메뉴 건너뛰기




Volumn 116, Issue 2, 2010, Pages 382-396

Cross-sector review of drivers and available 3Rs approaches for acute systemic toxicity testing

Author keywords

3Rs; Acute toxicity; Harmonization; Hazard labeling; Limit dose; Redundancy; Regulatory classification; Systemic toxicity

Indexed keywords

AGRICULTURAL CHEMICAL; BIOCIDE; COSMETIC;

EID: 77955168444     PISSN: 10966080     EISSN: 10960929     Source Type: Journal    
DOI: 10.1093/toxsci/kfq143     Document Type: Review
Times cited : (41)

References (86)
  • 1
    • 1642575134 scopus 로고    scopus 로고
    • Acute systemic toxicity-prospects for tiered testing strategies
    • Botham, P. A. (2004). Acute systemic toxicity-prospects for tiered testing strategies. Toxicol. In Vitro 18, 227-230.
    • (2004) Toxicol. In Vitro , vol.18 , pp. 227-230
    • Botham, P.A.1
  • 2
    • 10544227294 scopus 로고
    • A new approach to the classification of substances and preparations on the basis of acute toxicity
    • British Toxicology Society (BTS)
    • British Toxicology Society (BTS). (1984). A new approach to the classification of substances and preparations on the basis of acute toxicity. Hum. Toxicol. 3, 85-92.
    • (1984) Hum. Toxicol. , vol.3 , pp. 85-92
  • 3
    • 58749111973 scopus 로고    scopus 로고
    • Estimation of acute oral toxicity using the No Observed Adverse Effect Level (NOAEL) from the 28-day repeated dose toxicity studies in rats
    • Bulgheroni, A., Kinsner-Ovaskainen, A., Hoffmann, S., Hartung, T., and Prieto, P. (2009). Estimation of acute oral toxicity using the No Observed Adverse Effect Level (NOAEL) from the 28-day repeated dose toxicity studies in rats. Regulat. Toxicol. Pharmacol. 53, 16-19.
    • (2009) Regulat. Toxicol. Pharmacol. , vol.53 , pp. 16-19
    • Bulgheroni, A.1    Kinsner-Ovaskainen, A.2    Hoffmann, S.3    Hartung, T.4    Prieto, P.5
  • 5
    • 85054112079 scopus 로고    scopus 로고
    • Chinese Ministry of Agriculture (MOA). Available at Accessed March 15, 2010
    • Chinese Ministry of Agriculture (MOA). (2001). Requirements of the Pesticide Registration Document. Available at: www.chinapesticide.gov.cn/en/2.pdf. Accessed March 15, 2010.
    • (2001) Requirements of the Pesticide Registration Document
  • 7
    • 0011779906 scopus 로고    scopus 로고
    • European Commission (EC). European Commission, Brussels, Belgium. Available at Accessed March 15, 2010
    • European Commission (EC). (2001a). Guidance on Submissions for Food Additive Evaluations by the Scientific Committee on Food. European Commission, Brussels, Belgium. Available at: http://ec.europa.eu/food/fs/sc/scf/out98_en.pdf. Accessed March 15, 2010.
    • (2001) Guidance on Submissions for Food Additive Evaluations by the Scientific Committee on Food
  • 12
    • 55149101880 scopus 로고    scopus 로고
    • European Chemicals Agency (ECHA). Available at Accessed March 15, 2010
    • European Chemicals Agency (ECHA). (2008a). Guidance on Information Requirements and Chemical Safety Assessment. Available at: http://guidance .echa.europa.eu/docs/guidance_document/information_requirements_en.htm?t ime=1258583530. Accessed March 15, 2010.
    • (2008) Guidance on Information Requirements and Chemical Safety Assessment
  • 13
    • 85054106497 scopus 로고    scopus 로고
    • European Chemicals Agency (ECHA). Chapter R.5: Adaptation of Information Requirements. Available at Accessed March 15, 2010
    • European Chemicals Agency (ECHA). (2008b). Technical Guidance Document for Preparing the Chemical Safety Assessment. Chapter R.5: Adaptation of Information Requirements. Available at: http://guidance .echa.europa.eu/docs/guidance_document/information_requirements_r5_en.pd f?vers=20_08_08. Accessed March 15, 2010.
