O.Ottl**:II.~2'** It.'20 0.111 1.lO3 

# " 

# ., U3.0 0.012 1.121 t.'11 O.OtT 1.115 0."" II 302.0 0.01' 

### :a .()J:II 11.040 0.1.' 1.136 1.123 It 30'.0 O.OI! 2.1l" 10.'12 0.0" 2.11' •• IU 

### O. 214.' 

## o .• n :II.IlO' t.U!! 0.'" 1.'" .... !!



## REGULATORY/REPORT



## - ?fJ7

## 90 DAY INHALATION rOXICIY STUDY IN THE RAT 

## W1'UI RECOVERY PHASE 

# APPENDIX 11 • INDIVIDUAL ORGAN WEIGHTS (g)

GIiI:IIn ••• 0Q8I. t.&V&L. '01) ppa MI., J"JaIN.II JI1IDN, JIOPl'IIISCII't lIf/CUI 

# ........ 1IIIJIOtD l'l'IU/D' 

# .......

110. (g)
.. 1
.... 

## al'" DI ... wrJlOlll B'GII!' 

# - 11 lit •• 0 0.5P3 0.7l<! 0.432 •• 017 ".010 

# - 1.6:14 1:1. 3U •• ..511. 0
...... 11.124 •• 02:1 

### O.olS 1.423 

# .3 3 •••• 

### o.a•• 

# 0.". •• 33' ..8:13 0.010 1.411 

# ., lin •• 0.503 •• 7'" 

# D.a'" '.812 •• 00' 1.":1: .11 :"11.0 

# •. '9' 0.733 0.'.0 •• 810 0.00' 1.452 .6 326.0 1.22. 0.7" •• 014 0.020 1. 'Ill 

# 0." •• 17 :113.0 •• 536 0.". O.4t7 ' •• 2.6 '.011) 1.4" II .w2.0 0.717 

## •• '3e 0.417 (/.017 

### o.OU I.Ut 19 .... 3 0.711 0.410 

### •• OZ' 0.022 

### 1.a66 to 214.0 

### O.18Z 0.6.1 

### O.J.' t.014 0.0111 

### 1.754 " •• 0



## :/RBGULATORYIREPORT

- 368

## 90 DAY 

## INHALATION TOXICTY sruDY IN THE RAT WITH 

## RECOVERY PHASE 

## APPENDIX 11 - INDIVIDUAL ORGAN WEIGHTS 

# (9)

GIIOVP. 

# o. DOSJI**~.** 1000 :p.­ 

## sa. J'mIII.I:S AIIDIIL

ItO. IIODJ'DJQft (I) .I.DIlIIII.IL '" IIO'InI IEIJlD1'
.., 110ft LIYU nIGIIl'l! !WAllY 

### ft_ II1I&.I. nJGll'l! D&Ilf n:llillD' U 309 •• •• 011 2.0n 

## '.6n. 0.10:! 1.17:1 1.lt •**.~** 

# 32' .• •. on 2.0U 10.3M 0.113 1.'" 1.U • t.! 3U.0 0.091 2.1112 

### ' .• J. 0.111 I
..... O.tll I
.. 2U.0 •• G,O 1.713 '.U2 0 •• " 1.112 0 •• 01 II 2ct.0 0.061 

# 1.41' 7.1" •• 0,. 1 •• 61 0 •• 0. 

# •• t7 3U.0 309.0 •• 0.' 0 •••• 2.012 2 •• 31 11.1" 1 •• 2'. 0.131 

# ..u, 1.ttl 1.92' 

## 1.as" 1.101 II 

# . , 30&,. 27-1 •• 0 •• "
•• 07' 

# 1.'" 1."2 11.3"

•• 715 •• 133 0.112 1.ttl 1."7 1.00. 0.12' lOt 2'7.0 0.0'. 1.'31 '.41.1 0.113 1.'16 0.'114



