Public Interest Incorporated Foundation BioSafety Research Center

Transcription

1 Public Interest Incorporated Foundation BioSafety Research Center Ver Building #1(Test and research annex) Building #2 (Administrat ion office) Building #3 (Toxicity test annex for Building #4 middle-size (Reproduction animals) test annex) Building #5 (Multiplicity test annex) Building #6 Energy (Genetic facility toxicology test annex) Building #7(2nd Breeding Test and research pool annex) - 1 -

2 Corporate History Biosafety Research Center, Foods, Drugs and Pesticides (BSRC)[Anpyo-center] Founded on September 11, , Shioshinden, Iwata, Shizuoka , Japan Competent Authority: Ministry of Health, Labour and Welfare (primary) Ministry of Agriculture, Forestry and Fisheries Transfer to a new corporation on April 1, 2012 Public Interest Incorporated Foundation Biosafety Research Center (BSRC) Competent Authority: Cabinet Office, Government of Japan Principle We are living with several tens of thousands of chemical substances and accepting their benefits, however, some of them are hazardous and has risk for human safety. They are pharmaceutical drugs, agricultural chemicals, food-related substances, and industrial chemicals. Such chemical substances are evaluated for health hazards to human beings and for environmental impact, and those whose safety has been assured before into the market. We, BSRC, contributes to the well-being of our lives through safety evaluations that are based on science

3 Aims The Corporation aims to provide accurate and reliable information of chemical safety to be evaluated the risks of chemical substances by authorized specialists. BSRC also conduct research to develop/improve the assay systems more accurately and reliably to identify hazard of chemicals. In addition, as a group of specialists in regulatory science, BSRC supports evaluation and interpretation of the safety study results, and conducts education of regulatory scientists for chemical risk assessment. We, however, consider always 3R s. Services BSRC performs the following : 1. To perform GLP tests to evaluate the safety of chemical substances, pharmaceutical drugs, agricultural chemicals, food and related chemicals, etc. 2. To conduct evaluations of study results statistically, and make advice for interpretation for safety of the substance. 3. To develop/improve the assay methods and technology, technical transfer, and to education specialists for evaluation of chemical safety. 4. To engage research on regulatory science, to seek the way of transparent, fair, accurate evaluation of chemical safety. 5. To perform any other services that are necessary to achieve the aims of BSRC. These services shall be performed both in Japan and abroad

4 BSRC organization (GLP organization) General Affairs Section Board of Directors Board of Scientific Councilors R. Tanaka General Affairs Unit Facility Maintenance Section Informatics Systems Unit I. Narama R. Tanaka* F. Mizuhashi President I. Narama Manager Vice Manager Business Promotion Unit Business Promotion Section Managing Director R. Tanaka Document Administration Section Directors H. Asahina K. Ouchi President Emeritus R. Kato M. Hayashi Technical advisors M. Enomoto A. Maekawa K. Imai K. Suzuki M. Sano T. Asano S. Masumori Safety Assessment Unit Toxicological Laboratory Ecotoxicology & Chemical Analysis Laboratory Genotoxicology Laboratory Pathology Examination Laboratory *Test Facility Management Quality Assurance Unit The number of Study Directors Study Directors : 21 General toxicity study 5 Reproductive study 2 Carcinogenicity study 2 Specific toxicity study 3 Genotoxicity study 6 Aquatic organisms toxicity study 4 Chemical analysis 2 Clinical test/pathological test 5-4 -

5 Qualifications GLP personnel PhD Master Laboratory medical technologist Laboratory health technologist Pharmacist Veterinarian Experimental animal technologist 1st grade Experimental animal technologist 2nd grade Diplomate of the Japanese Society of Toxicology Certified pathologist by Japanese Society of Toxicologic Pathology Japanese College of Veterinary Pathologist Capacity of animal rooms Barrier (Building: #7) Rats: 10,528 Mice: 22,560 Conventional (Building: #7) Rats: 1,232 Mice: 2,640 Hamsters: 280 Guinea pigs: 640 Rabbits:

6 We do: General toxicology studies, including carcinogenicity studies Reproductive and developmental toxicity studies Specific toxicity studies We do: Genotoxicity studies Ecotoxicology studies Consultation Others - 6 -

7 General toxicology studies, Carcinogenicity studies Single dose (acute) toxicity study Repeated dose (subacute) toxicity study Chronic toxicity study Carcinogenicity (oncogenicity) study Chronic toxicity/carcinogenicity combined study Test chemical storage Freezer Room temperature Decicator - 7 -

8 Animal facility Clean side Animal facility - 8 -

9 Reproductive and developmental toxicity studies Study of fertility and early embryonic development to implantation (Seg-Ⅰ/StudyA) Study for effects on embryo-fetal development (Seg-Ⅱ/StudyC) Study for effects on pre- and post-natal development including maternal function (Seg-Ⅲ/StudyB) Teratogenicity study Reproduction toxicity study ReproTox Reproduction/developmental toxicity screening test Developmental neurotoxicity study - 9 -

10 Specific toxicity studies Implantation test Systemic toxicity study Pyrogen test Cumulative skin irritation study Hemolytic test Intradermal reactivity test Eye irritation test Skin irritation test Cheek pouch irritation test Antigenicity test Skin sensitization test Skin phototoxicity test Skin photosensitization test Genotoxicity studies Reverse mutation assay (Ames test) In vitro mammalian cell gene mutation test Chromosomal aberration test with cultured cells In vitro micronucleus study Transformation assay Cytotoxicity assay (colony formation inhibition, MTT assay) In vivo micronucleus study (manual, flowcytometry) In vivo comet assay In vivo gene mutation test using transgenic animals Combination assay (comet assay + micronucleus study) Micronucleus assay on liver, skin and digestive tract

11 Genotoxicity

12 Ecotoxicology studies Acute toxicity studies using fish Daphnia sp., Acute immobilisation test Daphnia magna Reproduction test Growth inhibition studies using Pseudokirchneriella subcapitata Whole Effluent Toxicity (WET) test Chironomus sp., Acute immobilisation test

13 Ecotoxicology Fish Daphnia

14 Green algae Others Pharmacological study rat/mouse/dog/rabbit/guinea pig Immunotoxicity study Karyotype analysis Soft agar colony formation assay Tumorigenicity test Drug efficacy test using tumor-bearing mice

15 Consultation Study design Evaluation and interpretation of study results Statistical analysis Making of application dossier for registration Translation GLP authorization, etc. Aug Nov Apr May 2016 Nov Nov GLP inspection by the Ministry of Agriculture, Forestry and Fisheries, Japan (February 1, 2016: APPROVED) GLP inspection by Pharmaceuticals and Medical Devices Agency (February 1, 2016 : APPROVED) GLP inspection based on the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. by the Ministry of Health, Labour and Welfare, Japan (May 12, 2016: APPROVED) GLP inspection based on the Industrial Safety and Health Act by the Ministry of Health, Labour and Welfare, Japan (June 22, 2016: APPROVED) AAALAC accreditation (March 1, 2017: FULL ACCREDITATION) GLP inspection based on the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. by the Ministry of the Environment, Japan (March 24, 2017: APPROVED)

16 Thank you