Document 5kB23gkEXE5kONgve84RwmYYN

EPL EXPERIMENTAL PATHOLOGY LABORATORIES, INC. PATHOLOGY REPORT ON THE BRAINS FROM MICE, HAMSTERS, AND RATS EXPOSED TO VINYL CHLORIDE IN IBT STUDY 663-03222 Submitted to: Chemical Manufacturers Association Washington, D. C. 20009 May 14, 1980 EPL 01095 EPL EXPERIMENTAL PATHOLOGY LABORATORIES, INC. PATHOLOGY REPORT ON THE BRAINS FROM MICE, HAMSTERS, AND RATS EXPOSED TO VINYL CHLORIDE IN IBT STUDY 663-03222 I. INTRODUCTION At the request of the Chemical Manufacturers Association, Experimental Pathology Laboratories, Ine. conducted a pathology evaluation of the available brains from mice, hamsters, and rats either exposed to vinyl chloride or used as controls in Industrial Bio-Test (IBT) Study 663-03222. This inhalation toxicology study was conducted in the IBT facilities at Decatur, Illinois, and was initiated on September 10, 1973. The experimental design for this study is as follows: Group Control Tl* T2* T3* T4** Number of Animals MiceRatsHamsters MF MF MF 100 100 100 100 100 100 100 100 -_ 100 100 100 100 100 100 100 100 100# 100 100 100 100 100 100 100 100 -- Exposure Levels 50 ppm Vinyl Chloride 200 ppm Vinyl Chloride 2500 ppm Vinyl Chloride 2500 ppm Vinyl Chloride *No food, water, or bedding in cages during exposure **Food, water, and bedding to remain in cages during exposure #A11 rats of same sex, either sex permitted The protocol as amended called for the inhalation exposure of the above groups six hours per day, five days per week. Mice were to be exposed for nine months; rats and hamsters for twelve months. These groups were originally scheduled to be held for equal additional periods of time (nine or twelve months); but, subsequently it was agreed that EPi 01096 EPL EXPERIMENTAL PATHOLOGY LABORATORIES, INC. they would be kept for their lifetime or sacrificed if moribund. All animals were to be necropsied either at the time of death or sacrifice, and a relatively complete set of tissues was to be preserved in 10% neutral buffered formalin. These tissues were to be examined from all animals in the control, T2, and T3 groups. If exposure related lesions were detected in the organs of the T2 or T3 groups, these same organs from the T1 group were to be examined. An EPL pathologist (Dr. William Busey) and four histology/ pathology technicians traveled to IBT at Northbrook, Illinois, where the material from the study is archived. At IBT, facilities were provided for examination of the residual wet tissue, paraffin blocks, and microscope slides. In addition, facilities were provided for the histologic processing of brains recovered from the residual wet tissue. II. MATERIALS AND METHODS A. Residual Wet Tissue All of the bags of residual fixed wet tissue from the mice, hamsters, and rats were examined for brain material. If brain material was discovered in the bag, it was recovered, examined grossly for any alterations, and trimmed into three to five sections for histologic processing. B. Paraffin Blocks All of the paraffin blocks from the mice, hamsters, and rats were examined for the presence of embedded brain material. If brains were discovered, the blocks were set aside for microtoming and staining. EPL 01097 -2- EPL EXPERIMENTAL PATHOLOGY LABORATORIES, INC. C. Microscope Slides (IBT Prepared) All of the microscope slides from the mice, hamsters, and rats were examined for brains. All brain slides were examined microscopically at IBT by the EPL pathologist. -- D. Pathology Sheets y The original pathology sheets from the mice, hamsters, and rats were examined for gross descriptions of brain