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!}n&uAt/uxLl BIO -TEST 2aJi<yiciJxyuAll 3nc. 1810 FRONTAGE ROAD NORTH BROOK. I LLI NOI S 60062 V'~ 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 102272 3nduAt/ual BIO -TEST 2aIy>n>Gi&iiz6,, 3m. 1310 FRONTAGE ROAD NORTHBROOK. ILLINOIS 60062 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 Toxicity 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 cMM02273 jrtdHdi'ual B I O - T E S T labwiabvu&i. 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. CMA102274 }*tda<UtiaL B I O - T E S T 2aj*MatoA*A, II. Summary 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 nan-treated observation period. CMA102275 9dudiuai B I O * T E S T JjamAatateeS, 9*tc. 3 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: A&aisuai lu me ividiiagcx Decatur Research Laboratories Report approved by: W. Goode, Ph.D. 5er Decatur Research Laboratories /> ' Jy Florence K. Kinds hita,/Ph .D . Technical Manager Toxicology Manager, Toxicology lb CMA 102276 jtuLtd&ual B I O - T E S T Jial&ia&yUeA, Una. 4 III. Chamber Concentration Data 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 CMA102277 BIO -TEST CMA 102278 Day Number 213 214 215 218 219 220 221 222 225 226 227 228 229 232 233 234 235 236 TABLE I TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic VapOflr Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Chamber Concentration Data Exposure Number T-I Range Mean Chamber Concentration (ppm) T-II T-III Range Mean Range Mean T-1V Range 153 45.5 48.5 47.5 176 214 197 1820 2680 2467 2340 2500 154 50.5 55.0 51.5 180 242 206 2300 2820 2459 2400 2640 155 Holiday , no exposures 156 43.5 53.5 46.5 180 242 202 2180 3000 2554 2140 2380 157 46.5 52.5 50.4 154 194 184 2320 2600 2457 2160 2400 158 36.5 52.5 45.0 138 250 192 1440 2600 2240 2500 3020 159 44.5 55.0 49.2 130 138 134 2460 2620 2540 2600* * 160 38.6 67.5 45.1 124 260 196 2000 3120 2687 1100 2510 161 47.0 61.0 53.1 130 200 179 2380 2920 2384 2500 3000 162 47.5 53.0 57.8 150 232 181 2380 2700 2484 2340 2700 163 50.0 53.5 51.5 180 210 195 2440 2800 2580 2740 3040 164 47.0 53.0 52.1 184 202 187 2200 2660 2488 2600 2900 165 46.5 56.0 49.4 190 216 200 2420 2800 2583 2660 2800 166 47.0 71.0 52.3 184 228 201 2100 2820 2520 2160 2500 167 42.5 53.0 47.9 180 204 199 2300 2740 2479 2480 2940 168 38.0 55.5 49-4 180 226 193 2160 2800 2472 2200 2800 169 44.0 51.0 47 .6 196 215 207 2440 3710 2932 2500 2900 170 48.0 56.5 53.6 184 216 205 2120 3100 2528 2460 2980 Mean 2409 2493 2231 2294 2760 2600* 2264 2664 2456 2815 2669 2755 2353 2667 2545 2729 2668 TABLE I continued TEST MATERIAL; Vinyl Chloride (Ethylene Derived) Chronic VapqgT Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Chamber Concentration Data Day Number Exposure Number 239 240 241 242 243 246 247 248 249 250 253 254 255 256 257 260 261 262 O 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-I1I Range Mean Range 46.0 51.5 49.3 186 198 47.0 50.5 48.5 202 214 44.5 55.5 50.4 154 220 46.5 53.0 47.9 180 222 48.5 52.5 50.5 194 206 45.0 54.5 48.8 182 210 47.5 55.0 51.0 - 47.5 52.5 51.2 186 222 44.0 56.0 49.4 164 236 Equipment malfunction. no exposures 45.5 57.0 51.4 188 218 44.0 51.5 50.0 184 212 43.0 75.0 57.4 88 22 47.0 55.0 50.9 172 230 39.0 57.5 48.0 180 214 35.0 66.0 48.6 182 250 38.0 75.5 49.9 170 266 43.0 50.0 47.4 196 224 191 209 197 194 199 198 203 201 204 193 171 203 199 209 202 205 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 Mean 2488 2339 2532 2512 2496 2536 2673 2640 1900 2420 2100 2040 2280 2200 2500 2460 2760 2500 