## /REGUlATORY/REPORT

- 369

## 90 DAY INHALATION TOXICI'Y STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 11
.. INDIVIDUAL ORGAN WEIGHTS (g)

GIIOUI'. o. DOIm I'&9JIL I 

## leoo PPI lID. nIU.:I UDIlIL 

### aovzn:IQft 

## n/cav SJr.aII 'fIIJ.'JlO11 fI!'II"Jrf 

# r._ WI'

10. (II' nlGft UI ... UIR'! 1ft' BOn U:I8Ift' 80ft 

# -

,. 91 30 •• ' 0.732 •• 121 0.t20 0.016 0.011 1.:1:12 12 326.0 0.766 0.7D' o.e" 0.011 0.'17 I ••• 

### n 311.0 0.n7 

## o.no o•• u 0.01lt O.ote 1.621 2".0 1.2<117 

## o.n. O • .IU 0.011 O.OU 1.1. :UI.O O.Ul 0.613 o.Ut 0.01' 0.011 1.2"



# .. " '11 32 •• 0 0.550 0.716 0
.... 0.01lt O.OU 1.619 97 30'.0 0.701 

## o. no 0.503 0.012 

## o.oUo 1 •• '" 301.0 0 • .01 0.011 I.OU 1.D. 0 •• " 0 •• " 

# .. 270.0 0.13' 0.1175 0 •• 11 0.01lt •• OU 1.330 100 217.0 

## o ••n 0.653 0.335 0.013 0.012 1.3ea



## IREGULATORY/REPORT • 37()

## 90 DAY 

# INHALATION TOXIcrY STUDY IN THE RATwrnI RECOVERY PHASE 

# APPENDIX 11 • INDMDUAL ORGAN WEIGHTS 

# (9)**~.** 115 DCa ....,... 0 ppa 

### ID, I'IIIIIUioII AIIDWO _BIllGIn' JiIIIIIIIIaL Itla.D' 

### LX .... 

### ovan: BU.DI IIIUl'l'

11). (gl 

## .., :eon .., JOn _IGIl!' '1'1 BOI'II _lOR 1IIIIIBr LOI 

## ua.o 0.0'7 2.LLO la.!lU 0.U6 2.063 1.U' 102 306.0 

## o.on 2.0
.... 

### 10.41' 0.117 1.117 0.110 103 302.0 0.018 a.2ll •• au 0.U3 1.ta7 1.1Oa**10~** 

## an.o 0.064 1. ,." 0.0'2 1
.... 0.'1' 105 217.0 0.0740 1.ttO 1.800 O.lal 2.0as 0."4 lOt 323.0 0.0" 2.251 11.320 0.130 2.0U 1.172 l07 353.0 0.074 2.na 13.631 0.111 1.'35 1.140' 101 307.0 0.071 2.017 10.aal 0.117 1.175 O.PI' I •• '"

10. UI.O 0.01Z a.l11 U.7'0 0.082 1.1" 1.,"' 2.02' ' •• 77 0.'l3 110 ZI5.0 0.057 0.0111 1.tl6



# IREGUlATORY/REPORT

- 371

## 90 DAY INHALAnON TOXICfY STUDY IN 

## 'DIE RATWrm RECOVERY PHASE 

# APPENDIX 11 - INDMDUAL 

# ORGAN WEIGHTS 

# (9)

folIIOU1'. 01 IlOSIi UUL, 0 ". BU, nar.B UIDIIoL BODDUliIII'I IImIUS IIIftOID 

## .Ion'
.... LUII8
.... 

# "',a.rI 

# ....... 110. (.) 

## ar.., 

# .. I.., WlI..,

.... 1lOIII 

## aleaft' 1lOIII 101 342.0 

## o •• n o. ,211 

# C.'" 0.01' ••• 04 1.U2 102 306.0 0."0 0.701 G.2" 0.022 0.110 1.115 103 302.0 

# G.'" 0 • .". G.431 0.01. 0.011 1.,"' 104 2'2.0 0.'30 0.11120 G.3" •• 011 0
.... 1.1" 105 217 •• 0.1" G.711 0.42' 0.014 0.012 1.SU 10. 323.0 0.'12 0.71' .... 2 0.01' 0.013 1.$1' 107 313.0 0.71110 0.'" 0.42' 0.011 0.014 1.1" 10e 307.0 0.1113 0.4010 0.017 0.014 1.314 10' S15.0 1.IlS 0.710 0.361 0.01' 0.014 1.'$1 110 211.0 0.4" 

