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Table 3.1: Summary of in vitro genotoxicity of hydrogen peroxide (IARC, 1999)
Test system Result a Dose b (LED or HID) Reference c
Without exogenous metabolic activation With exogenous metabolic activation
a +, positive; (+), weakly positive; –, negative; NT, not tested; ?, inconclusive
b LED, lowest effective dose; HID, highest ineffective dose; in-vitro tests, μg/mL; in-vivo tests, mg/kg bw/day; inj, injection; NG, not given
c The full references of the articles in Tables 3.1 and 3.2 are given separately at the end of the Opinion
d Negative for DNA–DNA and DNA–protein cross-links
e Positive at 50 μM (1.7 μg/mL) for HeLa, CaCo-2 colon cells and HepG2 liver cells.
PRB, Prophage, induction/SOS response/strand-breaks/or cross-links + NT 0.5 Müller & Janz (1993)
PRB, Prophage, induction/SOS response/strand-breaks/or cross-links + NT 1 Northrop (1958)
PRB, Prophage, induction/SOS response/strand-breaks/or cross-links + NT 45 Nakamura et al. (1987)
BRD, Escherichia coli, differential toxicity + NT 20 Hartman & Eisenstark (1978)
BRD, Escherichia coli, differential toxicity + NT 340 Ananthaswamy & Eisenstark (1977)
SAF, Salmonella typhimurium BA13, forward mutation + NT 0.2 Ariza et al. (1988)
SAF, Salmonella typhimurium (SV50), forward mutation + NT 0.22 Xu et al. (1984)
SA0, Salmonella typhimurium TA100, reverse mutation – NT 340 Stich et al. (1978)
SA0, Salmonella typhimurium TA100, reverse mutation (+) NT 136 Norkus et al. (1983)
SA0, Salmonella typhimurium TA100, reverse mutation – – 0.9 Xu et al. (1984)
SA0, Salmonella typhimurium TA100, reverse mutation (+) NT 5 Fujita et al. (1985)
SA0, Salmonella typhimurium TA100, reverse mutation (+) – 5780 Kensese & Smith (1989)
SA2, Salmonella typhimurium TA102, reverse mutation (+) – 5780 Kensese & Smith (1989)
SA2, Salmonella typhimurium TA102, reverse mutation (+) NT 20.4 Abu-Shakra & Zeiger (1990)
SA4, Salmonella typhimurium TA104, reverse mutation + NT 10 Abu-Shakra & Zeiger (1990)
SA7, Salmonella typhimurium TA1537, reverse mutation + – 4046 Kensese & Smith (1989)
SA8, Salmonella typhimurium TA1538, reverse mutation (+) – 5780 Kensese & Smith (1989)
SA9, Salmonella typhimurium TA98, reverse mutation – NT 340 Stich et al. (1978)
SA9, Salmonella typhimurium TA98, reverse mutation – – 0.9 Xu et al. (1984)
SA9, Salmonella typhimurium TA98, reverse mutation (+) – 5780 Kensese & Smith (1989)
SAS, Salmonella typhimurium hisC3108, reverse mutation + NT 30 Ames et al. (1981)
SAS, Salmonella typhimurium TA96, reverse mutation + NT 50 Levin et al. (1982)
SAS, Salmonella typhimurium TA97, reverse mutation (+) – 2890 Kensese & Smith (1989)
SAS, Salmonella typhimurium TA97, reverse mutation + NT 4.25 Abu-Shakra & Zeiger (1990)
SAS, Salmonella typhimurium SB1106p, reverse mutation + NT 5.1 Abu-Shakra & Zeiger (1990)
SAS, Salmonella typhimurium SB1111, reverse mutation (+) NT 10 Abu-Shakra & Zeiger (1990)
SAS, Salmonella typhimurium SB1106, reverse mutation + NT 10 Abu-Shakra & Zeiger (1990)
ECF, Escherichia coli (excluding K12), forward mutation + NT 3 Abril & Pueyo (1990)
ECR, Escherichia coli WP2, reverse mutation + NT 2160 Demerec et al. (1951)
BSM, Bacillus subtilis, multigene test + NT 7.2 Sacks & MacGregor (1982)
MAF, Micrococcus aureus, forward mutation + NT 6 Clark(1953)