abnormalities. The descriptions of any brain abnormalities were recorded along with the date of death of any animal with a recorded gross or microscopic brain lesion. In addition to the gross description of any brain ab normality, the microscopic findings of the IBT pathologist were also recorded. In the animals for which brain material was recovered from either the residual wet tissue, paraffin blocks, or microscope slides, an attempt was made to verify the animal identification. This was done by comparing the animal number and date of death recorded on the pathology sheet with the animal numbers and date of death recorded on the bags of residual wet tissue and with the animal numbers embedded in the paraffin blocks or recorded on the microscope slides. EPL 01098 -3- EPL EXPERIMENTAL PATHOLOGY LABORATORIES, INC. The brains recovered from the residual wet tissue were processed, embedded, microtomed, and mounted on microscope slides at IBT. The paraffin blocks containing brain material, previously embedded by IBT, were microtomed and mounted on microscope slides. Duplicate slides were prepared from each paraffin^block containing brain. One set of slides was left at IBT and the other set was returned to EPL, stained with hematoxylin and eosin, and evaluated by an EPL pathologist. III. RESULTS A. Number of Recovered Brains The following table details the number of brains recovered from either the residual wet tissue or paraffin blocks previously prepared by IBT: Number of Brains Recovered from Residual Wet Tissue or IBT Paraffin Embedded Blocks Group Untreated Control T1 T2 T3 T4 Mice MF 54 13 8 37 12 14 - Hamsters MF 43 84 14 10 13 6 _ Rats MF 18 20 15 13 23 11 23 17 _ 12 EPL 01099 -4- EPL EXPERIMENTAL PATHOLOGY LABORATORIES, INC. B. Pathology 1. Mice and Hamsters With the exception of focal encephalitis in Group T3 male hamster No. 2208, no gross or microscopic alterations were seen in any of the bnains examined from the mice and hamsters. 2. Rats Grossly detected changes in the brain were described at the time of necropsy by IBT in four male rats from the T3 group. These gross observations are as follows: Animal No. 641 664 667 672 Gross Observation 1 cm. mass located in front of brain in skull leaving a compression in brain. A gelatinous-like focus beginning on the anterior frontal half of the brain beneath the meninges compressing the adjacent brain tissue. Mid sagittal section of the brain reveals an 8 mm white firm focus involving olfactory region and compression of adjacent cerebrum. A soft tan mass was found in the right frontal region in the skull cap compressing the front quarter of the brain. Mass located between the meninges and the skull cap 1 cm. in diameter. Front portion of brain was gelatinous and very soft. In addition to the above four gross brain abnormalities, the following brain with a gross abnormality was detected by EPL personnel: EPL 0X100 -5- EPL EXPERIMENTAL PATHOLOGY LABORATORIES, INC. Animal No. __________ Gross Observation 649 0.2 x 0.5 tan mass attached to the left olfactory bulb. The detailed histologic findings for the microscopic evaluation of the brains are presented in Table II. A summary of the findings is presented in Table I. *- Microscopic evaluation of the brains from the control and vinyl chloride exposed male and female rats revealed olfactory neuro blastomas (esthesioneuroblastoma, esthesioneuroepithelioma, medullo- epithelioma) in five T3 males (641, 649, 664, 667, and 672), one T3 female rat (761), and one T4 female rat (2413). A single glioblastoma multi forme was detected in the brain