# .. ,., 0.314 •• 013 0.014 1.271 0 •• '



## 'RBOULATORY/REPORT
- 372

## 90 DAY INHAlATION TOXICfY STUDY IN TIm 

## RAT WITH RECOVERY PHASE 

# APPENDIX 11 • INDIVIDUAL ORGAN WEIGHTS (g) 

# rau.. GIIOUl'.OI D08I L
...... 1.000 PJIIl SU, 

# ..,..., UDaL IOO'fUIGB'I lWIIDUo lUlImI'f 

### r.J;YD OVAII:r MAD

110. (II) ft' 110ft ft'_ DJGIft ft' 1lO'I'II DleII! DllIft 111 SU.O 0.07. 1.''1. 10.'.3 O.U' 1.'77 1.0&7 112 ltO.O 0.013 2..0'12 10.23. 0.014 1.123 0.'" liS 1".0 0.074 1.'11 10.061 0.0" l.tl2 0.tl3**11~** '00.0 0.01t 2.0" t.U" 0.117 I.US l.t13 l15 at5.0 0.013 2.010 t.170 0.177 a.03' I.'U 1:1.6 HO.O 0.012 2.272 10.213 1.117 2.0:z.t O.,U 117 112.0 0.1" 2.23'11 11.12t 1.112 1.'" 1.1'2 11. I1t.O 0.07. 2.17. 10·00 I.OIt 1 •• Tt J..OlO 11. '1'.0 0.0111 2.03. 18.750 1.112 2.03' 0.tl5 .20 111.0 o.OTt 1."0 '.332 O.US 2.013 0."7



## IREGUlATORY/REPORT - 373

## 90 DAY INHALATION TOXICTY STIJDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 11 • INDIVIDUAL ORGAN WEIGHTS 

# fa)

GIIOD. 

# O. DOD Llr9U.. 10.0 

# ... mu: • 

# ...... MDW'. IIOIImIIIIIII'I' VI/CUY 

# Dr..:. I'KDIDII t'InIIOlD 

### un/u 

## r..- 1ft'

110. (.) DIG1ft' Wl:GU DIGiII'l' 1ft' lIOII. 81l1l'i' BO'lIII

111 3at •• •• tl7 •• 110 0.3" ••• 11 0.016 1.at' 112 290.0 0.111 0.621 0.1311 0 •• 11 0 •• l1 1.317 113 211.0 0.1" 0."" 0.372 ••• 14 0 •• 13 1.522 11
.. 300.0 0.13' G.13I2 0.375 ..017 0.01" 1.2" 111> 215.11 0.5'" 0.301 0.017 0.021 1.133 

# '.n, 116 300.0 0.613 0.771 0.313 0.012 0.013 1.2S1 

# 11,. 31Z.0 •• Sl5 G.701 0.317 0.016. 0.01' 1.U' 111 319.0 0.1" 0.311 0 •• 18 •• 010 1.2'" 

# I.'" 11. 306.0 0.160 

### a,'fll,. 0.:1122 0 •• 13 0
.... '.2413 120 2".0 0.'" 0.659 0.315 0.014 0.0:6 1.211



## IREGUlATORY.'REPORT 

## • 374

## 90 DAY INHAlATION TOXlCI"Y 

## STUDY IN THE RAT 

# wrm R.BCOVER.Y PHASE 

# APPENDIX 12 • INDMDUAL PATHOLOGY CROSS REFERENCE CMICROSCOPlC) 

# Key: N.A.D.

- no abnonnalities detected

/REGULATOR.Y/REPOR.T • 375

## 90 DAY INHALATION TOXlcrY STUDY IN THE RAT WITH RECOVERY PHASE 

# APPENDIX 12
.. INDMDUAL PATHOLOGY CROSS REFERENCE (MICROSCOPIC)

JtIIII07JU.
........ RBIII&L DOIm I.JIYIIL. 0 lID. DLII 1 

# ... 1:&."67"0**..-a!o~** ..................................................... . trotoJlll,C) boDe .......... '"' ... .................................................. *
.. .. .. .. .. .. .. ............. 

