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動物実験の3Rにおける国内外の動向

参考文献

1) 動物の愛護及び管理に関する法律(2010)
Available at: http://www.env.go.jp/nature/dobutsu/aigo/amend_law2/law.pdf

2) 実験動物の飼養及び保管並びに苦痛軽減に関する基準(2006)
Available at: http://www.env.go.jp/nature/dobutsu/aigo/law_series/nt_h180428_88.html

3) 動物の愛護及び管理に関する施策を総合的に推進するための基本的な指針(2006)
Available at: http://www.env.go.jp/nature/dobutsu/aigo/2_data/laws/guideline_h181031.pdf

4) 文部科学省 研究機関等における動物実験等の実施に関する基本指針(2010)
Available at: http://www.mext.go.jp/b_menu/hakusho/nc/06060904.htm

5) 厚生労働省 厚生労働省の所管する実施機関における動物実験等の実施に関する基本指針(2010)
Available at: http://www.mhlw.go.jp/general/seido/kousei/i-kenkyu/doubutsu/0606sisin.html

6) 農林水産省 農林水産省の所管する研究機関等における動物実験等の実施に関する基本指針(2010)
Available at: http://www.maff.go.jp/www/press/2006/20060601press_2b.pdf

7) 日本学術会議 動物実験の適正な実施に向けたガイドライン(2010)
Available at: http://www.scj.go.jp/ja/info/kohyo/pdf/kohyo-20-k16-2.pdf

8) 重茂浩美, “動物実験に関する近年の動向、科学技術動向”, 2006, 10-20.

9) 中央環境審議会動物愛護部会(2010)
Available at: http://www.env.go.jp/council/14animal/yoshi14.html

10)鍵山直子,“動物愛護管理法における3R原則の明文化と実験動物の適正な飼養保管”,日獣会誌,2010, 395-398.

11)AAALAC International Association(2010)
Available at: http://www.aaalac.org/

12)佐々木弥生(2008)
Available at: http://www.soc.nii.ac.jp/jsaae/WC6_followup/WC6_Follow_Sasaki.pdf

13)大学法人動物実験施設協議会(2010)
Available at: http://www.kokudou-kyou.org/annai/

14)日本動物実験協同組合(2010)
Available at: http://www.labanimal.org/freme.html

15)United Kingdom Protection of Animals Act(2000)
Available at: http://www.veggieglobal.com/protection-of-animals-act-uk.htm#2000

16)Update on the revision of EU lab animallaws(2010)
Available at: http://www.rspca.org.uk/ImageLocator/LocateAsset?asset=document&assetId=1232720902775&mode=prd

17)Commission Staff Working Documents; Time Tables for the phasing-out of animal testing in the framework of the 7th Amendment to the Cosmetics Directive (Council Directive 76/768/EEC); EN, SEC82004) 1210 (2004).

18)ECH(2008)
Available at: http://ec.europa.eu/echa/home_en.html

19)COLIPA(2010)
Available at: http://www.colipa.eu/about-colipa-the-european-cosmetic-cosmetics-association.html

20)ECVAM(2010)
Available at: http://ecvam.jrc.ec.europa.eu/

21)T.Hartung,(2006)
Available at: http://wwwsoc.nii.ac.jp/jsaae/20kai.html

22)JRC(2010)
Available at: http://www.vet.uu.nl/nca/userfiles/other/REACH and the need for intelligent testing strategies.pdf#search
=’Integrated%20Testing%20Strategies%20REACH'

23)OECD(2010)
Available at: http://www.oecd.org/document/55/0,3343,en_2649_34377_2349687_1_1_1_1,00.html

24)Animal Welfare Act,
Available at: http://awic.nal.usda.gov/nal_display/index.php?info_center=3&tax_level=3&tax_subject=182&topic_id=1118&
level3_id=6735&level4_id=0&level5_id=0&placement_default=0

25)Health Research Extension Act,
Available at: http://grants.nih.gov/grants/olaw/references/hrea1985.htm

26)ILRA(2010)
Available at: http://dels.nas.edu/ilar/

27)OIE(2010)
Available at: http://www.oie.int/eng/bien_etre/en_introduction.htm

28)Y. Ohno, ILAR Journal, 2002, 43, s95-98.

29)厚生労働省(2010)
Available at: http://www.mhlw.go.jp/houdou/2008/08/h0814-1.html

30)OECD(2005)OECD Series on testing and assessment Number 34, Guidance document on the validation and international acceptance of new or updated test methods for hazard assessment, ENJ/JM/MONO(2005)14

31)ICCVAM (1997) Validation and regulatory acceptance of toxicological test methods: a report of the ad hoc Interagency Coordinating Committee on the Validation of Alternative Methods. NIH Publication No:
97-3981, 1997, National Institute of Environmental Health Sciences (NIEHS)

32)ICCVAM(2010)
Available at: http://iccvam.niehs.nih.gov/docs/ocutox_docs/EPreport/ocu_report.htm

33)KoCVAM(2010)
Available at: http://www.nifds.go.kr/nitr/contents/m91100/view.do

34)O. A. Presgrave, Altern Lab Anim., 2008, 36(6), 705-8.

