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AR226-3188 DuPont-4739 TRADE SECRET Study Title H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproduction Evaluations Volume 5 of 5 Laboratory Project ID: DuPont-4739 TEST GUIDELINES: U.S. EPA Health Effects Test Guidelines OPPTS 870.3100 (1998) AUTHOR: Don A. Delker, Ph.D. STUDY COMPLETED ON; October 23, 2001 PERFORMING LABORATORY: E.I. du Pont de Nemours and Company Haskell Laboratory for Health and Environmental Sciences Elkton Road, P.O. Box 50 Newark, Delaware 19714-0050 WORK REQUEST NUMBER: JsuQ SERVICE CODE NUMBER:pBM SPONSOR STUDY NUMBER:!------1^------yff Page 1197 of 1537 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 APPENDIX KK INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS 1198 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - PI ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM MALE RATS GROUP: 1-0 0 mg/kg/day ANIMAL NUMBER FINAL BODY THYROID GLAMD 641114 641217 641204 641158 641100 641060 641188 641106 641175 641079 641125 641186 641052 641140 641135 641174 641107 641072 641053 641168 760.0 539.1 614.7 565.9 507.6 745.2 593.4 567.7 724.1 543.7 541.5 579.3 539.1 638.5 576.0 0.024 0.017 0.009 0.015 0.017 0.031 0.015 0.031 0.027 0.018 0.028 0.027 0.024 0.027 0.023 0.027 0.014 0.030 0.022 0.025 ' Animals inadvertently not weighed on the day of necropsy 1199 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Pi ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM MALE RATS GROUP: ANIMAL NUMBER III-O 50 mg/kg/day FINAL BODY 641087 641108 641118 641128 641091 641199 641209 641163 641129 641138 641103 641181 641171 641111 641062 641156 641173 641121 641074 641191 612.2 536.1 528.5 567.7 575.5 658.3 600.7 667.5 535.0 564.7 618.0 603.5 616.3 616.0 580.9 THYROID GLAND 0.019 0.013 0.017 0.021 0.022 0.025 0.032 0.024 0.026 0.031 0.026 0.031 0.032 0.021 0.023 0.018 0.031 0.026 0.023 0.025 ' Animals inadvertently not weighed on the day of necropsy 1200 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL ANIMAL FINAL BODY AMD ORGAN WEIGHTS - Pi ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM MALE RATS GROUP: V-0 ANIMAL NUMBER 641170 641065 641126 641058 641131 641176 641119 641075 641180 641117 641124 641082 641151 641195 641122 641184 641142 641120 641179 641164 250 mg/kg/day FINAL BODY 563.6 627.6 560.3 593.7 647.9 661.1 520.2 561.7 608.6 571.9 514.1 514.5 660.3 674.8 635.5 THYROID GLAND 0.017 0.025 0.016 0.020 0.020 0.024 0.022 0.021 0.027 0.024 0.023 0.022 0.020 0.028 0.029 0.017 0.024 0.021 0.021 0.022 a Animals inadvertently not weighed on the day of necropsy 1201 not eonteEn TSCA CBI H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Pi ADULTS FINAL BODY AMD ABSOLUTE ORGAN WEIGHTS (grams) PROM MALE RATS GROUP: ANIMAL NUMBER VI I-0 641110 641096 641212 641068 641093 641054 641208 641193 641207 641139 641080 641078 641177 641112 641210 641152 641182 641150 641211 641145 1000 mg/kg/day FINAL BODY 567.2 425.0 560.4 615.6 528.1 539.0 516.9 664.9 581.2 594.1 534.2 494.0 471.3 482.6 488.7 THYROID GLAND 0.019 0.025 0.017 0.019 0.022 0.034 0.019 0.015 b 0.019 0.022 0.028 0.031 0.031 0.022 0.017 0.024 0.03 0.029 0.024 a Animals inadvertently not weighed on the day of necropsy b Thyroid gland was not available. 1202 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - PI ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM FEMALE RATS GROUP: ANIMAL NUMBER II-O 641345 641236 641337 641328 641310 641324 641371 641332 641358 641389 641317 641255 641403 641388 641261 641306 641349 641346 641308 0 mg/kg/day FINAL BODY 293.4 353.9 354.4 374.2 317.2 334.7 334.8 360.2 329.5 335.4 360.7 346.8 389.8 384.5 335.2 340.0 361.9 357.6 340.5 THYROID GLAND 0.022 0.015 0.019 0.018 0.035 0.013 0.012 0.018 0.022 0.017 0.024 0.008 0.018 0.016 0.017 0.017 0.020 0.019 0.012 1203 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - PI ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM FEMALE RATS GROUP: ANIMAL NUMBER IV-0 50 mg/kg/day FIN.AL BODY 641378 641263 641297 641304 641274 641351 641272 641258 641276 641350 641376 641315 641286 641231 641338 641318 641373 ; 641365 641348 641323 373 .5 323 .1 350 .7 339 .6 377 .7 329 .3 308 .0 376 .5 404 .8 335 .5 342 .6 366 .1 340 .7 318 .0 322 .7 340 .5 396 .7 349 .3 397 .1 346 .2 THYROID GLAND 0.018 0.025 0.015 0.018 0.024 0.018 0.027 0.013 0.026 0.014 0.016 0.019 0.018 0.018 0.033 0.015 0.017 0.018 0.022 0.017 1204 Does not contain TSCA w H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Pi ADULTS GROUP: FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM FEMALE RATS VI-0 250 mg/kg/day ANIMAL NUMBER FINAL BODY THYROID GLAND 641271 641280 641252 641386 641277 641233 641238 641235 641392 641360 641381 641333 641239 641228 641334 641347 641367 641303 641339 641316 343.1 323.7 339.6 339.2 355.4 356.9 324.0 319.1 _a 326.7 380.4 411.0 388.2 390.7 324.0 361.0 367.3 318.0 367.5 353.8 0.018 0.020 0.016 0.019 0.019 0.018 0.017 0.013 0.020 0.028 0.024 0.012 0.035 0.015 0.021 0.021 0.019 0.015 0.020 a Pound dead on day 107; final body and thyroid weights were not taken. 1205 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Pi ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM FEMALE RATS GROUP: ANIMAL NUMBER VIII-0 641265 641393 641402 641246 641320 641353 641401 641307 641368 641343 641254 641242 641284 641230 641273 641296 641248 641370 641243 641329 1000. ing/kg/day FINAL BODY THYROID GLAND 360.9 335.0 300.0 310.7 367.4 302.3 320.9 318.3 349.5 393.3 355.5 374.6 357.6 318.8 318.4 313.1 355.3 357.2 374.3 315.3 0.008 0.022 0.012 0.018 0.008 0.025 0.019 0.015 0.022 0.018 0.020 0.013 0.019 0.016 0.022 0.018 0.012 0.012 0.022 0.013 1206 '^ H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Fi ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM MALE RATS GROUP: 1-1 - 0 mg/kg/day ANIMAL NUMBER FIN.AL BOD'Y LI-VER THYROID GLAND PROS'TATE SEM:INAL VESH2LES TESTES EPID:IDYMIDE!3 644438 644439 644440 644441 644442 644443 644444 644445 644446 644447 644448 644449 644450 644451 644452 644453 644454 644455 404 .8 390 .2 387 .4 477 .2 373 .4 388 .5 398 .2 412 .6 483 .4 389 .7 453 .8 415 .4 398 .5 378 .2 428 .5 401 .8 423 .0 376 .2 14 .551 17 .516 18 .016 20 .448 17 .713 17 .158 17 .330 19 .261 24 .554 18 .852 21 .354 19 .266 17 .973 16 .815 19 .112 18 .135 19 .295 17 .240 0. 025 0. 027 0. 028 0. 022 0. 018 0. 024 0. 017 0. 019 0. 025 0. 025 0. 026 0. 024 0. 020 0. 029 0. 022 0. 026 0. 031 0. 021 . 0 .414 0 .522 0 .569 0 .439 0 .393 0 .481 0 .368 0 .518 0 .412 0 .481 0 .605 0 .712 0 .440 0 .503 0 .458 0 .690 0 .434 0 .204 1 .398 1 .347 0 .915 0 .949 0 .919 1 .427 1 .341 1 .081 1 .272 1 .628 1 .450 1 .349 1 .140 1 .299 1 .138 1 .187 1 .429 1 .518 3.177 3.113 3.126 3.106 3.179 3.436 3.331 2.976 3.509 3.058 3.224 3.098 3.252 2.949 3.136 3.653 3.308 3.264 0 .874 3 .916' 0 .727 0 .752 0 .830 1 .068 0 .802 0 .745 0 .887 0 .735 0 .869 0 .984 0 .760 0 .837 0 .875 0 .870 0 .828 0 .798 ' Weighing error; value excluded from statistical analyses, 1207 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations GROUP: III-l ANIMAL NUMBER 644508 644509 644510 644511 644512 644513 644514 644515 644516 644517 644518 644519 644520 644521 644522 644523 644524 644525 INDIVIDUAL ANIMAL FINAL BODY AMD ORGAN WEIGHTS - Fi ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM MALE RATS 50 ing/kg/day FINAL BODY LIVER THYROID GLAND PROSTATE SEMINAL VESICLES TESTES EPIDIDYMIDES 468.4 429.1 459.2 481.4 403.8 . 413.7 398.1 390.5 368.7 421.3 421.4 422.1 409.3 408.8 361.2 434.3 431.8 .428.6 19.739 19.301 22.948 20.162 16.488 17.892 17.696 18.126 16.666 20.338 18.949 18.865 19.878 18.913 15.891 21.120 16.240 21.168 0.027 0.027 0.024 0.036 0.022 0.018 0.024 0.025 0.021 0.019 0.027 0.018 0.014 0.015 0.020 0.026 0.028 0.018 0.396 0.506 0.499 0.631 0.413 0.348 0.838 0.568 0.370 0.592 0.561 0.498 0.455 0.499 0.449 0.475 0.525 0.560 1.126 1.192 1.323 1.348 1.269 1.286 1.098 1.147 1.044 1.152 1.439 1.318 1.070 1.171 1.204 1.443 1.080 1.091 3.225 2.995 3.063 3.442 3.233 2.970 2.998 3.182 3.179 3.546 3.327 3.181 3.308 3.230 2.979 3.391 3.550 3.166 0.900 0.768 0.835 0.981 0.806 0.757 0.819 0.838 0.832 0.823 0.826 0.796 0.747 0.818 0.796 0.886 0.683 0.785 1208 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Fi ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM MALE RATS GROUP: V-l - ANIMAL NUMBER 250 mg/kg/day FINAL BODY LIVER THYROID GLAMD PROSTATE SEMINAL VESICLES TESTES EPIDIDYMIDES 644577 644578 644579 644580 644581 644582 644583 644584 644585 644586 644587 644588 382.3 425.1 373.6 465.8 314.5 376.5 431.7 379.4 413.9 405.6 428.3 358.5 17.245 17.344 16.026 21.447 11.296 17.256 19.424 15.655 18.257 21.213 21.062 15.429 0.020 0.020 0.014 0.020 0.014 0.020 0.021 0.016 0.018 0.018 0.017 0.016 0.377 0.422 0.506 0.464 0.217 ' 0.654 0.525 0.462 0.461 0.274 0.532 0.409 1.100 1.372 0.893 1.825 0.370 1.498 1.314 1.097 1.130 1.158 1.349 1.008 3.575 3.518 3.219 3.786 2.679 2.989 2.995 3.260 3.367 3.469 3.266 3.342 0.886 0.850 0.790 1.013 0.570 0.795 0.884 0.805 0.911 0.708 0.784 0.791 1209 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations GROUP: VI I-1 ANIMAL NUMBER 644625 644626 644627 644628 644629 644630 644631 644632 644633 644634 644635 644636 644637 644638 644639 644640 644641 644642 INDIVIDUAL ANIMAL FINAL. BODY AND ORGAN WEIGHTS - Fi ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM MALE RATS 1000 mg/kg/day FINAL BODY LIVER THYROID GLAND PROSTATE SEMINAL VESICLES TESTES EPIDIDYMIDES 457.2 406.2 395.2 366.6 413.2 365.8 344.3 389.9 423.3 414.0 403.9 458.3 382.7 379.9 424.3 413.0 402.4 344.9 20.507 18.627 17.445 15.456 18.679 14.059 13.993 17.347 18.700 17.312 19.322 19.061 18.354 15.100 18.856 18.461 16.408 17.995 0.020 0.013 0.018 0.020 0.017 0.016 0.012 0.022 0.013 0.022 0.018 0.019 0.010 0.013 0.018 0.020 0.018 0.013 0.538 0.409 0.604 0.447 0.624 0.416 0.501 0.611 0.562 0.559 0.426 0.513 0.389 0.372 0.472 0.534 0.464 0.445 1.458 1.215 1.457 1.540 0.827 0.945 0.972 1.307 1.078 1.424 1.267 1.474 1.005 1.359 1.301 1.529 1.115 0.915 3.446 3.023 3.147 3.457 3.201 2.984 2.982 3.439 3.118 3.419 3.145 3.642 2.905 2.796 3.608 3.142 3.066 3.628 0.775 0.885 0.742 0.743 0.801 0.809 0.694 0.845 0.879 0.875 0.757 1.030 0.749 0.681 0.801 0.804 0.718 0.764 1210 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Pi ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM FEMALE RATS GROUP: II-l - ANIMAL NUMBER 0 mg/kg/day FIN?J/ BOE1Y L IVER THY ROID G LAND UT ERUS B RAIN 644698 644699 644700 644701 644702 644703 644704 644705 644706 644707 644708 644709 644710 644711 644712 644713 644714 644715 238. 0 231. 1 252. 9 278. 4 242. 6 260. 4 271. 4 256. 9 240. 4 254. 9 270. 7 245. 0 245. 0 231. 3 252. 9 245. 6 230. 6 213. 