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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

  • 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.
  • 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).

Long-Term Carcinogenicity

  • 2 years (Gavage)  (C91005C)  Report Review 
    • 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)  (S0660)  Completed 
    • Preliminary Toxicokinetic Study
    • Rats: F344/N; Male and Female Mice: B6C3F1; Rats: F344/N; 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 Rabbit: 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 Rabbit: New Zealand White
    • Dose: 0, 10, 50, 100, 200, OR 300 MG/KG.