메뉴 건너뛰기




Volumn 28, Issue 2, 2011, Pages 95-102

Examining the regulatory value of multi-route mammalian acute systemic toxicity studies

Author keywords

Dermal toxicity; Intelligent testing; Redundancy; Regulatory classification

Indexed keywords

INDUSTRIAL CHEMICAL; PESTICIDE;

EID: 80052882168     PISSN: 09467785     EISSN: None     Source Type: Journal    
DOI: 10.14573/altex.2011.2.095     Document Type: Article
Times cited : (17)

References (30)
  • 1
    • 0025773702 scopus 로고
    • Why modification of the LD50 will not be enough
    • Balls, M. (1991). Why modification of the LD50 will not be enough. Lab. Anim. 25, 198-206.
    • (1991) Lab. Anim. , vol.25 , pp. 198-206
    • Balls, M.1
  • 3
    • 73649130953 scopus 로고    scopus 로고
    • Acute toxicity testing of chemicals: Opportunities to avoid redundant testing and use alternative approaches
    • Creton, S., Dewhurst, I. C., Earl, L. K. et al. (2010). Acute toxicity testing of chemicals: opportunities to avoid redundant testing and use alternative approaches. Crit. Rev. Toxicol. 40, 50-83.
    • (2010) Crit. Rev. Toxicol. , vol.40 , pp. 50-83
    • Creton, S.1    Dewhurst, I.C.2    Earl, L.K.3
  • 10
    • 80053538382 scopus 로고    scopus 로고
    • Washington, DC: US EPA. (accessed 06.06.10)
    • EPA (2007). Label Review Manual, Chapter 7: Precautionary Statements. Washington, DC: US EPA. http://www.epa.gov/oppfead1/labeling/lrm/chap-07.pdf (accessed 06.06.10).
    • (2007) Label Review Manual, Chapter 7: Precautionary Statements
  • 11
    • 80053533241 scopus 로고    scopus 로고
    • Washington, DC: US EPA. (accessed 06.06.10)
    • EPA (2009). Fact sheets on new active ingredients. Washington, DC: US EPA. http://www.epa.gov/opprd001/factsheets (accessed 06.06.10).
    • (2009) Fact Sheets on New Active Ingredients
  • 12
    • 80053480533 scopus 로고    scopus 로고
    • Washington, DC: US EPA. (accessed 06.06.10)
    • EPA (2010). Pesticide reregistration status and decision documents. Washington, DC: US EPA. http://www.epa.gov/pesticides/reregistration/status.htm (accessed 06.06.10).
    • (2010) Pesticide Reregistration Status and Decision Documents
  • 13
    • 80053501641 scopus 로고    scopus 로고
    • International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (accessed 06.06.10)
    • ICH - International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2009). Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals - M3(R2). http://www.ich.org/ fileadmin/Public-Web-Site/ICH-Products/Guidelines/Safety/M3-R2/Step4/ M3-R2--Guideline.pdf (accessed 06.06.10).
    • (2009) Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals - M3(R2)
  • 14
    • 73649117097 scopus 로고    scopus 로고
    • Classification and labelling of new industrial chemicals for acute toxicity, skin and eye irritation
    • (abstract). In: Proceedings of the British Toxicology Society Annual Congress, University of Surrey, Guildford, 19-22 April 1998
    • Indans, I., Fry, T., Parsons, P. et al. (1998). Classification and labelling of new industrial chemicals for acute toxicity, skin and eye irritation (abstract). In: Proceedings of the British Toxicology Society Annual Congress, University of Surrey, Guildford, 19-22 April 1998. Hum. Exp. Toxicol. 17, 469-534.
    • (1998) Hum. Exp. Toxicol. , vol.17 , pp. 469-534
    • Indans, I.1    Fry, T.2    Parsons, P.3
  • 15
    • 80053508803 scopus 로고    scopus 로고
    • accessed 06.06.10
    • IPCS - International Programme on Chemical Safety (2009). INCHEM database. http://www.inchem.org (accessed 06.06.10).
    • (2009) INCHEM Database
  • 18
    • 0003188912 scopus 로고
    • Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances
    • Brussels: European Union
    • OJ - Official Journal of the European Communities (1967). Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances (1-98). Brussels: European Union.
    • (1967) OJ - Official Journal of the European Communities , pp. 1-98
  • 19
    • 0001748577 scopus 로고
    • Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes
    • Brussels: European Union
    • OJ (1986). Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes (1-28). Brussels: European Union.
    • (1986) OJ , pp. 1-28
  • 20
    • 0042554535 scopus 로고    scopus 로고
    • Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labeling of dangerous preparations
    • Brussels: European Union
    • OJ (1999). Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labeling of dangerous preparations (1-68). Brussels: European Union.
    • (1999) OJ , pp. 1-68
  • 21
    • 84866365043 scopus 로고    scopus 로고
    • Regulation (EC) No. 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)
    • Brussels: European Union
    • OJ (2007). Regulation (EC) No. 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) (1-849). Brussels: European Union.
    • (2007) OJ , pp. 1-849
  • 22
    • 80053475785 scopus 로고    scopus 로고
    • Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures
    • Brussels: European Union
    • OJ (2008). Regulation (EC) No. 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (1-355). Brussels: European Union.
    • (2008) OJ , pp. 1-355
  • 23
    • 80053487734 scopus 로고    scopus 로고
    • OSHA - United States Occupational Safety and Health Administration Washington, DC: Federal Register
    • OSHA - United States Occupational Safety and Health Administration (2009). Hazard communication; proposed rule (50280-50549). Washington, DC: Federal Register.
    • (2009) Hazard Communication; Proposed Rule , pp. 50280-50549
  • 25
    • 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. 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
  • 26
    • 0003915885 scopus 로고
    • London: Methuen & Co. Ltd. Reissued: Universities Federation for Animal Welfare, Herts, England
    • Russell, W. M. S. and Burch, R. L. (1959). The principles of humane experimental technique. London: Methuen & Co. Ltd. (Reissued: 1992, Universities Federation for Animal Welfare, Herts, England).
    • (1959) The Principles of Humane Experimental Technique
    • Russell, W.M.S.1    Burch, R.L.2
  • 27
    • 77955168444 scopus 로고    scopus 로고
    • Cross-sector review of drivers and available 3Rs approaches for acute systemic toxicity testing
    • Seidle, T., Robinson, S., Holmes, T. et al. (2010). Cross-sector review of drivers and available 3Rs approaches for acute systemic toxicity testing. Tox. Sci. 16, 382-396.
    • (2010) Tox. Sci. , vol.16 , pp. 382-396
    • Seidle, T.1    Robinson, S.2    Holmes, T.3
  • 28
    • 55549102468 scopus 로고    scopus 로고
    • What does a dermal acute toxicity study add to the information on a plant protection pesticide?
    • Thomas, H. D. and Dewhurst, I. C. (2007). What does a dermal acute toxicity study add to the information on a plant protection pesticide? Toxicol. 231, 104-119.
    • (2007) Toxicol. , vol.231 , pp. 104-119
    • Thomas, H.D.1    Dewhurst, I.C.2
  • 29
    • 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


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.