    • (2008) Technical Guidance Document for Preparing the Chemical Safety Assessment
  • 14
    • 85054106497 scopus 로고    scopus 로고
    • European Chemicals Agency (ECHA). Chapter R.7: Endpoint Specific Guidance. Available at Accessed March 15, 2010
    • European Chemicals Agency (ECHA). (2008c). Technical Guidance Document for Preparing the Chemical Safety Assessment. Chapter R.7: Endpoint Specific Guidance. Available at: http://guidance.echa.europa.eu /docs/guidance_document/information_requirements_r7a_en.pdf?vers=20_08_0 8. Accessed March 15, 2010.
    • (2008) Technical Guidance Document for Preparing the Chemical Safety Assessment
  • 15
    • 55449127573 scopus 로고    scopus 로고
    • European Commission Scientific Committee on Consumer Products (SCCP). 6th Revision. European Commission, Brussels, Belgium. Available at Accessed March 15, 2010
    • European Commission Scientific Committee on Consumer Products (SCCP). (2006). The SCCP's Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation. 6th Revision. European Commission, Brussels, Belgium. Available at: http://ec.europa.eu/health/ph_risk /committees/04_sccp/docs/sccp_o_03j.pdf. Accessed March 15, 2010.
    • (2006) The SCCP's Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation
  • 16
    • 77955147229 scopus 로고
    • European Medicines Agency (EMEA). European Medicines Agency, London, UK. Available at Accessed March 15, 2010
    • European Medicines Agency (EMEA). (1987). Single Dose Toxicity. European Medicines Agency, London, UK. Available at: http://www.emea.europa.eu /pdfs/human/swp/3bs1aen.pdf. Accessed March 15, 2010.
    • (1987) Single Dose Toxicity
  • 19
    • 72149103443 scopus 로고    scopus 로고
    • Government of Canada (GC). Canada Gazette, ON, Ottawa, Canada. Available at Accessed March 15, 2010
    • Government of Canada (GC). (2005). New Substances Notification Regulations (Chemicals and Polymers). Canada Gazette, ON, Ottawa, Canada. Available at: http://www.gazette.gc.ca/archives/p2/2005/2005-09-21/html/sor-dors247-en g.html. Accessed March 15, 2010.
    • (2005) New Substances Notification Regulations (Chemicals and Polymers)
  • 20
    • 77955141864 scopus 로고    scopus 로고
    • Government of Canada (GC). Department of Justice, Ottawa, ON, Canada. Available at Accessed March 15, 2010
    • Government of Canada (GC). (2006). Pest Control Products Act. Department of Justice, Ottawa, ON, Canada. Available at: http://laws.justice.gc.ca/en /P-9.01/. Accessed March 15, 2010.
    • (2006) Pest Control Products Act
  • 21
    • 85054108204 scopus 로고    scopus 로고
    • Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). National Toxicology Program, Research Triangle Park, NC. Available at Accessed March 15, 2010
    • Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). (2008). Validation Study of In Vitro Cytotoxicity Test Methods: Recommendations and Agency Responses. National Toxicology Program, Research Triangle Park, NC. Available at: http://iccvam.niehs.nih.gov /methods/acutetox/inv_nru_recommend.htm. Accessed March 15, 2010.
    • (2008) Validation Study of In Vitro Cytotoxicity Test Methods: Recommendations and Agency Responses
  • 22
    • 0003550440 scopus 로고    scopus 로고
    • Interagency Coordinating Committee on the Validation of Alternative Methods /National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (ICCVAM/NICEATM). National Toxicology Program, Research Triangle Park, NC. Available at Accessed March 15, 2010
    • Interagency Coordinating Committee on the Validation of Alternative Methods /National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (ICCVAM/NICEATM). (2001a). Guidance Document on Using In Vitro Data to Estimate In Vivo Starting Doses for Acute Toxicity. National Toxicology Program, Research Triangle Park, NC. Available at: http://iccvam.niehs.nih.gov/docs/acutetox_docs/guidance0801 /iv_guide.pdf. Accessed March 15, 2010.