1 8 .235 9 .617 10 .213 12 .185 8 .945 12 .516 10 .925 10 .887 9 .323 12 .716 11 .178 11 .245 10 .555 9 .659 9 .311 10 .105 9 .206 7 .920 0 .019 0 .022 0 .020 0 .016 0 .019 0 .023 0 .018 0 .015 0 .018 0 .016 0 .019 0 .022 0 .021 0 .026 0 .016 0 .021 0 .019 0 .020 0 .333 0 .666 0 .455 0 .428 0 .408 0 .698 0 .457 0 .362 0 .620 0 .363 0 .384 0 .365 0 .399 0 .440 0 .448 0 .888 0 .458 .0 .347 1 .809 1 .809 1 .815 1 .778 1 .852 1 .839 1 .750 1 .819 1 .868 1 .836 1 .690 1 .900 1 .790 1 .720 1 .763 1 .879 1 .778 1 .794 1211 rt8?n T8CA C31 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Fi ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM FEMALE RATS GROUP: IV-1 - 50 mg/kg/day ANIMAL NUMBER PIN.AL BO DY L IVER THY ROID G LAND UT:ERUS B:RAIN 644770 644771 644772 644773 644774 644775 644776 644777 644778 644779 644780 644781 644782 644783 644784 644785 644786 644787 249 .7 225 .9 251 .0 285 .1 249 .0 231 .3 241 .4 235 .2 222 .1 216 .1 269 .1 257 .1 206 .5 272 .6 255 .4 235 .3 302 .8 273 .1 8 .989 8 .952 11 .176 12 .954 10 .282 10 .327 10 .477 9 .959 9 .893 9 .549 10 .664 11 .256 8 .494 12 .379 11 .791 9 .073 11 .129 13 .212 0 .023 0 .023 0 .018 0 .020 0 .021 0 .016 0 .026 0 .015 0 .012 0 .015 0 .020 0 .016 0 .020 0 .017 0 .018 0 .016 0 .020 0 .018 0 .824 0 .867 0 .440 0 .630 0 .465 0 .587 0 .585 0 .495 0 .482 - 0 .390 1 .051 0 .603 0 .388 0 .417 0 .417 0 .498 0 .408 0 .548 1 .735 1 .770 1 .829 1 .897 1 .828 1 .938 1 .955 1 .866 1 .776 1 .699 1 .889 1 .877 1 .803 1 .818 1 .868 1 .831 1 .784 1 .889 1212 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL ANIMAL FINAL BODY AND ORGAN WEIGHTS - Fi ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM FEMALE RATS GROUP: VI-1 - 250 mg/kg/day ANIMAL NUMBER FINAL BO DY L IVER 644842 644843 644844 644845 644846 644847 644848 644849 644850 644851 644852 644853 211 .4 283 .7 251 .3 234 .9 238 .5 285 .8 216 .3 243 .7 312 .7 233 .5 287 .7 215 .3 7 .386 12 .143 10 .140 9 .002 9 .330 12 .352 9 .638 10 .673 13 .393 9 .804 13 .499 7 .588 THY ROID G LAND 0 .018 0 .015 0 .012 0 .015 0 .021 0 .018 0 .008 0 .016 0 .020 0 .015 0 .013 0 .017 UT ERUS 0 .418 0 .744 0 .565 0 .444 0 .475 0 .375 0 .403 0 .496 0 .402 0 .748 0 .512 0 .563 B RAIN 1 .813 1 .940 11 .975' 1 .802 1 .698 1 .969 1 .455 1 .827 1 .874 1 .746 1 .951 1 .837 a Weighing error; value excluded from statistical analyses. 1213 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL AMIMAL FINAL BODY AMD ORGAN WEIGHTS - Fi ADULTS FINAL BODY AND ABSOLUTE ORGAN WEIGHTS (grams) FROM FEMALE RATS GROUP: VIII-1 - 1000 mg/kg/day ANIMAL NUMBER FIN.AL BO DY L IVER 644889 644890 644891 644892 644893 644894 644895 644896 644897 644898 644899 644900 644901 644902 644903 644904 6449G5 644906 258 .0 203 .9 247 .9 228 .0 228 .6 210 .0 249 .7 248 .5 245 .0 257 .8 241 .6 265 .0 259 .8 229 .4 242 .5 238 .1 248 .5 218 .9 10 .240 8 .026 11 .333 9 .467 9 .800 7 .878 11 .905 9 .072 10 .882 11 .043 10 .214 10 .565 11 .569 9 .097 10 .381 10 .700 8 .467 8 .516 THY ROID G LKND 0 .015 0 .007 a 0 .013 0 .010 0 .013 0 .009 0 .012 0 .010 0 .010 0 .017 0 .010 0 .011 0 .013 0 .006 0 .008 0 .011 0 .007 UTERUS 0 .388 0 .356 0 .398 0 .440 0 .514 0 .737 0 .372 0 .440 0 .532 0 .481 0 .291 0 .429 0 .448 0 .321 0 .341 0 .484 0 .407 0 .413 B:RAIN 1 .785 1 .740 1 .784 1 .906 1 .816 1 .771 1 .802 1 .660 1 .834 1 .771 1 .786 1 .794 1 .835 1 .810 1 .769 1 .837 1 .581 1 .813 ' Thyroid gland inadvertently not weighed. 1214 1 Does not contain TSCA CBI H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 APPENDIX LL INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS FOR Pi ADULTS 1215 Santeed. Does wt e-^f^ ^CA cer H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS KEY TO APPENDIX ABBREVIATIONS: FD SD - FOUND DEAD SACRIFICED BY DESIGN LESION GRADING: Histopathological changes are described according to their morphologic character, distribution and severity. The distribution (extent of tissue involvement) is indicated, where appropriate, by modifiers such as focal, multifocal, diffuse, unilateral, bilateral, etc. A severity score, if appropriate, is also assigned as follows: MINIMAL: MILD: MODERATE: SEVERE: The amount of change present barely exceeds that which is considered to be within normal limits. In general, the lesion is easily identified but of limited severity. The lesion probably does not produce any functional impairment. The lesion is prominent but there is significant potential for increased severity. Limited tissue or organ dysfunction is possible. The degree of change is either as complete as considered possible or great enough in intensity or extent to expect significant tissue or organ dysfunction. COMMENT: Grades minimal through severe represent progressive involvement/severity along a continuum with minimal lesions being the least severe and severe lesions being the most severe. While the grades refer to the morphological characteristics of lesions, they also indicate their relative biological significance. Gross observations listing multiple masses for a tissue are distinguished with letters (i.e., a, b, c, d, etc.). 1216 H-24616: Subchromc Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641052 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C INCIDENCE TABLES: NONE 1217 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________ INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641053 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1218 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ____ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641060 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP'AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1219 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations______________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641072 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1220 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641079 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: VESICLES, TESTIS COAGULATING GLAND, EPIDIDYMIS, PROS THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1221 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641100 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1222 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641106 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1223 H-24616: Subchromc Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641107 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAW NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1224 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641114 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES MOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1225 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641125 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1226 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: 1-0 DOSE: 0 ing/kg/day ANIMAL #: 641135 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1227 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ____________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641140 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1228 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641158 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1229 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641168 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1230 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641174 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1231 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ___ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - _____ Pi ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641175 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: VESICLES, TESTIS COAGULATING GLAND, EPIDIDYMIS, PRO THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C INCIDENCE TABLES: NONE 1232 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations______________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: 1-0 DOSE: 0 ing/kg/day ANIMAL #: 641186 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1233 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641188 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1234 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations ______________________________ INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641204 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1235 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - _____ Pi ADULTS MALE RATS GROUP: 1-0 DOSE: 0 mg/kg/day ANIMAL #: 641217 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1236 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - _____ PI ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641062 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1237 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - ____ PI ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641074 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1238 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641087 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1239 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AUTO MICROSCOPIC OBSERVATIONS - _____ Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641091 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: VESICLES, TESTIS COAGULATING GLAND, EPIDIDYMIS, PROS THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1240 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641103 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: SKIN MICROSCOPIC CORRELATE (selected - ALOPECIA, VENTRAL, NECK; ULCERATED MICROSCOPIC OBSERVATIONS: OTHER - SKIN: INFLAMMATION/ULCER, MINIMAL THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: SEMINAL VESICLES, TESTES COAGULATING GLAND, EPIDIDYMIDES, PR THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLY2ED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1241 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641108 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1242 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641111 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1243 H-24616: Subchromc Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations______________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 ing/kg/day ANIMAL #: 641118 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1244 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641121 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1245 H-24616: Subchronic Toxicfty 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations______________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641128 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1246 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - __ PI ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ___ _____ ____ ANIMAL #: 641129 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: VESICLES, TESTIS COAGULATING GLAND, EPIDIDYMIS, PRO THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN MOT CO INCIDENCE TABLES: NONE 1247 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations__________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641138 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1248 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - ____ Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641156 DAYS ON TEST: 110 MODE OF DEATH: SD ______ ___ GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C INCIDENCE TABLES: NONE 1249 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641163 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1250 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - ^^ Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 ing/kg/day ANIMAL #: 641171 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1251 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS __ - PI ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641173 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE MOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1252 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ____ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - _______________________ Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 nig/kg/day ANIMAL #: 641181 DAYS ON TEST: 109 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1253 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations________________________________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641191 