from T2 male rat No. 412, and a single astrocytoma was detected in the brain of T2 female rat No. 566. The histological features of the seven olfactory neuroblastomas were remarkably similar. They were characterized by a proliferation of deeply basophilic cylindrical cells with abundant cytoplasm supported by small blood vessels. Characteristic pseudo-rosettes were present along with numerous mitotic figures. In most instances these neoplasms compressed the anterior portion of the cerebrum; and, in some cases, infiltration under the meninges was evident. The glioblastoma multiforme was characterized by a proliferation of a mixture of highly pleomorphic cells containing large nuclei. Numerous giant cells and mitotic figures were also evident. The astrocytoma was characterized by a proliferation of well differentiated astrocytes infiltrating the neuropile, forming no particular structural pattern. A few mitotic figures were eivdent. EPL 01101 -6- EPL EXPERIMENTAL PATHOLOGY LABORATORIES, INC. Scattered instances of meningoencephalitis, suppurative meningitis, encephalomalacia, and focal encephalitis were detected in a few rats from both the control and vinyl chloride exposed groups. The incidence of these inflammatory lesions was low and not related to any treatment group. IV. DISCUSSION AND CONCLUSION The presence of seven olfactory neuroblastomas in the brains from vinyl chloride exposed rats indicates a causal relationship between the exposure and the development of these neoplasms. Olfactory neuro blastomas rarely, if ever, occur spontaneously in the rat. Three of these neoplasms were initially diagnosed by IBT as neuroepitheliomas. Subsequent review of the slides indicates the classification of olfactory neuroblastoma to be appropriate for these neoplasms. The glioblastoma multi forme detected in T2 male rat No. 412 was also initially diagnosed as a neuroepithelioma by IBT. Subsequent evaluation of this neoplasm indicates that this lesion is more properly classified as a mixed glioma or glioblastoma multiforme. The olfactory neuroblastomas detected in these vinyl chloride exposed rats are apparently identical to the neuroblastomas reported by 17 Maltoni in 1975, and again in 1977. In 1975, Maltoni reported at the New York Academy of Sciences Symposium on the toxicity of vinyl chloride- ^Carcinogenicity Bioassays of Vinyl Chloride: Current Results, Maltoni, C.and Lefemine, G., Annual New York Academy of Science, Vol. 246 (1975), 195-218. 2 Vinyl Chloride Carcinogenicity: An Experimental Model for Carcinogenesis Studies, Maltoni, C., Origins of Human Cancer, Cold Spring Harbor Conferences on Cell Proliferation, Vol 4, 1977. EPIj 01102 -7- EPL EXPERIMENTAL PATHOLOGY LABORATORIES, INC. poly vinyl chloride. The results of his BT1 experiment revealed seven neuroblastomas in rats exposed to 10,000 ppm of vinyl chloride, three neuroblastomas in rats exposed to 6,000 ppm, and five neuroblastomas in rats exposed to 2,500 ppm of vinyl chloride. In 1977, at the Cold Spring Harbor Conference on Cell Prol1^ration, he again reported the results of his BT1 experiment in addition to the results of his BT3 and BT7 experiments where neuroblastomas were induced in rats exposed to vinyl chloride at 10,000, 6,000, and 2,500 ppm. The findings of olfactory neuroblastomas in the T3 male and female rats and a T4 female rat confirms tne findings of Mai torn* of an oncogenic effect on the rat brain from vinyl chloride exposure. The shortcomings of this study have been previously documented. Regardless of these, the rarity of this neurological neoplasm