    • (2001) Guidance Document on Using In Vitro Data to Estimate In Vivo Starting Doses for Acute Toxicity
  • 23
    • 85054110251 scopus 로고    scopus 로고
    • Interagency Coordinating Committee on the Validation of Alternative Methods/ National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (ICCVAM/NICEATM). National Toxicology Program, Research Triangle Park, NC. Available at Accessed March 15, 2010
    • Interagency Coordinating Committee on the Validation of Alternative Methods/ National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (ICCVAM/NICEATM). (2001b). Report of the International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity. National Toxicology Program, Research Triangle Park, NC. Available at: http://iccvam.niehs.nih.gov/methods/acutetox/inv_cyto_wksp.htm. Accessed March 15, 2010.
    • (2001) Report of the International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity
  • 24
    • 85054112615 scopus 로고    scopus 로고
    • Interagency Coordinating Committee on the Validation of Alternative Methods/ National Toxicology Program Interage ncy Center for the Evaluation of Alternative Toxicological Methods (ICCVAM/NICEATM). National Toxicology Program, Research Triangle Park, NC. Available at Accessed March 15, 2010
    • Interagency Coordinating Committee on the Validation of Alternative Methods/ National Toxicology Program Interage ncy Center for the Evaluation of Alternative Toxicological Methods (ICCVAM/NICEATM). (2006). Validation Study of In Vitro Cytotoxicity Test Methods. National Toxicology Program, Research Triangle Park, NC. Available at: http://iccvam.niehs. nih.gov/methods/acutetox/inv_nru_tmer.htm. Accessed March 15, 2010.
    • (2006) Validation Study of In Vitro Cytotoxicity Test Methods
  • 25
    • 85054105311 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). International Federation of Pharmaceutical Manufacturers and Associations, Geneva, Switzerland. Available at Accessed March 15, 2010
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). (2009). Revised ICH Topic M3(R2): Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals. International Federation of Pharmaceutical Manufacturers and Associations, Geneva, Switzerland. Available at: http://www.ich.org/LOB/media/MEDIA5544.pdf. Accessed March 15, 2010.
    • (2009) Revised ICH Topic M3(R2): Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
  • 26
    • 85054111612 scopus 로고    scopus 로고
    • International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). International Federation for Animal Health, Brussels, Belgium. Available at Accessed March 15, 2010
    • International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). (2008). VICH GL 43 (Target Animal Safety). International Federation for Animal Health, Brussels, Belgium. Available at: http://www.vichsec.org/pdf/0708/GL43-st7.doc. Accessed March 15, 2010.
    • (2008) VICH GL 43 (Target Animal Safety)
  • 27
    • 85054113233 scopus 로고    scopus 로고
    • Japan Food and Agricultural Materials Inspection Center (FAMIC). (undated). Government of Japan, Saitama, Japan. Available at Accessed March 15, 2010
    • Japan Food and Agricultural Materials Inspection Center (FAMIC). (undated). Appendix to Data Requirements for Supporting Registration of Pesticides. Government of Japan, Saitama, Japan. Available at: http://www.acis.famic .go.jp/eng/shinsei/8147appendix.pdf. Accessed March 15, 2010.
    • (2000) Appendix to Data Requirements for Supporting Registration of Pesticides
  • 28
    • 77955163234 scopus 로고
    • Japan Ministry of Agriculture, Forestry and Fisheries (MAFF). Government of Japan, Tokyo, Japan. Available at Accessed March 15, 2010
    • Japan Ministry of Agriculture, Forestry and Fisheries (MAFF). (1948). Agricultural Chemicals Regulation Law. Government of Japan, Tokyo, Japan. Available at: http://www.env.go.jp/en/chemi/pops/Appendix/05-Laws/agri-chem-laws.pdf. Accessed March 15, 2010.