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1254 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641199 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLY2ED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1255 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-O DOSE: 50 mg/kg/day ANIMAL #: 641209 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLY2ED,- DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1256 Wwwi y, *--^^"i H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: V-0 DOSE: 250 ing/kg/day ANIMAL #: 641058 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: VESICLES, TESTIS COAGULATING GLAND, EPIDIDYMIS, PRO THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1257 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641065 DAYS ON TEST: 107 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: VESICLES, TESTIS COAGULATING GLAND, EPIDIDYMIS, PROS THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1258 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - __ Pi ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641075 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1259 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641082 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: SEMINAL VESICLES. TESTES COAGULATING GLAND, EPIDIDYMIDES, P THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLY2ED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C INCIDENCE TABLES: NONE 1260 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________ INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641117 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1261 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations __________ INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: V-0 DOSE: 250 ing/kg/day ANIMAL #: 641119 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1262 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641120 DAYS ON TEST: 110 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1263 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641122 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1264 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________ INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641124 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: PROSTATE - INFLAMMATION, SUBACUTE/CHRONIC, MINIMAL THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: VESICLES, TESTES COAGULATING GLAND, EPIDIDYMIDES, SE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1265 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations______________ INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641126 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: VESICLES, TESTIS COAGULATING GLAND, EPIDIDYMIS, PROS THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1266 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641131 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLY2ED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1267 my H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641142 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: SEMINAL VESICLES, TESTES COAGULATING GLAND, EPIDIDYMIDES, PR THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1268 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641151 DAYS ON TEST: 109 MODE OF DEATH: SD ____ GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1269 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS - _______ PI ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641164 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1270 H-24616: Subchronic Toxidty 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations______________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641170 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1271 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641176 DAYS ON TEST: 108 MODE OF DEATH: SD ___ GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1272 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations _______________________________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day AMIMAL #: 641179 DAYS OM TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1273 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641180 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLY2ED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1274 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641184 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NOME SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1275 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: V-0 DOSE: 250 mg/kg/day ANIMAL #: 641195 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: SEMINAL VESICLES, TESTES COAGULATING GLAND, EPIDIDYMIDES, PR THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1276 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - ____ Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641054 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1277 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - ___ Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641068 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1278 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641078 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: SEMINAL VESICLES, TESTES COAGULATING GLAND, EPIDIDYMIDES, PR THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 0 1279 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 ing/kg/day ANIMAL #: 641080 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: MO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID MOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1280 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641093 DAYS ON TEST: 107 MODE OP DEATH: SD GROSS OBSERVATIONS: EPIDIDYMIDES TESTES MICROSCOPIC CORRELATE (selected - DISCOLORATION, YELLOW, RIGHT; HEAD - SOFT, PALE, RIGHT MICROSCOPIC OBSERVATIONS: EPIDIDYMIS TESTIS - GRANULOMA, SPERM, MILD - OLIGOSPERMIA/GERM CELL DEBRIS, SEVERE - DEGENERATION/ATROPHY, SEMINIFEROUS TUBULES, SEVERE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: COAGULATING GLAND, PROSTATE, SEMINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1281 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641096 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1282 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641110 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1283 ^jHII^'" :^ ^;,y H-24616: Subchromc Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 ing/kg/day ANIMAL #: 641112 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: MO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1284 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - ______ Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641139 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: .NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1285 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641145 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C INCIDENCE TABLES: NONE 1286 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641150 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1287 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations__________________________________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641152 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1288 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641177 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1289 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641182 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE MOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1290 ^|y H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641193 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1291 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 ing/kg/day ANIMAL #: 641207 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1292 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641208 DAYS ON TEST: 108 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C INCIDENCE TABLES: NONE 1293 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generadon Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 ing/kg/day ANIMAL #: 641210 DAYS ON TEST: 109 MODE OF DEATH: SD GROSS OBSERVATIONS: LUNGS MICROSCOPIC CORRELATE (selected - DISCOLORATION, TAN. LEFT; 5MM DIA MICROSCOPIC OBSERVATIONS: OTHER - LUNGS: FOREIGN MATERIAL, MINIMAL - LUNGS: INFLAMMATION, GRANULOMATOUS, MINIMAL THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: SEMINAL VESICLES, TESTES COAGULATING GLAND, EPIDIDYMIDES, PR THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE. FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1294 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641211 DAYS ON TEST: 110 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1295 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations________________________________ INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: VII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641212 DAYS ON TEST: 107 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1296 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641236 DAYS ON TEST: 118 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1297 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641255 DAYS ON TEST: 118 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1298 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: II-O DOSE: 0 ing/kg/day ANIMAL #: 641261 DAYS ON TEST: 117 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1299 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641289 DAYS ON TEST: 116 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C INCIDENCE TABLES: NONE 1300 tgr H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641306 DAYS ON TEST: 114 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1301 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 nig/kg/day ANIMAL #: 641308 DAYS ON TEST: 118 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLY2ED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NOME SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1302 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641310 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1303 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641317 DAYS ON TEST: 115 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1304 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641324 DAYS ON TEST: 116 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1305 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: II-O DOSE: 0 ing/kg/day ANIMAL #: 641328 DAYS ON TEST: 115 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLY2ED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1306 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day AMIMAL #: 641332 DAYS ON TEST: 117 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1307 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641337 DAYS ON TEST: 116 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1308 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641345 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1309 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641346 DAYS ON TEST: 115 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NOME THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C INCIDENCE TABLES: NONE 1310 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641349 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1311 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641358 