化學(xué)品毒性鑒定技術(shù)規(guī)范

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目 錄

一、總則………………………………………………………………………………3
二、試驗(yàn)方法
（一）第一階段試驗(yàn)…………………………………………………………………15
1、急性吸入毒性試驗(yàn) ……………………………………………………………16
2、急性經(jīng)皮毒性試驗(yàn)……………………………………………………………20
3、急性經(jīng)口毒性試驗(yàn) ……………………………………………………………23
4、急性眼刺激性/腐蝕性試驗(yàn)……………………………………………………26
5、皮膚刺激性/腐蝕性試驗(yàn)………………………………………………………32
6、皮膚變態(tài)反應(yīng)試驗(yàn)（皮膚致敏試驗(yàn)）………………………………………36
（二）第二階段試驗(yàn)………………………………………………………………54
1、鼠傷寒沙門氏菌回復(fù)突變?cè)囼?yàn)（Ames試驗(yàn)）………………………………55
2、體外哺乳動(dòng)物細(xì)胞染色體畸變?cè)囼?yàn)…………………………………………62
3、體內(nèi)哺乳動(dòng)物骨髓細(xì)胞染色體畸變?cè)囼?yàn)……………………………………68
4、體內(nèi)哺乳動(dòng)物骨髓嗜多染紅細(xì)胞微核試驗(yàn)…………………………………75
5、哺乳動(dòng)物精原細(xì)胞/初級(jí)精母細(xì)胞染色體畸變?cè)囼?yàn)，或…………………79
精子畸形試驗(yàn)…………………………………………………………………87
6、嚙齒類動(dòng)物顯性致死試驗(yàn)……………………………………………………90
7、免疫毒性評(píng)價(jià)試驗(yàn)方法………………………………………………………95
8、亞急性吸入（14/28天）毒性試驗(yàn)…………………………………………104
9、亞急性經(jīng)皮（21/28天）毒性試驗(yàn)…………………………………………110
10、亞急性經(jīng)口（28天）毒性試驗(yàn)……………………………………………115
（三）第三階段試驗(yàn)………………………………………………………………121
1、亞慢性吸入毒性試驗(yàn)…………………………………………………………122
2、亞慢性經(jīng)皮毒性試驗(yàn)…………………………………………………………126
3、亞慢性經(jīng)口毒性試驗(yàn)…………………………………………………………130
4、致畸試驗(yàn)………………………………………………………………………136
5、兩代繁殖毒性試驗(yàn)……………………………………………………………142
6、遲發(fā)性神經(jīng)毒性試驗(yàn)…………………………………………………………147
（四）第四階段試驗(yàn)………………………………………………………………153
1、慢性吸入毒性試驗(yàn)……………………………………………………………154
2、慢性經(jīng)皮毒性試驗(yàn)……………………………………………………………160
3、慢性經(jīng)口毒性試驗(yàn)……………………………………………………………166
4、致癌試驗(yàn)，或…………………………………………………………………172
慢性毒性/致癌性合并試驗(yàn) ………………………………………………180
5、毒物代謝動(dòng)力學(xué)試驗(yàn) ………………………………………………………189
6、接觸人群調(diào)查與觀察（參考國(guó)內(nèi)外有關(guān)專著或教科書）
（五）參考試驗(yàn)……………………………………………………………………196
1、皮膚變態(tài)反應(yīng)試驗(yàn)-局部淋巴結(jié)法…………………………………………197
2、大腸桿菌回復(fù)突變?cè)囼?yàn)………………………………………………………202
3、酵母菌基因突變?cè)囼?yàn)………………………………………………………210
4、體外哺乳動(dòng)物細(xì)胞正向基因突變?cè)囼?yàn)……………………………………214
5、果蠅伴性隱性致死試驗(yàn)………………………………………………………220
6、枯草桿菌基因重組試驗(yàn)………………………………………………………224
7、體外哺乳動(dòng)物細(xì)胞程序外DNA合成（UDS）試驗(yàn)……………………………232
8、體內(nèi)哺乳動(dòng)物外周血細(xì)胞微核試驗(yàn)…………………………………………238
9、體外哺乳動(dòng)物姊妹染色單體交換（SCE）試驗(yàn)………………………………244
10、體內(nèi)哺乳動(dòng)物骨髓細(xì)胞姊妹染色體交換（SCE）試驗(yàn)……………………250
11、繁殖/生長(zhǎng)發(fā)育毒性篩選試驗(yàn)………………………………………………256
12、亞急性毒性合并繁殖/發(fā)育毒性篩選試驗(yàn)…………………………………262
13、一代繁殖試驗(yàn)………………………………………………………………269
14、神經(jīng)毒性篩選組合試驗(yàn)……………………………………………………274

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