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R&S 113685 BIO-MEDICAL. RESEARCH DOCUMENT DESCRIPTION FORM Duplicate . in all cards: -- 63 68 69 76 0000432 year as-1961- File number [Right justify [Numeric only] Author(s), as Last Name FS (No Punctuation) and coden for journal as JAMA preceeded by one blank space fA ' -- -r J --U/rs~/r, -A - 77 78 G1E Sub-Index Code 'jy 61 62 11 12 13 Title of Report; end with space-hyphen-hyphen-space. Follow with Index Terms, separated from each other with comma-space. Avoid other punctuation; do not abbreviate. 61 62 21 22 23 24 Source (Journal, Vol., Number, Pages, Date ) 12 61 62 31 32 Brief Summary 12 10 SUMMARY: 61 62 61 62 63 64 kiAl BOB WEST ASSOCIATES, INC. m z 0 Unett/ijir .Juifu/afc ttf n rnrunun/fr/- '( a h> C' f/n'lttiraL P.O.BOX 2001 STAMFORD, CONNECTICUT 06S06 203-322-4466 6900432 Review and Audit of IBT No. 663-03222, Chronic Vapor inhalation. Toxicity Study with Vinyl Chloride (Ethylene D^ri-ved) in Albino Rats, Albino Mice and. Golden Hamsters for the Manufacturing Chemists Association ^ Th& review and audit of this study was conducted at IBT's offices in Northbrook.,. Hi* April 14 to April 18* 1980. The review and audit on. this- study concentrated on the con duct and monitoring- of tha exposures.. However-* attention was also devoted ta the source of the animals and body ~.i- weight data as. they affected fate and mortality. Xu addi-- 'JpF*' ... ~ tiony the review and audit included inspection of hand T. ' written observation, books reflecting- exposure concentrations, as well as. gas chromatographic charts where they were avail able* hand written and computer body weight printouts:* hand written mortality logs* hand written observations and cor respondence. CORRESPONDENCE* PROTOCOL AND TIMETABLE ____ The timetable indicates the exposures were to be ini tiated on. 9/10/73 for the T-I, T-XX and T-riX groups and on 10/1/73 for the T-IV groups. The termination, of the exposures for the first three groups was to be at 9/8/74 and for the T-IV group at 9/27/74. The animals were then to be held for a year prior to terminal sacrifice. A letter dated June IS, 30 (/) 03 .r~\ v; O) 00 O) I 1 \ 4111 4 4 1 1 <1 00 So (/) oC>O 00 V IBT. No. 663-03222 -2- 1973 from Dr. Torkelson of Dow reflects a site visit was made by the MCA. Task. Force, visiting- the Decatur research labs of IBT where the study was conducted. Questions were raised about: the adequacy of equipment/ the exposures main-- tainedr the. exposure concentrations/ the question of contam ination and record keeping. & major concern was raised about the adequacy of the analyses and record keeping. Hand written, notes alongside the margin of this letter indicate that certain corrective actions- were taken at IBT. Z was mrbTe ta tell whether there were any other documented site visits:. In addition, a progress report issued October 13, : 1973 after about a month, of exposure, reflects adjustments that were made to compensate for the issues that were raised during the MCA. site visit. MffMSKS. HP05INS AND HUSBANDRF The animals for this study were supplied by the Charles River Breeding Laboratories. Unfortunately/ we are not able to identify specific animal receipts with this project. However/- we were able to identify from September invoices receipts of hamsters as replacements without charge for ani mals that were dead on arrival in the August shipment. We were able to identify an additional receipt of hamsters in early November, 1973, two months after the study started., which indicated 130 males and 130 females were received at that time. BOB WEST ASSOCIATES-, INC. Agr. '. jr 'V ' XBT No.., 633-03222 -3- t- ' rirt~t'initialnn.ifcn ihariimiii iM . --. /-:-. ' - ' ' . ;'v:iv'-.' R&S 113688 Inspection of the body weights early in the study in dicates despite the report not reflecting the mortalities that there was a rather high mortality in. the hamsters early in the study. At four and five months there were extensive replacements of the hamster groups. .