Document zzRwv7Y25rLO5ZYw8xMMyQdv0

SocSusSlulI BIO -TEST J!aJ3<yujiym6ri Sac. 1810 FRONTAGE ROAD NORTH 8ROOK. I LU NOIS 60062 VC 1 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 CMA 002005 BIO -TEST Xal30^iJjyuz6>, 9nc. 1810 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, , I ha / ^ IfN. J. C. Calandra President JCC:bp CMA 002006 'Jndudiual B I O - T E S T Ja&naiyiiM, !)* 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 ;WiW>W B I O - T E 5 T J.d*vud&u*i> !)he. 2 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 non-treated observation period. CMA 002008 JrtdudtMal B I O * T E S T 2alx>\ai&U*d., y*c. 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: Dennis C. Lindberg, B\S, Assistant to the Manager Decatur Research Laboratories Report approved by: l/J MJ-JL*------ W. Goode, Ph.D. lager Decatur Research Laboratories i, Florence K. Kinoshita, ^h.D . Technical Manager Toxicology Manager, Toxicology lb CMA 002009 2tvL*ibiaL 8 I O T E S T AabotatoniM, Hue. 4 Ill. 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. Top Middle Bottom Mean Vapor Concentration (ppm) T-I T-II T-III 48.5 48.7 49.9 49.0 208 205 205 206 2555 2459 2538 2517 T-IV 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 213 214 215 218 219 220 221 222 225 226 227 228 229 232 233 234 235 236 G 55 o to o 153 154 155 156 157 158 159 160 161 162 163 164 165 166 167 168 170 4T-I Rang e Mean Chamber Concentration (ppm) T-II '-III Range Mean Rang e Mean 45.5 48.5 47.5 176 214 197 1820 2680 2467 50.5 55.0 51.5 180 242 206 2300 2820 2459 Holiday, no exposures 43.5 53.5 46.5 180 242 202 2180 3000 2554 46.5 52.5 50.4 154 194 184 2320 2600 2457 36.5 52.5 45.0 138 250 192 1440 2600 2240 44.5 55.0 49.2 130 138 134 2460 2620 2540 38.6 67.5 45.1 124 260 196 2000 3120 2687 47.0 61.0 53.1 130 200 179 2380 2920 2384 47.5 53.0 57.8 150 232 181 2380 2700 2484 50.0 53.5 51.5 180 210 195 2440 2800 2580 47.0 53.0 52.1 184 202 187 2200 2660 2488 46.5 56.0 49.4 190 216 200 2420 2800 2583 47.0 71.0 52.3 184 228 201 2100 2820 2520 42.5 53.0 47.9 180 204 199 2300 2740 2479 38.0 55.5 49.4 180 226 193 2160 2800 2472 44.0 51.0 47.6 196 215 207 2440 3710 2932 48.0 56.5 53.6 184 216 205 2120 3100 i 2528 T-IV Range 2340 2400 2500 2640 2140 2160 2500 2600* 1100 2500 2340 2740 2600 2660 2160 2480 2200 2500 2460 2380 2400 3020 * 2510 3000 2700 3040 2900 2800 2500 2940 2800 2900 2980 Mean 2409 2493 2231 2294 2760 260Q: 2264 2664 2456 2815 2669 2755 2353 2667 2545 2729 2668 BIO-TEST M U1 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 239 240 241 242 243 246 247 248 249 250 253 254 255 256 257 260 261 262 n O o to 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 T-I Rang e Mean Chamber Concentration (ppm) T-II Rang e Mean T-III Rang e 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 Rang e 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 2673, 2640] ** j li 2347 2464 2580 2355. 2380 2392 2545 2524 r- % 0B I - T EST TABLE I continued B IO -T E S T Jc 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 Rang e Mean Chamber Concentration (ppm) T-II T-III Range Mean Range Mean T-IV Range Mean 263 189 264 190 267 191 268 192 269 193 270 194 271 195 274 196 275 197 276 198 277 199 278 200 281 201 282 202 283 203 284 204 i285 288 > 220066 o to o H W Holiday, no exposures 41.0 50.5 47.5 45.5 58.5 50.2 46.0 57.0 50.5 41.0 55.5 50.5 48.0 54.5 50.1 43.5 50.5 47.3 44.5 51.0 47.9 38.0 56.0 49.5 45.5 52.5 48.9 47.0 56.0 50.3 37.0 52.5 48.3 40.0 56.0 47.5 43.5 54.0 48.2 43.0 54.0 49.7 47.0 57.0 52.5 43.0 58.5 50.3 Equipment malfunction. 