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8-Methoxypsoralen

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8-Methoxypsoralen NATIONAL TOXICOLOGY PROGRAM Technical Report Series NQ. 359 TOXICOLOGY AND CARCINOGENESIS STUDIES OF 8-METHOXYPSORALEN (CAS NO. 298-81-7) IN F344/N RATS (GAVAGE STUDIES) U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service National Institutes of Health FOREWORD The National Toxicology Program (NTP) is made up of four charter agencies of the U.S. Department of Health and Human Services (DHHS): the National Cancer Institute (NCI), National Institutes of Health; the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health; the National Center for Toxicological Research (NCTR), Food and Drug Administration; and the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control. In July 1981, the Carcinogenesis Bioassay Testing Program, NCI, was transferred to the NIEHS. The NTP coordinates the relevant programs, staff, and resources from these Public Health Service agen- cies relating to basic and applied research and to biological assay development and validation. The NTP develops, evaluates, and disseminates scientific information about potentially toxic and hazardous chemicals. This knowledge is used for protecting the health of the American people and for the primary prevention of disease. The studies described in this Technical Report were performed under the direction of the NIEHS and were conducted in compliance with NTP chemical health and safety requirements and must meet or exceed all applicable Federal, state, and local health and safety regulations. Animal care and use were in accordance with the Public Health Service Policy on Humane Care and Use of Animals. All NTP toxicology and carcinogenesis studies are subjected to a comprehensive audit before being pre- sented for public review. This Technical Report has been reviewed and approved by the NTP Board of Scientific Counselors' Peer Review Panel in public session; the interpretations described herein rep- resent the official scientific position of the NTP. These studies are designed and conducted to characterize and evaluate the toxicologic potential, in- cluding carcinogenic activity, of selected chemicals in laboratory animals (usually two species, rats and mice). Chemicals selected for NTP toxicology and carcinogenesis studies are chosen primarily on the bases of human exposure, level of production, and chemical structure. Selection per se is not an indicator of a chemical's carcinogenic potential. Anyone who is aware of related ongoing or published studies not mentioned in this report, or of any errors in this report, is encouraged to make this information known to the NTP. Comments and ques- tions about these Technical Reports on Toxicology and Carcinogenesis Studies should be directed to Dr. J.E. Huff, NIEHS, P.O. Box 12233, Research Triangle Park, NC 27709 (919-541-5722). These NTP Technical Reports are available for sale from the National Technical Information Service, U.S. Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161 (703-487-4650). A list- ing of printed NTP Technical Reports appears on the inside back cover. Single copies of this Tech- nical Report are available without charge while supplies last from the NTP Public Information Office, NIEHS, P.O. Box 12233, Research Triangle Park, NC 27709 (919-541-3991). 8-Methoxypsoralen, NTP TR 359 NTP TECHNICAL REPORT ON THE TOXICOLOGY AND CARCINOGENESIS STUDIES OF 8-METHOXYPSORALEN (CAS NO. 298-81-7) IN F344/N RATS (GAVAGE STUDIES) June K. Dunnick, Ph.D., Study Scientist NATIONAL TOXICOLOGY PROGRAM P.O. Box 12233 Research Triangle Park, NC 27709 July 1989 NTP TR 359 NIH Publication No. 89-2814 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service National Institutes of Health CONTENTS PAGE ABSTRACT ................................................................ 3 EXPLANATION OF LEVELS OF EVIDENCE OF CARCINOGENIC ACTIVITY .................. 6 CObTRIBUTORS ............................................................ 7 PEERREVIEWPANEL ........................................................ 8 SUMMARY OF PEER REVIEW COMMENTS ......................................... 9 I. INTRODUCTION ........................................................ 11 II. MATERIALS AND METHODS .............................................. 17 III. RESULTS ............................................................. 33 RATS ............................................................. 34 GENETICTOXICOLOGY ............................................... 46 IV. DISCUSSION AND CONCLUSIONS ........................................... 51 V. REFERENCES ......................................................... 55 APPENDIXES APPENDIX A SUMMARY OF LESIONS IN MALE RATS IN THE TWO-YEAR GAVAGE STUDY OF8-METHOXYPSORALEN ......................................... 