2620 2460 2500 2600 2560 2560 2347 2464 2580 2355 2380 2392 2545 2524 ot(Oo -vl CD BIO -TEST A o- BIO -TEST A CMA 102280 Day Number 263 264 267 268 269 270 271 274 275 276 277 278 281 282 283 284 285 288 TABLE I continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Chamber Concentration Data Exposure Number T-I Rang e Mean Chamber Concentration (ppm) T-II T-III Range Mean Range Mean T-IV Range 189 Holiday, no exposures 190 41.0 50.5 47.5 192 210 198 2300 2620 2431 ** ** 191 45.5 58.5 50.2 192 251 196 2160 2540 2350 2240 2320 192 46.0 57.0 50,5 182 214 200 2320 2620 2452 2380 2440 193 41.0 55.5 50.5 186 234 215 2380 2880 2633 2420 2760 194 48.0 54.5 50.1 172 214 204 2260 2660 2447 2140 2400 195 43.5 50.5 47.3 190 208 200 2140 2560 2439 2380 2500 196 44.5 51.0 47.9 188 216 202 2180 2580 2377 2400 2460 197 38.0 56.0 49.5 174 242 198 2160 2640 2386 2440 2440 198 45.5 52.5 48.9 188 214 199 2320 2720 2457 2340 2740 199 47.0 56.0 50.3 170 220 201 2280 2860 2585 2300 2920 200 37.0 52.5 48.3 176 226 200 2220 2700 2473 2580 2900 201 40.0 56.0 47.5 168 232 204 2360 2740 2515 2520 2720 202 43.5 54.0 48.2 176 236 202 2120 2940 2459 2280 2520 203 43.0 54.0 49.7 188 216 206 2340 2920 2550 2540 2780 204 47.0 57.0 52.5 144 220 194 1400 3420 2620 2210 2600 205 43.0 58.5 50.3 154 224 199 2100 2980 2504 2140 2560 206 Equipment malfunction. but animals were exposed Mean ** 2272 2400 2540 2270 2408 2440 2440 2564 2656 2672 2600 2413 2640 2478 2397 B IO -T E S T Jc C M A 102281 Day Number 289 290 291 292 295 296 297 298 299 302 303 304 305 306 309 310 311 312 TABLE I continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapofr Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Chamber Concentration Data Exposure Number T-I Range Mean Chamber Concentration (ppm) T-II T-III Range Mean Range Mean 1'-IV Rang e 207 42.5 59.0 48.5 194 206 200 2360 2820 2593 2480 2620 108 40.0 53.5 45.9 204 218 209 2280 2820 2482 2280 2560 209 45.5 51.5 49.3 166 220 203 2380 2680 2521 2440 2560 210 Equipment malfunction. no ex posure 211 46.5 54.5 47 .6 186 230 207 2280 3200 2577 2280 2520 212 43.5 53.0 49.3 200 210 205 2480 2660 2613 2520 2680 213 Vinyl Chloride gas regulator broken. no exposures 214 Holiday, no exposures 215 Holiday, no ex posures 216 Vinyl Chloride gas regulator broken, no exposures 217 Vinyl Chloride gas regulator broken, no exposures 218 45.5 50.5 48.2 202 226 218 2140 2460 2288 2400 2500 219 44.5 52.5 48.6 186 210 204 2280 2740 2565 2400 2520 220 45.0 57.5 42.3 190 218 203 2360 2660 2481 2400 2500 221 41.5 49.5 45.9 168 192 185 2080 2500 2258 2360 2500 222 47.5 55.0 51.0 186 196 193 2280 2500 2380* 2280 2500 223 44.5 57.5 51.3 160 226 184 * * 2280* * * 224 39.0 46.0 42.8 148 172 160 1800 2040 1920 2640 2960 Mean 2528 2424 2516 2428 2585 2480 2445 2440 2410 2364 2440* 2800 B IO -T E S T 2c ,MA 102282 Day Number 315 316 317 318 319 322 323 324 325 326 329 330 331 332 333 336 337 338 TABLE I continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Chamber Concentration Data Exposure Number 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 T-I Rang;e Mean Chamber Concentration (ppm) T-II T-III Range Mean Range 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 exposed **** 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 2580 2500 2380 2600 2620 2860 2580 Mean 2073 2473 2558 2022 2542 2699 2475 2405 2597 2576 2540 2376 2300 2556 2481 2685 2366 T-IV Range 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 *** 2400 2640 2460 2333 2348 2370 2576 ** ** 2420 2084 2584 2380 Vo BIO -TEST A CMA 102283 