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Testing Status of 2-Hydroxy-4-methoxybenzophenone 10260-S

 

CASRN: 131-57-7

Formula: C14-H12-O3

Synonyms/Common Names

  • Benzophenone 3
  • Escalol 567
  • HMB
  • (2-Hydroxy-4-methoxyphenyl)phenylmethanone
  • 4-Methoxy-2-hydroxybenzophenone
  • MOB
  • Oxybenzone
  • Sunscreen UV 15

Short-Term Toxicity

  • 2 weeks (Dosed-Feed)  (C60957A)  Completed 
    • TOX-21 (NIH Number: 92-3344)  (Peer Review Approval 11/21/1991A )
      Toxicity Studies of 2-Hydroxy-4-methoxybenzophenone (CASRN 131-57-7) Administered Topically and in Dosed Feed to F344/N Rats and B6C3F1 Mice
    • Rats: F344/N; Mice: B6C3F1
  • 2 weeks (Topical Application)  (C60957B)  Completed 
    • TOX-21 (NIH Number: 92-3344)  (Peer Review Approval 11/21/1991A )
      Toxicity Studies of 2-Hydroxy-4-methoxybenzophenone (CASRN 131-57-7) Administered Topically and in Dosed Feed to F344/N Rats and B6C3F1 Mice
    • Rats: F344/N; Mice: B6C3F1
  • 14-Day (Topical Application)  (C60957C)  Completed 
    • TOX-21 (NIH Number: 92-3344)  (Peer Review Approval 11/00/1991A )
      Toxicity Studies of 2-Hydroxy-4-methoxybenzophenone (CASRN 131-57-7) Administered Topically and in Dosed Feed to F344/N Rats and B6C3F1 Mice
    • Rats: F344/N; Mice: B6C3F1
  • 13 weeks (Dosed-Feed)  (C60957A)  Completed 
    • TOX-21 (NIH Number: 92-3344)
      Toxicity Studies of 2-Hydroxy-4-methoxybenzophenone (CASRN 131-57-7) Administered Topically and in Dosed Feed to F344/N Rats and B6C3F1 Mice
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R&M: 0, 3125, 6250, 12,500, 25,000, 50,000 ppm.
  • 13 weeks (Topical Application)  (C60957B)  Completed 
    • TOX-21 (NIH Number: 92-3344)
      Toxicity Studies of 2-Hydroxy-4-methoxybenzophenone (CASRN 131-57-7) Administered Topically and in Dosed Feed to F344/N Rats and B6C3F1 Mice
    • Rats: F344/N; Mice: B6C3F1
    • Dose: R: 0, 12.5, 25, 50, 100, 200 mg/kg. M: 0, 22.75, 45.5, 91, 182, 364 mg/kg.

Long-Term Carcinogenicity

  • 2 years (Dosed-Feed)  (C10260)  Completed 
    • TR-597 
      Toxicology and Carcinogenesis Studies of 2-Hydroxy-4- methoxybenzophenone (CASRN 131-57-7) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley SD) Rats and B6C3F1/N Mice
    • Rats: Harlan Sprague-Dawley; Mice: B6C3F1
    • Carcinogenesis Results
      • Male Rats Equivocal Evidence 
      • Female Rats Equivocal Evidence 
      • Male Mice No Evidence 
      • Female Mice No Evidence 
    • Dose: R&M: 0, 1000, 3000, or 10,000 ppm. R: 60/sex/dose @ 0 or 10,000 ppm and 50/sex/dose @ 1000 or 3000 ppm. M: 50/sex/dose.

