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Testing Status of 3'-Azido-3'-deoxythymidine (AIDS) M88195

 

CASRN: 30516-87-1

Formula: C10-H13-N5-O4

Synonyms/Common Names

  • Azidothymidine
  • AZT (AIDS initiative)
  • Retrovir
  • Zidovudina

Short-Term Toxicity

  • 13 weeks (Gavage)  (C88072)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: DOSES GIVEN twice a day AT 9AM & 3PM--R: 0, 125, 250, 500, OR 1000; M: 0, 25, 50, 100, 400, OR 1000 MG/KG.

Long-Term Carcinogenicity

  • 2 years (Gavage)  (C20309B)   
    • AZT/3TC
    • TR-569 (NIH Number: 11-5911)  (Peer Review Approval 04/05/2011A )
      Toxicology and Carcinogenesis Studies of Mixtures of 3'-Azido-3'-Deoxythymidine (AZT), Lamivudine (3TC), Nevirapine (NVP), and Nelfinavir Mesylate (NFV) (CASRNs 30516-87-1, 134678-17-4, 129618-40-2, 159989-65-8) in B6C3F1 Mice (Transplacental Exposure Studies)
    • Mice: B6C3F1/NCTR BR (C57BL/6N x C3H/HEN MTV-)
    • Carcinogenesis Results
      • Male Mice No Evidence 
      • Female Mice Equivocal Evidence 
    • Dose: 0, 80/40, 160/80, or 240/120 mg/kg.
  • 2 years (Gavage)  (C20309C)   
    • AZT/3TC/NVP
    • TR-569 (NIH Number: 11-5911)  (Peer Review Approval 04/05/2011A )
      Toxicology and Carcinogenesis Studies of Mixtures of 3'-Azido-3'-Deoxythymidine (AZT), Lamivudine (3TC), Nevirapine (NVP), and Nelfinavir Mesylate (NFV) (CASRNs 30516-87-1, 134678-17-4, 129618-40-2, 159989-65-8) in B6C3F1 Mice (Transplacental Exposure Studies)
    • Mice: B6C3F1/NCTR BR (C57BL/6N x C3H/HEN MTV-)
    • Carcinogenesis Results
      • Male Mice Some Evidence 
      • Female Mice Equivocal Evidence 
    • Dose: 0, 80/40/56, 160/80/112, or 240/120/168 mg/kg.
  • 2 years (Gavage)  (C20309D)   
    • AZT/3TC/NFV
    • TR-569 (NIH Number: 11-5911)  (Peer Review Approval 04/05/2011A )
      Toxicology and Carcinogenesis Studies of Mixtures of 3'-Azido-3'-Deoxythymidine (AZT), Lamivudine (3TC), Nevirapine (NVP), and Nelfinavir Mesylate (NFV) (CASRNs 30516-87-1, 134678-17-4, 129618-40-2, 159989-65-8) in B6C3F1 Mice (Transplacental Exposure Studies)
    • Mice: B6C3F1/NCTR BR (C57BL/6N x C3H/HEN MTV-)
    • Carcinogenesis Results
      • Male Mice No Evidence 
      • Female Mice No Evidence 
    • Dose: 0, 80/40/336, 160/80/672, or 240/120/1, 008 mg/kg.
  • 2 years (Gavage)  (C20309)  Completed 
    • AZT
    • TR-569 (NIH Number: 11-5911)  (Peer Review Approval 04/05/2011A )
      Toxicology and Carcinogenesis Studies of Mixtures of 3'-Azido-3'-Deoxythymidine (AZT), Lamivudine (3TC), Nevirapine (NVP), and Nelfinavir Mesylate (NFV) (CASRNs 30516-87-1, 134678-17-4, 129618-40-2, 159989-65-8) in B6C3F1 Mice (Transplacental Exposure Studies)
    • Mice: B6C3F1; Mice: B6C3F1/NCTR BR (C57BL/6N x C3H/HEN MTV-)
    • Carcinogenesis Results
      • Male Mice No Evidence 
      • Female Mice Equivocal Evidence AZT
    • Dose: Dosed: GD 12-18 -- 1) AZT 80 mg/kg + 3TC 40 mg/kg; 2) AZT 160 mg/kg + 3TC 80 mg/kg; 3) AZT 240 mg/kg + 3TC 120 mg/kg + 168 mg/kg NVP; 4) AZT 80 mg/kg + 3TC 40 mg/kg + 336 mg/kg NVP; 5) AZT 160 mg/kg + 3TC 80 mg/kg + 672 mg/kg NVP; 6) controls.
  • 30 weeks and 45 weeks (Gavage)  (C20310C)  Completed 
    • GMM-14 (NIH Number: 14-5967)  (Peer Review Approval 02/00/2012A )
      Toxicology and Carcinogenicity Studies of 3'-Azido-3'-Deoxythymidine (CASRN 30516-87-1) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (In utero and Postnatal Gavage Studies)
    • Mice: C3B6F1-+/TRP53<TM1BRD> (NCTR)
    • Carcinogenesis Results
      • Male Mice Clear Evidence 
      • Female Mice Equivocal Evidence 