## x.. .. AOWrA ••••••••••••••••••••••••••••••••••• , •••••••••••••••••••••••••• aa.K**~w"'"** 

# ........................................• " •••••• ". aa.K''''+8'l'%n.:a J01ll1'
.................................. " •••••••••

... 0
................ .................................... • •• " •••• ". CIII;CUIiI
................................................... •••• • • • • • • 

## cor.c. ....... ........ ............. ....... .•• .............. .." •••••••



# ...... 

# ............................. 

# .............. 

# ."" 

# .. " 

# ... "**"ID~8** 

### .•••.•••••••.•.•••..•••..•.••....••.••..•.••••• ."." •••••• KYI + 

### 1KYr...OptIC
..... •••••••••••••••••••••••••.••••••• "."."" ••• " 

# ••..•••............•......................••• 

# " 

# ..... .**1Io_.a~** 0
... 1· .taf.lltrat.t_
.......................... •••••••• 1 •



## ur, IIOItPIIOLOIIJ" D9Dlft • 11M IIICOIIDD 1 Id.Jdaa1 " •• A.II. 2 IlUgIlt 

### o maaDIIQ , IIIMM:nt. 

### + ftJlID'f '1UL1:'Ird 11. ., 8QDI1'1'

### ~GULArORY~ORT 

## - 376

# •••••••••• •••••••••• •••••••••• •••••••••• •••••••••• •••••••••• 90 DAY lNHALATIONTOXlCfY STUDY IN 'f.Ht 

## RAT WlTHRECOVBRY PHASE. 

# APPENDIX 12 • INDIVIDUAL PATHOLOGY CROSS REFERENCE (MICROSCOPIC)

'AIIIIWt.L. 1IItIo&C*.**~u.** 

### 110111: WIYIIIio. • 

## su ......... 

# ... 1 l 

### S ,

...... 1' ., ••••••••••••••••••••••••• , ...................... ..



### Degeaeratl••**c~** 

### ••••••••••••.••••••••••••••• It.llClll
............................. ,. ....... .,. .. ,. ...**~** ••••• "
........ 1'
.......... .,. .... .



# ................. "' 

# ..................................................... "" 

# u_ .................................................. . +++ ........ .**~_** .... .,.ratl.J.
..................................... .

ra".nlJ.t.la1 

# _...,.1
.. 1' "all. ;I.af:U:tat.t. ••••••••••••• Lac:anrN. car.&IID
.......................................... .

...... 1111;
................................................. .. L:mat
................................................... .

__'GOlear or .... .tatl_t:U!' oNl .bt11tntJ. •••••

..... UU.**{tooal/lR.lt-.t.t'~** 1afl_U_ ritJa a_d.)**~** 

# ..**~** 

# ........ , 

# ............................ .................... . L:rJII'Ir 1IlOD.-CJmVIC&lo
..................................... .**r.~t** 

### ... p1'91U....-t:L0II
................................ ..**p~** _lJ. ,Pftl,J..t'_at.1oA
............................. .

...................... ................................. <I "" 

### LI1IU IIODS-a......ue**~ ~**  of"
.. .. 

## ur. • .". JllCOiQIIII)
., •• A.D. 

## o USIi'lJICl •**~.I'USIIft** lr 110 IIa'IIIlt1.'I' 

## __ Ift 1**~** 2 .Ujl!ftt S**~t:. .~..s**  1 

### I • , I • 0



# ...........

.. 

# . " ). 

# ....... "

11111 ••• 1. • •• 1. ••• 1 ••

• + ....**+.+~.** • • J • I J • J • 

### J .lIl.1
... 1.


# ....... " 

# .... ,1
.. 'II
.... " •• 

## • • a •• 2: • 1

A

### REGULATORY~ORT 

## 3i7

# •••••••••• •••••••••• ••••••••••

•••••••••• •••••••••• 90 DAY**INHALATIO~** 

## TOXICTY STUDY IN 

## mE RAT WITH RBCOVEIY PHASE 

# APPENDIX 12 -INDMDUAL PATHOLOGY CROSS REFERENCE (MICROSCOPIC)

ItJINOVAr. 