- ? The *WiiwT were ear punched, and the toes removed so the animals could be individually identified. This was to ; allow for Identification for individual body weight determin ation and i qty of when the animals diedr because fehe animals were group housed in groups of 1--5 in stainless steel cages. Inspection of some of the hand written notes shows the layout of the rats in the fade and; indicates that extra animat were to be spaced evenly throughout the rack. In addition,, another hand written sheet shows the arrangement of the gang cages in the chambers. There were 18 gangr cages, ff rats eachr to equal 144 rats. However, the protocol;-only v.? -w * f i calls for 100 rats at each level. This procedure allows for ample opportunities for replacement and substitution. Despite the fact that the animals were identified by ear punching and toe removal, most of the rima* the animals were, not weighed individually but rather by the cage, e,g, r 1--5 animals. Numerous hand written notes showing the arrangement of some of the animal a in the racks reflect the animals excaped or were cannibalised, along with mortality dates for the remain ing individual animals , BOB WEST ASSOCIATES. INC. R&S 113689 IBT No- 633-03222 4 m VnrgL CHLORIDE, SOURCE, IDENTITY Vinyl chloride (ethylene based) appears to have been, supplied as, e.g., containers in excess, of 500 pounds, by PPG: Industries, Industrial Chemical Division, Lake Charles, LA. A letter from W. S. Braybill of PPG to Dr* John Goode of Bio-Test in Decatur indicates that one cylinder would be required per month* Heel sample analyses front the Bio--Test residues., were also performed by PPG at the. Lake Charles, LA operation and thosia that were available appeared to be in good agreement with the new sample analyses supplied, to Bio-- . ^ Test. there was no inventory log at IBT for vinyl chloride. PPG personnel should be asked for account- ability of the vinyl chloride sent to IBT. In addition, they would also have records of the returns for heel analyses. GENERATION OF VINYL CHLORIDE. VAPORS ^ The vinyl chloride supply tanks were kept in an explos-- 'f ;f' `'-V ion room. The material was piped to the test chambers through thin-walled stainless steel tubing. Before the thin-walled tubing delivered the vinyl chloride, to the chambers, it was- connected to a micrometering valve and a. glass rotameter to. - control and monitor the supply of vapor to each chamber. Vapor--air mixture entered the top of the inhalation chamber, circulated through the and was exhausted at the bot tom. Unfortunately, we were unable to find a daily log for BOB WEST ASSOCIATES, INC- IBT No. 633-03222 -5-- the weighing or measuring of" the vinyl chloride that was dispensed during each daily run. CHAMBER MONITORING There are records: of standardizations being conducted in September of 1973,. covering the range from 20 to 100 ppm. standardization and from SO to 400 ppm for the 200 ppm standardization and from.400--4000 ppm for the 2500 ppm level* Standardizations were performed at approximately weekly in tervals prior to. that point where the automatic sampling system was hooked up to the on-line gas chromatograph record er. The initial samples from the chambers for the first part of the study (six: weeks) were obtained by use. of grab- samples which were then analyzed by the gas chromatograph. , ffe were unable to find any record of daily sample analyses being . taken in the research books for the month of October, 1973, the second month of the stndy^- other than ranges and mean concentrations* There also was no evidence of chamber temp erature or humidity being recorded. General Observations ........................... The following observations were obtained by inspection of research log books which present means and ranges of exposure concentrationstime; interval sampling for the gas chromatographic concentrations and charts, as well as the hand written observations in the research log books. BOB WEST ASSOCIATES, INC. H0 IBT No. 633-03222 L, Most of the time, the chambers were not. on for six hours. 2.. Most- of the time the chambers were not even monitored for five hours, in some instances they were only moni-- tored for one to two hours 3i In same instances there was selected data for the daily exposure concentration, e.g., values on the low side may have been eliminated or values, on the high side may have been eliminated. 4. Periodically, there were mechanical problems associated. . with the rotameter, e.g., broken or clogged or unclean lines. 