    • (1948) Agricultural Chemicals Regulation Law
  • 29
    • 85054106278 scopus 로고    scopus 로고
    • Japan Ministry of Economy, Trade and Industry (METI). Government of Japan, Tokyo, Japan. Available at Accessed March 15, 2010
    • Japan Ministry of Economy, Trade and Industry (METI). (2005). Act on The Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. Government of Japan, Tokyo, Japan. Available at: http://www.meti.go. jp/english/policy/mono_info_service/kagaku/chemical_substances/chemical_ substances03.html. Accessed March 15, 2010.
    • (2005) Act on The Evaluation of Chemical Substances and Regulation of Their Manufacture, etc
  • 30
    • 69449106665 scopus 로고    scopus 로고
    • Japanese Ministry of Health, Labor and Welfare (MHLW). Government of Japan, Toxyo, Japan. Available at Accessed March 15, 2010
    • Japanese Ministry of Health, Labor and Welfare (MHLW). (2000). Standards for Cosmetics. Government of Japan, Toxyo, Japan. Available at: http: //www.mhlw.go.jp/english/topics/cosmetics/index.html. Accessed March 15, 2010.
    • (2000) Standards for Cosmetics
  • 31
    • 85054113507 scopus 로고    scopus 로고
    • Japanese Ministry of Health, Labor and Welfare (MHLW). Government of Japan, Tokyo, Japan. Available at Accessed March 15, 2010
    • Japanese Ministry of Health, Labor and Welfare (MHLW). (2009). The Guidelines for Designation of Food Additives, and for Revision of Standards for Use of Food Additives. Government of Japan, Tokyo, Japan. Available at: http://www.mhlw.go.jp/english/topics/foodsafety/foodadditives/index.html . Accessed March 15, 2010.
    • (2009) The Guidelines for Designation of Food Additives, and for Revision of Standards for Use of Food Additives
  • 34
    • 0021048099 scopus 로고
    • A new approach to practical acute toxicity testing
    • Lorke, D. (1983). A new approach to practical acute toxicity testing. Arch. Toxicol. 54, 275-287.
    • (1983) Arch. Toxicol. , vol.54 , pp. 275-287
    • Lorke, D.1
  • 35
    • 84925560919 scopus 로고
    • Ministry of Health of the People's Republic of China (MHP). Ministry of Health, Beijing, China. Available at Accessed March 15, 2010
    • Ministry of Health of the People's Republic of China (MHP). (1989). Regulations Concerning The Hygiene Supervision Over Cosmetics. Ministry of Health, Beijing, China. Available at: http://tradeinservices.mofcom.gov.cn/en/b/1989-11-13/26891.shtml. Accessed March 15, 2010.
    • (1989) Regulations Concerning The Hygiene Supervision Over Cosmetics
  • 36
    • 85054114080 scopus 로고    scopus 로고
    • Ministry of Environmental Protection, Peoples' Republic of China (MEP). Ministry of Health, Beijing, China. Available at Accessed March 15, 2010
    • Ministry of Environmental Protection, Peoples' Republic of China (MEP). (2003). Provisions for the Environmental Administration of New Chemical Substances. Ministry of Health, Beijing, China. Available at: http://www.crc-mep .org.cn/newchem/enewchem.htm. Accessed March 15, 2010.
    • (2003) Provisions for the Environmental Administration of New Chemical Substances
  • 37
    • 85054106001 scopus 로고    scopus 로고
    • Ministry of Environmental Protection, Peoples' Republic of China (MEP). Beijing, China. Available at Accessed March 15, 2010
    • Ministry of Environmental Protection, Peoples' Republic of China (MEP). (2004a). Guideline for the Hazard Evaluation of New Chemical Substances: HJ/T 154-2004. Beijing, China. Available at: http://www.mep.gov.cn /image20010518/4342.pdf. Accessed March 15, 2010.
