Document GzKjjKgaXQnYj9224Ra7wme3m

VC J-1 !)fu&iuUcai BIO - T E S T JPalxyiafotizb, Sac. 1810 FRONTAGE ROAD NORTHBROOK, ILLINOIS 60062 CONFIDENT T A T. Subject to Protective Order in R|v. ^onooo^Inc^, !Jo. 90-4837 14th Juuicial District Court Calcasieu Parish,, Louisiana EIGHTEEN MONTH STATUS SUMMARY TO MANUFACTURING CHEMISTS ASSOCIATION CHRONIC VAPOR INHALATION TOXICITY STUDY WITH VINYL CHLORIDE (ETHYLENE DERIVED) IN ALBINO RATS, ALBINO MICE AND GOLDEN- HAMSTERS MAY 13, 1975 IBT NO. 663-03222 CMA 002005 9nduM/LLal BIO -TEST 1810 frontage road NORTHBROOK. ILLINOIS 60062 .. 3nc. May 13, 1975 Mr. Milton Freifeld Project Manager, Vinyl Chloride Research Manufacturing Chemists Association 1825 Connecticut Avenue, N. W. Washington, D. C. 20009 Dear Mr. Freifeld: Re: IBT No. 663-03222 - Eighteen Month Status Summary of a Chronic Vapor Inhalation Toscicity Study with Vinyl Chloride (Ethylene Derived) in Albino Rats, Albino Mice and Golden Hamsters We are submitting herewith our laboratory report prepared in connection with the above study. Very truly yours. JCC:bp J. C. Calandra President CMA 002006 9*du&tMal B I O - T E S T lafryiaiiyu*^ Hhc. ..... - - nnKFlPWIAE' SttSBBKSf EIGHTEEN MONTH STATUS SUMMARY TO MANUFACTURING CHEMISTS ASSOCIATION CHRONIC VAPOR INHALATION TOXICITY STUDY WITH VINYL CHLORIDE (ETHYLENE DERIVED) IN ALBINO RATS, ALBINO MICE AND GOLDEN HAMSTERS. MAY 13, 1975 IBT NO. 663-03222 I. Introduction A chronic vapor inhalation toxicity study with Vinyl Chloride (Ethylene Derived) was initiated on September 10, 1973, and terminated on September 10, 1974. Animals were then placed on observation. A summary of all data obtained through the eighteenth month is reported herein. CMA 002007 3*tdi4&bual B I O - T E S T 2aJ*yiaityu*U 9*c. II. Summary .^'^`^--CQNFJDSN'riAL Subject to Protective C-r^or in Boss v, Conoco, Ino. , -'o 50-4337 14th judicial District Court Calcasieu Parish, Louisiana 2 Exposure of mice to Vinyl Chloride was terminated after nine months of testing . At this time all surviving mice were placed under observation for the remainder of the investigation with the exception of the T-III group (2,500 ppm) which was sacrificed during the eleventh month. Rats and hamsters were exposed to Vinyl Chloride for twelve months before being placed under a non-treated observation period. CMA 002008 3*td&tMaL BIO-TEST _C0^FIBOTIAL 9hc, Subject to Protective c-der *n ^ Eoss, v. ^noco^Inc^ Vo/90-4337 14th Judicial District Court u.,, Calcasieu Parish,, Louisiana No significant dose related body weight effects were noted among any of the species tested. However, possible mortality effects among high and middle dose level animals have been noted. Hematologic studies were conducted on a selected number of rats after 18 months with no adverse effects being noted. Respectfully submitted, INDUSTRIAL BIO-TEST LABORATORIES, INC. .. Report prepared by: / Dennis C. Lindberg, B'. Assistant to the Manager Decatur Research Laboratories Report approved by: |LofV l/J W. Goode, Ph.D. lager Decatur Research Laboratories Toxicology Manager, Toxicology lb CMA 002009 9*uiudt\iaL BIO-TEST , 9*c. III. Chamber Concentration Data Q OHFID^NT I A.L Subject to Protective Crier in Bose v. Conooo. Xr.c., Vo. 90 - 4837 14th Judicial District Court Calcasieu Parish.