5. Some days there was no exposure because of equipment failure or TV filming or only a one-hour exposure was conducted. 6 . There was evidence that, the chambers did not have an adequate clearance time, since measurements made 45 minutes after termination of the exposure still showed rather high-levels of vinyl chloride presents 7. There was evidence of contamination in the solvents room and the pilot plant which were in dose proximity-.. . to: the exposure room. . 8. Some days there was no analytical data recorded for the exposure concentrations. 9. In some cases, the research log book showed means and ranges for exposure concentrations, with no raw supporti BOB WEST ASSOCIATES, INC E R&S 113691 JR.*- iWiWUranWiiw BT NO. 633-03222 r7- - shown for- periodic sampling with the- gas* chromato graph* 10* Tn some instances , the 50. ppm nominal concentration may have reached- a concentration as. high as 100 ppm and , in one instance, as high as* 400 ppm which is not reflected ire the m^ans or ranges presented in the interim report* 'l l-- ttt some instances, the control chamber indicated levels of vinyl, chloride in a range of 5-11.5 ppm* 12* . Hr. September of 15-74, near the end of the year of expos ure, there was some research booh data reflecting1 exposure concentrations hut no supportive gas chromato-- graphic data* . 12* m some there is io available for one or two levels out of the four exposure chambers being run* 14* There were periodic problems with the gas chromatograph itself, gjthaT- with the Ignitor, Detector or the Recorder* 15* In some instances there were means and ranges presented in the* research book but no interval, data were available. 16* In some instances, the chamber may have been on for four or five hours yet gas chromatographic readings were only taken for two hours. LT* There were a- number of instances where the data presented t in the research book do not agree with the data shown on the gas chromatographic chart* CO GO o> CO ro i' *KV ! BOB WEST ASSOCIATES. INC. *f. .'H |?sit mu mm* littn'rtrirninwia BifltaiiiiiiiifiH XBT No. 633-03222 -8- Specific Exposure Observations The- following notations were associated with- the spe cific exposures and may also be used together with the ^ nH*i a-hirm chamber- concentrations, presented in Table I*. The exposure concentrations presented in Table I are those presented by XBT and one can see with the use of these spe cific notations that the values presented in Table X are not an accurate reflection, in many instances, of the exposure concentrations or are based on minimal supportive, analytical, data. Exposure Number Comment __________ - 5 The values for the T--X mean and the range for the raw date in the report do not agree. 20 & 35 In the daily intervals, there were problems with ' sampling and the curve does not appear to be of value. 52 200 ppm equaled 400 ppm. 55 The gas chromatographic charts are no good and the research book concentration is not shown, or . - recorded. . 80 The gas chromatographic chart agrees with the data: in the research book. 83 There are no gas chromatographic charts but there, is data in. the research book. BOB WEST ASSOCIATES, INC. *T No633-03222 -9 Exposure Number 8S 35 lOff-110 L34&I3S 141 144 145. Comment There are na T-I or T-H data, on the chart or in the book- T-XXX data is present in the research book, but not on the gas chromatographic chart. The gas chromatographic chart and the data in the research book agree but the exposure concentra tions are on the low side. The gas chromatographic charts- do not match, the data in the log book. Observations were noted that some of the data was off the GC chart andthere were some operator errors and missing" data. There were no? GC charts to go with the data pre sented in the research books. No charts available for the exposures 110--135. & line was- drawn through the first hour values and apparently' discarded. There are gas chromatographic charts, and. research book data available but another notebook says that exposures were not run. m addition, the control line shows contamination. A. notation was made that some of the readings were off the chart. -- wide excursions on both