    • (2004) Guideline for the Hazard Evaluation of New Chemical Substances: HJ/T 154-2004
  • 38
    • 0003488241 scopus 로고    scopus 로고
    • Ministry of Environmental Protection, Peoples' Republic of China (MEP). Available at Accessed March 15, 2010
    • Ministry of Environmental Protection, Peoples' Republic of China (MEP). (2004b). Guideline for the Testing of Chemicals: HJ/T 153-2004. Available at: http://english.mep.gov.cn/standards_reports/standards/Solid_Waste/other_ standards1/200710/t20071024_111961.htm. Accessed March 15, 2010.
    • (2004) Guideline for the Testing of Chemicals: HJ/T 153-2004
  • 40
    • 85054114632 scopus 로고
    • Official Journal of the European Communities (OJ). EU Publications Office, Brussels, Belgium. Available at Accessed March 15, 2010
    • Official Journal of the European Communities (OJ). (1992). Council Directive Concerning the Placing of Plant Protection Products on the Market. EU Publications Office, Brussels, Belgium. Available at: http://europa.eu /eur-lex/en/consleg/pdf/1991/en_1991L0414_do_001.pdf. Accessed March 15, 2010.
    • (1992) Council Directive Concerning the Placing of Plant Protection Products on the Market
  • 41
  • 44
    • 85054106770 scopus 로고    scopus 로고
    • Corrigendum to Commission Directive 2004/73/EC adapting to technical progress for the 29th time Council Directive 6/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances
    • Official Journal of the European Communities (OJ). EU Publications Office, Brussels, Belgium. L 216, 3-310
    • Official Journal of the European Communities (OJ). (2004). Corrigendum to Commission Directive 2004/73/EC adapting to technical progress for the 29th time Council Directive 6/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. Official Journal of the European Union. EU Publications Office, Brussels, Belgium. L 216, 3-310.
    • (2004) Official Journal of the European Union
  • 45
    • 85054115221 scopus 로고    scopus 로고
    • Official Journal of the European Communities (OJ). EU Publications Office, Brussels, Belgium. Available at Accessed March 15, 2010
    • Official Journal of the European Communities (OJ). (2006). Council Directive on the Approximation of Laws of the Member States Relating to Cosmetic Products. EU Publications Office, Brussels, Belgium. Available at: http: //eurlex.europa.eu/LexUriServ/site/en/consleg/1976/L/01976L0768-20060809 -en.pdf. Accessed March 15, 2010.
    • (2006) Council Directive on the Approximation of Laws of the Member States Relating to Cosmetic Products
  • 49
    • 27744521726 scopus 로고
    • Organization for Economic Cooperation and Development (OECD). OECD, Paris, France. Available at Accessed March 15, 2010
    • Organization for Economic Cooperation and Development (OECD). (1981). Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals. OECD, Paris, France. Available at: http://www.oecd.org/document/41/03343,en_2649_34365_1890473_1_1_1_1,00.h tml. Accessed March 15, 2010.
    • (1981) Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals
  • 50
    • 85054110747 scopus 로고    scopus 로고
    • 50 Acute Toxicity Test
    • Organization for Economic Cooperation and Development (OECD). OECD, Paris, France. Available at Accessed March 15, 2010
    • Organization for Economic Cooperation and Development (OECD). (2002). OECD Test Guideline 401 was Deleted in 2002: A Major Step in Animal Welfare: OECD Reached Agreement on the Abolishment of the LD50 Acute Toxicity Test. OECD, Paris, France. Available at: http://www.oecd.org /document/52/0,3343, en_2649_34377_2752116_1_1_1_1,00.html. Accessed March 15, 2010.
    • (2002) OECD Test Guideline 401 was Deleted in , vol.2002
  • 51
    • 85054108655 scopus 로고    scopus 로고
    • Organization for Economic Cooperation and Development (OECD). OECD Series on Testing and Assessment No. 70. OECD, Paris, France
    • Organization for Economic Cooperation and Development (OECD). (2007a). Report on Preparation of GHS Implementation by the OECD Countries. OECD Series on Testing and Assessment No. 70. OECD, Paris, France.
