Genotoxicity: Hauv kev sim tshuaj hauv cov vitro xws li Ames kuaj, Escherichia coli kuaj thiab CHO-K1 tshuaj ntsuam hloov, tsis muaj kev hloov pauv hauv cov khoom no. Hauv tib neeg lymphocyte chromosome aberration thiab nas micronucleus kuaj, kuj tsis pom cov khoom no yog inducing fission effect.
Cov tshuaj tiv thaiv kev ua me nyuam yaus: Kev kawm txog cov kev cuam tshuam ntawm cov khoom no ntawm kev muaj me nyuam tsis tau nqa tawm, tab sis lub sijhawm ntev ntawm cov khoom no ntau dua los yog sib npaug li 1mg / kg / hnub (nws cov ntshav Cssmax thiab AUC0-24h yog 19 lub sijhawm thiab 9 zaug ntawm lub sijhawm siab dua li cov hauv kev noj qab haus huv tom qab), thiab ovarian hypertrophy thiab follicular cysts pom. Tsis tas li ntawd, tus poj niam canine ncua ntev lub sijhawm ntawm cov khoom no ntau dua los yog sib npaug li 1mg / kg / hnub (nws cov ntshav Cssmax thiab AUC0-24h feem ntau dua li cov neeg noj qab nyob zoo tom qab tau txais kev pom zoo ntawm 22 zaug thiab 16 zaug zaus) siab tshaj qhov), pom ntawm uterine hyperplasia. Nws tsis paub meej txog qhov cuam tshuam ntawm kev ua me nyuam tsiaj plab hnyuv siab raum cuam tshuam txog kev puas tsuaj ntawm tib neeg kev xeeb tub.
Cov poj niam cev xeeb tub noj cov khoom no tuaj yeem ua rau embryo toxicity. Cov nas thiab luav tau muab 0.1 mg / kg (los ntawm thaj chaw thaj tsam ntawm lub cev) ntawm lub qhov ncauj ntawm cov khoom, uas yog kwv yees li 3/4 thiab 1.5 npaug ntawm cov koob tshuaj pom zoo, feem, pom tias cov khoom no tuaj yeem nkag rau hauv qhov chaw tiv thaiv kab mob. Cov nas tsuag thiab luav tau muab cov khoom no hauv cov txheej txheem hauv nruab nrog cev, thiab ntau npaum li cas yog ntau dua lossis sib npaug ntawm 0.1 thiab 0.02 mg / kg / Hnub (txhais los ntawm lub cev sab hauv cheeb tsam), thaum kwv yees li 3/4 thiab 1/3 ntawm cov koob tshuaj pom zoo muaj sib npaug rau hauv cov chaw kho mob, qhov feem pua ntawm cev xeeb tub tau nce (qhov nce ntawm qhov poob ntawm lub cev thiab tom qab cog qhov txhab, kev nqus ntawm lub cev muaj zog, qhov muaj neeg nyob tsawg), thiab kev noj tshuaj tso siab los ntawm cov nas cov teebmeem. Qhov hnyav ntawm placenta nce ntau heev thaum qhov ntsuas ntawm 0.1 yog mg / kg / hnub lossis siab dua hauv nas. Cov koob tshuaj nas tau nce mus txog 1 mg / kg / hnub (nws lub plasma Cssmax thiab AUC0-24h yog 19 zaug thiab 9 lub sijhawm siab dua qhov kev pom zoo ntawm cov neeg noj qab nyob zoo), thiab cov embryo toxicity tau pom. Nrog rau kev txhim kho lub embryo qeeb (xws li: ua tsis tiav ossification thiab kev loj hlob ntawm lub cev hauv plab lub cev hnyav), cov nas nyob hauv qhov ntau npaum ntawm cov tshuaj tsis tshwm sim teratogenic. Cov luav muab cov tshuaj no ntau dua los yog sib npaug rau 1.0 mg / kg / Hnub (txhais los ntawm thaj chaw hauv lub cev, kwv yees li 16 npaug npaug tshaj qhov sib npaug ntawm cov koob tshuaj uas pom zoo), tuaj yeem ua rau kev xeeb tub tsis taus. Cov kab mob luav tau nce mus txog 0.2mg / kg / hnub (txhais los ntawm thaj chaw hauv lub cev, kwv yees li 3 zaug ntawm qhov sib npaug ntawm cov chaw txhaj tshuaj pom zoo), tsis muaj teratogenic pom. Tsis muaj kev kawm txaus thiab kev tswj hwm nruj txog kev siv tshuaj rau cov poj niam cev xeeb tub, yog tias siv cov khoom no thaum cev xeeb tub lossis thaum siv cov tshuaj no cev xeeb tub, tus neeg mob yuav tsum paub txog qhov muaj peev xwm ntawm cov tshuaj rau cov menyuam hauv plab thiab kev pheej hmoo. ntawm rho menyuam.
Cov khoom no tsis meej nyob rau hauv tib neeg cov kua mis, vim tias ntau yam tshuaj muaj peev xwm ua rau tib neeg cov kua mis, cov niam mis rau menyuam noj yuav tsum ceev faj txog cov khoom no.
Carcinogenicity: Tsis muaj lub sij hawm ntev kev tshawb nrhiav tshuaj lom carcinogenic cov ntaub ntawv tshawb fawb ntawm cov tsiaj.