    • Dose: 30-Week Study: 0 or 240 mg/kg (GD 12-18 -- AZT only); 0 or 120 mg/kg (PND 1-10); 0 or 240 mg/kg (PND 11-9 mo) -- 45-Week Study: 0, 80, 160, or 240 mg/kg (GD 12-18 -- AZT only); 0, 40, 80, or 120 mg/kg (PND 1-10); 0, 80, 160, or 240 mg/kg (PND 11-9 mo) -- 45-Week Stop-Study: 0 or 240 mg/kg (GD 12-18 -- AZT only); 0 or 40 mg/kg (PND 1-8); pups were then maintained on study until 45 weeks of age without dosing.
  • 45 weeks (Gavage)  (C20310D)  Completed 
    • GMM-16 (NIH Number: 14-5973)  (Peer Review Approval 02/00/2012A )
      Toxicology and Carcinogenicity Study of Mixtures of 3'-Azido-3'-Deoxythymidine (AZT), Lamivudine (3TC), and Nevirapine (NVP) (CASRNs 30516-87-1, 134678-17-4, 129618-40-2) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (In Utero and Postnatal Gavage Studies)
    • Mice: P53 +/- (FVB/N)
    • Carcinogenesis Results
      • Male Mice Clear Evidence 
      • Female Mice No Evidence 
    • Dose: 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.
  • 45 weeks (Gavage)  (C20310E)  Completed 
    • 3TC-H
    • GMM-16 (NIH Number: 14-5973)  (Peer Review Approval 02/00/2012A )
      Toxicology and Carcinogenicity Study of Mixtures of 3'-Azido-3'-Deoxythymidine (AZT), Lamivudine (3TC), and Nevirapine (NVP) (CASRNs 30516-87-1, 134678-17-4, 129618-40-2) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (In Utero and Postnatal Gavage Studies)
    • Mice: P53 +/- (FVB/N)
    • Carcinogenesis Results
      • Male Mice No Evidence 
      • Female Mice Equivocal Evidence 
    • Dose: 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.
  • 45 weeks (Gavage)  (C20310F)  Completed 
    • NVP-H
    • GMM-16 (NIH Number: 14-5973)  (Peer Review Approval 02/00/2012A )
      Toxicology and Carcinogenicity Study of Mixtures of 3'-Azido-3'-Deoxythymidine (AZT), Lamivudine (3TC), and Nevirapine (NVP) (CASRNs 30516-87-1, 134678-17-4, 129618-40-2) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (In Utero and Postnatal Gavage Studies)
    • Mice: P53 +/- (FVB/N)
    • Carcinogenesis Results
      • Male Mice No Evidence 
      • Female Mice Equivocal Evidence 
    • Dose: 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.
  • 45 weeks (Gavage)  (C20310G)  Completed 
    • AZT/3TC-H
    • GMM-16 (NIH Number: 14-5973)  (Peer Review Approval 02/00/2012A )
      Toxicology and Carcinogenicity Study of Mixtures of 3'-Azido-3'-Deoxythymidine (AZT), Lamivudine (3TC), and Nevirapine (NVP) (CASRNs 30516-87-1, 134678-17-4, 129618-40-2) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (In Utero and Postnatal Gavage Studies)
    • Mice: P53 +/- (FVB/N)
    • Carcinogenesis Results
      • Male Mice Clear Evidence 
      • Female Mice Equivocal Evidence 
    • Dose: 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.
  • 45 weeks (Gavage)  (C20310H)  Completed 
    • AZT/3TC/NVP- L,M,H
    • GMM-16 (NIH Number: 14-5973)
      Toxicology and Carcinogenicity Study of Mixtures of 3'-Azido-3'-Deoxythymidine (AZT), Lamivudine (3TC), and Nevirapine (NVP) (CASRNs 30516-87-1, 134678-17-4, 129618-40-2) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (In Utero and Postnatal Gavage Studies)
    • Mice: P53 +/- (FVB/N)
    • Carcinogenesis Results
      • Male Mice Clear Evidence 
      • Female Mice Equivocal Evidence 
    • Dose: 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.
  • 2 years (Gavage)  (C88072)  Completed 
    • TR-469 (NIH Number: 99-3959)  (Peer Review Approval 12/11/1996A )
      Toxicology and Carcinogenesis Studies of AZT (CASRN 30516-87-1) and AZT/ a-Interferon A/D B6C3F1 Mice (Gavage Studies)
    • Mice: B6C3F1
    • Carcinogenesis Results
      • Male Mice Equivocal Evidence 
      • Female Mice Clear Evidence 
    • Dose: MICE ONLY: 0, 30, 60, OR 120 MG/KG; 50/SEX.