Day Number 339 340 343 344 345 346 347 350 351 352 353 354 357 358 359 360 361 364 365 TABLE I continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters Chamber Concentration Data Exposure Number T-I Range Mean Chamber Concentration (ppm) T-II T-III Range Mean Range Mean T-IV Range Mean 243 40.0 60.0 48.9 184 234 203 2380 2960 2607 2380 2440 ' 2413 244 29.0 53.0 50.7 182 210 199 2300 2560 2420 2380 2500 2428 245 46.5 55.0 50.7 198 210 203 2420 2720 2638 2420 2640 2536 246 43.5 52.0 47.6 186 204 195 2300 2560 2458 2400 2500 2467 247 49.5 51.0 50.0 190 210 203 2140 2620 2525 2420 2480 2436 248 48.5 52.5 50.1 194 206 200 2420 2580 2528 2400 2460 2435 249 49.0 53.0 50.8 194 200 197 2240 2520 2422 2320 2460 2375 250 - - - 180 250 213 2700 2940 2800 2180 2280 2240 251 35.0 45.5 39.5 180 246 228 2640 2900 2783 2100 2260 2176 252 34.5 64.0 44.3 216 228 219 2560 2820 2680 2280 2500 2395 253 54.5 70.0 59.0 206 214 207 2340 2560 2490 2280 2480 2372 254 53.0 70.0 58.7 192 202 199 2330 2940 2635 2420 2500 , 2447 255 Holiday , no exposures 256 21.5 54.0 43.5 214 240 225 2420 2800 2654 2420 2500 2460 257 46.0 71.0 56.0 202 208 206 2420 2560 2487 2320 2380 2350 258 44.5 59.5 50.7 170 216 202 2360 2840 2602 2460 2640 2512 259 44.5 54.0 49.7 202 212 206 2340 2600 2480 2380 2460 2440 260 40.0 53.0 46.8 196 212 204 2300 2800 2597 2560 2860 2730 261 46.5 55.0 51.6 190 200 197 2620 2840 2718 2440 2540 2484 - no exposure * only 1 sample taken ** no sample taken *** equipment failure, no exposure **** equipment failure, animals exposed Vj c, Jrtdu&t'iial B I O - T E S T J.aJto/iatosu&i, 3*tc, IV , Body Weight Data The mean body weight data for albino rats , albino mice and hamsters are presented in Tables II, III and IV, respectively. A02284 CM* B IO -T E S T CMA 102285 TAUhE U 'i'EbT MATEKIAL: Vinyl Chluride (Ethylene Derived) Chronic Vapor inhalation Toxicity btudy ~ Albino ltd Is, Albino Mice and Golden Hamsters Summary ol Mean body Weights - Albino Rats w Mean Body Weights (g rams) Month Number. Sex Group 0 1 Z 3 4 5 6 7 tt 4 111 II 12 13 14 15 16 17 10 Change Male UC 205 36) 456 490 517 537 543 560 559 697 6 77 609 692 700 739 769 702 779 703 T-l 209 346 440 491 526 545 554 567 593 651 640 670 696 704 7 32 754 765 773 704 T-ll 201 360 457 490 522 549 567 565 505 601 663 696 7 36 740 764 706 795 701 701 Till 200 351 453 499 529 500 567 576 501 627 629 600 710 729 764 760 750 - 570 575 500 - Female UC 160 235 275 299 315 320 326 344 356 392 366 300 390 397 424 444 463 475 491 T-l 160 232 274 297 310 300 323 340 367 357 363 374 304 395 425 440 450 457 472 T-ll 1V1 242 209 302 313 316 329 342 350 360 362 306 393 414 441 479 462 440 4t>U Till 165 240 207 303 312 321 329 346 359 359 356 374 3 70 420 45U - T1V 101 251 202 200 291 314 324 330 340 363 363 304 NA 395 NA 393 421 331 304 279 - - = No more animals remaining in group. NA - Nol available. if fa 0j*dM6&uaJ. B I * T E S T CMA 102286 TAIU,E iU TEST MATElUAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study ~ Albino Kalb, Albino Mice and Golden Hamsters Summary of Mean llody Weights * Albino Mice Mean Body Weights (g rams) Month Number: Sex Group 0 1 2 3 4 5 6 7 H > 10 11 12 13 14 15 16 17 18 Change Male u.c. 35 48 41 43 46 43 46 52 49 47 43 47 48 47 45 46 44 43 43 T-I 33 39 39 43 44 42 43 45 43 41 48 48 49 48 48 50 48 - - T-n 36 40 38 42 44 42 45 43 44 46 37 44 45 - - *- T-UI 36 38 40 43 44 38 45 41 41 4 i 31 - - ~ ~"" 8 * " Female uc 29 32 33 35 36 35 38 37 41 40 37 40 40 40 41 42 40 40 39 T-I 30 34 34 33 39 38 40 41 40 40 42 43 42 43 44 39 38 ' - T-II 28 31 34 35 3? 