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: OVARIES, UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1312 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: II-O DOSE: 0 ing/kg/day ANIMAL #: 641371 DAYS ON TEST: 114 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1313 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641388 DAYS ON TEST: 117 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C INCIDENCE TABLES: NONE 1314 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 mg/kg/day ANIMAL #: 641389 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: OVARIES, UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1315 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-O DOSE: 0 ing/kg/day ANIMAL #: 641403 DAYS ON TEST: 116 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1316 vsyit,^. . H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641231 DAYS ON TEST: 117 MODE OF DEATH: SD GROSS OBSERVATIONS: VAGINA MICROSCOPIC CORRELATE (selected - DISCOLORATION, TAN, RAISED; 3MM DIA MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1317 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 ing/kg/day ANIMAL #: 641258 DAYS ON TEST: 126 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NOME 1318 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641263 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1319 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641272 DAYS ON TEST: 115 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1320 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641274 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: OVARIES, UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1321 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641276 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: OVARIES, UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1322 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641286 DAYS ON TEST: 118 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED . MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1323 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641297 DAYS ON TEST: 115 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1324 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641304 DAYS ON TEST: 115 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1325 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641315 DAYS ON TEST: 120 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NOME THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1326 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641318 DAYS ON TEST: 117 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1327 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641323 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1328 '.-/' H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641338 DAYS ON TEST: 115 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1329 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day AMIMAL #: 641348 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C INCIDENCE TABLES: NONE 1330 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 ing/kg/day ANIMAL #: 641350 DAYS ON TEST: 118 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C INCIDENCE TABLES: NONE 1331 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641351 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN MOT CO INCIDENCE TABLES: NONE 1332 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641365 DAYS ON TEST: 115 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMINA THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNT INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COU INCIDENCE TABLES: NONE 1333 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641373 DAYS ON TEST: 118 MODE OF DEATH: SD GROSS OBSERVATIONS: SKIN MICROSCOPIC CORRELATE (selected - ALOPECIA, MODERATE, VENTRAL BODY MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN ! INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1334 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats wifh One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 ing/kg/day ANIMAL #: 641376 DAYS ON TEST: 118 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 0 INCIDENCE TABLES: NONE 1335 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-0 DOSE: 50 mg/kg/day ANIMAL #: 641378 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1336 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641228 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: OVARIES, UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1337 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641233 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1338 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641235 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1339 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 ing/kg/day ANIMAL #: 641238 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1340 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641239 DAYS ON TEST: 116 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1341 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641252 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: OVARIES, UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1342 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641271 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1343 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641277 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1344 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641280 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: OVARIES, UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1345 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 .DOSE: 250 mg/kg/day ANIMAL #: 641303 DAYS ON TEST: 116 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1346 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641316 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1347 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641333 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: OVARIES, UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1348 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641334 DAYS ON TEST: 124 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NOME THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1349 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641339 DAYS ON TEST: 115 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1350 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641347 DAYS ON TEST: 118 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1351 ^y H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641360 DAYS ON TEST: 117 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1352 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641367 DAYS ON TEST: 113 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: OVARIES, UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1353 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641381 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: OVARIES - ATROPHY, MILD THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES MOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1354 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 ing/kg/day ANIMAL #: 641386 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: OVARIES, UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1355 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: VI-0 DOSE: 250 mg/kg/day ANIMAL #: 641392 DAYS ON TEST: 107 MODE OF DEATH: FD GROSS OBSERVATIONS: URINARY BLADDER KIDNEYS VAGINA MICROSCOPIC CORRELATE (selected - DILATATION, SEVERE; THICK TAN FLUID PILLED - CALCULUS, MODERATE, BILATERAL, PELVIS - FLUID, GREEN, GELATINOUS MICROSCOPIC OBSERVATIONS: OTHER - HYDRONEPHROSIS, BILATERAL, MILD - KIDNEYS: INFLAMMATION, ACUTE, SEVERE - URINARY BLADDER: INFLAMMATION, SUBACUTE/CHRONIC, MILD THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: OVARIES, UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE' FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1356 ^B?1 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641230 DAYS ON TEST: 117 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1357 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 nig/kg/day ANIMAL #: 641242 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: OVARIES, UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN MOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT.CO INCIDENCE TABLES: NONE 1358 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641243 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1359 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641246 DAYS ON TEST: 115 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NOME SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1360 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641248 DAYS ON TEST: 118 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1361 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641254 DAYS ON TEST: 115 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1362 \..^ H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641265 DAYS ON TEST: 117 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1363 ^y H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641273 DAYS ON TEST: 113 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: OVARIES, UTERUS, VAGINA THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1364 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641284 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1365 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641296 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1366 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641307 DAYS ON TEST: 114 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1367 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641320 DAYS ON TEST: 118 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1368 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641329 DAYS ON TEST: 117 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1369 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641343 DAYS ON TEST: 116 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1370 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641353 DAYS ON TEST: 114 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1371 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641368 DAYS ON TEST: 115 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1372 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641370 DAYS ON TEST: 118 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1373 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641393 DAYS ON TEST: 115 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1374 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641401 DAYS ON TEST: 113 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1375 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: VIII-0 DOSE: 1000 mg/kg/day ANIMAL #: 641402 DAYS ON TEST: 116 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN INCIDENCE TABLES: NONE SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1376 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations APPENDIX MM INDIVIDUAL ANIMAL GROSS OBSERVATIONS FOR Fi PUPS 1377 ''<-&'' H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DAM ANIMAL NUMBER PUP SEX PUP ANIMAL NUMBER INDIVIDUAL ANIMAL GROSS OBSERVATIONS - Fi PUPS DAM GROUP: II-O DOSE: 0 MG/KG/DAY DAYS ON TEST FATE OBSERVATIONS 641310 F 643825 -21 FD 643826 -21 