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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)



(regulatory toxicology)


:

:[(good laboratory practiceGLP)]


1987IARC50

199560

199975

200288

200497

2007102

2008105,





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



1976(Environmental Protection Agency, EPA)

1983(National Research councilNRC)-


EPA


1toxicity

2risk

3 (safety)



4acceptable risk:

5(virtual safe dose,VSD)


11-1 10-6

(1.4/d)

(0.5l/d)

(lh/d)

24Okm

9600km

2


6(risk assessment)

VSD


-


()

(hazard identification)

;;


1

1


-(structure-activity relationshipSAR)

N-


2





3


:



2

1



2

-

IARC 2BEPACEPAIARC or EPA


-

doseresponse assessmentquantitative risk assessment

:(criteria)


1

NOAELLOAEL


1reference doseRfDRfDADIRfDmg(kgd

2uncertainty factorUFSFRfDNOAELLOAEL

3RfD

NOAELLOAEL

NOAELLOAELUFUFsMF

:RfD=NOAELLOAEL/UfsMF


UFs:

1)10

2)10

3)10

4)LOAELNOAFTRfD10

5)()10


MF<10UFSMF1


101,000,000100

EPARfDUFs21000UFsRfD


4benchmark doseBMD

BMD951%5%10%

RfD:

RfD = BMD / UFs MF

-


BMD95%()BMD

NOAELBMD

BMD


2-


-


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

(2)(mechanistic models):

(one-hit model)

(multi-hit model)

(linear multi-stage model)


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


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


()

exposure assessment





risk characterization


1


2








120

2500107

31000,


(toxicological safety evaluation)


NOAELLOAEL-NOAELLOAEL


18

20

FDA 1979

OECD 1982


80

11994.8.10 832003

21995.8.17 91

31994. 85

41987.5.28

51993.5 ()

61987

1999.3

(8) 2003.

92000.



1

2

3 GLP

4

5


()

1

2

3


1

2


3

4

(1)

(2)

(3)

(4)


()

1. LD50LC50


2.

:


Ames


3.

LOAELNOAEL

-


4.

NOAELLOAEL


()


1

2

3

4

5



GLP and SOP

GLP:GLP


(standard operation procedureSOP)SOP


1

2

3

4

5


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