36 38 36 40 39 30 40 37 38 40 38 38 - - T-1U 28 31 34 35 36 33 33 34 37 39 27 10 - - - Mo more animals remaining in group. & 0]etdut3ual B l * T ES T 2a*k*iaLtyu&L, C M A 102287 TAUI.t IV TEST MATEKIAE. Vinyl CUlui nle (Ethylene Derived) Chruiuc Vapor Inhalation loxiciiy Study Albiuu Knlb, Album Mi^c and CIuMcu HtUinnin !> Summary ol Menu Hotly Weights - Golden Hamsters '>1e Mcdii Uu<iy Weights (g iiimb ) * Month Number; Sex Group 0 1 2 3 4 6 6 7 0 9 10 n 12 13 14 15 16 17 10 Cha nt*t MUe uc 73 T-I 71 T 11 63 Till 60 9 40 09 07 no 101 94 91 120 114 99 93 129 120 119 91 130 121 100 00 1331 130 122 120 120 no 112 no 130 126 122 116 141 no 117 116 129 126 115 no 115 115 11611 1114 126 115 121 110 131 121 126 123 120 124 13 120 125 122 129 124 126 125 130 129 133 112 133 130 130 112 114 127 65 61 71 67 Female UC 77 T-i 70 T-U 74 TUI 64 104 96 94 97 100 110 120 121 124 126 120 133 119 116 117 115 122 119 115 120 no 102 99 100 112 100 106 no 107 106 no 106 104 122 114 no 130 112 no 126 116 106 126 no 107 no 112 103 no 112 99 no 109 101 116 114 105 117 116 109 121 117 112 122 122 96 125 126 124 122 41 46 4ti - - No more animals remaining in group T jHdmtuai B I O - T E 5 T JlaJj&iat&uM-, Jhc, 15 V. Mortality Data 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-II 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 102288 jtuLi&iual B I O - T E S T JiaJi&uitoAi&L, 9no. Month Number 1 2 3 4 <3" 6 7 8 9 10 11 12* 13 14 15 16 17 18 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 UC: M Cumulative Number of Mortalities at End of Month t-i T-II T-HI F MF MF MF 00000000 00201000 0 120 1004 0 2 4 11 3 0 1 4 235 16134 34616154 448 2626 5 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 cyto genic study. () Indicate* moribund or sick animals sacrificed. CMA 102289 9ncLtdAial B I O T E S T JcUuytai&u&L, 3no. Month Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 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 UC: M Cumulative Number of Mortalities at End of Month T-I T-II T-HI F MF MF MF 000000 00 00 03 0000 2 06 43 0 10 5 1 19 5 4 1 4 7 8 2 26 6 4 2 8 7 12 2 30 6 8 3 10 9 18 5 31 11 9 12 13 23 18 5 32 14 16 30 30 46 23 8 38 24 37 58 56 75 28 10 42 31 78 82 76 98 30 15 54 46 96 94 100 100 34 16 57 66 98 95 100 100 44 23 70 80 99 97 100 100 54 28 79 91 100 100 100 100 67 39 88 97 100 100 100 100 82 46 100 100 100 100 100 100 82 54 100 100 100 100 100 100 82 58 100 100 100 100 100 100 CMA 102290 B I O - T E S T Jlahytaivued-, 9no. 13 Month Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 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 UC M Cumulative Number of Mortalities at End of Month T-I T-II T-HI F MF MF MF 5 4447 5 2 5 8 11 10 12 9 16 10 11 8 13 12 14 12 18 14 13 9 15 16 16 15 19 15 13 9 18 16 16 16 20 15 15 13 18 16 16 20 21 16 16 13 28 24 19 22 33 18 26 14 28 24 19 23 35 19 28 14 29 24 20 25 36 20 28 14 30 26 20 26 37 23 29 15 31 28 21 26 38 28 36 18 36 34 33 37 46 40 45 23 40 43 49 46 49 49 58 28 46 49 58 54 53 61 69 39 61 53 72 66 55 71 84 50 78 58 83 74 59 84 100 (3) 57 81 61 85 76 66 ' 86 100 62 85 62 86 77 75 88 100 () Indicates moribund or sick animals sacrificed. CMA102291 }ndn6&ual B I O - T E S T XaJtiyuil&ued,, 'Java. 1? VI, Hematologic Studies The results of hematologic studies done on male and female rats from the control group and from treatment groups I and II 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-II. These data are presented in Table X. CMA 102292 Chronic Group Animal Number Untreated Control 1 2 4 5 7 10 11 13 15 16 