FD 641306 M 643805 -21 FD F 643827 -21 FD 641349 F 643828 -21 FD XXX= JLH STOMACH - NO MILK SPOT LUNGS - NOT EXPANDED XXX= JLH STOMACH - NO MILK SPOT LUNGS - NOT EXPANDED XXX= SWR STOMACH - NO MILK SPOT LUNGS - NOT EXPANDED XXX= JLH STOMACH - NO MILK SPOT LUNGS - NOT EXPANDED XXX= SWR STOMACH - NO MILK SPOT LUNGS - NOT EXPANDED 1378 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS OBSERVATIONS - Fi PUPS DAM GROUP: IV-0 DOSE: 50 MG/KG/DAY DAM ANIMAL NUMBER PUP SEX PUP ANIMAL NUMBER DAYS ON TEST FATE OBSERVATIONS 641351 F 643830 -21 FD XXX= JLH STOMACH - NO MILK SPOT LUNGS - NOT EXPANDED 1379 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS OBSERVATIONS - Fi PUPS DAM GROUP: VI-0 DOSE: 250 MG/KG/DAY DAM ANIMAL NUMBER PUP SEX PUP ANIMAL NUMBER DAYS ON TEST FATE OBSERVATIONS 641271 F 643835 -21 FD 641238 F 643836 -21 FD 643837 -7 FD XXX= JLH STOMACH - NO MILK SPOT LUNGS - NOT EXPANDED XXX= JLH STOMACH T NO MILK SPOT LUNGS - NOT EXPANDED PERITONEAL CAVITY - FLUID, CLEAR, MODERATE 1380 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS OBSERVATIONS - Pi PUPS DAM GROUP: VIII-0 DOSE: 1000 MG/KG/DAY DAM ANIMAL NUMBER PUP SEX PUP ANIMAL NUMBER DAYS ON TEST FATE OBSERVATIONS 641393 M 643823 -21 FD 641353 M 643820 -21 FD 641296 M 643821 -21 FD 643822 -21 FD STOMACH - NO MILK SPOT LUNGS - NOT EXPANDED XXX=SWR STOMACH LUNGS - - NO MILK SPOT NOT EXPANDED XXX= SWR STOMACH - NO MILK SPOT LUNGS - NOT EXPANDED XXX= SWR WHOLE BODY - AUTOLYSIS 1381 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 APPENDIX NN INDIVIDUAL ANIMAL GROSS OBSERVATIONS FOR Fi WEANLINGS 1382 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 INDIVIDUAL ANIMAL GROSS OBSERVATIONS - Fi WEANLINGS EXPLANATORY NOTES Note Day of weaning == Test Day 1. 1383 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations IND'IVIDUiUj ANIMAL GROSS3 OBSERVATIONS - Fi WEANLINGS MftLE RATS GROUP: 1-1 DOSE: 0 Big/kg/day ANIMAL NUMBER DAYS CIN TEST: FATE OBSEIWATIONS 644456 1 SP NO ABNORMALITIES DETECTED 644457 1 SP NO ABNORMALITIES DETECTED 644458 1 SP NO ABNORMALITIES DETECTED 644459 1 SP NO ABNORMALITIES DETECTED 644460 1 SP NO ABNORMALITIES DETECTED 644461 1 SP NO ABNORMALITIES DETECTED 644462 1 SP HO ABNORMALITIES DETECTED 644463 1 SP NO ABNORMALITIES DETECTED 644464 1 SP NO ABNORMALITIES DETECTED 644465 1 SP MO ABNORMALITIES DETECTED 644466 1 SP NO ABNORMALITIES DETECTED 644467 1 SP NO ABNORMALITIES DETECTED 644468 1 SP NO ABNORMALITIES DETECTED 644469 1 SP NO ABNORMALITIES DETECTED 644470 1 SP NO ABNORMALITIES DETECTED 644471 1 SP NO ABNORMALITIES DETECTED 644472 1 SP NO ABNORMALITIES DETECTED 644473 1 SP NO ABNORMALITIES DETECTED 644474 1 SP NO ABNORMALITIES DETECTED 644475 1 SP NO ABNORMALITIES DETECTED 644476 1 SP NO ABNORMALITIES DETECTED 644477 1 SP NO ABNORMALITIES DETECTED 644478 1 SP NO ABNORMALITIES DETECTED 644479 1 SP NO ABNORMALITIES DETECTED 644480 1 SP NO ABNORMALITIES DETECTED DuPont-4739 1384 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER DAYS CIN TES1' IND:rVTDUiU, ANIMAL GROSS3 OBSERVATIONS - Fi WEANLINGS MALE RATS GROUP: 1-1 DOSE: 0 mg/kg/day PATE OBSE1OVATIONS 644481 1 SP NO ABNORMALITIES DETECTED 644482 1 SP NO ABNORMALITIES DETECTED 644483 1 SP HO ABNORMALITIES DETECTED 644484 1 SP NO ABNORMALITIES DETECTED 644485 1 SP NO ABNORMALITIES DETECTED 644486 1 SP NO ABNORMALITIES DETECTED 644487 1 SP NO ABNORMALITIES DETECTED 644488 1 SP NO ABNORMALITIES DETECTED 644489 1 SP NO ABNORMALITIES DETECTED 644490 1 SP NO ABNORMALITIES DETECTED 644491 1 SP NO ABNORMALITIES DETECTED 644492 1 SP NO ABNORMALITIES DETECTED 644493 1 SP NO ABNORMALITIES DETECTED 644494 1 SP NO ABNORMALITIES DETECTED . 644495 1 SP NO ABNORMALITIES DETECTED 644496 1 SP NO ABNORMALITIES DETECTED 644497 1 SP NO ABNORMALITIES DETECTED 644498 1 SP NO ABNORMALITIES DETECTED 644499 1 SP NO ABNORMALITIES DETECTED 644500 1 SP NO ABNORMALITIES DETECTED 644501 1 SP NO ABNORMALITIES DETECTED 644502 1 SP NO ABNORMALITIES DETECTED 644503 1 SP NO ABNORMALITIES DETECTED 644504 1 SP NO ABNORMALITIES DETECTED 644505 1 SP NO ABNORMALITIES DETECTED 644506 1 SP NO ABNORMALITIES DETECTED 644507 1 SP NO ABNORMALITIES DETECTED DuPont-4739 1385 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER DAYS 0 'N TEST' IND IVIDUJVL ANIMAL GROS;3 OBSERVATIONS - Fi WEANLINGS MAL:E RATS3 GROUP: :[II-l DOSE: 50 mg/kg/day PATE OBSE]aVATIONS 644526 1 SP NO ABNORMALITIES DETECTED 644527 1 SP NO ABNORMALITIES DETECTED 644528 1 SP NO ABNORMALITIES DETECTED 644529 1 SP NO ABNORMALITIES DETECTED 644530 1 SP NO ABNORMALITIES DETECTED 644531 1 SP NO ABNORMALITIES DETECTED 644532 1 SP NO ABNORMALITIES DETECTED 644533 1 SP MO ABNORMALITIES DETECTED 644534 1 SP NO ABNORMALITIES DETECTED 644535 1 SP NO ABNORMALITIES DETECTED 644536 1 SP NO ABNORMALITIES DETECTED 644537 1 SP MO ABNORMALITIES DETECTED 644538 1 SP NO ABNORMALITIES DETECTED 644539 1 SP MO ABNORMALITIES DETECTED 644540 1 SP MO ABNORMALITIES DETECTED 644541 1 SP NO ABNORMALITIES DETECTED 644542 1 SP NO ABNORMALITIES DETECTED 644543 1 SP NO ABNORMALITIES DETECTED 644544 1 SP NO ABNORMALITIES DETECTED 644545 1 SP MO ABNORMALITIES DETECTED 644546 1 SP a 644547 1 SP NO ABNORMALITIES DETECTED 644548 1 SP NO ABNORMALITIES DETECTED 644549 1 SP MO ABNORMALITIES DETECTED 644550 1 SP MO ABNORMALITIES DETECTED 644551 1 SP NO ABNORMALITIES DETECTED 644552 1 SP a a Due to error, data were not recorded. 1386 DuPont-4739 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations AMIMAL NUMBER D.AYS ON TEST IND][VIDTOUi ANIMAL GROSS3 OBSERVATIONS - Fi WEANLINGS MALS! RATEi GROUP: 3:II-1 DOSE: 50 mg/kg/day FATE OBSEIWATIONS 644553 1 SP NO ABNORMALITIES DETECTED 644554 1 SP NO ABNORMALITIES DETECTED 644555 1 SP NO ABNORMALITIES DETECTED 644556 1 SP NO ABNORMALITIES DETECTED 644557 1 SP NO ABNORMALITIES DETECTED 644558 1 SP NO ABNORMALITIES DETECTED 644559 1 SP NO ABNORMALITIES DETECTED 644560 1 SP NO ABNORMALITIES DETECTED 644561 1 SP NO ABNORMALITIES DETECTED 644562 1 SP NO ABNORMALITIES DETECTED 644563 1 SP NO ABNORMALITIES DETECTED 644564 1 SP NO ABNORMALITIES DETECTED 644565 1 SP NO ABNORMALITIES DETECTED 644566 1 SP NO ABNORMALITIES DETECTED 644567 1 SP NO ABNORMALITIES DETECTED 644568 1 SP NO ABNORMALITIES DETECTED 644569 1 SP NO ABNORMALITIES DETECTED 644570 1 SP NO ABNORMALITIES DETECTED 644571 1 SP NO ABNORMALITIES DETECTED 644572 1 SP NO ABNORMALITIES DETECTED 644573 1 SP NO ABNORMALITIES DETECTED 644574 1 SP NO ABNORMALITIES DETECTED 644575 1 SP NO ABNORMALITIES DETECTED 644576 1 SP NO ABNORMALITIES DETECTED DuPont-4739 1387 . Does not coniain TSCA CBI H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER DAYS ON TEST INDIVIDUAL ANIMAL GROSS OBSERVATIONS - FI WEANLINGS MALE RATS GROUP: V-l DOSE: 250 mg/kg/day FATE OBSERVATIONS 644589 SP NO ABNORMALITIES DETECTED 644590 SP NO ABNORMALITIES DETECTED 644591 SP NO ABNORMALITIES DETECTED 644592 SP NO ABNORMALITIES DETECTED 644593 SP NO ABNORMALITIES DETECTED 644594 SP NO ABNORMALITIES DETECTED 644595 SP NO ABNORMALITIES DETECTED 644596 SP NO ABNORMALITIES DETECTED 644597 SP NO ABNORMALITIES DETECTED 644598 SP NO ABNORMALITIES DETECTED 644599 SP NO ABNORMALITIES DETECTED 644600 SP NO ABNORMALITIES DETECTED 644601 SP NO ABNORMALITIES DETECTED 644602 SP NO ABNORMALITIES DETECTED 644603 SP NO ABNORMALITIES DETECTED DuPont-4739 1388 , Does not ?><><.;-. v, H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER DAYS 0 'N TEST' IND:IVIDUJVL ANIMAL GROSS3 OBSERVATIONS - F], WEANLINGS MALE RATS GROUP: V-l DOSE: 250 mg/kg/day FATE OBSEIOVATIONS 644604 1 SP NO ABNORMALITIES DETECTED 644605 1 SP NO ABNORMALITIES DETECTED 644606 1 SP NO ABNORMALITIES DETECTED 644607 1 SP NO ABNORMALITIES DETECTED 644608 1 SP NO ABNORMALITIES DETECTED 644609 1 SP NO ABNORMALITIES DETECTED 644610 1 SP NO ABNORMALITIES DETECTED 644611 1 SP MO ABNORMALITIES DETECTED 644612 1 SP NO ABNORMALITIES DETECTED 644613 1 SP a 644614 1 SP NO ABNORMALITIES DETECTED 644615 1 SP NO ABNORMALITIES DETECTED 644616 1 SP NO ABNORMALITIES DETECTED 644617 1 SP NO ABNORMALITIES DETECTED 644618 1 SP NO ABNORMALITIES DETECTED 644619 1 SP NO ABNORMALITIES DETECTED 644620 1 SP NO ABNORMALITIES DETECTED 644621 1 SP NO ABNORMALITIES DETECTED 644622 1 SP NO ABNORMALITIES DETECTED 644623 1 SP NO ABNORMALITIES DETECTED 644624 1 SP NO ABNORMALITIES DETECTED DuPont-4739 a Due to error, data were not recorded. 1389 --- *.,^, ,^ H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER DAYS OM TEST IND][VIDUJVL ANIMAL GROS;3 OBSERVATIONS - Fi WEANLINGS MALE RATS GROUP: VI:I-1 DOSE: 1000 mg/kg/day FATE OBSEIWATIONS 644643 1 SP NO ABNORMALITIES DETECTED 644644 1 SP NO ABNORMALITIES DETECTED 644645 1 SP NO ABNORMALITIES DETECTED 644646 1 SP NO ABNORMALITIES DETECTED 644647 1 SP NO ABNORMALITIES DETECTED 644648 1 SP NO ABNORMALITIES DETECTED 644649 1 SP NO ABNORMALITIES DETECTED 644650 1 SP NO ABNORMALITIES DETECTED 644651 1 SP NO ABNORMALITIES DETECTED 644652 1 SP NO ABNORMALITIES DETECTED 644653 1 SP NO ABNORMALITIES DETECTED 644654 1 SP NO ABNORMALITIES DETECTED 644655 1 SP NO ABNORMALITIES DETECTED 644656 1 SP NO ABNORMALITIES DETECTED 644657 1 SP NO ABNORMALITIES DETECTED 644658 1 SP NO ABNORMALITIES DETECTED 644659 1 SP NO ABNORMALITIES DETECTED 644660 1 SP NO ABNORMALITIES DETECTED 644661 1 SP NO ABNORMALITIES DETECTED 644662 1 SP NO ABNORMALITIES DETECTED 644663 1 SP NO ABNORMALITIES DETECTED 644664 1 SP NO ABNORMALITIES DETECTED 644665 1 SP NO ABNORMALITIES DETECTED 644666 1 SP NO ABNORMALITIES DETECTED 644667 1 SP NO ABNORMALITIES DETECTED DuPont-4739 1390 '--'"^^TSCACB^ H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations IND:rVIDTEKL ANIMAL GROSS3 OBSERVATIONS - F]. WEANLINGS MALE RATS ANIMAL NUMBER DAYS 0 N TEST FATE GROUP: V3:I-1 DOSE: 1000 mg/kg/day OBSEIWATIONS 644668 1 SP NO ABNORMALITIES DETECTED 644669 1 SP NO ABNORMALITIES DETECTED 644670 1 SP NO ABNORMALITIES DETECTED 644671 644672 644673 1 SP 1 SP 1 SP NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED 644674 1 SP . NO ABNORMALITIES DETECTED 644675 644676 1 SP 1 SP NO ABNORMALITIES DETECTED HO ABNORMALITIES DETECTED 644677 1 SP NO ABNORMALITIES DETECTED 644678 644679 644680 644681 644682 1 SP 1 SP 1 SP 1 SP 1 SP NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED 644683 644684 1 SP 1 SP NO ABNORMALITIES DETECTED NO ABNORMALITIES DETECTED 644685 644686 644687 1 SP 1 SP 1 SP NO ABNORMALITIES DETECTED a NO ABNORMALITIES DETECTED 644688 1 SP NO ABNORMALITIES DETECTED DuPont-4739 3 Due to error, data were not recorded. 