    • (2007) Report on Preparation of GHS Implementation by the OECD Countries
  • 52
    • 72149108274 scopus 로고    scopus 로고
    • Guidance on Grouping of Chemicals
    • Organization for Economic Cooperation and Development (OECD). OECD, Paris, France. Available at Accessed March 15, 2010
    • Organization for Economic Cooperation and Development (OECD). (2007b). Series on Testing and Assessment Number 80: Guidance on Grouping of Chemicals. OECD, Paris, France. Available at: http://www.olis.oecd.org /olis/2007doc.nsf/LinkTo/NT0000426A/FILE/JT03232745.PDF. Accessed March 15, 2010.
    • (2007) Series on Testing and Assessment Number , vol.80
  • 55
    • 84880583922 scopus 로고    scopus 로고
    • Organization for Economic Cooperation and Development (OECD). OECD, Paris, France. Available at Accessed March 15, 2010
    • Organization for Economic Cooperation and Development (OECD). (2009c). OECD Guidelines for the Testing of Chemicals. Section 4: Health Effects. OECD, Paris, France. Available at: http://masetto.sourceoecd.org /vl=1083876/cl=12/nw=1/rpsv/cw/vhosts/oecdjournals/1607310x/v1n4/contp1- 1.htm. Accessed March 15, 2010.
    • (2009) OECD Guidelines for the Testing of Chemicals. Section 4: Health Effects
  • 57
    • 69249231966 scopus 로고    scopus 로고
    • Are acute toxicity studies required to support overdose for new medicines? Regul
    • Robinson, S., and Chapman, K. (2009). Are acute toxicity studies required to support overdose for new medicines? Regul. Toxicol. Pharmacol. 55, 110.
    • (2009) Toxicol. Pharmacol. , vol.55 , pp. 110
    • Robinson, S.1    Chapman, K.2
  • 58
    • 41949094635 scopus 로고    scopus 로고
    • A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development
    • Robinson, S., Delongeas, J.-L., Donald, E., Dreher, D., Festag, M., Kervyn, S., Lampo, A., Nahas, K., Nogues, V., Ockert, D., et al. (2008). A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development. Regul. Toxicol. Pharmacol. 50, 345-352.
    • (2008) Regul. Toxicol. Pharmacol , vol.50 , pp. 345-352
    • Robinson, S.1    Delongeas, J.-L.2    Donald, E.3    Dreher, D.4    Festag, M.5    Kervyn, S.6    Lampo, A.7    Nahas, K.8    Nogues, V.9    Ockert, D.10
  • 61
    • 85054113713 scopus 로고    scopus 로고
    • State Council of the People's Republic of China. State Council of P.R. China, Beijing, China. Available at Accessed March 15, 2010
    • State Council of the People's Republic of China. (2001). Regulations on Pesticide Administration. State Council of P.R. China, Beijing, China. Available at: http://www.gov.cn/english/laws/2005-08/24/content_25760.htm. Accessed March 15, 2010.
    • (2001) Regulations on Pesticide Administration
  • 62
    • 0001308373 scopus 로고
    • The error of determination of toxicity
    • Trevan, J. W. (1927). The error of determination of toxicity. Proc. R. Soc. Lond. 1.1B, 483.
    • (1927) Proc. R. Soc. Lond. , vol.1 , Issue.1 B , pp. 483
    • Trevan, J.W.1
  • 63
    • 85054112759 scopus 로고    scopus 로고
    • U.K. Home Office (HO). Available at Accessed March 15, 2010
    • U.K. Home Office (HO). (1999). LD50 Test-Changes To Licensing Procedures. Available at: http://www.apc.gov.uk/press_releases/991021.htm. Accessed March 15, 2010.
    • (1999) 50 Test-Changes To Licensing Procedures
  • 65
    • 0003893494 scopus 로고
    • United States Code (USC). §§ 2601 et seq. United States Government, Washington, DC. Available at Accessed March 15, 2010
    • United States Code (USC). (1976). The Toxic Substances Control Act (TSCA) 15 U.S.C. §§ 2601 et seq. United States Government, Washington, DC. Available at: http://www.epa.gov/compliance/civil/tsca/tscaenfstatreq.html. Accessed March 15, 2010.
