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Target Organs and Levels of Evidence for GMM-16

Toxicology and Carcinogenicity Study of Mixtures of 3′-Azido-3′-Deoxythymidine (AZT), Lamivudine (3TC), and Nevirapine (NVP) (CASRN 30516-87-1, 134678-17-4, 129618-40-2) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (In Utero and Postnatal Gavage Studies)

Chemical (Study Title)
CASRN
Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
3'-Azido-3'-deoxythymidine (AIDS)
30516-87-1
(AZT/3TC/NVP- L,M,H)
Pyrimidine nucleoside analog with antiviral activity used in the treatment of AIDS (Merck 1989)Gavage
AZT/3TC: 0, 240, or 150 mg/kg bw/day - AZT/3TC/NVP combo for P53 mice: AZT: 0, 80, 160, or 240 mg/kg bw/day; 3TC: 0, 50, 100, or 150 mg/kg bw/day; NVP 1-3: 0, 56, 112, or 168 mg/kg bw/day; 1/8 dose NVP PND 1-3 and 1/2 dose NVP PND 4-10
National Center for Toxicological Research

Levels of Evidence

Male Mice: Clear Evidence
TypeOrgan/Tissue (Lesion)
Neoplastic Lesions
  • Liver: hepatocellular adenoma 1/25, 7/25, 7/23, 9/23; hepatocellular adenoma or carcinoma 1/25, 9/25, 8/23, 10/23
  • Liver: hepatocellular adenoma 1/25, 9/25; hepatocellular adenoma or carcinoma 1/25, 10/25
May Have Been Related
  • All Organs: malignant lymphoma 1/25, 3/25
    Female Mice: Equivocal Evidence
    TypeOrgan/Tissue (Lesion)
    May Have Been Related
    • All Organs: malignant lymphoma 2/25, 2/25, 4/22, 4/25
    • All Organs: malignant lymphoma 2/25, 4/24
    • Mammary Gland: adenoacanthoma or adenocarcinoma 1/25, 4/25


    Chemical (Study Title)
    CASRN
    Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
    3'-Azido-3'-deoxythymidine (AIDS)
    30516-87-1
    02/00/2012Pyrimidine nucleoside analog with antiviral activity used in the treatment of AIDS (Merck 1989)Gavage
    AZT/3TC: 0, 240, or 150 mg/kg bw/day -- AZT/3TC/NVP combo for P53 mice: AZT: 0, 80, 160, or 240 mg/kg bw/day; 3TC: 0, 50, 100, or 150 mg/kg bw/day; NVP 1-3: 0, 56, 112, or 168 mg/kg bw/day; 1/8 dose NVP PND 1-3 and 1/2 dose NVP PND 4-10
    National Center for Toxicological Research

    Levels of Evidence

    Male Mice: Clear Evidence
    TypeOrgan/Tissue (Lesion)
    Neoplastic Lesions
    • Liver: hepatocellular adenoma 1/25, 8/23
    May Have Been Related
    • All Organs: malignant lymphoma 1/25, 3/24
    Female Mice: No Evidence


    Chemical (Study Title)
    CASRN
    Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
    3'-Azido-3'-deoxythymidine (AIDS)
    30516-87-1
    (NVP-H)
    02/00/2012Pyrimidine nucleoside analog with antiviral activity used in the treatment of AIDS (Merck 1989)Gavage
    AZT/3TC: 0, 240, or 150 mg/kg bw/day -AZT/3TC/NVP combo for P53 mice: AZT: 0, 80, 160, or 240 mg/kg bw/day; 3TC: 0, 50, 100, or 150 mg/kg bw/day; NVP 1-3: 0, 56, 112, or 168 mg/kg bw/day; 1/8 dose NVP PND 1-3 and 1/2 dose NVP PND 4-10
    National Center for Toxicological Research

    Levels of Evidence

    Male Mice: No Evidence
    Female Mice: Equivocal Evidence
    TypeOrgan/Tissue (Lesion)
    May Have Been Related
    • All Organs: malignant lymphoma 2/25, 5/25


    Chemical (Study Title)
    CASRN
    Peer Review DatePrimary UsesRoute/Exposure LevelsStudy Laboratory
    AZT+3TC+NVP combination
    AZT3TCCOMBO
    02/00/2012Special combination to study AIDS therapeuticsGavage
    25 animals/group; Dose combinations AZT, 3TC, NVP, AZT/3TC, AZT/3TC/NVP
    National Center for Toxicological Research

    Levels of Evidence