1391 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations AMIMAL NUMBER DAYS ON TEST INDIVIDUAL ANIMAL GROSS OBSERVATIONS - Fi WEANLINGS MALE KATS GROUP: VII-1 DOSE: 1000 nig/kg/day FATE OBSERVATIONS 644689 SP NO ABNORMALITIES DETECTED 644690 SP NO ABNORMALITIES DETECTED 644691 SP NO ABNORMALITIES DETECTED 644692 SP NO ABNORMALITIES DETECTED 644693 SP NO ABNORMALITIES DETECTED 644694 SP NO ABNORMALITIES DETECTED 644695 SP NO ABNORMALITIES DETECTED 644696 SP NO ABNORMALITIES DETECTED 644697 SP NO ABNORMALITIES DETECTED DuPont-4739 1392 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations IMDI VIDUAL ANIMAL GROSS OBSERVATIONS - F^ WEANLINGS FEMA;LE RATS ANIMAL NUMBER DAYS ON TEST FATE GROUP: II-l OBSERVATIONS DOSE: 0 mg/kg/day 644716 644717 1 SP ,N0 ABNORMALITIES DETECTED 1 SP MO ABNORMALITIES DETECTED 644718 1 SP NO ABNORMALITIES DETECTED 644719 1 SP NO ABNORMALITIES DETECTED 644720 1 SP NO ABNORMALITIES DETECTED 644721 1 SP NO ABNORMALITIES DETECTED 644722 1 SP KIDNEYS - DILATATION, MODERATE, RIGHT, PELVIS 644723 1 SP NO ABNORMALITIES DETECTED 644724 1 SP NO ABNORMALITIES DETECTED 644725 1 SP NO ABNORMALITIES DETECTED 644726 1 SP NO ABNORMALITIES DETECTED 644727 1 SP NO ABNORMALITIES DETECTED 644728 1 SP NO ABNORMALITIES DETECTED 644729 1 SP NO ABNORMALITIES DETECTED 644730 1 SP NO ABNORMALITIES DETECTED 644731 1 SP NO ABNORMALITIES DETECTED 644732 1 SP NO ABNORMALITIES DETECTED 644733 1 SP NO ABNORMALITIES DETECTED 644734 1 SP NO ABNORMALITIES DETECTED 644735 1 SP NO ABNORMALITIES DETECTED 644736 1 SP NO ABNORMALITIES DETECTED 644737 1 SP NO ABNORMALITIES DETECTED 644738 1 SP NO ABNORMALITIES DETECTED 644739 1 SP NO ABNORMALITIES DETECTED 644740 1 SP NO ABNORMALITIES DETECTED DuPont-4739 1393 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER DAYS 0 'N TEST' IND:IVIDTO\L ANIMAL GROS;3 OBSERVATIONS - FI WEANLINGS FESSULE KlITS GROUP;: II-l DOSE: 0 mg/kg/day FATE OBSE1RVATIONS 644741 1 SP NO ABNORMALITIES DETECTED 644742 1 SP NO ABNORMALITIES DETECTED 644743 1 SP NO ABNORMALITIES DETECTED 644744 1 SP NO ABNORMALITIES DETECTED 644745 1 SP NO ABNORMALITIES DETECTED 644746 1 SP NO ABNORMALITIES DETECTED 644747 1 SP NO ABNORMALITIES DETECTED 644748 1 SP NO ABNORMALITIES DETECTED 644749 1 SP NO ABNORMALITIES DETECTED 644750 1 SP NO ABNORMALITIES DETECTED 644751 1 SP NO ABNORMALITIES DETECTED 644752 1 SP NO ABNORMALITIES DETECTED 644753 1 SP NO ABNORMALITIES DETECTED 644754 644755 1 SP 1 SP NO ABNORMALITIES DETECTED a 644756 1 SP NO ABNORMALITIES DETECTED 644757 1 SP NO ABNORMALITIES DETECTED 644758 1 SP NO ABNORMALITIES DETECTED 644759 1 SP NO ABNORMALITIES DETECTED 644760 1 SP NO ABNORMALITIES DETECTED 644761 1 SP NO ABNORMALITIES DETECTED DuPont-4739 a Due to error, data were not recorded. 1394 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER DAYS ON TEST INDIVIDUAL ANIMAL GROSS OBSERVATIONS - FI WEANLINGS FEMALE RATS GROUP: II-l DOSE: 0 mg/kg/day FATE OBSERVATIONS 644762 SP MO ABNORMALITIES DETECTED 644763 SP NO ABNORMALITIES DETECTED 644764 SP NO ABNORMALITIES DETECTED 644765 SP NO ABNORMALITIES DETECTED 644766 SP NO ABNORMALITIES DETECTED 644767 SP NO ABNORMALITIES DETECTED 644768 SP NO ABNORMALITIES DETECTED 644769 SP NO ABNORMALITIES DETECTED DuPont-4739 1395 t (*mini.t-. r-, H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER DAYS ON TEST' IND:[VIDTO\L ANIMAL GROS;3 OBSERVATIONS - Fi WEANLINGS FEMALE RATS GROUP: IV-1 DOSE: 50 mg/kg/day FATE OBSE]RVATIONS 644788 1 SP N0 ABNORMALITIES DETECTED 644789 1 SP N0 ABNORMALITIES DETECTED 644790 1 SP N0 ABNORMALITIES DETECTED 644791 1 SP N0 ABNORMALITIES DETECTED 644792 1 SP N0 ABNORMALITIES DETECTED 644793 1 SP N0 ABNORMALITIES DETECTED 644794 1 SP N0 ABNORMALITIES DETECTED 644795 1 SP MO ABNORMALITIES DETECTED 644796 1 SP N0 ABNORMALITIES DETECTED 644797 1 SP KO ABNORMALITIES DETECTED 644798 1 SP N0 ABNORMALITIES DETECTED 644799 1 SP MO ABNORMALITIES DETECTED 644800 1 SP N0 ABNORMALITIES DETECTED 644801 1 SP N0 ABNORMALITIES DETECTED 644802 1 SP N0 ABNORMALITIES DETECTED 644803 1 SP N0 ABNORMALITIES DETECTED 644804 1 SP KO ABNORMALITIES DETECTED 644805 1 SP N0 ABNORMALITIES DETECTED 644806 1 SP N0 ABNORMALITIES DETECTED 644807 1 SP MO ABNORMALITIES DETECTED 644808 1 SP N0 ABNORMALITIES DETECTED 644809 1 SP N0 ABNORMALITIES DETECTED 644810 1 SP N0 ABNORMALITIES DETECTED 644811 1 SP N0 ABNORMALITIES DETECTED 644812 1 SP N0 ABNORMALITIES DETECTED DuPont-4739 1396 t-5J H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER DAYS 0 N TEST IND:[VIDTO\L ANIMAL GROSS3 OBSERVATIONS - Fi WEANLINGS FEMALE RA'TS GROUP: IV-1 DOSE: 50 mg/kg/day FATE OBSE]OVATIONS 644813 1 SP N0 ABNORMALITIES DETECTED 644814 1 SP MO ABNORMALITIES DETECTED 644815 1 SP N0 ABNORMALITIES DETECTED 644816 1 SP N0 ABNORMALITIES DETECTED 644817 1 SP N0 ABNORMALITIES DETECTED 644818 1 SP N0 ABNORMALITIES DETECTED 644819 1 SP N0 ABNORMALITIES DETECTED 644820 1 SP N0 ABNORMALITIES DETECTED 644821 1 SP N0 ABNORMALITIES DETECTED 644822 1 SP N0 ABNORMALITIES DETECTED 644823 1 SP N0 ABNORMALITIES DETECTED 644824 1 SP N0 ABNORMALITIES DETECTED 644825 1 SP N0 ABNORMALITIES DETECTED 644826 1 SP N0 ABNORMALITIES DETECTED 644827 1 SP N0 ABNORMALITIES DETECTED 644828 1 SP N0 ABNORMALITIES DETECTED 644829 1 SP N0 ABNORMALITIES DETECTED 644830 1 SP N0 ABNORMALITIES DETECTED 644831 1 SP N0 ABNORMALITIES DETECTED 644832 1 SP N0 ABNORMALITIES DETECTED 644833 1 SP MO ABNORMALITIES DETECTED 644834 1 SP MO ABNORMALITIES DETECTED DuPont-4739 1397 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER DAYS ON TEST INDIVIDUAL ANIMAL GROSS OBSERVATIONS - Fi WEANLINGS FEMALE RATS GROUP: IV-1 DOSE: 50 nig/kg/day FATE OBSERVATIONS 644835 SP NO ABNORMALITIES DETECTED 644836 SP NO ABNORMALITIES DETECTED 644837 SP NO ABNORMALITIES DETECTED 644838 SP NO ABNORMALITIES DETECTED 644839 SP NO ABNORMALITIES DETECTED 644840 SP NO ABNORMALITIES DETECTED 644841 SP NO ABNORMALITIES DETECTED DuPont-4739 1398 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDTOU, ANIMAL GROSS3 OBSERVATIONS - Fi WEANLINGS FEMAL E RA1'S GROUP: VI-1 DOSE: 250 mg/kg/day ANIMAL NUMBER DAYS 0 N TEST FATE OBSEIWATIONS 644854 1 SP N0 ABNORMALITIES DETECTED 644855 1 SP N0 ABNORMALITIES DETECTED 644856 1 SP N0 ABNORMALITIES DETECTED 644857 1 SP LUNGS - DEFORMITY, IRREGULAR, LEFT 644858 1 SP NO ABNORMALITIES DETECTED 644859 1 SP NO ABNORMALITIES DETECTED 644860 1 SP NO ABNORMALITIES DETECTED 644861 1 SP NO ABNORMALITIES DETECTED 644862 1 SP NO ABNORMALITIES DETECTED 644863 1 SP NO ABNORMALITIES DETECTED 644864 1 SP NO ABNORMALITIES DETECTED 644865 1 SP NO ABNORMAL ITIES DETECTED 644866 1 SP NO ABNORMALITIES DETECTED 644867 1 SP NO ABNORMALITIES DETECTED 644868 1 SP NO ABNORMALITIES DETECTED 644869 1 SP NO ABNORMALITIES DETECTED 644870 1 SP NO ABNORMALITIES DETECTED 644871 1 SP NO ABNORMALITIES DETECTED 644872 1 SP NO ABNORMALITIES DETECTED 644873 1 SP NO ABNORMALITIES DETECTED 644874 1 SP NO ABNORMALITIES DETECTED 644875 1 SP NO ABNORMALITIES DETECTED 644876 1 SP NO ABNORMALITIES DETECTED 644877 1 SP NO ABNORMALITIES DETECTED 644878 1 SP NO ABNORMALITIES DETECTED 644879 1 SP NO ABNORMALITIES DETECTED 644880 1 SP NO ABNORMALITIES DETECTED 644881 1 SP NO ABNORMALITIES DETECTED DuPont-4739 1399 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER DAYS ON TEST INDIVIDUAL ANIMAL GROSS OBSERVATIONS - Pi WEANLINGS FEMALE RATS GROUP: VI-1 DOSE: 250 mg/kg/day FATE OBSERVATIONS 644882 SP NO ABNORMALITIES DETECTED 644883 SP NO ABNORMALITIES DETECTED 644884 SP NO ABNORMALITIES DETECTED 644885 SP NO ABNORMALITIES DETECTED 644886 SP NO ABNORMALITIES DETECTED 644887 SP NO ABNORMALITIES DETECTED 644888 SP NO ABNORMALITIES DETECTED DuPont-4739 1400 ampwy SanRteeA 0os not e.wWn TSCA CB8 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER IND3[VIDTOUj ANIMAL GROSS3 OBSERVATIONS - Fi WEANLINGS FEMALE RATS DAYS ON TEST, pATE GROUP: V III-l OBSEIWATIONS DOSE: 1000 mg/kg/day 644907 1 SP NO ABNORMALITIES DETECTED 644908 1 SP NO ABNORMALITIES DETECTED 644909 1 SP NO ABNORMALITIES DETECTED 644910 1 SP NO ABNORMALITIES DETECTED 644911 1 SP NO ABNORMALITIES DETECTED 644912 1 SP NO ABNORMALITIES DETECTED 644913 1 SP NO ABNORMALITIES DETECTED 644914 1 SP NO ABNORMALITIES DETECTED 644915 1 SP NO ABNORMALITIES DETECTED 644916 1 SP NO ABNORMALITIES DETECTED 644917 1 SP NO ABNORMALITIES DETECTED 644918 1 SP NO ABNORMALITIES DETECTED 644919 1 SP NO ABNORMALITIES DETECTED 644920 1 SP NO ABNORMALITIES DETECTED 644921 - 1 SP NO ABNORMALITIES DETECTED 644922 1 SP NO ABNORMALITIES DETECTED 644923 1 SP NO ABNORMALITIES DETECTED 644924 1 SP NO ABNORMALITIES DETECTED 644925 1 SP NO ABNORMALITIES DETECTED 644926 1 SP NO ABNORMALITIES DETECTED 644927 1 SP NO ABNORMALITIES DETECTED 644928 1 SP NO ABNORMALITIES DETECTED 644929 1 SP NO ABNORMALITIES DETECTED 644930 1 SP NO ABNORMALITIES DETECTED 644931 1 SP NO ABNORMALITIES DETECTED DuPont-4739 Coimpany; 1401 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER IHD:IVIDU;KL ANIMAL GROS!3 OBSERVATIONS - Fi WEANLINGS FEMALE, RATS DAYS 0 IN TEST' FATE GROUP: V III-l OBSE]WATIONS DOSE: 1000 mg/kg/day 644932 1 SP MO ABNORMALITIES DETECTED 644933 1 SP WO ABNORMALITIES DETECTED 644934 1 SP NO ABNORMALITIES DETECTED 644935 1 SP NO ABNORMALITIES DETECTED 644936 1 SP NO ABNORMALITIES DETECTED 644937 1 SP NO ABNORMALITIES DETECTED 644938 1 SP NO ABNORMALITIES DETECTED 644939 1 SP NO ABNORMALITIES DETECTED 644940 1 SP NO ABNORMALITIES DETECTED 644941 1 SP NO ABNORMALITIES DETECTED 644942 1 SP NO ABNORMALITIES DETECTED 644943 1 SP NO ABNORMALITIES DETECTED 644944 1. SP NO ABNORMALITIES DETECTED 644945 1 SP NO ABNORMALITIES DETECTED 644946 1 SP NO ABNORMALITIES DETECTED 644947 1 SP NO ABNORMALITIES DETECTED 644948 1 SP NO ABNORMALITIES DETECTED 644949 1 SP NO ABNORMALITIES DETECTED 644950 1 SP NO ABNORMALITIES DETECTED 644951 1 SP NO ABNORMALITIES DETECTED DuPont-4739 1402 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL NUMBER INDIVIDUAL ANIMAL GROSS OBSERVATIONS - FI WEANLINGS FEMALE RATS DAYS ON TEST FATE GROUP: VIII-1 DOSE: 1000 lag/kg/day OBSERVATIONS 644952 SP NO ABNORMALITIES DETECTED 644953 SP NO ABNORMALITIES DETECTED 644954 SP NO ABNORMALITIES DETECTED 644955 SP NO ABNORMALITIES DETECTED 644956 SP MO ABNORMALITIES DETECTED 644957 SP NO ABNORMALITIES DETECTED DuPont-4739 1403 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations DuPont-4739 APPENDIX 00 INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS FOR Fi ADULTS 1404 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations_____________DuPont-4739 INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS KEY TO APPENDIX NOTE: Day of weaning = Test Day 1. ABBREVIATIONS: FD SD - POUND DEAD SACRIFICED BY DESIGN LESION GRADING: Histopathological changes are described according to their morphologic character, distribution and severity. The distribution (extent of tissue involvement) is indicated, where appropriate, by modifiers such as focal, multifocal, diffuse, unilateral, bilateral, etc. A severity score, if appropriate, is also assigned as follows: MINIMAL: MILD: MODERATE: SEVERE: The amount of change present barely exceeds that which is considered to be within normal limits. In general, the lesion is easily identified but of limited severity. The lesion probably does not produce any functional impairment. The lesion is prominent but there is significant potential for increased severity. Limited tissue or organ dysfunction is possible. The degree of change is either as complete as considered possible or great enough in intensity or extent to expect significant tissue or organ dysfunction. COMMENT: Grades minimal through severe represent progressive involvement/severity along a continuum with minimal lesions being the least severe and severe lesions being the most severe. While the grades refer to the morphological characteristics of lesions, they also indicate their relative biological significance. Gross observations listing multiple masses for a tissue are distinguished with letters (i.e., a, b, c, d, etc.). 