coupled with the fact that it has only been reported in rats exposed to known carcinogens indicates a relationship between their presence in this study and exposure to vinyl chloride. As mentioned previously, the finding of these neoplasms confirms previously reported results from vinyl chloride exposures by Maltoni. Since the exposure conditions in this study have not been confirmed, the levels of vinyl chloride inducing these neoplasms cannot be stated at this time. Similarly, because of the large number of missing brains from the Control and exposed rats, the true incidence of these neoplasms in IBT Study 663-03222,resulting from vinyl chloride exposure, cannot be determined. WILLIAM M. BUSE^f D.V.M., Ph.D. Pathologist WMB/sfh -B- EPL 01103 EPL EXPERIMENTAL PATHOLOGY LABORATORIES, INC. IBT STUDY 663-03222 TABLE I SUMMARY INCIDENCE TABLES EpL 01104 IBT Study 663-03222 Vinyl Chloride Male Mice BRAINS (NO. EXAMINED) SUMMARY INCIDENCE TABLE Untreated Control (5) T1 (13) T2 T3 (3) (12) F A _____ _____________________________ EPL Experimental Pathology Laboratories. Ini -9- EPL 01105 IBT Study 663-03222 Vinyl Chloride Female Mice BRAINS (NO. EXAMINED) SUMMARY INCIDENCE TABLE Untreated Control (4) T1 T2 (8) _ _ (7) T3 (14) 1 " ......... W II 9 EPL Experimental Patholoyv Laboratories, Inc -10- Olio6 IBT Study 663-03222 Vinyl Chloride Male Hamsters BRAINS (NO. EXAMINED) Focal Encephalitis SUMMARY INCIDENCE TABLE Untreated Control (4) T1 (8) T2 (14) T3 (13) 1 S IP EPL Experimental Pathologs Laboratories, Inr -11- EpL 011Q7 IBT Study 663-03222 Vinyl Chloride Female Hamsters BRAINS (NO. EXAMINED) SUMMARY INCIDENCE TABLE Untreated Control (3) T1 (4) T2 (10) T3 (6) ---------- --^--- II i EPL Experimental Patholo^s Laboratories, Ini -12- EPL 01108 1 IBT Study 663-03222 Vinyl Chloride Male Rats SUMMARY INCIDENCE TABLE BRAINS (NO. EXAMINED) Meningoencephalitis Suppurative Meningitis Encephalomalacia Focal Encephalitis Olfactory Neuroblastoma Glioblastoma Multiforme Untreated Control (18) 1 1 Tl (15) 1 T2 (23) 1 1 T3 (23) 1 5 A V s EPt Experimental Pathology laboratories Inc -13- EPL 01109 IBT Study 663-03222 Vinyl Chloride Female Rats SUMMARY INCIDENCE TABLE BRAINS (NO. EXAMINED) Meningoencephalitis Astrocytoma Olfactory Neuroblastoma Pituitary Carcinoma Untreated Control Tl (30) (13) * 1 T2 (ID 1 1 T3 (17) 1 T4 (12) 1 V I1fe.__________________________________ EPL Experimental Pathology Laboratories Inr -14- EPL 0111 EPL EXPERIMENTAL PATHOLOGY LABORATORIES, INC. IBT STUDY 663-03222 TABLE II HIST0PATH0L0GY INCIDENCE TABLES EPL Ollii IBT Study 663-03222 Vinyl Chloride Male Mice HISTOPATHOLOGY INCIDENCE TABLE Untreated Control EPL Experimental Pathology Laboratories, Inc. -15- Key P * Present 1 * Minimal. 5 ~ Severe/High N - No Section 2 = Slight I = Incomplete Section A -- Autolysis 3 -- Moderate X - Not Remarkable 4 -- Moderately SevereiHIgh IBT Study 663-03222 Vinyl Chloride Male Mice BRAIN ANIMAL NUMBER 1009 1012* 1013 1024 1025 1030 1031 1049 1 1052 1 1065 1 1066 | 1082 1084 HISTOPATHOLOGY INCIDENCE TABLE T1 XXXXXXXXXXXXX i -i I *Missexed f.pl Oil13 EPL Experimental Pathology Laboratories, Inc. Key: P *> Present 1 - Minimal. 5 - Severe/High N = No Section 2 " Slight I = Incomplete Section A * Autolysls 3 -- Moderate X TM Not Remarkable 4 - Moderately Severe'High IBT Study 663-03222 Vinyl Chloride Hale Mice BRAIN ANIMAL NUMBER 1218 1223 1259 H1STOPATHOLOGY INCIDENCE TABLE T2 XXX 1 t epl 01114 EPL Fxprriment.il Pathology Laboratories, Inc. -17- Key: P - Present 1 = Minimal. 