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第十一章 管理毒理学 PowerPoint PPT Presentation


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第十一章 管理毒理学. 概述. 在人类的生产和生活环境中存在着多种多样的化学物质,既有天然生成的,也有人工合成的。 据估计,目前常用的 7 万多种化学物质中约有 10% 左右为致突变物。 国际癌症研究机构 (IARC) 颁布的文集中确定约有 105 种 ( 至 2008 年 ) 化学毒物或生产过程对人类有致癌性。. 对特定化学物质产生毒害的可能性 作出准确的评价,在此基础上制定相关的法律、法规、标准和条例,作为国家行政部门监督执法的依据 , 对化学品实施有效的管理以保护人民的身体健康和生产生活环境,显得十分重要。为适应此种需要,管理毒理学应运而生并迅速地发展起来。.

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第十一章 管理毒理学

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710%(IARC)105(2008)


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(regulatory toxicology)


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:

:[(good laboratory practiceGLP)]


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1987IARC50

199560

199975

200288

200497

2007102

2008105,


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NOAEL(safety factor,SF)NOAEL(acceptable daily intake,ADI)


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1976(Environmental Protection Agency, EPA)

1983(National Research councilNRC)-


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EPA


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1toxicity

2risk

3 (safety)


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4acceptable risk:

5(virtual safe dose,VSD)


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11-1 10-6

(1.4/d)

(0.5l/d)

(lh/d)

24Okm

9600km

2


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6(risk assessment)

VSD


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-


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()

(hazard identification)

;;


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1

1


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-(structure-activity relationshipSAR)

N-


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2


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3


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:


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2

1


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2

-

IARC 2BEPACEPAIARC or EPA


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-

doseresponse assessmentquantitative risk assessment

:(criteria)


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1

NOAELLOAEL


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1reference doseRfDRfDADIRfDmg(kgd

2uncertainty factorUFSFRfDNOAELLOAEL

3RfD

NOAELLOAEL

NOAELLOAELUFUFsMF

:RfD=NOAELLOAEL/UfsMF


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UFs:

1)10

2)10

3)10

4)LOAELNOAFTRfD10

5)()10


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MF<10UFSMF1


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101,000,000100

EPARfDUFs21000UFsRfD


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4benchmark doseBMD

BMD951%5%10%

RfD:

RfD = BMD / UFs MF

-


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BMD95%()BMD

NOAELBMD

BMD


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2-


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-


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(1)(Probability distribution models):(Probit model)LogisticWeibull

(2)(mechanistic models):

(one-hit model)

(multi-hit model)

(linear multi-stage model)


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(3)(Physiologically based toxicokinetic model,PB-TK):()


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(4)-(biologically based dose-response modelBBDR):


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()

exposure assessment


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risk characterization


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1


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2


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120

2500107

31000,


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(toxicological safety evaluation)


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NOAELLOAEL-NOAELLOAEL


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18

20

FDA 1979

OECD 1982


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80

11994.8.10 832003

21995.8.17 91

31994. 85

41987.5.28

51993.5 ()

61987

1999.3

(8) 2003.

92000.


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1

2

3 GLP

4

5


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()

1

2

3


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1

2


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3

4

(1)

(2)

(3)

(4)


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()

1. LD50LC50


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2.

:


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Ames


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3.

LOAELNOAEL

-


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4.

NOAELLOAEL


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()


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1

2

3

4

5


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GLP and SOP

GLP:GLP


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(standard operation procedureSOP)SOP


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2

3

4

5


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