Modified One-Generation

  • GD 6 to PND 28 Dose Range Finding (Dosed-Feed)  (MOG002)  Completed 
    • Citation: National Toxicology Program (NTP). 2022. NTP developmental and reproductive toxicity technical report on the modified one-generation study of 2-hydroxy-4-methoxybenzophenone (CASRN 131-57-7) administered in feed to Sprague Dawley (Hsd:Sprague Dawley SD) rats with prenatal and reproductive performance assessments in F1 offspring. Research Triangle Park, NC: National Toxicology Program. DART Report 05. https://doi.org/10.22427/NTP-DART-05
    • Female Rats: Harlan Sprague-Dawley
  • Developmental Toxicity (Dosed-Feed)  (MOG002B)  Completed 
    • Citation: Mutlu E, Pierfelice J, McIntyre BS, Cunny HC, Kissling GE, Burback B, Waidyanatha S. Simultaneous Quantitation of 2-Hydroxy-4-Methoxybenzophenone, a Sunscreen Ingredient, and its Metabolites in Harlan Sprague Dawley Rat Plasma Following Perinatal Dietary Exposure. J Anal Toxicol. 2017 Nov 1;41(9):744-754. doi: 10.1093/jat/bkx070.
    • Citation: National Toxicology Program (NTP). 2022. NTP developmental and reproductive toxicity technical report on the modified one-generation study of 2-hydroxy-4-methoxybenzophenone (CASRN 131-57-7) administered in feed to Sprague Dawley (Hsd:Sprague Dawley SD) rats with prenatal and reproductive performance assessments in F1 offspring. Research Triangle Park, NC: National Toxicology Program. DART Report 05. https://doi.org/10.22427/NTP-DART-05
    • Rats: Harlan Sprague-Dawley
    • Dose: 0, 3000, 10,000, or 30,000 ppm.
  • F0 Generation (Dosed-Feed)  (MOG002B)  Completed 
    • Citation: Mutlu E, Pierfelice J, McIntyre BS, Cunny HC, Kissling GE, Burback B, Waidyanatha S. Simultaneous Quantitation of 2-Hydroxy-4-Methoxybenzophenone, a Sunscreen Ingredient, and its Metabolites in Harlan Sprague Dawley Rat Plasma Following Perinatal Dietary Exposure. J Anal Toxicol. 2017 Nov 1;41(9):744-754. doi: 10.1093/jat/bkx070.
    • Citation: National Toxicology Program (NTP). 2022. NTP developmental and reproductive toxicity technical report on the modified one-generation study of 2-hydroxy-4-methoxybenzophenone (CASRN 131-57-7) administered in feed to Sprague Dawley (Hsd:Sprague Dawley SD) rats with prenatal and reproductive performance assessments in F1 offspring. Research Triangle Park, NC: National Toxicology Program. DART Report 05. https://doi.org/10.22427/NTP-DART-05
    • Rats: Harlan Sprague-Dawley
    • Dose: 0, 3000, 10,000, or 30,000 ppm.
  • Fertility Assessment (Dosed-Feed)  (MOG002B)  Completed 
    • Citation: Mutlu E, Pierfelice J, McIntyre BS, Cunny HC, Kissling GE, Burback B, Waidyanatha S. Simultaneous Quantitation of 2-Hydroxy-4-Methoxybenzophenone, a Sunscreen Ingredient, and its Metabolites in Harlan Sprague Dawley Rat Plasma Following Perinatal Dietary Exposure. J Anal Toxicol. 2017 Nov 1;41(9):744-754. doi: 10.1093/jat/bkx070.
    • Citation: National Toxicology Program (NTP). 2022. NTP developmental and reproductive toxicity technical report on the modified one-generation study of 2-hydroxy-4-methoxybenzophenone (CASRN 131-57-7) administered in feed to Sprague Dawley (Hsd:Sprague Dawley SD) rats with prenatal and reproductive performance assessments in F1 offspring. Research Triangle Park, NC: National Toxicology Program. DART Report 05. https://doi.org/10.22427/NTP-DART-05
    • Rats: Harlan Sprague-Dawley
    • Dose: 0, 3000, 10,000, or 30,000 ppm.