the low and high sides. In addition, the controls were contaminated.. BOB WEST ASSOCIATES, INC. IBT. No. 633-03222 -10- Exposure Numbex' 146ISO 152 158 159 165 Comments Some of the data from the charts* has been dis carded. The T--XX value at the first sampling interval does not agree with the data presented in. the research boot. The negative control, line also shows con tamination. The T--HI value is on the high side and reaches 3420. . ft broken rotameter on- line T--r. The values for- the T-UI line indicate they are not working and they have bees deleted. The control background is high. Selected data has bees used for the * tabulated data presented. Analytical samples are present for four* hours. There are missing data when one compares the GC charts versus that present in the research book. The chambers were only on for two hours. There are no exposure concentrations for T--XX, T--XXI and T-XT at the first sampling. There are incomplete values for the second sample at two hours. '- - The chamber was operated for 4 1/2 hours. Zero time was taken ten minutes after the start of the exposure, at which time the gas chromatographic readings were taken. Environmental samples on the i?;. R&S 113695 BOB WEST ASSOCIATES, INC. - dk H *3 -,v IBT No- 633-03222 <1- : -11 i.i Exposure *s>; y.j Number Comments i L65 roof appeared, high- Hood efficiency, where the ' =i (coat'd) syringes were cleaned was poor- Vinyl chloride was- still detectable in the T-rv chamber 45 min-- . utes after the exposure was terminated- ; The solvent room, and the pilot plant both showed 166 vinyl chloride contamination. The first, reading on the gas chromatographic chart is 1:55 pm- The readings continue until. 4 5.4a pm at sharply lower concentration- The i - chamber was turned on at Iff o'clock in the mom-- "/ ` / "- ingr- ./ . r. . .i 16?* Sampling- was only conducted for 4 hours- The 'i ) T--XTX value was 1710 ppm- For the T--X and T-IX lines, there was no sample taken for the second - sampling interval or the fourth interval- 18U Basically no analytical, data on exposure concen tration. 196 Exposures were sampled for five hours- Selected: data in the daily range and no noon samples. The- - control line was contaminated. . L9T The chambers ran for five hours and GC data, are available for three.. BOB WEST'ASSOCIATED INC W , * v/ V'*\ J `i i ' ' i' 30 C/> ! W 05 CD 05 \ f : :) '1. i :{!;! tki} ** i \ \ i -r ' ? ; f ! .t 3- - i 5 Hi R&S 113697 ` "f;T7; " '^X-- - ' - " ^ ~: L r" 11;1 . v I3T No*. 633-03222 -12- Exposure Number Comment 201 A. seven-hour exposure is indicated as having: been run. The sampling for GC analysis was run for somewhat less than five hours. Selected data has been, taken at the Initial reading and then spor adic data is missing throughout the run. 206 The chambers were not monitored and no data are 210 available. No sampling. Exposures were only on for one hour with, a notation of TV filming. 213 There was one reading for each line for the first two hours* obtained manually. Naif of the- samp-- .lings were done on automatic* but two* rather than threer* samples, were obtained. 224- Notation is made of CBS filming tomorrowy expos ures were run for 4 1/2 hours. The line control had a reading of 6. The GC chart shows no agree ment with the research booh* which is sparse. However* it does show T-XIX range from 3--320 ppnr. The T-r 50 ppm range equals 445 ppm* 225 No gas chromatographic charts to support the mini mal data in. the' research booh. The chambers were turned on at 9:00 am and were off at 11:40 am-.i GC readings were tahen only at 10:00 and 11:00 am. BOB WEST ASSOCIATES, INC. rSm i. >;!.! i .rj,. .v 1 .......... r ,in , ,hl- mxrniiijm 11 Himmfmmmm#*"**** h * n ia iii hm-. i i1i - 11 m< NfcSpRT . f .;:v4 r a .' /7yi:> =:'/>;. y.'r- ; IBT No. 533--03222 ; \.' .,,- * .. ".. '-7^* -- - ` - ;.* -13- iv.-y "" -v:: ;$f: Exposure Number Comment: 228 For T-r and T-II, there are missing- data* For T-III, there are no values for the first and 231 second samplings. One-third of the values which were on the low .A side were deleted from the calculation of the lm*: ' averages, one of which was off the graph. Se lected. data is shown. The control shows a peak, height of T.5r indicating some: contamination. R&S 113698 *v . 