192 210 198 2300 192 251 196 2160 182 214 200 2320 186 234 215 2380 172 214 204 2260 190 208 200 2140 188 216 202 2180 174 242 198 2160 188 214 199 2320 170 220 201 2280 176 226 200 2220 168 232 204 2360 176 236 202 2120 188 216 206 2340 144 220 194 1400 154 224 199 2100 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 ** 2272 2400 2540 2270 2408 2440 2440 2564 2656 2672 2600 2413 2640 2478 2397 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 289 290 291 292 295 296 297 298 299 302 303 304 305 306 309 310 311 O 312 c> o hot~oi 20? 108 209 210 211 212 213 214 215 216 217 218 219 220 221 222 223 224 r-i Rang e Mean Chamber Concentration Cppm) T-II T-UI Range Mean Range Mean T-IV Range 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* .- 1920 2400 2400 2400 2360 2280 * 2640 2620 2560 2560 2520 2680 2500 2520 2500 2500 2500 * 2960 Mean 2528 2424 2516 2428 2585 2480 2445 2440 2410 2364 2440* 2800 BIO -TEST M OO 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 31? 227 318 228 319 229 322 230 323 231 324 232 325 233 326 234 329 235 330 236 331 237 332 238 333 239 336 240 337 338 1> 224412 o o to o U1 37.0 52.5 44.2 46.0 55.0 54.0 46.5 55.5 50.6 46.5 52.0 49.2 44.5 52.0 49.1 49.5 56.5 52.0 49.4 62.0 54.9 49.5 54.5 50.7 45.5 56.5 49.7 48.0 62.0 54.0 Equipment malfunction. **** **** 58.0 53.5 58.5 55.5 56.0 56.0 56.0 47.5 55.0 51.3 41.0 44.5 42.8 40.0 48.5 46.0 43.0 53.5 49.6 146 196 174 182 220 208 152 242 205 170 280 192 192 222 201 198 222 210 176 250 208 200 208 204 190 206 196 170 238 202 but animals exposed 200 204 202 186 198 191 206 208 208 185 210 202 164 182 168 172 200 184 168 200 190 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 2400 2640 2460 2333 2348 2370 2576 ** ** 2420 2084 2584 2380 BIO-TEST M 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 339 243 340 244 343 245 344 246 345 247 346 248 347 249 350 250 351 251 352 353 55 252 253 354 254 357 2 255 358 256 359 257 360 258 361 259 364 260 365 261 T-I Range Mean Chamber' Concentration (pp m) T-II 1'-III Range Mean Rang e 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 - - - 160 250 213 2700 2940 2800 35.0 45.5 39.5 180 246 228 2640 2900 2783 34.5 64.0 44.3 216 226 219 2560 2820 2660 54.5 70.0 59.0 2 06 214 207 2340 2560 2490 53.0 70.0 58.7 192 202 199 2330 2940 2635 Holiday , no exposures 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 t 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 2500 2480 2500 2420 2320 2460 2380 2560 2440 2500 2380 2640 2460 2860 2540 Mean 2413 2428 2536 2467 2436 2435 2375 2240 2176 2395 2372 2447 2460 2350 2512 2440 2730 2484 - no exposure * only 1 sample taken ** no sample taken *** equipment failure, no exposure CD o tn r ^nduii^Uai B I O - T E S T J.<sJianat&ua&, 9*te. 11 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. CMA 002017 BIO -TEST M 002018 TAIil.fc U XhST MA'i'KKiAL; Vinyl Chloride (bihylene derived) Chronic Vapor Inhalation Toxicity Study - Albino Hats, Albino Mice end Gulden liauislers Summary ul Mean Body Weights * Albino Rats Mean Body Weights (grams) Month Number: Sex Group 0 1 2 3 4 6 6 7 8 9 10 il 12 13 14 15 16 17 18 CJidiiue Mute uc 205 363 456 498 517 537 543 550 559 697 677 689 692 708 739 769 782 779 783 . 