1405 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644438 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING INCIDENCE TABLES: NONE TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1406 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644439 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1407 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644440 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1408 ^^-^ H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644441 DAYS ON TEST: 43 GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MODE OF DEATH: SD MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1409 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644442 DAYS ON TEST: 43 < MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1410 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644443 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT'PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING INCIDENCE TABLES: NONE TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1411 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644444 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1412 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644445 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1413 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644446 DAYS ON TEST: 43 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1414 %.r H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644447 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: KIDNEYS - DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1415 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644448 DAYS ON TEST: 43 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1416 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644449 DAYS OM TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAMD THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1417 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644450 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1418 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644451 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING.TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; INCIDENCE TABLES: NONE ORGAN NOT CO 1419 \^ H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL #: 644452 INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1420 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL #: 644453 INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC INCIDENCE TABLES: NONE EXAMINATION; ORGAN NOT CO 1421 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY ANIMAL #: 644454 GROSS OBSERVATIONS: KIDNEYS DAYS ON TEST: 43 MODE OP DEATH: SD - DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAMD THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1422 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL #: 644455 INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: 1-1 DOSE: 0 MG/KG/DAY DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1423 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644508 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1424 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644509 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1425 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644510 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID MOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1426 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644511 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: KIDNEYS - DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1427 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL #: 644512 INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO JS INCIDENCE TABLES: 3. NONE 1428 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644513 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1429 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644514 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1430 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644515 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1431 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644516 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1432 t^ H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generadon Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644517 DAYS ON TEST: 43 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1433 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644518 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1434 '-,,,,,/ H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644519 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1435 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644520 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1436 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644521 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1437 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644522 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1438 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644523 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1439 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644524 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1440 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - FI ADULTS MALE RATS GROUP: III-l DOSE: 50 MG/KG/DAY ANIMAL #: 644525 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; INCIDENCE TABLES: NONE ORGAN NOT CO 1441 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: V-l DOSE: 250 MG/KG/DAY ANIMAL #: 644577 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: KIDNEYS MICROSCOPIC CORRELATE (selected - DILATATION, MILD, RIGHT, PELVIS MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1442 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: V-l DOSE: 250 MG/KG/DAY ANIMAL #: 644578 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1443 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: V-l DOSE: 250 MG/KG/DAY ANIMAL #: 644579 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1444 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS MALE RATS GROUP: V-l DOSE: 250 MG/KG/DAY ANIMAL #: 644580 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; INCIDENCE TABLES: NONE ORGAN NOT CO 1445 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: V-l DOSE: 250 MG/KG/DAY ANIMAL #: 644581 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1446 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: V-l DOSE: 250 MG/KG/DAY ANIMAL #: 644582 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: KIDNEYS - DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1447 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: V-l DOSE: 250 MG/KG/DAY ANIMAL #: 644583 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT INCIDENCE TABLES: NONE FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1448 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: V-l DOSE: 250 MG/KG/DAY ANIMAL #: 644584 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC INCIDENCE TABLES: NONE EXAMINATION; ORGAN NOT CO 1449 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL #: 644585 INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: V-l DOSE: 250 MG/KG/DAY DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1450 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: V-l DOSE: 250 MG/KG/DAY ANIMAL #: 644586 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1451 H-24616: Subchroiric Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: V-l DOSE: 250 MG/KG/DAY ANIMAL #: 644587 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1452 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: V-l DOSE: 250 MG/KG/DAY ANIMAL #: 644588 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1453 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644625 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: KIDNEYS - DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; INCIDENCE TABLES: NONE ORGAN NOT CO 1454 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644626 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1455 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644627 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; INCIDENCE TABLES: NONE ORGAN NOT CO 1456 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644628 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: KIDNEYS - DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC INCIDENCE TABLES: NONE EXAMINATION; ORGAN NOT CO 1457 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation. Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644629 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1458 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644630 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAM NOT COUN SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1459 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644631 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID HOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; INCIDENCE TABLES: NONE ORGAN NOT CO 1460 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644632 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1461 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644633 DAYS ON TEST: 43 MODE,OF DEATH: SD GROSS OBSERVATIONS: KIDNEYS - DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1462 ^^/:' H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644634 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1463 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATION'S - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644635 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1464 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644636 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE ' MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1465 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644637 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAMD THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1466 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644638 DAYS ON TEST: 43 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: THYROID GLAND - ALTERATION, COLLOID, MINIMAL THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1467 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644639 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1468 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644640 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1469 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644641 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING INCIDENCE TABLES: NONE TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1470 ^^^^^^^s^g^ssssws&ia H-24 616: Subchronic Toxicity jO-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS MALE RATS GROUP: VII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644642 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; INCIDENCE TABLES: NONE ORGAN NOT CO 1471 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY AMIMAL #: 644698 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1472 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644699 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE MOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1473 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644700 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1474 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644701 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1475 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS - FI ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644702 DAYS ON TEST: 43 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1476 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644703 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1477 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KQ/DAY ANIMAL #: 644704 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1478 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644705 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1479 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: II~1 DOSE: 0 MG/KG/DAY ANIMAL #: 644706 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1480 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644707 