263&Z2T The gas chromatograph was not working; no data "j: , y but have been, reported for one value at one J:1. :-.j interval. Z38&239- The research booh shows a mean." and ranges but no * supportive data-were available. 'J 242 The line control shows a peak, height of 8 - One- ; .!< third of the data from the GC charts were not used in the calculations- or averages in the research book. 244. Samples are- only, shown for three hours. Z5L The GC chart data is sparse. The line control is shown as:. 8.5* The 50 ppm equaled 400 ppm and a notation of major problems. 255 Air recirculated was causing high concentrations in the control chamber. The chambers were turned '} * 1 'i J BOB WEST ASSOCIATES, INC. t 1, Id -*,., 4j * R&S 113699 IBT. No - 633-03222 -14- Exposure Number Comment; 255 tcont'd) off. The control, chamber had a level equal, to 3.4 ppm of vinyl chloride. A. notation of definite leakage into the room was recorded. Selected data only far two hours, of the exposure was used. 257 That T-IV chambers were turned on two hours after the rest of the chambers. The line control shows vinyl chloride contamination. One of the 50 ppm . values is equal to at least 100 ppm. In addition, one-third of the values were unavailable se-- . lacted data were used. '255 The first exposure concentration readings were . taken at 1:15 pm and. also at 2:15, despite the fact the chambers were turned on at 11:30 in the morning. Most of the data were incomplete. This appeared to be the last exposure where gas chroma tographic chart data were available. The research book has data - for exposures 259, 250 , 261, 262, but there are no. sup portive gas chromatographic data. -1 _ - BOB WESlT ASSOCIATES, INC. IBT Ho. 633-03222 -15- BODY WEIGHTS Body weights: were available,- either as hand written <*tmita-Mma or as computer printouts. Unfortunately/ many of the" computer printout body weight tabulations reflected the awimatg being weighed on a- gang-cage basis. Therefore^ it becomes more difficult to determine substitutions- A tatlore beginning with month 5 and proceeding through month 13"- is shown below for the body weight data. This com pares. the presented in the interim: XBT reports versus tHat -i TTwt when one inspects the computer printout itself. These data have only been examined for the T--III group:. MEAS- BODY WEIGHTS FROM PRINTOUTS VIHYE. CHLORIDE RAIS* T-HT -- 2,000 PPM* Month Male- Female Month Male Female 5 Report 54? 321 Printout _ 550.5 312. 9 Report Printout 681 621 35* 35* 6 Report 567" 32* Printout 567.3 339- 10 Report Printout' 663 62* 356 356 T Report 565 Printout*' 714 691 ~~ 702 606 346 436 11 Report Printout 12 Report Printout 696 680 736 718 374 374- 378 378 a Report 585 . 359: Printout**'- 581 35*. 13* Report Printout 740 - 420* 72* 420: *A11 values- shown on printout Subtracted 329.' grams, front printout mean Inspection of these, data indicates that during the seventh month, there la a major difference, between the body weights in the printouts- and chose presented in the final report,, suggesting replacements. BOB WEST ASSOCIATES, INC. / R&S 113701 t J i< !1 i, '> ,1 '*! f1 ' 'J ii IBT No. 633-03222 -16- MORTALITY AND FATE Hand written sheets reflecting tabulations of mortali ties are available. These sheets bear various dates at periodic intervals. Additional, tabulation reflects animals that are missing or cannibalized,, based upon the gang hous ing. However, there are numerous errors present and inconsis tencies in these tabulations. A. chart of missing rats, pre pared near the end of the third month of the study, shows, numerous animals not accounted for in Dr. Shah* s tabulation. These differences sure as follower . ._ Untreated control male rats - 2 animals missing?- none shown on Dr. Shah' s tabulation. Untreated control females -- 3 missing? none shown on Dr." Shah's tabulation. T--I male rats - 7 missing? 1 shown on Dr. Shah's tabulation. T--IX male rats -- 6. missing? none shown on Dr. Shah's tab ulation. T-m male rats -- 4 missing? none shown on Dr. Shah's tab ulation. 