    • (1976) The Toxic Substances Control Act (TSCA) 15 U.S.C
  • 66
    • 85054114706 scopus 로고    scopus 로고
    • United States Code (USC). § 301 et seq. United States Government, Washington, DC. Available at Accessed March 15, 2010
    • United States Code (USC). (2008a). Federal Food, Drug and Cosmetic Act (FFDCA) of 1938 21 U.S.C. § 301 et seq. United States Government, Washington, DC. Available at: http://www.law.cornell.edu/uscode/21/usc_sup_01_21_10_9.html. Accessed March 15, 2010.
    • (2008) Federal Food, Drug and Cosmetic Act (FFDCA) of 1938 21 U.S.C
  • 67
    • 85054110475 scopus 로고    scopus 로고
    • United States Code (USC). § 136 et seq. United States Government, Washington, DC. Available at Accessed March 15, 2010
    • United States Code (USC). (2008b). Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) of 1947 7 U.S.C. § 136 et seq. United States Government, Washington, DC. Available at: http://agriculture.senate.gov/Legislation/Compilations/Fifra/FIFRA.pdf. Accessed March 15, 2010.
    • (2008) Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) of 1947 7 U.S.C
  • 68
    • 70350729661 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services and U.S. Environmental Protection Agency (HHS & EPA). HHS & EPA, Research Triangle Park, NC. Available at Accessed March 15, 2010
    • U.S. Department of Health and Human Services and U.S. Environmental Protection Agency (HHS & EPA). (2008). Memorandum of Understanding on High Throughput Screening, Toxicity Pathway Profiling, and Biological Interpretation of Findings. HHS & EPA, Research Triangle Park, NC. Available at: http://ntp.niehs.nih.gov/files/ntpncgcepamou.pdf. Accessed March 15, 2010.
    • (2008) Memorandum of Understanding on High Throughput Screening, Toxicity Pathway Profiling, and Biological Interpretation of Findings
  • 71
    • 77955130686 scopus 로고    scopus 로고
    • U.S. Environmental Protection Agency (EPA). U.S. EPA, Washington, DC. Available at Accessed March 15, 2010
    • U.S. Environmental Protection Agency (EPA). (2004). Chemical Hazard Classification and Labeling: Comparison of OPP Requirements and the GHS. U.S. EPA, Washington, DC. Available at: http://www.epa.gov /oppfead1/international/global/ghscriteria-summary.pdf. Accessed March 15, 2010.
    • (2004) Chemical Hazard Classification and Labeling: Comparison of OPP Requirements and the GHS
  • 72
    • 85054115856 scopus 로고    scopus 로고
    • U.S. Environmental Protection Agency (EPA). U.S. EPA, Washington, DC. Available at Accessed March 15, 2010
    • U.S. Environmental Protection Agency (EPA). (2007a). OECD SIDS Manual Sections 3.4 and 3.5. U.S. EPA, Washington, DC. Available at: http://www.epa.gov/HPV/pubs/general/sidsappb.htm. Accessed March 15, 2010.
    • (2007) OECD SIDS Manual Sections 3.4 and 3.5
  • 73
    • 59349107521 scopus 로고    scopus 로고
    • Pesticides; data requirements for conventional chemicals, technical amendments, and data requirements for biochemical and microbial pesticides; final rules
    • U.S. Environmental Protection Agency (EPA)
    • U.S. Environmental Protection Agency (EPA). (2007b). Pesticides; data requirements for conventional chemicals, technical amendments, and data requirements for biochemical and microbial pesticides; final rules. 27 Fed. Regist. 60934.
    • (2007) Fed. Regist , vol.27 , pp. 60934
  • 74
    • 85054112412 scopus 로고    scopus 로고
    • Data requirements for antimicrobial pesticides; proposed rule
    • U.S. Environmental Protection Agency (EPA)
    • U.S. Environmental Protection Agency (EPA). (2008a). Data requirements for antimicrobial pesticides; proposed rule. 73 Fed. Regist. 59382.
