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Testing Status of Phenolphthalein 10050-Y

 

CASRN: 77-09-8

Formula: C20-H14-O4

Synonyms/Common Names

  • 3,3-Bis(4-hydroxyphenyl)-1(3H)-isobenzofuranone (9CI)

Short-Term Toxicity

  • 13 weeks (Dosed-Feed)  (C55798)  Completed 
    • Rats: F344/N; Mice: B6C3F1
    • Dose: 0, .3, 5 %/5 PER GROUP.

Long-Term Carcinogenicity

  • 2 years (Dosed-Feed)  (C55798B)  Completed 
    • TR-465 (NIH Number: 97-3390)  (Peer Review Approval 12/05/1995A )
      Toxicology and Carcinogenesis Studies of Phenolphthalein in F344/N Rats and B6C3F1 Mice (Feed Studies)
    • Rats: F344/N; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats Clear Evidence 
      • Female Rats Some Evidence 
      • Male Mice Clear Evidence 
      • Female Mice Clear Evidence 
    • Dose: R: 0, 1.2, 2.5, OR 5%; M: 0, 0.3, 0.6, OR 1.2% IN FEED (50/SEX/SPECIES/GROUP).

Special Studies

  • Absorption Distribution Metabolism Excretion (Gavage)  (S0755)  Completed 
    • Citation: Griffin RJ, Godfrey VB, Burka LT. Metabolism and disposition of phenolphthalein in male and female F344 rats and B6C3F1 mice. Toxicol Sci. 1998 Apr;42(2):73-81.Pubmed Abstract
    • Male and Female Rats: F344/N; Male and Female Mice: B6C3F1
    • Dose: 800 mg/kg.
  • Toxicokinetic Study (Dosed-Feed; Intravenous; Dosed-Feed; Intravenous)  (S0594)  Completed 
    • Male and Female Rats: F344/N; Male and Female Mice: B6C3F1
    • Dose: 200, 375, 750, 3000, and 12,000 ppm. 25 mg/kg [R,M]. 375, 750, 3000, 12,000, and 50,000 ppm.

Genetic Toxicology

  • Chromosome Aberrations  (A53649)  Completed 
    • Mice
    •  Negative (Nonstandard Protocol) 
  • In Vitro Cytogenetics (CA/SCE)  (101813)  Completed 
    • Sister Chromatid Exchange Negative 
    • Chromosome Aberrations Positive 
  • Micronucleus  (A13109)  Completed 
    • Mice: P16(Ink4a)/(+/-) (C57BL/6)
    • Male Positive 
    • Female Positive 
  • Micronucleus  (A20259)  Completed 
    • Mice: P16(Ink4a)/(+/-) (C57BL/6)
    • Male Positive 
    • Female Positive 
  • Micronucleus  (A34828)  Completed 
    • Mice: P16(Ink4a)/(+/-) (C57BL/6)
    • Male Positive 
    • Female Positive 
  • Micronucleus  (A93351)  Completed 
    • Citation: Witt, K.L., Knapton, A., Wehr, C.M., Hook, G.J., Mirsalis, J., Shelby, M.D., and MacGregor, J.T. Micronucleated Erythrocyte Frequency in Peripheral Blood of B6C3F1 Mice from Short-Term, Prechronic, and Chronic Studies of the NTP Carcinogenesis Bioassay Program. Environ. Molec. Mutagen. Vol. 36 (2000) 163-194
    • Mice: B6C3F1
    • Male Positive 
    • Female Positive 
  • Micronucleus  (A93723)  Completed 
    • Mice: P16(Ink4a)/(+/-) (C57BL/6)
    • Male Positive 
    • Female Positive 
  • Micronucleus  (A93901)  Completed 
    • Mice: B6C3F1
    • Male Positive 
  • Salmonella  (041772)  Completed 
    • Citation: Mortelmans, K., Haworth, S., Lawlor, T., Speck, W., Tainer, B., and Zeiger, E. Salmonella mutagenicity tests. II. Results from the testing of 270 chemicals Environ. Mutagen. Vol. 8 (Suppl 7) (1986) 1-119
    •  Negative 
  • Salmonella  (768193)  Completed 
    • Citation: Mortelmans, K., Haworth, S., Lawlor, T., Speck, W., Tainer, B., and Zeiger, E. Salmonella mutagenicity tests. II. Results from the testing of 270 chemicals Environ. Mutagen. Vol. 8 (Suppl 7) (1986) 1-119
    •  Negative 
  • Salmonella  (A71314)  Completed 
    •  Equivocal 
  • Salmonella  (A99430)  Completed 
    •  Negative 

Organ Systems Toxicity

  • greater than 120 days Continuous Breeding (Legacy) (Dosed-Feed)  (RACB89066)  Completed 
    • Male and Female Mice: Swiss
    • Dose: N/A; 0, .1, .7, 3%; 0, .7%; 0, .1, .7%.