5 Severe/Htgh N = No Section 2 - Slight I = Incomplete Section A - Aulolysis 3 -- Moderate X - Not Remarkable 4 = Moderately Severe/High IBT Study 663-03222 Vinyl Chloride Hale Mice H1STOPATHOLOGY INCIDENCE TABLE T3 EPL Fxponmont.il Pathology Laboratories, Inc. Key: P Present 1 " Minimal, 5 " Severe/High N No Seclion 2 - Slight I Incomplete Section A Autolysis X - Not Remarkable 3 Moderate 4 - Moderately Severe/High IBT Study 663-03222 Vinyl Chloride Female Mice HISTOPATHOLOGY INCIDENCE TABLE Untreated Control *Missexed EPL Experimental Pathology Laboratories, Inc. -19- Key. P 1 5 " Present Minimal, = Severe/High N = No Section 2 = Slight I Incomplete Section A * Autolysis 3 ** Moderate X " Not Remarkable 4 - Moderately Severe/High IBT Study 663-03222 Vinyl Chloride Female Mice BRAIN ANIMAL NUMBER 1110 1112 1118 1139 LA151 1 1156 1167 son HISTOPATHOLOGY INCIDENCE TABLE T1 XX X X X X XA 1 fi 1 ------------------------------------- EPL 01117 EPL Experimental Pathology Laboratories, Inc. -20- Key: P -- Present 1 * Minima). 5 Severe/High N " No Section. 2 - Slight. I " Incomplete Section A -- Autolysis 3 -- Moderate X " Not Remarkable 4 - Moderately Severe/High IBT Study 663-03222 Vinyl Chloride Female Mice BRAIN ANIMAL NUMBER 1 1301 1 1308 1368 1382 1386 1390 HISTOPATHOLOGY IN' :NCE TABLE T2 to CTi cn XXXXXXX i T EPL 01118 EPL Experimental Pathology Laboratories, Inc -21- Key: P -- Present 1 = Minima). 5 = Severe/High N = No Section 2 - Slight. I = incomplete Section A * Aulolysis 3 " Moderate X - Not Remarkable 4 - Moderately Severe/High IBT Study 663-03222 Vinyl Chloride Female Mice BRAIN ANIMAL NUMBER 1508 1516 1519 1522 1525 1527 1534 1545 1556 | 1573A| 1578 1592 | 1599 | HISTOPATHOLOGY INCIDENCE TABLE T3 CtiL-oVOHJ XXXX XXXXXXXXXX H 1 EpL Ollis, EPL i Experimental Pathology Laboratories, Inc. -22- Key: P - Present 1 * Minimal. 5 -- Severe/High N * No Section 2 - Slight I * Incomplete Section A * Autotysis 3 -- Moderate X - Not Remarkable 4 ~ Moderately Severe/High IBT Study 663-03222 Vinyl Chloride Male Hamsters BRAIN Focal Encephalitis ANIMAL NUMBER 1608 1612 1698 HtSTOPATHOLOGY INCIDENCE TABLE Untreated Control r-i CSJ VO rH XXXX 1 EPL 01120 EPL Experimental Pathology Laboratories, Inc. -23- Key: P -- Present 1 TM Minimal. 5 -- Severe/High N * No Section. 2 = Sight I -- Incomplete Section A = Aulolysis 3 -- Moderate X -- Not Remarkable 4 " Moderately Severe/High IBT Study 663-03222 Vinyl Chloride Male Hamsters BRAIN Focal Encephalitis ANIMAL NUMBER H1STOPATHOLOGY INCIDENCE TABLE T1 orH co o> rH *3- LD O CO KO 1^. 00 00 Ov 00 00 00 00 00 00 00 00 --i rH rH rH rH iH XXXXXXXX i 1 EPL Experimentcil Pathology Laboratories, Inc. -24- Key: P - Present 1 -- Minimal. 5 -- Severe/High N * No Seclion 2 = Slight I = Incomplete Section A " Aotolysis 3 -- Moderate X < Not Remarkable 4 > Moderalely Severe/High EPL 01121 IBT Study 663-03222 Vinyl Chloride Male Hamsters BRAIN Focal Encephalitis ANIMAL NUMBER 2016 2033 2034 2037 2054 2073 2076 1 2082 1 | 2099 1 | 2100 | ^E HISTOPATHOLOGY INCIDENCE TABLE T2 0too0 CM 0o0 CM Ooi a<crr CM CM CM XXXX XXX XXXXX XX 1 1 EPl Experimental Pathology Laboratories. Inc. -25- Key: P Presenl 1 Minimal. 5 -- Severe/High N * No Section 2 Slight I = Incomplete Section A - Autolysis 3 -- Moderate X - Not Remarkable 4 -- Moderately Severe/High EPL 01122 IBT Study 663-03222 Vinyl Chloride Hale Hamsters BRAIN Focal Encephalitis ANIMAL NUMBER 2208 2222 2226 2237 2244 2259 2260 2261 2273 2275 2277 2295 HISTOPATHOLOGY INCIDENCE TABLE T3 N C\J CM CM X XA XAXX XX XX X 3 t --- 1 EPl I xiH'rimrnt.il Pntliolonv Laboratories, Inc. -26- Key: P 1 5 - PresenI Minimal. " Severe/High N No Section 2 - Slight I * Incomplete Section A " Aulotysis 3 -- Moderate X " Not Remarkable 4 - Moderately SevereiHigh EPL 01123 IBT Study 663-03222 Vinyl Chloride Female Hamsters BRAIN ANIMAL NUMBER 1701 1702 1716 HISTOPATHOLOGY INCIDENCE TABLE Untreated Control XXX i it --- T EPL Experimental Pathology Laboratories, Inc. -27- Key: P -- Present 1 -- Minimal. 