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1481 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644708 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLY2ED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1482 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644709 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; INCIDENCE TABLES: NONE ORGAN NOT CO 1483 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644710 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: KIDNEYS DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1484 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644711 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: KIDNEYS DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT INCIDENCE TABLES: NONE FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1485 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644712 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1486 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644713 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1487 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS - F^ ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644714 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; INCIDENCE TABLES: NONE ORGAN NOT CO 1488 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: II-l DOSE: 0 MG/KG/DAY ANIMAL #: 644715 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLY2ED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; INCIDENCE TABLES: NONE ORGAN NOT CO 1489 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644770 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1490 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644771 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN MOT CO 1491 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644772 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: LIVER MASS, DARK, FIRM, RIGHT MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1492 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations ANIMAL #: 644773 INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C 1493 H-24 616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644774 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1494 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644775 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLY2ED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC INCIDENCE TABLES: NONE EXAMINATION; ORGAN NOT CO 1495 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644776 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1496 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644777 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C 1497 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644778 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: KIDNEYS DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selecte MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAM THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC INCIDENCE TABLES: NONE EXAMINATION; ORGAN NOT C 1498 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644779 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1499 H-24616: Subchromc Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644780 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1500 H-24616; Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Pi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644781 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE THE FOLLOWING FOLLOWING TISSUES TISSUES WERE fi WERE UNREMARKABLE MICROSCOPICALLY: AUTOLYZED; DEGREE OF AUTOLYSIS NONE DID MOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; INCIDENCE TABLES: NONE ORGAN NOT CO 1501 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - FI ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644782 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1502 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644783 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1503 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644784 DAYS ON TEST: 43 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1504 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL AMIMAL GROSS AND MICROSCOPIC OBSERVATIONS - FI ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644785 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: KIDNEYS - DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC INCIDENCE TABLES: NONE EXAMINATION; ORGAN NOT CO 1505 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644786 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1506 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: IV-1 DOSE: 50 MG/KG/DAY ANIMAL #: 644787 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1507 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VI-1 DOSE: 250 MG/KG/DAY ANIMAL #: 644842 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLY2ED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC INCIDENCE TABLES: NONE EXAMINATION; ORGAN NOT CO 1508 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VI-1 DOSE: 250 MG/KG/DAY ANIMAL #: 644843 DAYS ON TEST: 43 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT C 1509 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VI-1 DOSE: 250 MG/KG/DAY ANIMAL #: 644844 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC INCIDENCE TABLES: NONE EXAMINATION; ORGAN NOT C 1510 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VI-1 DOSE: 250 MG/KG/DAY ANIMAL #: 644845 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1511 ^^' ^ H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VI-1 DOSE: 250 MG/KG/DAY ANIMAL #: 644846 DAYS ON TEST: 43 MODE OP DEATH: SD GROSS OBSERVATIONS: KIDNEYS DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1512 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VI-1 DOSE: 250 MG/KG/DAY ANIMAL #: 644847 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1513 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - FI ADULTS FEMALE RATS GROUP: VI-1 DOSE: 250 MG/KG/DAY ANIMAL #: 644848 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: BRAIN - SOFT, CEREBELLUM MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1514 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rate with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VI-1 DOSE: 250 MG/KG/DAY ANIMAL #: 644849 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT INCIDENCE TABLES: NONE FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1515 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VI-1 DOSE: 250 MG/KG/DAY ANIMAL #: 644850 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO Wi;-".. 4 1516 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VI-1 DOSE: 250 MG/KG/DAY ANIMAL #: 644851 DAYS ON TEST: 43 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1517 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VI-1 DOSE: 250 MG/KG/DAY ANIMAL #: 644852 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: KIDNEYS - DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF_AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OP THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1518 ^ H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VI-1 DOSE: 250 MG/KG/DAY ANIMAL #: 644853 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: NONE THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; INCIDENCE TABLES: NONE ORGAN NOT CO 1519 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644889 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1520 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644890 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMI THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU SECTIONS OF THE FOLLOWING TISSUES WERE MOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1521 W H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644891 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING INCIDENCE TABLES: NONE TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1522 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644892 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1523 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644893 DAYS ON TEST: 43 MODE OP DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COU SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC INCIDENCE TABLES: NONE EXAMINATION; ORGAN NOT CO ''v.y 1524 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644894 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1525 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644895 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1526 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644896 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1527 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644897 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID MOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; INCIDENCE TABLES: NONE ORGAN NOT CO 1528 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644898 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1529 H-24616: Subchronic Toxicity 90-Day Gavage Study m Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644899 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO INCIDENCE TABLES: NONE 1530 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644900 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: KIDNEYS - DILATATION, RIGHT, PELVIS MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1531 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644901 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1532 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644902 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC INCIDENCE TABLES: NONE EXAMINATION; ORGAN NOT CO 1533 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AND MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644903 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING INCIDENCE TABLES: NONE TISSUES WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1534 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - PI ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644904 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUNT SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OP THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT COU 1535 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644905 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OP AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE SEVERELY AUTOLYZED; INCIDENCE TABLES: NONE MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES INCIDENCE TABLES: NONE WERE INSUFFICIENT FOR MICROSCOPIC EXAMINATION; ORGAN NOT CO 1536 H-24616: Subchronic Toxicity 90-Day Gavage Study in Rats with One-Generation Reproductive Evaluations INDIVIDUAL ANIMAL GROSS AMD MICROSCOPIC OBSERVATIONS - Fi ADULTS FEMALE RATS GROUP: VIII-1 DOSE: 1000 MG/KG/DAY ANIMAL #: 644906 DAYS ON TEST: 43 MODE OF DEATH: SD GROSS OBSERVATIONS: NO ABNORMALITIES DETECTED MICROSCOPIC CORRELATE (selected MICROSCOPIC OBSERVATIONS: NONE THE FOLLOWING TISSUES WERE UNREMARKABLE MICROSCOPICALLY: THYROID GLAND THE FOLLOWING TISSUES WERE AUTOLYZED; DEGREE OF AUTOLYSIS DID NOT PRECLUDE MICROSCOPIC EXAMIN THE FOLLOWING TISSUES WERE INCIDENCE TABLES: NONE SEVERELY AUTOLYZED; MICROSCOPIC DIAGNOSES NOT MADE, ORGAN NOT COUN SECTIONS OF THE FOLLOWING TISSUES WERE NOT PRESENT FOR MICROSCOPIC EXAMINATION: NONE SECTIONS OF THE FOLLOWING TISSUES WERE INSUFFICIENT FOR MICROSCOPIC INCIDENCE TABLES: NONE EXAMINATION; ORGAN NOT CO 1537
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