* Louisiana 4 The daily range and mean of the Vinyl Chloride concentrations in each test chamber from exposure number 153 through the end of the twelfth testing month are shown in Table I. Data previous to this were presented in the seven-month status report. The overall average daily vapor concentrations were calculated to be 49.0, 206, 2517 and 2472 ppm for the T-I through T-IV chambers, respectively. Below is a summary of mean values for each sample port in each chamber; T-IV chamber had only one sample port. Vapor Concentration (ppm) T-I T-II T-m T-IV Top Middle Bottom Mean 48.5 48.7 49.9 49.0 208 205 205 206 2555 2459 2538 2517 2472 2472 CMA 002010 TABLE I TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Chamber Concentration Data Day Number Exposure Number T-I Range Mean Chamber Concentration (ppm) T-II T-III Range________ Mean________ Range Mean T-IV Range 213 214 215 218 219 220 221 222 225 226 227 228 229 232 233 234 235 Q 236 5 o oto o H H 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 169 170 45.5 48.5 47.5 176 214 197 1820 2680 2467 2340 2500 50.5 55.0 51.5 180 242 206 2300 2820 2459 2400 2640 Holiday, no exposures 43.5 53.5 46.5 180 242 202 2180 3000 2554 2140 2380 46.5 52.5 50.4 154 194 184 2320 2600 2457 2160 2400 36.5 52.5 45.0 138 250 192 1440 2600 2240 2500 3020 44.5 55.0 49.2 130 138 134 2460 2620 2540 2600* * 38.6 67.5 45.1 124 260 196 2000 3120 2687 1100 2510 47.0 61.0 53.1 130 200 179 2380 2920 2384 2500 3000 47.5 53.0 57.8 150 232 181 2380 2700 2484 2340 27Q0 50.0 53.5 51.5 180 210 195 2440 2800 2580 2740 3040 47.0 53.0 52.1 184 202 187 2200 2660 2488 2600 2900 46.5 56.0 49.4 190 216 200 2420 2800 2583 2660 2800 47.0 71.0 52.3 184 228 201 2100 2820 2520 2160 2500 42.5 53.0 47.9 180 204 199 2300 2740 2479 2480 2940 38.0 55.5 49.4 180 226 193 2160 2800 2472 2200 2800 44.0 51.0 47.6 196 215 207 2440 3710 2932 2500 2900 48.0 56.5 53.6 184 216 205 2120 3100 : 2528 2460 2980 Mean 2409 2493 2231 2294 2760 *5 e 26G0* tr 2264 | woMW eo', Clj. < aCD 2664 2456 2815 | % o o*1 " tJ $h bOO O 'Oj* uj M 2669 Hf n *-J tJ W 2755 F b 2353 2667 m 1 ^ 1 Ott! tsi h3 M !* 2545 2729 { 0 2668 * a I0N1 TABLE I continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Chamber Concentration Data Day Number Exposure Number 239 240 241 242 243 246 247 248 249 250 253 254 255 256 257 260 261 3 262 | o o to o to 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 T-I Range Mean Chamber Concentration (ppm) T-II T-III Range Mean Range 46.0 51.5 49.3 47.0 50.5 48.5 44.5 55.5 50.4 46.5 53.0 47.9 48.5 52.5 50.5 45.0 54.5 48.8 47.5 55.0 51.0 47.5 52.5 51.2 44.0 56.0 49.4 Equipment malfunction. 45.5 57.0 51.4 44.0 51.5 50.0 43.0 75.0 57.4 47.0 55.0 50.9 39.0 57.5 48.0 35.0 66.0 48.6 38.0 75.5 49.9 43.0 50.0 47.4 186 198 202 214 154 220 180 222 194 206 182 210 - 186 222 164 236 no exposures 188 218 184 212 88 22 172 230 180 214 182 250 170 266 196 224 191 209 197 194 199 198 203 201 204 193 171 203 199 209 202 205 2260 2180 1500 2100 2380 2320 2440 2420 2560 1900 2320 2000 2300 2140 2140 2140 2160 2620 2600 3340 2560 2780 2760 2780 2700 2740 2760 2500 2640 2720 2400 2888 3240 2560 Mean 2487 2478 2468 2367 2487 2534 2618 2573 2645 2347 2396 2364 2501 2328 2397 2537 2400 T-IV Range 2400 2140 2340 2480 2460 2320 2560 2580 ** 2580 2460 2760 2600 2520 2660 2820 2700 ** 1900 2420 2100 2040 2280 2200 2500 2460 2760 2500 2620 2460 2500 2600 2560 2560 Mean 2488 2339 2532 2512 2496 2536 td 2673 M cn 2640L oft. g ^ < 2347c a 2464j? ooMooo 2580H- l-l 23555* u o 2380^ * 2392S o 2545 w 0 2524g * C+ CO CONFIDENTIAL S ubject to P ro te c tiv e 0: B io .T E S T TABLE I continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalatibn Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Chamber Concentration Data Day Number Exposure Number iT-I Rang e Mean Chamber Concentration (ppm) T-II T-I1I Range Mean Range Mean T-IV Ra nge 263 189 264 190 267 191 268 192 269 193 270 194 271 195 274 196 275 197 276 198 277 199 278 200 281 201 282 202 283 203 284 o 204 285 3 205 288 > 206 o o o u> Holiday, no exposures 41.0 50.5 47.5 192 210 198 2300 45.5 58.5 50.2 192 251 196 2160 46.0 57.0 50.5 182 214 200 2320 41.0 55.5 50.5 186 234 215 2380 48.0 54.5 50.1 172 214 204 2260 43.5 50.5 47.3 190 208 200 2140 44.5 51.0 47.9 188 216 202 2180 38.0 56.0 49.5 174 242 198 2160 45.5 52.5 48.9 188 214 199 2320 47.0 56.0 50.3 170 220 201 2280 37.0 52.5 48.3 176 226 200 2220 40.0 56.0 47.5 168 232 204 2360 43.5 54.0 48.2 176 236 202 2120 43.0 54.0 49.7 188 216 206 2340 47.0 57.0 52.5 144 220 194 1400 43.0 58.5 50.'3 154 224 199 2100 Equipment malfunction. but animals were exposed 2620 2540 2620 2880 2660 2560 2580 2640 2720 2860 2700 2740 2940 2920 3420 2980 2431 2350 2452 2633 2447 2439 2377 2386 2457 2585 2473 2515 2459 2550 2620 2504 ** 2240 2380 2420 2140 2380 2400 2440 2340 2300 2580 2520 2280 2540 2210 2140 ** 2320 2440 2760 2400 2500 2460 2440 2740 2920 2900 2720 2520 2780 2600 2560 tp o IA Mean *+ 2272 2400 2540 2270 2408 2440 2440 2564 2656 2672 2600 2413 2640 2478 2397 o pHOPw (PDS ctlf*r CCMH--4- O d t-j. P M t3* t* H* Wct* Hto0-*- J-i H* Oc+ CO on - t CONFIDENTIAL Subject to P ro te ctive Order Ift Ross v . Conoco, In c ., "o . 30-4837 TABLE I continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Chamber Concentration Data Day Number Exposure Number r-i Rang e Mean Chamber Concentration (ppm) T-II T-III Range Mean Range Mean T-IV Range 289 290 291 292 295 296 297 298 299 302 303 304 305 306 309 310 311 n 312 o o o tJf-SJ 207 108 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 42.5 59.0 48.5 194 206 200 2360 40.0 53.5 45.9 204 218 209 2280 45.5 51.5 49.3 166 220 203 2380 Equipment malfunction. no exposure 46.5 54.5 47.6 186 230 207 2280 43.5 53.0 49.3 200 210 205 2480 Vinyl Chloride gas regulator broken. no exposures Holiday, no exposures Holiday, no exposures Vinyl Chloride gas regulator broken, no exposures Vinyl Chloride gas regulator broken. no exposures 45.5 50.5 48.2 202 226 218 2140 44.5 52.5 48.6 186 210 204 2280 45.0 57.5 42.3 190 218 203 2360 41.5 49.5 45.9 168 192 185 2080 47.5 55.0 51.0 186 196 193 2280 44.5 57.5 51.3 160 226 184 * 39.0 46.0 42.8 148 172 160 1800 2820 2820 2680 3200 2660 2593 2482 2521 2577 2613 2480 2280 2440 2280 2520 2460 2740 2660 2500 2500 * 2040 2288 2565 2481 2258 2380* 2280* s 1920 2400 2400 2400 2360 2280 * 2640 2620 2560 2560 2520 2680 2500 2520 2500 2500 2500 * 2960 09 0 1 t/i > Mean 2528 2424 2516 f- r 2428 2585 w S tn M O'. < <OD 2480 2445 2440 :vH o si o o o S3 o t-H c+ fcl 8-g o M S3 ' -* i-3 Sa2410 2364 2440* Is O tr o ft vO...) <n3 !