Testing Status of Agents at NTP
3'-Azido-3'-deoxythymidine (AIDS)
CASRN: 30516-87-1
Formula: C10-H13-N5-O4
Synonyms/Common Names:
- AZIDOTYMIDINE
- AZT (AIDS INITIATIVE)
- RETROVIR
- ZIDOVUDINE
Known Uses:
PYRIMIDINE NUCLEOSIDE ANALOG WITH ANTIVIRAL ACTIVITY USED IN THE TREATMENT OF AIDS (MERCK 1989)
Short-Term Toxicity
- 9-Month (Gavage)
(C20310D) On Test
- Mice: P53 +/- (FVB/N)
- 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; NVP1-3: 0, 56, 112, OR 168 MG/KG BW/DAY; 1/8 DOSE NVP PND 1-3 AND 1/2 DOSE NVP PND 4-10
- 13-WEEK (Gavage)
(C88072) Completed
- NTIS No. PB99-145807
(Peer Review 12/11/1996)
Citation: Toxicology and Carcinogenesis Studies of AZT (CAS No. 30516-87-1) and AZT/ a-Interferon A/D B6C3F1 Mice (Gavage Studies) - 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
- NTIS No. PB99-145807
(Peer Review 12/11/1996)
Long-Term Carcinogenicity
- 2-YEAR (Gavage)
(C20309) Histopathology
- Mice: B6C3F1; Mice: B6C3F1/NCTR BR (C57BL/6N x C3H/HEN MTV-)
- Dose: DOSED: GD 12-18 -- 1) AZT 80 mg/kg + 3TC 40 mg/kg (loaded 4); 2) AZT 160 mg/kg + 3TC 80 mg/kg (loaded 4); 3) AZT 240 mg/kg + 3TC 120 mg/kg + 168 mg/kg NVP (loaded 12); 4) AZT 80 mg/kg + 3TC 40 mg/kg + 336 mg/kg NVP (loaded 12); 5) AZT 160 mg/kg + 3TC 80 mg/kg + 672 mg/kg NVP (loaded 36); 6) Controls (loaded 36)
- 9-MONTH (Gavage)
(C20310C) Histopathology
- Mice: C3B6F1-+/TRP53<TM1BRD>; Mice: C3B6F1-+/TRP53<TM1BRD>
- Dose: 0, 80, 160, OR 240 MG/KG BW (GD 12-18 -- AZT ONLY); 0, 40, 80, OR 120 MG/KG BW (PND 1-10); 0, 80, 160, OR 240 MG/KG BW (PND 11-9 MO)
- 2-YEAR (Gavage)
(C88072) Report Complete
- TR-469 (NTIS No. PB99-145807)
(Peer Review 12/11/1996)
Toxicology and Carcinogenesis Studies of AZT (CAS No. 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
- TR-469 (NTIS No. PB99-145807)
(Peer Review 12/11/1996)
Genetic Toxicology
- In Vitro Cytogenetics (CA/SCE)
(476222) Completed
- Chromosome Aberation Negative
- Sister Chromatid Exchange Positive
- 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
Organ Systems Toxicity
- Dominant Lethal (Female)
(DLF96001) Completed
- F 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)
- M Mice: C3H X 101
- Mice Male Negative
- 28 Days Immunotoxicity (Gavage)
(IMM20306) Report in Preparation
- F Mice: B6C3F1
- Dose: 0, 134, 266, OR 400 MG/KG/DAY
- 28 Days Immunotoxicity (Gavage)
(IMM20401) Report in Preparation
- F Mice: B6C3F1
- Dose: 0, 134, 266, OR 400 MG/KG/DAY -- DAMS
- 180 DAYS Immunotoxicity (Gavage)
(IMM96003) Completed
- F Mice: B6C3F1
- Dose: 0, 50, 125, 250, OR 500 MG/KG/DAY
- 2 GENERATIONS Continuous Breeding (Gavage)
(RACB98003) Completed
- NTIS No. PB2004101163
Citation: Azidothymidine (AZT): Multigenerational Reproductive Assessment by Continuous Breeding when Administered to Swiss CD-1® Mice by Gavage - M/F Mice: Swiss CD-1
- Dose: 0, 50, 100, OR 200 MG/KG; 2X/DAY
- NTIS No. PB2004101163
Web page last updated on November 24, 2008