1F-1 female rats -- 6 missing? none shown on Dr. Shah's tab ulation. T--IXI female rats -- 2 missing? none shown on Dr. Shah's, tab ulation. t-III female rats -- 4-5 missing; none shown, on Dr. Shah's tabulation. BOB WEST ASSOCIATES, INC. '#X- ' IBT" No* 633-03222 17 There axe numerous: evidences, of errors in the animal numbers or the a. being missexed, e.g., animal 751 female should be 638 male in the T-XIX group; animal 787 female' should, be male 691 in. the T--XXX group; animal 788 female should be 692: male in the T-XXX group; animal 689/ T--III male rat should be 686;605, T-III female rat, is a male- Autopsy sheets that reflect extra animals were avail ableA- mortality tabulation prepared from the animals avail able in each group, as determined by the body weight print outs^ beginning' with month five and continuing through month 13; isr shown in the accompanying; Table* Ton will, note a sub stantial. difference in the numbers available as tabulated between the printout and that presented in the report fox the male T-IH groups month 7, 12. and 13. Similarly substantial differences in the females in months 12 and 13, as well, also suggests substitution of the animals was- occurring- Close attention was paid to determining the- specifier fate of the five animals examined in detail by Or* Bussey, in the T-Hr male group, as reported to have brain tumors* . Inspection of the hand written post mortem tabulations by XBT staff, as opposed to the data presented on the autopsy sheets and the mortality data presented in the final report indicates substantial, discrepancies* BOB WEST ASSOCIATES, INC. R&S 113703 i; 1 5! :i,, >I ) <' IBT No. 633-03222 -18- k Animal fr.641, T-XXX male, was found dead at: 369 days, according to the report. Hand written P.M. tabulation sheet shows the animal to be dead by 8/6/74, which is about 33Q days into the study. The necropsy sheet shows the animal's date of death- as 9/3/74 (359 days) . These differences-have not been explained. In the case of animal #649, the necropsy sheet and the report shows that the animal died at 402 days. The sheet presenting post mortem tabulations, dated 9/11/74, however, shows the *nim*-i as being dead. This date would be approxi mately one year into the study. Animal #664 was reported as having died at 372 days. * This animal is shown as being dead 7/17/74 on the necropjs sheet and as being dead on a hand written tabulation on 8/9/74 Therefore, the 373 day mortality presented in the report is incorrect .and was probably 311 days. Animal #672, shown in the report as having died at 310 days, is also shown on a post mortem mortality tabulation dated 7/26/74 as being dead by that time. A necropsy date of 7/16/74 for this anima 1 is- noted. Therefore, the fate of this animal appears to be correct. m the case of animal #667, the report indicates days on test as 383 but the necropsy sheet is dated 6/27/74, re flecting less than a year on test. A post mortem log dated 6/26/74 also shows the animal, as being dead. Therefore, the date presented as days on test in the report is. in error. BOB ttEST ASSOCIATES, INC. IBT No. 633-03222 . -19- C0NCLU5IQNS An intensive. audit of certain aspects of IBT No, 633-03222, chronic vapor inhalation toxicity study with, vinyl chloride, devoted to inspection of exposure concentrations and pertin ent body weight and mortality logs indicates the following: (a) There are numerous evidences of replacement of animals in this: study. There appears to be an exceptionally high replacement of the hamsters. Alsobecause of the dif-- - ferences in body weights and mortalities noted in' the . T--IH rats, it is possible that there was major substi tution of the animals between the sixth and seventh * months of the study and perhaps at .12 and 13 .months. There are evidences of extra animals being available for . the various species in the study. The accountability for the airinw-Ta and the mortalities show substantial discrepancies, (b) The monitoring of the exposure concentrations and the conduct of the exposures shows poor technique and selec tion of data in many instances- hut does seem to indicate .that a three-level study was conducted, even though the- . swings in exposure concentrations periodically may have been SO--100%. The instances of actual overlap, between exposure concentrations at the T-I level and. the. T--II level were relatively infrequent and there do. not