* f 2800 h lM, co I TABLE I continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Chamber Concentration Data Day Number Exposure Number T-I Range Mean Chamber Concentration (ppm) T-II T-III Range Mean Range Mean T-IV Range 315 225 316 226 317 227 318 228 319 229 322 230 323 231 324 232 325 233 326 234 329 235 330 236 331 237 332 238 333 239 336 240 n 337 241 338 o 242 O to o 37.0 52.5 44.2 146 196 174 46.0 55.0 54.0 182 220 208 46.5 55.5 50.6 152 242 205 46.5 52.0 49.2 170 280 192 44.5 52.0 49.1 192 222 201 49.5 56.5 52.0 198 222 210 49.4 62.0 54.9 176 250 208 49.5 54.5 50.7 200 208 204 45.5 56.5 49.7 190 206 196 48.0 62.0 54.0 170 238 202 Equipment malfunction, but animals ex posed **** **** 58.0 200 204 202 53.5 58.5 55.5 186 198 191 56.0 56.0 56.0 206 208 208 47.5 55.0 51.3 185 210 202 41.0 44.5 .. 42.8 164 182 168 40.0 48.5 46.0 172 200 184 43.0 53.5 49.6 168 200 190 1800 2080 2040 1960 2440 2500 2160 2220 2400 2300 2500 2220 2260 2160 2280 2500 1980 2440 2500 2800 2380 2620 2680 2840 2620 2840 2760 2073 2473 2558 2022 2542 2699 2475 2405 2597 2576 2580 2500 2380 2600 2620 2860 2580 2540 2376 2300 2556 2481 2685 2366 2500 2400 *** 2240 2500 2300 2260 2200 2220 2520 *** *** ** 1700 2420 - 2300 3100 2620 *+* 2580 2720 2620 2380 2460 2500 2760 *** *** ** 2300 2700 - 2500 Mean 2680 2480 *** V ip 2400 2640 2460 2333 Is* to 2348 I8S 2370 & S ^ o 2576 K o <+ o o o taj ** E? v M o * o M fcJ 2420 H 3 , > Q 2084* S- i *** i-3 2584 & M - & <+ ? p tr 23801 o OVC i vlj O*1J * w -1 TABLE I continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Chamber Concentration Data Day Number Exposure Number 339 340 343 344 345 346 347 350 351 3.52 o 353 > 354 O o 357 to o 358 H a\ 359 360 361 364 365 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 T-I Range Mean Chamber Concentration (ppm) T-II T-UI Range Mean Range Mean 40.0 60.0 48.9 184 234 203 2380 2960 2607 29.0 53.0 50.7 182 210 199 2300 2560 2420 46.5 55.0 50.7 198 210 203 2420 2720 2638 43.5 52.0 47.6 186 204 195 2300 2560 2458 49.5 51.0 50.0 190 210 203 2140 2620 2525 48.5 52.5 50.1 194 206 200 2420 2580 2528 49.0 53.0 50.8 194 200 197 2240 2520 2422 - - - 180 250 213 2700 2940 2800 35.0 45.5 39.5 180 246 228 2640 2900 2783 34.5 64.0 44.3 216 228 219 2560 2820 2680 54.5 70.0 59.0 206 214 207 2340 2560 2490 53.0 70.0 58.7 192 202 199 2330 2940 2635 Holiday, no iexposures 21.5 54.0 43,5 214 240 225 2420 2800 2654 46.0 71.0 56.0 202 208 206 2420 2560 2487 44.5 59.5 50.7 170 216 202 2360 2840 2602 44.5 54.0 49.7 202 212 206 2340 2600 2480 40.0 53.0 46.8 196 212 204 2300 2800 . 2597 46.5 55.0 51.6 190 200 197 2620 2840 2718 T-IV Range 2380 2380 2420 2400 2420 2400 2320 2180 2100 2280 2280 2420 2440 2500 2640 2500 2480 2460 2460 2280 2260 25.00 2480 2500 2420 2320 2460 2380 2560 2440 2500 2380 2640 2460 2860 2540 - no exposure * only 1 sample taken ** no sample taken *** equipment failure, no exposure 09 O m w Mean 2413 2428 jr p 2536 2467 2436 2435 Subject OSS V. 2375 su 2240o M 2176* $ 23952 f 2372H<o" H** o ' o o 2447* a O u Q? 2 H' 2460*m- 2 o - py o i-dr tt Ld 235(F - s. 251^ gl < M 244(g % ^ o > ir< 273( o 248 1 H * 3- CrfO* i.,t o UndMikial I O - T E S T JaiwataMai, 9*tc, IV. Body Weight Data ........ COUFIDSIITIAL Subject to Protective Order in jtosa v, Ccr.coo, Inc. , ITo- 90-4857 14th Judicial District Court ,, Calcasieu Pariah,, fc<J\l*UB The mean body weight data for albino rats , albino mice and hamsters are presented in Tables II, III and IV, respectively. CMA 002017 002018 TAbUS n TliST MATKU1AL: Vinyl Chloride (Ethylene Derived) Chronic Vapor hilulatlon Toxicity Study - Albino lUb, Albino Mice and Gulden Hamstert Summary uf Mean Dudy Weights - Albino Ibis Mean lludy Weights (grama) Month Number: Sex Group 0 1 2 1 4 5 6 7 8 9 10 II 12 11 14 15 16 17 18 Change Male UC 205 161 456 498 517 517 541 550 559 697 677 689 692 708 719 769 782 779 781 T-l 209 146 448 491 526 545 554 567 591 651 640 670 696 704 712 754 765 771 704 T-ll 201 160 457 490 522 549 567 565 505 681 661 696 716 740 764 786 795 701 701 T-Ill 200 151 451 499 529 500 567 576 501 627 629 680 710 729 764 768 750 - 578 575 580 " Female UC 160 215 275 299 115 120 126 144 156 192 166 180 198 197 424 444 461 47 5 491 T-I 160 212 274 297 110 100 121 148 167 157 161 174 184 195 425 440 450 457 472 T-ll 171 242 209 102 111 116 129 142 158 168 162 186 191 414 441 479 462 440 450 T-Ill 165 240 207 101 112 121 129 146 159 159 156 174 170 420 450 - - - T-1V 101 251 282 200 291 114 124 118 148 161 161 104 NA 195 NA 191 421 111 104 279 - - = No more animal* remaining in group * NA = Not available. CO o m w r M0a1 oe_j. oc+ cO*h o o 0r0a-t>1d- hH U t?2Jj i-3 M <0 O > tri ,rL kD 0 B l O * T E S T lal*yu2ltyu#L J*tc. TABLE 111 TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Tonicity Study - Albino Hats, Albino Mice and Golden Hamsters Summary of Mean Body Weights - Albino Mice Mean Body Weights (grams) Month Number: Sex Group 0 l 2 3 4 5 6 7 8 9 10 11 12 11 14 15 16 17 18 Change Male U.C. 35 40 41 43 46 43 46 52 49 47 41 47 48 47 45 46 44 43 43 T-l 13 39 39 43 44 42 47 45 47 47 48 48 49 48 48 50 48 - - T-U 36 40 38 42 44 42 45 41 44 46 37 44 45 - - - - - T-lll 36 38 40 43 44 38 45 41 41 41 31 - - - - - " " - 8 " Female UC 29 12 33 35 36 35 38 37 41 40 17 40 40 40 41 42 40 40 39 T-l 30 34 34 37 39 38 40 41 40 40 42 43 42 43 44 39 38 - - T-ll 28 31 34 35 37 36 38 36 40 39 30 40 37 38 40 18 38 - - T-lll 2a 31 34 35 36 37 37 34 37 39 27 - ~ " " ** " ~ 10 - " - = No more animals remaining in group. COUFID.sITI'I AL Subject to P ro te ctive Order in Ross v . Conoco, In s ,, Ko. 90-4837 14th J u d ic ia l d is tr ic t Court .l4 C a lca sie u P a ris h * L o u is ia n a 002019 ] u> B I O - T E S T I J M a b n i i . 0*c. tabu; iv TliST MATKltlAl,: Vinyl Chloride (Elbyiene Derived) Chronic Vapor Inhalaliun 'luxicily Study - Albino Kali, Albino Mice ami Guidon llauiileiij Sex Group 0 1 Male UC 73 90 T-l 71 90 T-ll 61 89 T-lll 60 87 Female UC 77 T-l 70 T-ll 74 T-lll 6V 104 95 94 92 Summary ul Moan Body Weights. - Golden Hamsters. Meanl Uudy Weights (grams) Mouth Number; 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 Change 110 120 129 no 1331 130 138 141 129 126 125 131 128 125 126 133 138 101 114 120 121 122 128 126 118 115 no 115 121 124 122 125 132 132 94 99 119 108 120 118 122 117 115 115 121 126 13 129 no 133 134 91 93 91 88 112 no 115 115 115111 114 no 123 120 124 129 no 127 65 61 71 67 108 118 120 121 124 125 128 133 119 116 117 115 122 119 115 120 118 102 112 118 118 122 130 126 125 118 no no 115 117 121 122 125 124 99 108 107 106 114 112 116 118 112 112 109 114 116 117 122 126 122 100 106 106 104 no 118 105 107 103 99 101 105 109 112 96 41 46 49 - = No more animals remaining in group. COCTFIDSflTIAL Subject to P ro te ctive Order in p-055 7 - Co?