35)ICATM (2010)
Available at: http://iccvam.niehs.nih.gov/about/icatm.htm

36)Alternative Research & Development Foundation(2010)
Available at: http://www.ardf-online.org/

37)CAAT(2010)
Available at: http://caat.jhsph.edu/

38)FRAME(2010)
Available at: http://www.frame.org.uk/

39)NCA(2010)
Available at: http://www.nca-nl.org/

40)NC3R(2010)
Available at: http://www.nc3rs.org.uk/

41)ZEBET(2010)
Available at: http://www.bfr.bund.de/cd/1591

42)EPAA(2010)
Available at: http://ec.europa.eu/enterprise/epaa/index_en.htm

43)OECD(2004) Test Guideline NO. 432: in vitro 3T3 NRU phototoxicity testing. OECD Guideleine for the Testing of Chemicals. Paris, France.

44)OECD(2004) Test Guideline No. 430: In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER), OECD Guideleine for theTesting of Chemicals. Paris, France.

45)OECD(2004) Test Guideline No.431: In Vitro Skin Corrosion: Human Skin Model Test, OECD Guideleine for the Testing of Chemicals. Paris, France.

46)OECD(2006) Test Guideline No.435: InVitro Membrane Barrier Test Method for Skin Corrosion, OECD Guideleine for the Testing of Chemicals. Paris, France.

47)ECVAM(2007) Statement on the validity of in-vitro tests for skin irritation, issued by the ECVAM Scientific Advisory Committee (ESAC26), 27 April 2007.
Available at: http://ecvam.jrc.ec.europa.eu/

48)ECVAM(2008) Statement on the scientific validity of in-vitro tests for skin irritation testing, issued by the ECVAM Scientific Advisory Committee (ESAC29), 5 November 2008.
Available at: http://ecvam.jrc.ec.europa.eu/

49)OECD(2010) Test Guideline No.439: In Vitro Skin Irritation Reconstructed Human Epidermis Test Method, OECD Guideleine for the Testing of Chemicals. Paris, France.

50)ICCVAM(2010)
Available at: http://iccvam.niehs.nih.gov/methods/ocutox/ocutox.htm

51) ESAC(2009) Statement on the Conclusions of the ICCVAM Retrospective Study on Organotypic In Vitro Assays as Screening Tests to Identify Potential Ocular Corrosives and Severe Irritants.

52)OECD(2010) Test Guideline No.437: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants, OECD Guideleine for the Testing of Chemicals. Paris, France.

53)OECD(2010) Test Guideline No.438: Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants, OECD Guideleine for the Testing of Chemicals. Paris, France.

54)ESAC(2009) ESAC statement on the scientific validity of two in vitro eye irritation test methods.

55)ICCVAM(2010)
Available at: http://iccvam.niehs.nih.gov/methods/acutetox/acutetox.htm

56)OECD(2010) No129: Guidance Document on using Cytotoxicity Tests to Estimate Starting Doses for Acute Oral Systemic Toxicity Tests, OECD Guideleine for the Testing of Chemicals. Paris, France.

57)G. F. Gerberic, J. D. Vassallo, R. E. Bailey, J. G. Chaney, S. W. Morral and J. P. Lepoittevin, Toxicol. Science, 2004, 81, 332-343.

58)T. Ashikaga, Y. Yoshida, M. Hirota, K. Yoneyama, H. Itagaki, H. Sakaguchi, M. Miyazawa, Y. Ito, H. Suzuki and Toyoda, Toxicol in Vitro, 2006, 767-773.

59)H. Sakaguchi, T. Ashikaga, M. Miyazawa, Y. Yoshida, Y. Ito, K. Yoneyama, M. Hirota, H. Itagaki, H. Toyoda and H. Suzuki, Toxicol in Vitro, 2006, 774-784.

60)P. Aeby, T. Ashikaga, S. Bessou-Touya, A. Schepky, F. Gerberick, P. Kern, M. Marrec-Fairley, G. Maxwell, J. M. Ovigne, H. Sakaguchi, K. Reisinger, M. Tailhardat, S. Martinozzi-Teissier and P. Winkler, Toxicol in Vitro, 2010, 24(6), 1465-73.

61)OECD(2009) Test Guideline Test No.455: The Stably Transfected Human Estrogen Receptor-alpha Transcriptional Activation Assay for Detection of Estrogenic Agonist-Activity of Chemicals, OECD Guideleine for the Testing of Chemicals. Paris, France.

62)HumaneSocietyInternational(2010)
Available at: http://www.hsi.org.au/

63)AXLR8(2010)
Available at: http://www.axlr8.eu/workshops/

64)National Research Council(2007)Toxicity Testing in the 21st century, A vision and astrategy, The National Acadamies Press, Washington, D. C., USA

65)A National Toxicology Program for the 21st century (2010)
Available at: http://ntp.niehs.nih.gov/files/NTPrdmp.pdf

66)Tox Cast(2010)
Available at: http://www.epa.gov/ncct/toxcast/summit.html

67)日本動物実験代替法学会(2010)
Available at: http://www.asas.or.jp/jsaae/

68)小島肇夫,LABIO21, 2009, 38, 17-20.