17 18 19 20 21 Mean TABLE VIII TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters 18-Month Hematologic Data - Male Albino Rats Total Leukocyte Count (thousands/mm J) Erythrocyte Count (millions/rum Hemoglobin Concentration (g/100 ml) Hematocrit Value (%) 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 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 38 50 52 54 51 45 44 50 48 Si i: CMA ttOoo Iv, o to CO Group T-I O 2 > ottoo CD -L- TABLE VIII continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic VgtpQT Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters 18-Month Hematologic Data - Male Albino Rats Animal Number 201 204 206 207 208 209 212 213 214 216 217 218 222 224 233 Mean Total Leukocyte Count (thousand s/mm^) 11.9 23.3* 16.6* 11.7 28.2* 8.6 11.3 8.9 11.0 12.8 24.4* 13.5 9.0 13.2 9.4 14.2 Erythrocyte Count (millions/mm^) 8.20 8.11 8.86 7.52 6.73 8.51 8.31 8.52 8.12 8.27 8.38 7.83 7.99 9.62 8.29 8.22 Hemoglobin Concentration (k/100 ml) 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 Hematocrit Value (%) 47 48 48 46 40 49 52 49 46 48 48 49 46 52 49 48 BIO -TEST A Group T-II O 2 > Mo CMO Ot TABLE VIII continued TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rata, Albino Mice and Golden Hamsters 18-Month Hematologic Data - Male Albino Rats Total Leukocyte Erythrocyte Hemoglobin Hematocrit Animal Count Count Concentration Value Number______________ (thousands/mm^)________ (inillions/mtn^)____________ (g/100 ml)__________________Ci) 403 408 412 413 416 418 419 421 425 428 429 430 434 435 436 Mean 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 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 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 40 41 47 44 34 44 44 46 55 48 40 46 44 50 50 45 * Differential leukocyte counts were performed on these animals. BIO -TEST A IJ `fm v p H x v f X s 3 1 * o I 8 TABLE IX TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vappr Inhalation Toxicity Study - Albino Rats, Albino Mice and Golden Hamsters 18-Month Hematologic Data - Female Albino Rats Group Animal Number Total Leukocyte Count (thousands/mm Erythrocyte Count -a (millions/mm ) Hemoglobin Concentration (g/100 ml) Hematocrit Value (%) Untreated Control 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 42 42 44 46 46 46 47 45 46 45 O C-C o tttooo a> Group O > oro ro 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 304 305 309 310 312 315 317 322 323 324 326 327 329 331 332 Mean Total Leukocyte Count (thousands/mm^) 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 Erythrocyte Count (millions/mm^) 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 Hemoglobin Concentration (k/100 ml) 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 Hematocrit Value (%) 44 44 48 42 48 44 38 45 46 43 44 44 43 33 36 43 BIO -TEST B IO -T E S T Jc 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 Total Leukocyte Count (thousands/mm^) Erythrocyte Count 1 (millions/mm J) Hemoglobin Concentration (g/100 ml) Hematocrit Value (%) 511 514 522 557 566 580 Mean 7.6 7 .8 4.8 5.3 7.5 11.1 7.4 6.60 7.20 6.22 7.24 6.44 6.85 6.76 12.0 13.7 11.7 13.4 12.6 13.2 12.8 40 43 40 44 42 43 42 I Group Untreated Control T-l T-ll T-I TABLE X TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - Albino Rata, Albino Mice and Golden Hamsters Animal Number and Sex 2-M 19-M 20-M 18-Month Hematologic Data - Albino Rata 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 0 2 0 2 429-M 26 73 0 1 331-F 61 39 0 0 Basophils (%) 0 0 0 0 0 0 0 0 0 O 2 > IXJ CT' o trcooo co