--?o, In c . . No. 90-4837 14tn J u d ic ia l D is tric t Court Calcasieu Parish,! Louisian* O 002020 ] 9ndndtMal B I O - T E S T jta&o*ato*i*&. Smc. V. Mortality Data CONFIDENTIAL Subject to Protective Order in 15 Eoss v. Conoco, Inc.. Ko. SO-4337 14th Judicial District Court Calcasieu Parish,i Louisiana The cumulative monthly mortality data are presented in Tables V through VII. / Marked increases in mortality were noted after the ninth month in both T-III male and female rats. The T-IV group which is composed of only females, and the females in the T-H group showed increases in mortality after the tenth month. Effects in mortality rates were also observed in mice. Mortality in all three test groups of mice were significantly higher than that of the control group. This phenomenon became apparent among females following the seventh test month, and was noted among males during the ninth month. A significant increase in mortality was noted among T-III male and female hamsters during the twelfth month of testing. CMA 002021 3*uiM&bUal BIO-TEST 2abi*a&ytia&, Httc. COffglDBNTIAL Subject" to Protective G^d0" i`n jto3S v Conoco, Ins., No. 90-4337 14th Judicial District Court Calcasieu Parish,. Louisiana TABLE V TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Summary of Mortality Data - Albino Rats Month Number I 2 3 4 5 6 7 8 9 10 11 12* 13 14 15 16 17 18 UC M Cumulative Number of Mortalities at End of Month T-I T-II T-HI F MF MF MF 0 00 0 00 00 0 02 0 1 0 00 0 1 2 0 1 0 0 4 0 2 4 11 3 0 1 4 2 3 5 1 6 134 3 46 1 6 1 54 448 2 6265 4 5 9 3 10 5 10 8 4 6 10 4 11 5 16 15 5 7 11 7 12 9 24 28 7 8 13 9 14 19 34 52 13 14 19 16 21 37 58 66 16 17 23 24 26 50 73 83 19 21 26 30 33 63 85 86 21 23 28 37 40 75 94 89 23 25 31 45 46 87 100 (4) 100 28 27 35 53 55 90 100 100 33 28 38 59 64 94 100 100 T-IV F 0 0 0 0 0 0 0 1 4 7 17 40 46 76 86 100 (1 100 100 * Includes 5 males and 5 females from each group excluding T-IV sacrificed for cytogenic study. () Indicates moribund or sick animals sacrificed. 002022 D*itLtiinial B I O - T E S T JaJttytaiiyutS, One. COffFIDSffTIAL Subjec'Pto Protective Order in 17 -Ross, v. Conoco, Inc. . Ka. 90-4337 14th Judicial District Coir*t Calcasieu Parish., Louisiana TABLE VI TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Summary of Mortality Data - Albino Mice Month Number UC M Cumulative Number of Mortalities at End of Month T-I T-II T-III F MF MF MF 1 00000000 2 00030000 3 20643010 4 5 1 19 5 4 1 4 7 5 8 2 26 6 4 2 8 7 6 12 2 30 6 8 3 10 9 7 18 5 31 11 9 12 13 23 8 18 5 32 14 16 30 30 46 9 23 8 38 24 37 58 56 75 10 28 10 42 31 78 82 76 98 11 30 15 54 46 96 94 100 100 12 34 16 57 66 98 95 100 100 13 44 23 70 80 99 97 100 100 14 54 28 79 91 100 100 100 100 15 67 39 88 97 100 100 100 100 16 82 46 100 100 100 100 100 100 17 82 54 100 100 100 100 100 100 18 82 58 100 100 100 100 100 100 002023 Otidit&btial BIO-TEST Ja&QMitoiiMv Otic. U U u C 2. u U i'i i AL Subject to Protective Order in Boss v. Conoco, Inc..No. 90-433^ 14th Judicial District Court Calcasieu Parish,. Louisiana TABLE