5 Severe/High N No Section. 2 - Slight, I Incomplete Section A Autotysis 3 Moderate X - Not Remarkable 4 Moderately Severe/High EPL 01124 IBT Study 663-03222 Vinyl Chloride Female Hamsters brain ANIMAL NUMBER 1948 1959 1961 1996 HISTOPATHOLOGY INWDENCE TABLE T1 XXXX t * EPl Fxporimcntal Pathology laboratories, Inc. -28- Key: P -- Present 1 - Minimal, 5 Severe/High N " No Section 2 - Slight I Incomplete Section A >* Autolysis 3 - Moderate X " Not Remarkable 4 " Moderately Severe/High EPL 01125 IBT Study 663-03222 Vinyl Chloride Female Hamsters BRAIN ANIMAL NUMBER 2115 2123 2153 2157 2170* 2187 2195 2198 2200* HISTOPATHOLOGY tNurDENCE TABLE T2 iC0rHHS0J XXXXXXXXXX *Missexed EPL Experimental Pathology Laboratories, Inc. -29- Key P -- Present 1 -- Minimal. 5 " Severe/High N " Mo Section 2 ~ Slight I Incomplete Section A - Autolysis 3 -- Moderate X Not Remarkable 4 - Moderately Severe/High EPL 01126 IBT Study 663-03222 Vinyl Chloride Female Hamsters BRAIN ANIMAL NUMBER 1 2310 | | 2324 | | 2326 | 2332 | 2356 1 HISTOPATHOLOGY INCIDENCE TABLE T3 coo CM XXXXXX 4 It EPl Experimental Pathology Laboratories, Inc. -30- Key: P Present 1 - Minimal. 5 " Severe/High N - No Section. 2 - Slight. I Incomplete Section A - Autolysis X - Not Remarkable 3 Moderate 4 Moderately Severe/High EPL 01127 IBT Study 663-03222 Vinyl Chloride Male Rats BRAIN Meningoencephalitis Suppurative Meningitis Encephalomalacia Focal Encephalitis Olfactory Neuroblastoma Glioblastoma Multi forme ANIMAL NUMBER HISTOPATHOLOGY INCIDENCE TABLE Untreated Control oa\ 00 a* CO 1in to H r*H in Ol CO ** co ^Srr--t H CM CM CM in m in in VO to co CO CF> X XXXXXXXXXXXXXXX 3 3 EPl Experimental Pathology Laboratories, Inc. -31- Key: P = Present 1 = Minimal, 5 Severe/High N = No Section 2 - Slight J = Incomplete Section A Aulolysis 3 Moderate X Not Remarkable 4 Moderately Severe/High IBT Study 663-03222 Vinyl Chloride Male Rats BRAIN Meningoencephalitis Suppurative Meningitis Encephalomalacia Focal Encephalitis Olfactory Neuroblastoma Glioblastoma Multi forme ANIMAL NUMBER HISTOPATHOLOGY INCIDENCE TABLE o CT>in ID o oO 00 00CM lO inpH rH CM CO ID VO ID o> VO cr> r^ CO cr CM CM CM CM CM CM CM CM CM CM CM CM CM CM CM X XXXXXXXXXXXXX i 3 ir EPL Experimental Pathology Laboratories, Inc. -32- Key: P 1 5 = Present => Minimal. - Severe/High N = No Section 2 = Sight I Incomplete Section EPb 01129 A *= Autolysis 3 *= Moderate X -- Not Remarkable 4 -- Moderately Severe/High IBT Study 663-03222 Vinyl Chloride Male Rats BRAIN Meningoencephalitis Suppurative Meningitis Encephalomalacia Focal Encephalitis Olfactory Neuroblastoma Glioblastoma Multi forme ANIMAL NUMBER HISTOPATHOLOGY IN' ENCE TABLE T2 ro co04 co 00 VO 00 o CO in VO o in CM co id * <T> *1" CT> r--( IT) as rH O r*H rH CM CM CO CO sl- LD lh in LO VO VO CO 00 as sr ^3- <3* =* X XXXXXX XXXXXXXXXXXXXX I 3 P E PL *Missexed Experimental Pathology Laboratories, Inc. -33- Key: P = Present 1 * Minimal, 5 Severe/High N = No Section 2 * Slight I Incomplete Section A * Autolysis 3 * Moderate X = Not Remarkable 4 Moderately Severe/High EPL 01130 IBT Study 663-03222 Vinyl Chloride Hale Rats brain Meningoencephalitis Suppurative Meningitis Encephalomalacia Focal Encephalitis Olfactory Neuroblastoma Glioblastoma Multiforme ANIMAL NUMBER HISTOPATHOLOGY INCIDENCE TABLE T3 H 00 Ho* to to CM CTi Ov pH LO CO CO rH CM to CM o o H in 00 <T>iH CM CO CO Lf> to to to VO CO 10to to to to to to to to to to to to to to VO to to to to to to to XX XXXX X XXX XX XXXXX 2 pP pp p | t PL Fxperiment.it Pathology Laboratories, Inc. -34- Key: P *> Present 1 * Minimal. 