69)Proceedings of 6th World Congresson Alternatives & Animal Use in the Life Sciences, Altern. Animal Test. EXperiment, 2008, 14, Special Issue.

70)WC6フォローアップシンポジウム「3Rsに基づく動物実験の規制と第三者認証」抄録集(2008).

71)大野泰雄,国立衛研報,2004, 122, 1-10.

72)小島肇夫,化粧品技術者会誌,2006, 40(4), 263-268.

73)小島肇夫,薬学雑誌,2008, 128(5), 747-752.

74)小島肇夫,コスメティックステージ,2010, 4(5), 56-61.

75)JaCVAM(2010)
Available at: http://jacvam.jp/

76)JaCVAM提案書(2008)腐食性試験代替法:「3次元培養ヒト皮膚モデル(Vitrolife-skinTM)を用いた腐食性試験」.

77)JaCVAM提案書(2009)皮膚刺激性試験代替法:「ヒト皮膚モデル(三次元皮膚EPISKIN)を用いた皮膚刺激性試験代替法」.

78)M. Katoh, F. Hamajima, T. Ogasawara and K. I. Hata, Journal of Toxicological Science, 2009, 34(3), 327-334.

79)Y. Ohno, etal., Toxicology in Vitro, 1999, 13, 73-98.

80)大野泰雄他, Altern. Animal Test. EXperiment, 2005, 10 (2), 54-157.

81)Y. Takahashi, M. Koike, H. Honda, Y. Ito, H. Sakaguchi, H. Suzuki and N. Nishiyama,(2008)Toxicology in Vitro, 2008, 22, 760-770.

82)K. Yamashita, K. Idehara, N. Fukuda, M. Yamagishi and N. Kawada, Altern. Animal Test. EXperiment, 2005, 11 (2), 136-144.

83)M. Takeyoshi, K. Yamasaki, Y. Yakabe and I. Kimber, Toxicol. Lett., 2001, 119, 203-208.

84)JaCVAM提案書(2008)皮膚感作性試験代替法:「皮膚感作性試験代替法 (LLNA-DA法)」

85)JaCVAM提案書(2009)皮膚感作性試験代替法:「皮膚感作性試験代替法 (LLNA-BrdU)」

86)OECD(2010) Test Guideline Test No.442A : Skin Sensitization Local Lymph Node Assay: DA, OECD Guideleine for the Testing of Chemicals. Paris, France.

87)OECD(2010)Test Guideline Test No. Test No. 442B: Skin Sensitization Local Lymph Node Assay: BrdU-ELISA, OECD Guideleine for the Testing of Chemicals. Paris, France.

88)S. Onoue, N. Igarashi, Y. Yamauchi, S. Yamada and Y. Tsuda, Journal of Pharmaceutical and Biomedical Analysis, 2008, 46 (1), 187-93.

89)M. Sugiyama, H. Itagaki, T. Hariya, N. Murakami and S. Kato, Altern. Animal Test. EXperiment, 1994, 2, 183-191.

90)M. Sugiyama, H. Itagaki and S. Kato, (1994)Altern. Animal Test. EXperiment, 1994, 2, 193-202.

91)M. Mori, M. Hoya, M. Sugiyama and H. Itagaki, Altern. Animal Test. EXperiment, 2003, 10 (1), 1-17.

92)JaCVAM評価報告書(2010)光毒性試験代替法:「酵母光生育阻害試験と赤血球光溶血性試験の組み合わせによる光毒性試験代替法」.

93)R. R. Tice, E. Agurell, D. Anderson, B. Burlinson, A. Hartmann, H. Kobayashi, Y. Miyamae, E. Rojas, J. C. Ryu, Y. F. Sasaki, Environ Mol Mutagen., 2000, 35 (3), 206-21.

94)A. Sakai, C. Suzuki, Y. Masui, A. Kuramashi, K. Takatori and N. Tanaka, Mutat Res., 2007, 630 (1-2), 103-11.

95)柘植英哉,森充生,大庭澄明,大内正,寺田三郎,五島隆志,田邊豊重,山影康次,田中憲穂,渡辺美香,畔上二郎,大向英夫,小島肇,医薬品医療機器レギュラトリーサイエンス, 2011.

96)厚生省薬務局医療機器開発課監修,“医療用具および医用材料の基礎的な生物学的試験のガイドライン解説”,薬事日報社,東京, 1996.

97)Bacterial Endotoxicin, European Pharmacopoeia 5.0, 2005, 161-168.

98)ICCVAM(2010)
Available at: http://iccvam.niehs.nih.gov/methods/pyrogen/pyrogen.htm

99)JaCVAM評価報告書(2010) in vitro 発熱性物質試験.

 

 

 

 

 

 

 

 

 

 

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