VII TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Summary of Mortality Data - Golden Hamsters Month Number UC M Cumulative Number of Mortalities at End of Month T-I T-H T-ni F MF MF MF 1 54447 525 2 8 11 10 12 9 16 10 11 3 8 13 12 14 12 18 14 13 4 9 15 16 16 15 19 15 13 5 9 18 16 16 16 20 15 15 6 13 18 16 16 20 21 16 16 7 13 28 24 19 22 33 18 26 8 14 28 24 19 23 35 19 28 9 14 29 24 20 25 36 20 28 10 14 30 26 20 26 37 23 29 n 15 31 28 21 26 38 28 36 12 18 36 34 33 37 46 40 45 13 23 40 43 49 46 49 49 58 14 28 46 49 58 54 53 61 69 15 39 61 53 72 66 55 71 84 16 50 78 58 83 74 59 84 100 (3) 17 57 81 61 85 76 66 86 100 18 62 85 62 86 77 75 88 100 () Indicates moribund or sick animals sacrificed. 002024 f+uLti&uaL B I O - T E S T J&l&ialvuU, 9c* VI, Hematologic Studies ' CONFIDENT I Ali Subject to Protective Order in^ flos3 v. Conoco, Inc. , $c. 90-4837 14th Judicial District Court Calcasieu Parish,, Louisiana The results of hematologic studies done on male and female rats from the control group and from treatment groups T and H are presented in Tables VIII and IX. Mean values for total leukocyte and erythrocyte counts, hemoglobin concentration and hematocrit of male and female rats in treatment groups I and II were normal when these values were compared to those of their respective control groups after 18 months of treatment. Differential leukocyte counts were done on individual animals that had high total leukocyte counts, as follows: 3 male control rats, 4 male rats in T-I, one female rat in T-I and one male rat in T-H, These data are presented in Table X. CMA 002025 TABLE VIII TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters 18-Month Hematologic Data - Male Albino Rats Group Animal Number Total Leukocyte Count (thousands/mm^) Erythrocyte Count (millions/mm ^) Hemoglobin Concentration (g/100 ml) Hematocrit Value (%) Untreated Control Q o o CO o to G\ 1 2 4 5 7 10 11 13 15 16 17 18 19 20 21 Mean 11.4 19.2* 9.6 9.3 9.4 88.2 10.7 11.8 8.5 7.8 8.9 11.6 24.6* 18.7* 8.4 11.9 v 8.78 8.25 8.55 9.30 9.01 7.36 7.73 6.29 8.12 8.95 8.91 8.93 7.84 8.13 8.12 8.28 14.8 15.6 15.0 15.4 14.8 13.7 14.6 11.4 15.9 15.6 17.0 15.5 13.8 13.2 14.4 14.7 47 50 48 50 48 ; 46 47 $SrL htr* mU o' CD 38 50 52 54 51 45 zl r2* foi * wcl- oc+ HO o 0 *4 MOU t(ODrl '-0 M u w tzS 1 il 44 50 pH ? O tH >> tr* 48 4 01 >i 0~1a J ro o Group T-I Q Oo too to -o TABLE VIII continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters 18-Month Hematologic Data - Male Albino Rats Total Leukocyte Animal Count Number______________ (thousands/mm______ Erythrocyte Hemoglobin Hematocrit Count Concentration Value (millions/mmJ)____________ (g/100 ml)__________________ (%) 201 204 206 207 208 209 212 213 214 216 217 218 222 224 233 Mean 11.9 23.3* 16.6* 11.7 28.2* 8.6 11.3 8.9 11.0 12.8 24.4* 13.6 9.0 13.2 9.4 14.2 8.20 8.11 8.86 7.62 6.73 8.61 8.31 8.62 8.12 8.27 8.38 7.83 7.99 9.62 8.29 8.22 14.2 14.4 14.6 13.9 12.6 15.0 16.1 14.6 14.2 14.7 14.6 14.7 14.6 15.7 15.0 14.6 47 48 48 46 40 49 52 49 46 48 48 49 46 52 49 48 O) -o Kl CONFIDENTIAL Unc, S u b je ct to P ro te c tiv e O rder in BI O - T EST Group T-II n o o to o to 03 TABLE VIII continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters 18-Month Hematologic Data - Male Albino Rats Animal Number 403 408 412 413 416 418 419 421 425 428 429 430 434 435 436 Mean Total Leukocyte Count -3 (thousands/mm *) 14.0 10.6 10.9 12.9 14.4 12.9 12.2 11.4 15.0 9.3 30.4* 9.5 8.1 10.4 14.0 13.1 Erythrocyte Count (millions/mm 7.23 5.30 7.87 8.30 5.86 7.52 7.84 7.22 9.56 8.30 8.22 8.90 7 .98 8.82 9.10 7.87 Hemoglobin Concentration (g/100 ml) 12.1 11.0 14.7 14.0 9.7 13.8 13.9 13.9 17.7 14.6 9.7 14.5 13.4 15.3 14.9 13.5 Hematocrit Value (%) 40 41 47 44 34 44 44 46 55 . 