578 T-l 20*) 346 448 491 526 545 554 567 593 651 640 670 696 704 732 754 765 773 764 575 Til 201 360 457 490 522 549 567 566 685 681 663 696 736 740 764 786 795 781 781 580 T 111 200 361 453 499 529 500 567 576 681 627 629 680 718 729 764 768 758 -" Female UC 160 235 275 299 315 320 326 344 356 392 366 380 398 397 424 444 463 475 491 T-l 160 232 274 297 310 308 323 348 367 357 363 374 384 395 425 448 458 457 472 T-ll 171 242 289 302 313 316 329 342 358 368 362 386 393 414 441 479 462 440 450 Till 166 240 287 303 312 321 329 346 369 359 356 374 378 420 450 - - * T-1V 181 251 282 288 291 314 324 338 348 363 363 384 NA 395 NA 393 421 331 304 279 " - = No more animals remaining in group. NA - Nut available. B IO -T E S T JU 002019 Sen Group 0 Male u.c. T-l T-ll TUI 35 31 36 36 Female UC T-l T-ll T-IU 29 30 28 28 TABLE 111 "Iliia'i MATEKIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Tonicity Study - Aibinu Hits, Albino Mice and Gulden Hamsters Summary uf Mean Body Welkins * AILnuij Mice Mean Body Weights (grams) Month Number; 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 40 41 43 46 43 46 52 49 47 43 47 48 47 45 46 44 43 39 39 43 44 42 47 45 47 47 48 48 49 48 48 50 48 40 38 42 44 42 45 43 44 46 37 44 45 * - " " 38 40 43 44 38 45 41 41 43 31 ~ "~ "` 32 33 35 36 35 38 37 41 40 37 40 40 40 41 42 40 40 34 34 37 39 38 40 41 40 40 42 43 42 43 44 39 38 31 34 35 37 36 38 36 40 39 30 40 37 38 40 38 38 - 31 34 35 36 37 37 34 37 39 27 18 Change 43 8 - 39 10 *" - - = No mure animal a remaining in group. O OJ BIO -TEST A CMA 0 0 2 0 2 0 TAbUi IV lUij'i' MATidUAh: Vinyl Chloride (bihyJenc Derived) Chronic Vapor Jiiiulaliuit lux icily Study * Albino Hab, Albino Mice and Golden llaiusilorb Summary oi Mean Uody Weiglilb - Golden lEam&tcra Sex Croup 0 I Male UC T-l T-ll TUI 73 71 63 60 90 90 09 07 Female UC T-l T-ll TUI 77 70 74 61 104 94 94 92 Mean lludy Weiylm (g rams) Mu itill Number; 2 3 4 5 6 7 0 9 10 II 12 13 14 15 16 17 10 Chanue no 120 129 130 1331 130 130 141 129 126 125 131 120 125 126 133 130 101 114 120 121 122 120 126 no 119 no 115 121 124 122 125 132 132 94 99 119 100 120 no 122 117 119 114 121 126 13 129 110 133 134 91 93 91 00 112 no 119 116 115111114 no 123 120 124 129 130 127 100 110 120 121 124 129 120 133 119 116 117 115 122 119 115 120 no 102 112 110 no 122 130 126 124 110 no no 115 117 121 L22 125 124 99 100 107 106 114 112 116 no 112 112 109 114 116 117 122 126 122 100 106 106 104 110 no 109 107 103 99 101 105 109 112 96 65 61 71 67 41 46 40 - - No mure animals remaining in group. JT 4- 9Hdt*&fauaL B I O - T E S T J.altMat<yU&, !)*&. 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 002021 Jndud&ual B I O - T E 5 T JafomiMM, 3no. 16 Month Number 1 2 3 4 5 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-m F MF MF MF 00000000 002 01 000 0 1 2 01004 0 2 4 11 3 0 1 4 2 3 5 16134 34616 154 448 26265 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 36 100 o 100 100 * Includes 5 males and 5 females from each group excluding T-IV sacrificed for cyto genic study. () Indicates moribund or sick animals sacrificed. 