Genetic Toxicology

  • In Vitro Cytogenetics (CA/SCE)  (476222)  Completed 
    • Sister Chromatid Exchange Positive 
    • Chromosome Aberrations Negative 
  • Micronucleus  (912603)  Completed 
    • Citation: Phillips, M.D., Nascimbeni, B., Tice, R.R., and Shelby, M.D. Induction of MN in Mouse BM cells: An evaluation of nucleoside analogues used in the treatment of Aids. Environ. Molec. Mutag. Vol. 18 (1991) 168-183
    • Mice: B6C3F1
    • Male Positive 
  • Micronucleus  (A69895)  Completed 
    • Citation: Phillips, M.D., Nascimbeni, B., Tice, R.R., and Shelby, M.D. Induction of MN in Mouse BM cells: An evaluation of nucleoside analogues used in the treatment of Aids. Environ. Molec. Mutag. Vol. 18 (1991) 168-183
    • Male Positive 
  • Micronucleus  (A88072)  Completed 
    • Mice: B6C3F1
    • Male Positive 
  • Salmonella  (860655)  Completed 
    •  Positive 
  • Salmonella  (G88195)  Completed 
    •  Weakly Positive 

Organ Systems Toxicity

  • Dominant Lethal (Female) (Gavage)  (DLF96001)  Completed 
    • Female Mice: C3H X 101
    • Mice Female Negative 
  • Dominant Lethal (Male)  (DLM96001)  Completed 
    • Citation: Shelby, MD, Russell, LB, Generoso, W. AZT, rodent somatic and germ cell mutagenicity and reproductive toxicity tests. Environ. Mol. Mutagen. 25 (Suppl.25): 48. (1995)
    • Male Mice: C3H X 101
    • Mice Male Negative 
  • 28 days Immunotoxicity (Gavage)  (IMM20306)  Completed 
    • Female Mice: B6C3F1
    • Dose: 0, 134, 266, or 400 mg/kg/day.
  • 28 days Immunotoxicity (Gavage)  (IMM20401)  Completed 
    • Female Mice: B6C3F1
    • Dose: 0, 134, 266, or 400 mg/kg/day (dams).
  • 180 days Immunotoxicity (Gavage)  (IMM96003)  Completed 
    • Female Mice: B6C3F1
    • Dose: 0, 50, 125, 250, OR 500 MG/KG/DAY.
  • 2nd generation Continuous Breeding (Legacy) (Gavage)  (RACB98003)  Completed 
    • Male and Female Mice: Swiss CD-1
    • Dose: 0, 50, 100, OR 200 MG/KG; 2X/DAY.