48 40 46 44 50 50 45 * Differential leukocyte counts were performed on these animals. ' " " "--t: confidential S ubject to P ro te c tiv o Cr-io 00 o m t/i 'fw i TABLE IX BIO -TEST J a k S rn c . TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters 18-Month Hematologic Data - Female Albino Rats Group Total Leukocyte Erythrocyte Hemoglobin Hematocrit Animal Count Count Concentration Value Number______________ (thousands/mm^)________ (millions/mm^)____________ (g/100 ml)__________________ (%) C O N FID EN TIAL Untreated Control Q o o to o to VD 102 103 104 105 107 108 110 111 112 113 114 115 117 118 119 Mean 9.1 8.0 9-1 9.4 7.8 14.6 6.0 5.8 6.5 6.3 9.8 5.2 4.2 5.3 6.5 7.6 7.26 7.02 5.90 7.71 7.59 7.05 6.58 6.36 7.04 7.26 6.80 6.72 7.35 6.68 7.27 6.97 14.7 13.4 11.5 14.2 14.2 14.7 13.0 13.0 14.0 14.1 14.0 14.0 14.6 13.8 14.6 13.8 46 44 40 46 46 48 o ( 42 o 42 f>> W e-* 1 ... 44 (D 46 46 46 47 45 46 O <0 45 ao & i +1 a. *+ * ra i-* w Group T-I n o o to o w o TABLE IX continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters 18-Month Hematologic Data - Female Albino Rats OB " ** tn Total Leukocyte Erythrocyte Hemoglobin Hematocrit Animal Count Count Concentration Value Number_____________ (thousands/mm^)_________(millions/mm~*)_____________(g/100 ml)__________________ (%) 304 305 309 310 312 315 317 322 323 324 326 327 329 331 332 Mean 3.0 12.7 6.9 12.9 13.2 7.7 6.0 8.3 5.6 7.2 7.9 7.1 8.8 16.0* 7.4 8.7 7.17 6.16 7.11 6.38 7.16 6.98 6.23 7.23 7.30 7.40 6.79 7.08 7.12 4.50 5.89 6.70 13.4 13.6 14.4 12.4 13.6 13.3 11.9 13.7 14.3 13.3 13.2 13.2 12.6 9.0 11.2 12.9 r44 44 48 42 48 to 44 B a cr* C-j. 38 CD o 45 ,, c_l p. c et o 46 43 %e t*rj Ho* (0 P ch O o 44 OM c-K o 44 8-2 CD O teJ ftj ch 43 t-3 33 g O tej tD M ?O i36 43 & on O a* CD n a 03 tv B IO -T E S T Group T-II TABLE IX continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters 18-Month Hematologic Data - Female Albino Rats Animal Number 511 514 522 557 566 580 Mean Total Leukocyte Count (thousands/mm 3) 7.6 7.8 4.8 5.3 7.5 11.1 7.4 Erythrocyte Count (millions/mm^) 6.60 7.20 6.22 7.24 6.44 6.85 6.76 Hemoglobin Concentration (r/100 ml) 12.0 13.7 11.7 13.4 12.6 13.2 12.8 Hematocrit Value (%) 40 43 40 44 42 43 42 n o o to o o o U) H **! M fc 'M to Ol M ** tr* Group Untreated Control T-I T-II T-I Q o o to o OJ to TABLE X TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - albino Rats, Albino Mice and Golden Hamsters Animal Number and Sex 2-M 19-M 20-M 18-Month Hematologic Data - Albino Rats Neutrophils (%) Differential Leukocyte Count (Number of Cells per Hundred) Lymphocytes Monocytes Eosinophils (%) (%) (%) 45 54 0 42 58 0 44 52 3 1 0 1 204-M 22 78 0 206-M 20 78 0 208-M 35 64 1 217-M 39 59 0 429-M 26 73 0 331-F 61 39 0 0 2 0 2 1 0 Basophils (%) 0 0 0 0 0 o& p 0 ra ^ 0 CD p *= 0 W ts tr m* * DJ 0 1- zC+ 1J -er-rr to O'