appear R&S 113704 BOB WEST ASSOCIATES, INC. XBT No* 633-03222 20 to be any real instances of overlap between the T-Il and T--III levels.. (c) The animals reported to have brain, tumors indicate discrepancies as to their actual dates of death versus those reported in interim reports and ih some cases on the necropsy sheets* m summary, the study was conducted in an extremely sloppy fashion and one would have to look at any of the re-- _ suits more from, a qualitative standpoint than, a quantitative standpoint* R&S 113705 Bob West, >ii*D i BW/am 1 Pater MayTST 1380 BOB WEST ASSOCIATES, INC WhE t' TRST, Mh?ERlJUf? Viriyl Chlpride (Ethylene Perived) Chronic* Vapor Tnhal^tiop Toxicity Study - AlJ?ino Rata, Albino Mice, and Golden Hamsters ti I1 Chamber Concentration Pata Pay 1 Exposure TE-I Numb r Number ____ Range____ __ Jiean chamber Concentration (ppm) TJ3-1I TE-III Range Mean Range Mean i 1 39 45 43 130 180 173 1820 2610 2510 4 4 45 54 51 24 162 87 1190 3600 2540 5 5 50 56 52 192 237 219 1160 3100 2202 16 12 42 63 60 54 266 156 2400 3100 2653 29 21 48 66 59 192 248 219 1090 2490 1561 39 29 42 55 43 188 216 209 190Q 3010* 2455 .. 66 48 49 114 94 172 492 . 298 2240 4000 2910 * - 73 53 42 58 49 178 211 202 2380 2700 2565 90 58 45 60 54 220 364 243 2020- .2760 2404 99 71 29 31 30 258 310 277 2740 3940 3185 130 86 45 46 45 168 232 199 I960 2960 2565 130 94 42 63 53 180 228 201 2680 3100 2883 ISO 108 35 58 49 90 288 200 178Q 2920 2556 151 109 32 62 44 150 234 493 1280 2800 2349 152 110 41,5 110 58,9 170 252 198 2300 2800 2497 171 123 35 55 48 186 210 197 2320 3020 2708 186 187 134 135 47 46,5 53 ,, ,49*6 55.5 " 50.7 184 100 224 262 209 194 2040 2680 2180 3400 2419 2550 197 . 200 141 144 40 38,5 55 56 ',' ,'4495** 179 179 216 31Q 196 223 2400 2700 2340 3120 2535 2561 201 145 37,5 55,5 49 174 212 197 2340 2740 2500 208 150 48 54,5 51,4 170 242 20Q 2260 3420 2627 212 152 36 64,5 48,1 154 282 194 2160 3200 2583 220 158 36,5 52.5 45 138 250 192 1440 2600 2240 2?21 159 44,5 55 ' 49,2 130 139 134 246Q 2620 2540 2?9 165 46,5 46 49,4 190 216 200 2420 280Q 2583 232 166 47 71 52,3 184 220 201 2100 2820 2520 "234 169 44 51 47.6 196 215 ?07 2440 3710 2932 TE-IV** Range Mean >.1 v'M ' %p . 7* j . V- . i VvJ.j ; /'\ | 1 />; .' i i t.-i? r' * , if'.-- i.1 90ZSU SSfcf R&s 113707 TABLE 1 continued .t t. , test materialj vinyl chlopide (Ethylene Derived) t.i *f * r Chronic Vapor Inhalation Tonicity Study - Albino Eats, Albino Mice and Golden Hamsters Chamber Concentration Paha * Day Exposure Number Number. TE-I Range V 248 ! 274 275 281 j 104 312 315 315 i 318 ; 323 332 333 339 345 ' 351 359 360 178 196 197 201 218 224 225 226 228 231 238 .239 243 247 251 257 248 47,5 44.5 38 40 45.5 39 37 46 46.5 49.4 56 47.5 40 49.5 35 46 44.5 52,5 51 56 56 50,5 46 52,5 55 52,0 62 56 55 60 51 45,5 71 59,5 Mean 51.2 47.9 49,5 47,5 48.2 42,8 44,2 54 49.2 54.9 56 51.3 48,9 50 39.5 56 50,7 Chamber Concentration (ppm) TE-II TE-III Range Mean Range Mean 186 222 203 188 216 202 174 242 198 168 232 204 202 226 218 148 172 160 146 196 174 182 220 208 170 280 192 176 250 208 206 208 208 185 210 202 184 234 203 190 210 203 180 246 228 202 208 206 170 216 202 242Q 2180 2160 2360 2140 1800 1800 2080 1960 2160 2260 2160 2380 2140 2640 2420 2360 2700 2580 2640 2740 2460 2040 2440 2500 2380 2840 2380 2600 2960 2620 2900 2560 2840 2573 2377 2386 2515 22Q8 1920 2073 2473 2022 2475 2300 2556 2607 2525 2783 2487 2602 T-IV** ------R---ang-e----------M---e-a--n---. 'p7^tsSr'rlr "ti&k . A.\ , y*r? cys , - ,r -*ci //3 r1- ` 1< fs`, - X.. [ i - - Previously reported by IPT as 1970-3770, with a mean of 2474 *0nliy gross inspections were made pf the TE-JV concentrations but the name problems existed wi thgftiis concentration as with the others. I - ;\ '-%'t : * ' 'i . :,f', 'A TABLE IX IBT No. 663-03222 VINYL. CHLORIDE RATS - SURVIVAL T--III - 2,000 ppm Month 5 Report Printout 6 Report Printout 7 Report Printout*" 3 Report Printout 9^ Report Printout Iff . Report Printout 11 Report Printout 12. Report Printout 13 Report Printout** Male 97 96 95 96 94 89 or 92 90 89 84 82 76 74 65 62 42 27 27 22 Female 96 95 96 94 95 92 92 90 85 ai 72 66 48 46. 34 15(2) 17 5(7) * Nona o fr's- or weights, agree with report ** i over the lot, 5 body weights shown.