Skip to Main Navigation
Skip to Page Content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Testing Status of Methylene blue trihydrate M90016

 

CASRN: 7220-79-3

Formula: C16-H18-N3-S.Cl.3H2-O

Synonyms/Common Names

  • C.I. Basic Blue 9, trihydrate
  • Phenothiazin-5-ium, 3,7-bis(dimethylamino)-, chloride, trihydrate

Short-Term Toxicity

  • 4 weeks (Gavage)  (C91005)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R&M: 0, 0.125, 0.25, 0.5, 1.0, OR 2.0 MG/KG BODY WT. R: 20/GROUP/SEX; M: 10/GROUP/SEX. R&M: 0, 125, 250, 500, 1000 or 2000 mg/kg 10/Group/Sex (10 core/10 clinical pathology).
  • 13 weeks (Gavage)  (C91005B)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R&M: 0, 25, 50, 100, OR 200 MG/KG; 30 SEX/SPECIES/GROUP.

Long-Term Carcinogenicity

  • 2 years (Gavage)  (C91005C)  Completed 
    • TR-540 (NIH Number: 08-4429)  (Peer Review Approval 06/12/2006A )
      Toxicology and Carcinogenesis Studies of Methylene Blue Trihydrate (CASRN 7220-79-3) in F344/N Rats and B6C3F1 Mice (Gavage Studies)
    • Rats: F344/N; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats Some Evidence 
      • Female Rats No Evidence 
      • Male Mice Some Evidence 
      • Female Mice Equivocal Evidence 
    • Dose: R: 0, 5, 25, OR 50 MG/KG; M: 0, 2.5, 12.5, OR 25 MG/KG; 50/SEX/SPECIES.

Special Studies

  • Preliminary Toxicokinetic Study (Gavage; Intravenous; Gavage; Intravenous)  (S0660)  Completed 
    • Preliminary Toxicokinetic Study
    • Rats: F344/N; Male and Female Mice: B6C3F1; Mice: B6C3F1
    • Dose: IV: 0.625 mg/ml (rats, 2 ml/kg); 0.125 mg/ml (mice, 4 ml/kg).

Genetic Toxicology

  • In Vitro Cytogenetics (CA/SCE)  (563848)  Completed 
    • Sister Chromatid Exchange Positive 
    • Chromosome Aberrations Positive 
  • Micronucleus  (A76244)  Completed 
    • Mice: B6C3F1
    • Male Negative 
  • Micronucleus  (A77225)  Completed 
    • Mice: B6C3F1
    • Male Negative 
    • Female Negative 
  • Salmonella  (811345)  Completed 
    •  Positive 
  • Salmonella  (A35880)  Completed 
    •  Positive 

Organ Systems Toxicity

  • Conventional Teratology (Gavage)  (TER92124)  Completed 
    • Rats: Sprague Dawley
    • Rats Maternal Positive 
    • Rats Fetal Positive 
    • Dose: REP I: 0, 50, 200, 350 MG/KG/DAY REP II: 0, 50, 125, 200 MG/KG/DAY.
  • 6 to 19 GD Conventional Teratology (Gavage)  (TER92125)  Completed 
    • Female Rabbits: New Zealand White
    • Rabbits Maternal Positive 
    • Rabbits Fetal Positive 
    • Dose: 0, 50, 100, 150 MG/KG/DAY.
  • 6 to 15 GD Teratology Pilot Studies (Gavage)  (TRP91018)  Completed 
    • Female Rats: Sprague Dawley
    • Dose: 0, 50, 100, 200, 400, OR 600 MG/KG.
  • 6 to 19 GD Teratology Pilot Studies (Gavage)  (TRP91019)  Completed 
    • Female Rabbits: New Zealand White
    • Dose: 0, 10, 50, 100, 200, OR 300 MG/KG.