Special Studies

  • Absorption Distribution Metabolism Excretion (Dermal; Gavage; Dermal; Gavage)  (K10260)  Completed 
    • Citation: Mutlu E, Garner CE, Wegerski CJ, McDonald JD, McIntyre BS, Doyle-Eisele M, Waidyanatha S. Metabolism and disposition of 2-hydroxy-4-methoxybenzophenone, a sunscreen ingredient, in Harlan Sprague Dawley rats and B6C3F1/N mice; a species and route comparison. Xenobiotica. 2020 Jun;50(6):689-704. doi: https://doi.org/10.1080/00498254.2019.1680906. Epub 2019 Oct 31.Pubmed Abstract
    • Male and Female Rats: Harlan Sprague-Dawley; Male and Female Rats: Sprague Dawley; Male and Female Mice: B6C3F1
    • Dose: 0.1, 10 mg/kg [R,M]. 10, 100, 500 mg/kg [R,M].
  • Absorption Distribution Metabolism Excretion (Gavage)  (S0073)  Completed 
    • Male Rats: F344/N
  • 3 days Hershberger Assay (Gavage)  (K10260C)  Completed 
    • Citation: National Toxicology Program (NTP). 2020. NTP technical report on the toxicology and carcinogenesis studies of 2-hydroxy-4-methoxybenzophenone (CASRN 131-57-7) administered in feed to Sprague Dawley (Hsd:Sprague Dawley SD) rats and B6C3F1/N mice. Research Triangle Park, NC: National Toxicology Program. Technical Report 597. https://doi.org/10.22427/NTP-TR-597
    • Male Rats: Harlan Sprague-Dawley
    • Dose: 0, 100, 320, 1000 mg/kg.
  • Toxicokinetic Study (Dosed-Feed; Intravenous; Gavage; Dosed-Feed; Intravenous; Gavage)  (S0593)  Completed 
    • Male and Female Rats: F344/N; Male and Female Mice: B6C3F1
    • Dose: 1000, 10,000 ppm [R,M]. 50 mg/kg. 50, 500 mg/kg. 8 mg/kg in rats. 8, 80 mg/kg.
  • 3 days Uterotrophic Assay (Gavage)  (K10260B)  Completed 
    • Citation: National Toxicology Program (NTP). 2020. NTP technical report on the toxicology and carcinogenesis studies of 2-hydroxy-4-methoxybenzophenone (CASRN 131-57-7) administered in feed to Sprague Dawley (Hsd:Sprague Dawley SD) rats and B6C3F1/N mice. Research Triangle Park, NC: National Toxicology Program. Technical Report 597. https://doi.org/10.22427/NTP-TR-597
    • Female Rats: Sprague Dawley
    • Dose: 0, 300, 1000 mg/kg.

Genetic Toxicology

  • In Vitro Cytogenetics (CA/SCE)  (059393)  Completed 
    • Sister Chromatid Exchange Positive 
    • Chromosome Aberrations Positive 
  • Micronucleus  (A48127)  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 Negative 
    • Female Negative 
  • Salmonella  (381877)  Completed 
    • Citation: Zeiger E, Anderson B, Haworth S, Lawlor T, Mortelmans K, Speck W. Salmonella mutagenicity tests: III. Results from the testing of 255 chemicals. Environ Mutagen. 1987;9 Suppl 9:1-109.
    •  Weakly Positive 
  • Salmonella  (613844)  Completed 
    • Citation: Zeiger E, Anderson B, Haworth S, Lawlor T, Mortelmans K, Speck W. Salmonella mutagenicity tests: III. Results from the testing of 255 chemicals. Environ Mutagen. 1987;9 Suppl 9:1-109.
    •  Negative 
  • 48 hours Salmonella (in-vitro)  (G10260)  Completed 
    • Citation: National Toxicology Program (NTP). 2020. NTP technical report on the toxicology and carcinogenesis studies of 2-hydroxy-4-methoxybenzophenone (CASRN 131-57-7) administered in feed to Sprague Dawley (Hsd:Sprague Dawley® SD®) rats and B6C3F1/N mice. Research Triangle Park, NC: National Toxicology Program. Technical Report 597.
    •  Negative 