5 = Severe/High N = No Section 2 Slight I Incomplete Section A Autolysis X = Not Remarkable 3 = Moderate 4 -- Moderately Severe/Htgh IBT Study 663-03222 Vinyl Chloride Female Rats BRAIN Meningoencephalitis Astrocytoma Olfactory Neuroblastoma Pituitary Carcinoma ANIMAL NUMBER HISTOPATHOLOGY INCIDENCE TABLE ,,. . .r . . Untreated Control orH CM to cd to r^ LO O VO r-v 00 CM CD to CTh 0*1 O to *3* to 00 <3 VO oo O iH rH tH CM CM CD CD CD CD If) LO VO VO r^. oo 00 a o> a> 1--1 tH rH r--4 rH rH tH tH tH ^H rH iH rH i--r tH rH t-H rH rH rH tH rH tH t"H rH rH H XXXXXXXXX XXXXXXXXXXXXXXXXXX P - EPL Experimental Pathology Laboratories, Inc. -35- Key: P * Present 1 = Minimal. 5 Severe/High N = No Section. 2 = Slight I ** Incomplete Section A = Autolysis 3 - Moderate X -- Not Remarkable 4 Moderately Severe/High IBT Study 663-03222 Vinyl Chloride Female Rats BRAIN Meningoencephalitis Astrocytoma Olfactory Neuroblastoma Pituitary Carcinoma ANIMAL NUMBER HISTOPATHOLOGY INlBENCE TABLE Untreated Control - Continued HoCT>l oo CM XX EPl Experimental Pathology Laboratories, Inc. 36- Key: P 1 5 * Present Minima). - Severe/High N - No Section 2 - Slight I * Incomplete Section A ** Autolysis 3 - Moderale X = Not Remarkable 4 Moderately Severe/High EPL 01133 IBT Study 663-03222 Vinyl Chloride Female Rats BRAIN Meningoencephalitis Astrocytoma Olfactory Neuroblastoma Pituitary Carcinoma ANIMAL NUMBER HISTOPATHOLOGY INCIDENCE TABLE oCM co O CO co too%LO m CM Ch LO H CM r^. 00 00CM co co LO LO co oo roco CO CO CO co co CO ro XXXX XXXXXXXXX EPL Experimental Pathology Laboratories, Inc. -37- Key: P Present 1 > Minimal. 5 = Severe/High N = No Section 2 = Slight I ** Incomplete Section A Autolysis 3 -- Moderate X " Not Remarkable 4 Moderately Severe/High EPL 01134 IBT Study 663-03222 Vinyl Chloride Female Rats BRAIN Meningoencephalitis Astrocytoma Olfactory Neuroblastoma Pituitary Carcinoma ANIMAL NUMBER HISTOPATHOLOGY INWdENCE TABLE T2 1--4 o rH CT>to O CM CM CM LO in CM in O in in rv LO to to to in to to in ^ in o> o\ LO XXXXXX X XX 4 p ' EPl Experimental Pathology Laboratories, Inc. -38- Key: P - Present 1 -- Minimal. 5 -- Severe/High N - No Section 2 Slight. I -- Incomplete Section A -- Autolysis 3 - Moderate X -- Not Remarkable 4 -- Moderately Severe/High EPL 01135 IBT Study 663-03222 Vinyl Chloride Female Rats BRAIN Meningoencephalitis Astrocytoma Olfactory Neuroblastoma Pituitary Carcinoma ANIMAL NUMBER HISTOPATHOLOGY INCIDENCE TABLE T3 oO rH i-H CM CVI 00 CM CM CO co CO in CO O *3* CM to rH ID CM to in to to 00 CO r^. 00 r** XXXXXXXXXXX XXXXX p EPL Experimental Pathology Laboratories, Inc. -39- Key: P * Present 1 Minimal. 5 * Severe/High N " No Section 2 - SKght. [ -- Incomplete Section A " Autofysis X 3 * Moderate 4 Not Remarkable Moderately SevererHigh EPL 01136 IBT Study 663-03222 Vinyl Chloride Female Rats BRAIN Meningoencephalitis Astrocytoma Olfactory Neuroblastoma Pituitary Carcinoma ANIMAL NUMBER | 2413 1 124161 2425 1 2438 1 | 2461 | 2462 | 2494 1 H CM CM CM CM CM CinO CCOO *3CM Cvl XX X X X XX XX X co X P EPl Experimental Pathology Laboratories, Inc. -40- - Present = Minimal. -- Severe/High N = No Section 2 Slight I * Incomplete Section A Autolysis 3 = Moderate X - Not Remarkable 4 - Moderately Severe/High EPL 01137