National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/38193

Target Organs and Levels of Evidence for GMM-14

Toxicology and Carcinogenesis Studies of 3'-Azido-3'-Deoxythymidine (AZT) (CASRN 30516-87-1) in Genetically Modified C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice (in Utero and Postnatal Gavage Studies)

Chemical (Study Title)
CASRN
Peer Review Date Primary Uses Route/Exposure Levels Study Laboratory
3'-Azido-3'-deoxythymidine (AIDS)
30516-87-1
02/00/2012 Pyrimidine nucleoside analog with antiviral activity used in the treatment of AIDS (Merck 1989) Gavage
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
National Center for Toxicological Research

Levels of evidence information for the in Utero/Postnatal Gavage Studies of AZT in C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice
  Male C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice Female C3B6.129F1-Trp53tm1Brd N12 Haploinsufficient Mice
  30 Week Study 45 Week Study 45 Week Stop-Study 30 Week Study 45 Week Study 45 Week Stop-Study
Levels of Evidence Clear evidence Clear evidence Clear evidence Equivocal evidence Equivocal evidence Equivocal evidence
May Have Been Related
  • Malignant Lymphoma: 0/27, 3/26 (30-Week Study)
None None None
  • Malignant lymphoma: 0/26, 0/27, 1/27, 3/27 (45-Week Study)
None
Neoplastic Lesions None
  • Liver: hepatocellular adenoma 3/26, 2/27, 6/27, 9/27 (45-Week Study)
  • Liver: hepatocelluar adenoma 3/24, 5/25; hepatocellular adenoma or carcinoma 3/24, 7/25 (45-Week Stop-Study)
None None None
Non-Neoplastic Lesions None None None None None None
NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.