63 APII’ENDIX B SUMMARY OF LESIONS IN FEMALE RATS IN THE TWO-YEAR GAVAGE STUDYOF8-METHOXYPSORALEN ................................... 91 APPENDIX C SENTINEL ANIMAL PROGRAM ...................................... 111 APPENDIX D INGREDIENTS. NUTRIENT COMPOSITION. AND CONTAMINANT LEVELS IN NIH 07 RAT AND MOUSE RATION ................................... 113 APPENDIX E TOXICITY OF 8.METHOXYPSORALEN. 5.METHOXYPSORALEN. 3.CARBETHOXYPSORALEN. OR 5-METHYLISOPSORALEN WITH ULTRAVIOLET RADIATION IN THE HAIRLESS (HRA/Skh) MOUSE ........................ 119 APPENDIX F AUDIT SUMMARY ............................................... 129 8.hfethoxypsoralen. NTP TR 359 2 OCH3 I 8-METHOXYPSORALEN CAS NO. 298-81-7 Cl2b04 Molecular weight 216.2 Synonyms: 9-methoxy-7H-furo[3,2-g]benzopyran-7-one;6-hydroxy-7-methoxy-5-benzofuranacrylic acid &lactone; 8-MP; 8-MOP; 8-methoxy-(furano-3',2':6,7-coumarin);8-methoxy-4',5':6,7- furocoumarin; 9-methoxypsoralen; 8-methoxypsoralene; methoxsalen; oxypsoralen Trade Names: Ammoidin; Meladinin (VAN); Meladinine; Meladoxen; Meloxine; Methoxa-Dome; Mopsoralen; Oxsoralen; Soloxsalen; Trioxun; Xanthotoxin; Xanthotoxine ABSTRACT Oral administration of 8-methoxypsoralen followed by exposure to longwave ultraviolet light (pri- marily ultraviolet A, 320-400 nm) is used in the treatment of vitiligo and psoriasis. 8-Methoxypsora- len also occurs naturally in a variety of vegetables. Toxicology and carcinogenesis studies of 8-meth- oxypsoralen without ultraviolet A were conducted by administering USP-grade 8-methoxypsoralen (99% pure) in corn oil by gavage to groups of F344/N rats once or for 16 days, 13weeks, or 2 years. In vitro genetic toxicology tests were performed with bacteria and mammalian cells. Single-Administration, Sixteen-Day, and Thirteen-Week Studies: In the single-administration stud- ies, the chemical was administered at doses of 0 and 63-1,000 mg/kg. Four of five male rats and 5/5 fe- male rats that received 1,000 mg/kg 8-methoxypsoralen died within 2 days. In the 16-day studies, the chemical was administered at doses of 0 and 50-800 mg/kg. All rats re- ceiving 800 mg/kg died within 5 days, and one male and one female at 400 mg/kg and one female at 200 mg/kg also died before the end of the studies. The final mean body weights of animals at 200 or 400 mg/kg were 14% or 30% lower than those of vehicle controls. No compound-related effects were observed at necropsy. In the 13-week studies, the chemical was administered at doses of 0 and 25-400 mg/kg. Six of 10 male rats and 8/10 female rats that received 400 mg/kg died before the end of the studies. The final mean body weight of male rats that received 100,200, or 400 mg/kg was 12%, 22%, or 45% lower than that of vehicle controls. The final mean body weight of female rats that received 200 or 400 mg/kg was 15% or 35% lower than that of vehicle controls. The liver weight to body weight ratios for all dosed groups of rats except the lowest (25 mg/kg),were greater than those for vehicle controls. Compound- related effects included fatty change in the liver in males and females and atrophy of the testis, semi- nal vesicles, and prostate. Based on these results, 2-year studies were conducted by administering 0, 37.5, or 75 mg/kg 8-meth- oxypsoralen in corn oil by gavage, 5 days per week for 103 weeks, to groups of 50 F344/N rats of each sex. 3 8-MethoxypsoralenI NTP TR 359 Body Weight and Survival in the Two-year Studies: The mean body weights of dosed male rats were generally 3%-14% lower than those of vehicle controls, and the mean body weights of high dose female rats were 5%-17% lower. The survival of both the low and the high dose groups of male rats was lower than that of the vehicle controls (male: vehicle control, 30/50; low dose, 16/50; high dose, 16/50; female: 39/50; 33/50; 36/50), likely because of kidney toxicity and neoplasia. Nonneoplastic and Neoplastic Effects in the Two-year Studies: Mineralization of the renal papilla was observed in high dose male rats (vehicle control, 0/50; low dose, 0/50; high dose, 31/49). The se- verit,y of nephropathy was increased in dosed male rats. Focal hyperplasia of renal tubular cells was observed in dosed male rats (0/50; 8/50; 8/49). The incidences of tubular cell adenomas (1/50; 11/50; 8/49], adenocarcinomas (0/50; 1/50; 3/49), and adenomas or adenocarcinomas (combined) (1150; 12/50; 11/49) were increased in dosed male rats. Hyperplasia of the parathyroid glands (2/49; 22/47; 18/48) and fibrous osteodystrophy (2/50; 10/50; 12/49) in male rats were secondary to chronic nephropathy. The incidences of carcinomas or squamous cell carcinomas (combined) of the Zymbal gland were in- creased in dosed male rats (1/50; 7/50; 4/49). The mean historical incidence for carcinomas or squa-
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