Organ Systems Toxicity

  • greater than 120 days Continuous Breeding (Legacy) (Dosed-Feed)  (RACB88076)  Completed 
    • Male and Female Mice: Swiss
    • Dose: 0, 1.25, 2.5, 5%; 0, .3125, .625, 1.25, 2.5, 5%; 0, 5%.
  • 35 days Developmental Toxicity (Dosed-Feed)  (R10260)  Completed 
    • Citation: Nakamura N, Inselman AL, White GA, Chang CW, Trbojevich RA, Sephr E, Voris KL, Patton RE, Bryant MS, Harrouk W, McIntyre BS, Foster PM, Hansen DK. Effects of maternal and lactational exposure to 2-hydroxy-4-methoxybenzone on development and reproductive organs in male and female rat offspring. Birth Defects Res B Dev Reprod Toxicol. 2015 Feb;104(1):35-51. doi: 10.1002/bdrb.21137.
    • Citation: Nakamura N, Vijay V, Desai VG, Hansen DK, Han T, Chang CW, Chen YC, Harrouk W, McIntyre B, Foster PM, Fuscoe JC, Inselman AL. Rebuttal to the comments by Dr. Yan Xu on the article "Transcript profiling in the testes and prostates of postnatal day 30 Sprague-Dawley rats exposed prenatally and lactationally to 2-hydroxy-4-methoxybenzophenone". Reprod Toxicol. 2020 Jun;94:102. doi: https://doi.org/10.1016/j.reprotox.2019.07.018. Epub 2019 Jul 22.
    • Citation: Nakamura N, Vijay V, Desai VG, Hansen DK, Han T, Chang CW, Chen YC, Harrouk W, McIntyre B, Foster PM, Fuscoe JC, Inselman AL. Transcript profiling in the testes and prostates of postnatal day 30 Sprague-Dawley rats exposed prenatally and lactationally to 2-hydroxy-4-methoxybenzophenone. Reprod Toxicol. 2018 Dec;82:111-123. doi: 10.1016/j.reprotox.2018.10.001. Epub 2018 Oct 11.
    • Male and Female Rats: Harlan Sprague-Dawley
    • Dose: 0, 1K, 3K, 10K, 25K and 50K ppm.
  • GD 6 to GD 15 Developmental Toxicity (Dosed-Feed)  (R10260B)  Completed 
    • Male and Female Rats: Harlan Sprague-Dawley
    • Dose: 0, 3K, 10K or 30K ppm and 0.05 ppm ethinyl estradiol; 25/sex/dose.
  • GD 6 to GD 15 Developmental Toxicity (Dosed-Feed)  (R10260C)  Completed 
    • Male and Female Rats: Harlan Sprague-Dawley
    • Dose: 0, 3K, 10K or 30K ppm; 25 sex/dose.
  • GD 6 to PND 21 Developmental Toxicity (Dosed-Feed)  (R10260D)  Completed 
    • Citation: Nakamura N, Vijay V, Desai VG, Hansen DK, Han T, Chang CW, Chen YC, Harrouk W, McIntyre B, Foster PM, Fuscoe JC, Inselman AL. Rebuttal to the comments by Dr. Yan Xu on the article "Transcript profiling in the testes and prostates of postnatal day 30 Sprague-Dawley rats exposed prenatally and lactationally to 2-hydroxy-4-methoxybenzophenone". Reprod Toxicol. 2020 Jun;94:102. doi: https://doi.org/10.1016/j.reprotox.2019.07.018. Epub 2019 Jul 22.
    • Citation: Nakamura N, Vijay V, Desai VG, Hansen DK, Han T, Chang CW, Chen YC, Harrouk W, McIntyre B, Foster PM, Fuscoe JC, Inselman AL. Transcript profiling in the testes and prostates of postnatal day 30 Sprague-Dawley rats exposed prenatally and lactationally to 2-hydroxy-4-methoxybenzophenone. Reprod Toxicol. 2018 Dec;82:111-123. doi: 10.1016/j.reprotox.2018.10.001. Epub 2018 Oct 11.
    • Male and Female Rats: Harlan Sprague-Dawley
    • Dose: 0, 3K, 10K or 30K ppm and 0.05 ppm ethinyl estradiol; 25/sex/dose.

Toxicogenomics

  • 13 weeks Microarray Analysis (Dosed-Feed)  (T10260)  Completed 
    • Rats: Harlan Sprague-Dawley

in vitro Testing

  • H295R Steroidogenesis Assay (Whole Body Exposure)  (V10260)  Completed 
    • H295R Steroidogenesis Assay
    • Human (Cell Lines)
  • Androgen Receptor Binding Assay (Whole Body Exposure)  (V10260B)  Completed 
    • Androgen Receptor Binding Assay
    • Rats: Sprague Dawley
  • Estrogen Receptor Binding Assay (Whole Body Exposure)  (V10260C)  Completed 
    • Estrogen Receptor Binding Assay
    • Rats: Sprague Dawley
  • Androgen Receptor Transactivation Assay (Whole Body Exposure)  (V10260D)  Completed 
    • Androgen Receptor Transactivation Assay
    • Human (Cell Lines)
  • Estrogen Receptor Transactivation Assay  (V10260E)  Completed 
    • Estrogen Receptor Transactivation Assay
    • Human (Cell Lines)
  • Human Recombinant Aromatase Assay  (V10260G)  Completed 
    • Human Recombinant Aromatase Assay
    • Human (Cell Lines)