## uaaoa.**~IUUI** DCI8II LIInL. 0 

## sa. 

# ar..
.... 1 12
... 167 •• 0 IIlI8AL CAVlft
............................................ .**~p** .Ill 1_
.................................. . oa8OI'IIMlUS
.............................................. . JIAIIiCIIDS
................................................ . PAllJl.fttJIOID GLMID
...................................... .. PIDIIIt'I JlA'I'CII,a
........................................ . naJl'DI%
................................................. . •**IftJ:~1'** GLaIIII
......................................... .**~tJ.** 

### .. .......................................... '" t .................... "
.......................... .. J1aOII'l'III. GLI.IID
.......................................... .

JIoIaoIlao1.ar 

## -u iat'11tnt1_ ••••.••...•••••.•••••••••• 'ro.tat1U
............................................ . IIIIC'I'B: ..............."................................................................................... SAL:IVU'I' 8IoIIIID
......................................... ..



## a:n:.
.,... DCOIIDIID ••• A.D. 

## o m:88DIG 

# • ..,...,r.o&!'......... I: JIO snmu:ft**IIDIU'BO~** 1DYJIU'l'Y 1**~** :iI 

## .u. ... t 3**~te**



# .. IIiII:dIe4 

# ........ +.

.. .. 

## .. .. .. 

# .. .. .. 

# "

..

••••• 00 ••• 

### •••••• 00 ••

•••••• + ••• • , •• I:.X ••• • • + • + 

### + • + + • ••• 2.1 •• 2 • •. 1.1 •• 1 ••



## fREGULATORY/REPORT
- 378

# •••••••••• •••••••••• •••••••••• •••••••••• •••••••••• •••••••••• •••••••••• 

# •••••••••• •••••••••• 90 DAY INHALATIOl\ TOXICfY STUDY IN THE RAT WITH 

# RECOVERY PHASE 

# APPENDIX 12
.. INDIVIDUAL PATHOLOGY CROSS REFERENCE (MICROSCOPIC)

....:l'III.L**~I** 'ISIIIlImL DOIQI t.II'nir. I 0 lIB. IIIILB PI1II 1 

### 1131."7.'0 BCIAYIC DIr9B
........................................... .**~11Da1:i.o** ..................... "
.................... . B'BIIJJIAL VDICLB .... '" .... ............................................ ,. ........................ .. Sltl. (_taT**r~)** ...................................... . IU'IIIUo COIID
............................................ ..**~** 

# ........................**s.~** * •••• t ......................... . 8'l'1l11111111 WI'l'II
__ IIIUIIIQIf
................................ .**8~** ................................................. . 'I'II$'I'X8
.................................................. .

Uau.atera1 

### 1:tih1ar ....-.r.tio. ...•.•...........•...••. 'l'IIDIDS
.................................................. .**~t:lall/~** ••• < ............................. .

Bpi tbel.:lal. 

### ar-t/. • .................................... . 'I'II'IJIOW eLAIID
........................................... .

..,...... ar-t/
........................................ . 'I'JIACIIII&
................................................. . 0'1. • lICIT Beo.DGI ••• A.D. 

## o IIISSIIIG

...**~PDIIIIII'I'** :I .0 1Ifiml1'l'!' lIOII:PlIOI'oCIO SJlVDIft 1 aiaiaa.l 2 

### .u.P1: 3 ...tou:.1: •

.. _Jr. •• • 'I' 'I' 'I' 'I' 'I' 'I' 'I' • • • 1 III 111 • •



# ............ • • • •• 1 • • ••
• • • • • • •• 1 • • :I • • • • • • ••
• • • • :I • :I • • •



# REGULATORynrnpORT

- 379

## 90 DAY lNHAI.ATION TOXICl'Y STUDY IN TIlE RAT WITH RECOVERY PHASE 

# APPENDIX 12 - INCIVIDUAL PATHOLOGY CROSS REFERENCE (MICROSCOPIC)

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# APPENDIX 12 • INDIVIDUAL PATHOLOGY CROSS REFERENCE (MICROSCOPIC)

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