    • (2008) Fed. Regist. , vol.73 , pp. 59382
  • 76
    • 75649124264 scopus 로고    scopus 로고
    • U.S. Environmental Protection Agency (EPA). U.S. EPA, Washington, DC. Available at Accessed March 15, 2010
    • U.S. Environmental Protection Agency (EPA). (2009). The U.S. Environmental Protection Agency's Strategic Plan for Evaluating the Toxicity of Chemicals. U.S. EPA, Washington, DC. Available at: http://www.epa.gov/osa/spc/toxicitytesting/docs/toxtest_strategy_032309. pdf. Accessed March 15, 2010.
    • (2009) The U.S. Environmental Protection Agency's Strategic Plan for Evaluating the Toxicity of Chemicals
  • 77
    • 85054117388 scopus 로고
    • U.S. Food and Drug Administration (FDA). Docket No. 86P-0224, 53 FR 39650. U.S. FDA, Rockville, MD
    • U.S. Food and Drug Administration (FDA). (1988). FDA Policy Statement on the LD50. Docket No. 86P-0224, 53 FR 39650. U.S. FDA, Rockville, MD.
    • (1988) 50
  • 78
    • 12444339321 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration (FDA). U.S. FDA, Rockville, MD. Available at Accessed March 15, 2010
    • U.S. Food and Drug Administration (FDA). (1996). Guidance for Industry: Single Dose Acute Toxicity Testing for Pharmaceuticals. U.S. FDA, Rockville, MD. Available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformati on/Guidances/ucm079270.pdf. Accessed March 15, 2010.
    • (1996) Guidance for Industry: Single Dose Acute Toxicity Testing for Pharmaceuticals
  • 79
    • 0042518159 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration (FDA). September 1999; Revised April 2002 Guidance for Industry. U.S. FDA, Rockville, MD. Available at Accessed March 15, 2010
    • U.S. Food and Drug Administration (FDA). (2002). Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations. September 1999; Revised April 2002 Guidance for Industry. U.S. FDA, Rockville, MD. Available at: http://www.fda.gov/Food/Guidance ComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPack aging/ucm081825.htm. Accessed March 15, 2010.
    • (2002) Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations
  • 80
    • 85054109956 scopus 로고    scopus 로고
    • U.S. Food and Drug Administration (FDA). U.S. FDA, Rockville, MD. Available at Accessed March 15, 2010
    • U.S. Food and Drug Administration (FDA). (2006). Summary Table of Recommended Toxicological Testing for Additives Used in Food June 2006 Guidance for Industry. U.S. FDA, Rockville, MD. Available at: http: //www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/Guidance Documents/FoodIngredientsandPackaging/ucm054658.htm. Accessed March 15, 2010.
    • (2006) Summary Table of Recommended Toxicological Testing for Additives Used in Food June 2006 Guidance for Industry
  • 82
    • 85054117785 scopus 로고    scopus 로고
    • Hazard communication; proposed rule
    • U.S. Occupational Safety and Health Administration (OSHA)
    • U.S. Occupational Safety and Health Administration (OSHA). (2009). Hazard communication; proposed rule. 74 Fed. Regist. 50280.
    • (2009) Fed. Regist. , vol.74 , pp. 50280
  • 83
    • 2342619321 scopus 로고    scopus 로고
    • World Health Organization (WHO). International Programme on Chemical Safety. WHO, Geneva, Switzerland. Available at Accessed March 15, 2010
    • World Health Organization (WHO). (2005). The WHO recommended classification of pesticides by hazard and guidelines to classification. International Programme on Chemical Safety. WHO, Geneva, Switzerland. Available at: http://www.who.int/ipcs/publications/pesticides_hazard_rev_3 .pdf. Accessed March 15, 2010.
    • (2005) The WHO recommended classification of pesticides by hazard and guidelines to classification
  • 86
    • 0019391510 scopus 로고
    • 50 test for the toxicological evaluation of chemical substances
    • Zbinden, G., and Flury-Roversi, M. (1981). Significance of the LD50 test for the toxicological evaluation of chemical substances. Arch. Toxicol. 47, 77-99.
    • (1981) Arch. Toxicol. , vol.47 , pp. 77-99
    • Zbinden, G.1    Flury-Roversi, M.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.