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Testing Status of 3'-Azido-3'-deoxythymidine and 2',3'-Dideoxyinosine (AIDS initiative) M90028

 

CASRN: AZTDDICOMB

Formula: C10-H13-N5-O4 C10-H12-N4-O3

Synonyms/Common Names

  • AZT + DDI
  • AZT + DDI (AIDS initiative)

Secondary:

  • 30516-87-1 - 3'-Azido-3'-deoxythymidine (AIDS)
  • 30516-87-1 - AZT transplacental carcinogenesis study
  • 69655-05-6 - 2',3'-Dideoxyinosine (AIDS Initiative)

Known Uses

Experimental therapy for AIDS

Short-Term Toxicity

  • 4 weeks (Gavage)  (C90001)  Completed 
    • Mice: B6C3F1
    • Dose: M: VARIOUS COMBINATIONS OF AZT 0, 250, 500, OR 1000 MG/KG/DAY (DIVIDED IN 2 DOSES) WITH DDI 0, 500, 1000, OR 2000 MG/KG/DAY (DIVIDED IN 2 DOSES).

Special Studies

  • Toxicokinetic Study (Gavage; Intravenous)  (S0408)  Completed 
    • Female Mice: Swiss CD-1
    • Dose: METHYLCELLULOSE: 250, 500, 1000 MG/KG MAALOX: 250 MG/KG MAALOX-TC: 50, 125, 250, 500 MG/KG IV: 20 MG/KG.

Genetic Toxicology

  • Micronucleus  (A03310)  Completed 
    • Citation: Bishop JB, Witt KL, Tice RR, Wolfe G. Genetic damage detected in CD-1 mouse pups exposed perinatally to 3'-azido-3'-deoxythymidine and dideoxyinosine via maternal dosing, nursing, and direct gavage. Environ Mol Mutagen. 2004;43(1):3-9.
    • Mice: Swiss CD-1
    • Male Positive 
  • Micronucleus  (A07834)  Completed 
    • Mice: Swiss CD-1
    • Male Positive 
  • Micronucleus  (A10804)  Completed 
    • Citation: Bishop JB, Witt KL, Tice RR, Wolfe G. Genetic damage detected in CD-1 mouse pups exposed perinatally to 3'-azido-3'-deoxythymidine and dideoxyinosine via maternal dosing, nursing, and direct gavage. Environ Mol Mutagen. 2004;43(1):3-9.
    • Mice: Swiss CD-1
    • Male Positive 
  • Micronucleus  (A24399)  Completed 
    • Citation: Witt KL, Tice RR, Wolfe GW, Bishop JB. Genetic damage detected in CD-1 mouse pups exposed perinatally to 3'-azido-3'-deoxythymidine or dideoxyinosine via maternal dosing, nursing, and direct gavage: II. Effects of the individual agents compared to combination treatment. Environ Mol Mutagen. 2004;44(4):321-8.
    • Mice: Swiss CD-1
    • Male Negative 
    • Female NA 
  • Micronucleus  (A28891)  Completed 
    • Citation: Witt KL, Tice RR, Wolfe GW, Bishop JB. Genetic damage detected in CD-1 mouse pups exposed perinatally to 3'-azido-3'-deoxythymidine or dideoxyinosine via maternal dosing, nursing, and direct gavage: II. Effects of the individual agents compared to combination treatment. Environ Mol Mutagen. 2004;44(4):321-8.
    • Mice: Swiss CD-1
    • Male Positive 
  • Micronucleus  (A29422)  Completed 
    • Mice: Swiss CD-1
    • Male Positive 
  • Micronucleus  (A38558)  Completed 
    • Mice: Swiss CD-1
    • Male Positive 
    • Female NA 
  • Micronucleus  (A43440)  Completed 
    • Citation: Witt KL, Tice RR, Wolfe GW, Bishop JB. Genetic damage detected in CD-1 mouse pups exposed perinatally to 3'-azido-3'-deoxythymidine or dideoxyinosine via maternal dosing, nursing, and direct gavage: II. Effects of the individual agents compared to combination treatment. Environ Mol Mutagen. 2004;44(4):321-8.
    • Mice: Swiss CD-1
    • Male Positive 
  • Micronucleus  (A53298)  Completed 
    • Mice: Swiss CD-1
    • Male Positive 
    • Female NA 
  • Micronucleus  (A54094)  Completed 
    • Citation: Witt KL, Tice RR, Wolfe GW, Bishop JB. Genetic damage detected in CD-1 mouse pups exposed perinatally to 3'-azido-3'-deoxythymidine or dideoxyinosine via maternal dosing, nursing, and direct gavage: II. Effects of the individual agents compared to combination treatment. Environ Mol Mutagen. 2004;44(4):321-8.
    • Mice: Swiss CD-1
    • Male Positive 
  • Micronucleus  (A60084)  Completed 
    • Citation: Bishop JB, Witt KL, Tice RR, Wolfe G. Genetic damage detected in CD-1 mouse pups exposed perinatally to 3'-azido-3'-deoxythymidine and dideoxyinosine via maternal dosing, nursing, and direct gavage. Environ Mol Mutagen. 2004;43(1):3-9.
    • Mice: Swiss CD-1
    • Male Positive 
  • Micronucleus  (A64786)  Completed 
    • Citation: Witt KL, Tice RR, Wolfe GW, Bishop JB. Genetic damage detected in CD-1 mouse pups exposed perinatally to 3'-azido-3'-deoxythymidine or dideoxyinosine via maternal dosing, nursing, and direct gavage: II. Effects of the individual agents compared to combination treatment. Environ Mol Mutagen. 2004;44(4):321-8.
    • Mice: Swiss CD-1
    • Male Positive 
    • Female NA 
  • Micronucleus  (A68101)  Completed 
    • Citation: Bishop JB, Witt KL, Tice RR, Wolfe G. Genetic damage detected in CD-1 mouse pups exposed perinatally to 3'-azido-3'-deoxythymidine and dideoxyinosine via maternal dosing, nursing, and direct gavage. Environ Mol Mutagen. 2004;43(1):3-9.
    • Mice: Swiss CD-1
    • Female Positive 
  • Micronucleus  (A70649)  Completed 
    • Citation: Witt KL, Tice RR, Wolfe GW, Bishop JB. Genetic damage detected in CD-1 mouse pups exposed perinatally to 3'-azido-3'-deoxythymidine or dideoxyinosine via maternal dosing, nursing, and direct gavage: II. Effects of the individual agents compared to combination treatment. Environ Mol Mutagen. 2004;44(4):321-8.
    • Mice: Swiss CD-1
    • Male NA 
    • Female Positive 
  • Micronucleus  (A76722)  Completed 
    • Citation: Bishop JB, Witt KL, Tice RR, Wolfe G. Genetic damage detected in CD-1 mouse pups exposed perinatally to 3'-azido-3'-deoxythymidine and dideoxyinosine via maternal dosing, nursing, and direct gavage. Environ Mol Mutagen. 2004;43(1):3-9.
    • Mice: Swiss CD-1
    • Male Positive 

Organ Systems Toxicity

  • 6 months in-life Continuous Breeding (Legacy) (Gavage)  (RACB20003)  Completed 
    • Male and Female Mice: C57BL/6
    • Dose: 0/0, 50/250, 75/375, OR 150/750 MG/KG/DAY.
  • 1 to 31 Repro/Dev Gen Tox (28-Day) (Gavage)  (RACB93153)  Completed 
    • Male and Female Mice: Swiss CD-1
    • Dose: N/A; N/A; N/A; N/A.