002022 9tuhidbuaL B I O - T E S T Jahtat&UAL, 9tie. 17 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-UI F MF MF MF 0 0 0 0 0 0 0 '0 ' 00030000 2 06 43 0 10 5 1 19 5 4 1 4 7 8 2 26 6 4 2 3 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 32 76 98 30 15 54 46 96 94 100 100 34 16 57 66 98 95 100 100 44 23 70 30 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 002023 jtuLubual B I O - T E S T JaAtyiafotfri, 9no. 18 Month Number 1 2 3 4 5 6 7 3 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-U T-ni F MF MF MF 54447 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 0 Indicates moribund or sick animals sacrificed. CMA 002024 Jttduii/uaL B I O - T E S T J.akviaia*i6, Jhc. 19 VI. Hematologic Studies The results of hematologic studies done on male and female rats from the control group and from treatment groups I 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 Untreated Control 3 o o to o to CTt 1 2 4 5 7 10 11 13 15 16 17 18 19 20 21 Mean Total Leukocyte Count (thousands/mm ^) 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 i Er ythrocyte Count (millions/mm-*) ' 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 6.28 Hemoglobin Concentration (g/100 ml) 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 Hematocrit Value (%) 47 50 48 50 48 46 47 38 50 52 54 51 45 44 50 48 BIO-TEST A to Group T-I o O o to o to -4 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 Total Leukocyte Count (thousands/mm ^) Erythrocyte Count (millions/mm^) Hemoglobin Concentration (g/100 ml) Hematocrit Value (%) 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* 13.5 9.0 13.2 9.4 14.2 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 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 w O Irt r 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 Group Animal Number Total Leukocyte Count (thousands/mm ^) Erythrocyte Count (millions/mm Hemoglobin Concentration (g/100 ml) Hematocrit Value (%) T-II o > O o to o to 00 403 408 412 413 416 418 419 421 425 428 429 430 434 435 436 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 5.66 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. t b io - test a fvJ TABLE IX 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 Animal Number Total Leukocyte Count (thousands/mm ^) Erythrocyte Count (m i llions / mm 3 ) Hemoglobin Concentration (g/100 ml) Hematocrit Value (%) Untreated Control o o o to o to Id 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 BIO-TEST M tOoJ Group T-I s o o to o OJ 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 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 (r/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 f 48 | 44 38 45 46 43 44 44 43 33 36 43 BIO-TEST A ro 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 3) Erythrocyte Count (millions/mm Hemoglobin Cone en tration (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 00 O tn i> I' frt r n o o to o w IO\Jl Group Untreated Control T-I T-II T-I TABLE X TEST MATERIAL: Vinyl Chloride (Ethylene Derived) Chronic Vapor Inhalation Toxicity Study - albino Rats, Albino Mice and Golden Hamsters 18-Month Hematologic Data - Albino Rats Animal Number and Sex 2-M 19-M 20-M 204-M 206-M 208-M 2I7-M 429-M 331-F Neutrophils (%) 45 42 44 22 20 35 39 26 61 Differential Leukocyte Count (Number of Cells per Hundred) Lymphocytes Monocytes Eosinophils (%) (%) (%) 54 0 58 0 52 3 1 0 1 78 0 78 0 64 1 59 0 0 2 0 2 73 0 1 39 0 0 Basophils (%) 0 0 0 0 0 0 0 0 0 o o o to oUJ CO rj O'