SCF, Saccharomyces cerevisiae ade2, forward mutation + NT 100 Thacker (1976)
SCF, Saccharomyces cerevisiae ade2, forward mutation + NT 2000 Thacker & Parker (1976)
SGR, Streptomyces griseoflavus, reverse mutation – NT 1440 Mashima & Ikeda (1958)
ANR, Aspergillus chevalieres, reverse mutation (+) NT 1440 Nanda et al. (1975)
NCF, Neurospora crassa, forward mutation (+) NT 9180 Han (1997)
NCR, Neurospora crassa, reverse mutation + NT 7140 Dickey et al. (1949)
NCR, Neurospora crassa, reverse mutation + NT 6800 Jensen et al. (1951)
DMX, Drosophila melanogaster, sex-linked recessive lethal mutations –   43200 inj Dipaolo (1952)
DIA, DNA single-strand breaks, Chinese hamster lung V79 cells in vitro (+)d NT 12 Bradley et al. (1979)
DIA, DNA single-strand breaks, rat hepatocytes in vitro + NT 3.4 Olson (1988)
DIA, DNA single-strand breaks, Chinese hamster ovary CHO cells in vitro + NT 3.4 Cantoni et al. (1989)
DIA, DNA single-strand breaks, Chinese hamster lung V79-379A fibroblasts in vitro + NT 0.34 Prise et al. (1989)
DIA, DNA single-strand breaks, Chinese hamster ovary CHO cells in vitro + NT 0.85 Cantoni et al. (1992)
DIA, DNA single-strand breaks, Chinese hamster ovary CHO cells in vitro + NT 0.68 Iliakis et al. (1992)
G9H, Gene mutation, Chinese hamster lung V79 cells, hprt locus in vitro – NT 12 Bradley et al. (1979)
G9H, Gene mutation, Chinese hamster lung V79 cells, hprt locus in vitro – NT 20 Bradley & Erickson (1981)
G9H, Gene mutation, Chinese hamster lung V79 cells, hprt locus in vitro – NT 3.4 Tsuda (1981)
G9H, Gene mutation, Chinese hamster lung V79 cells, hprt locus in vitro – NT 7 Nishi et al. (1984)
G9H, Gene mutation, Chinese hamster lung V79 cells, hprt locus in vitro – NT 13.6 Speit (1986)
G9H, Gene mutation, Chinese hamster lung V79 cells, hprt locus + NT 17 Ziegler-Skylakakis &
in vitro       Andrae (1987)
G9O, Gene mutation, Chinese hamster lung V79 cells, ouabain – NT 3.4 Tsuda (1981)
resistance in vitro        
G51, Gene mutation, mouse lymphoma L5178Y cell subline LY-R, hprt locus in vitro (+) NT 0.17 Kruszewski et al. (1994
G51, Gene mutation, mouse lymphoma L5178Y cell subline LY-S, hprt locus in vitro (+) NT 0.34 Kruszewski et al. (1994
SIC, Sister chromatid exchange, Chinese hamster lung V79 cells in vitro (+) NT 12 Bradley et al. (1979)
SIC, Sister chromatid exchange, Chinese hamster ovary CHO cells in vitro + NT 0.13 MacRae & Stich (1979)
SIC, Sister chromatid exchange, Chinese hamster ovary CHO cells in vitro (+) NT 17 Wilmer & Natarajan
SIC, Sister chromatid exchange, Chinese hamster lung V79 cells in vitro + NT 3.4 Speit et al. (1982)
SIC, Sister chromatid exchange, Chinese hamster lung V79 cells in vitro + (+) 0.34 Mehnert et al. (1984a)
SIC, Sister chromatid exchange, Chinese hamster ovary CHO cells in vitro + (+) 0.34 Mehnert et al. (1984a)
SIC, Sister chromatid exchange, Chinese hamster lung V79 cells in vitro (+) NT 7 Nishi et al. (1984)
SIC, Sister chromatid exchange, Chinese hamster lung V79 cells in vitro + NT 0.68 Speit (1986)
SIC, Sister chromatid exchange, Chinese hamster ovary CHO + NT 1.4 Tucker et al. (1989)
AU × 91 cells in vitro        
MIA, Micronucleus test, C57BL/6J mouse splenocytes in vitro – NT 0.68 Dreosti et al. (1990)
CIC, Chromosomal aberrations, Chinese hamster DON-6 cells in vitro + NT 34 Sasaki et al. (1980)
CIC, Chromosomal aberrations, Chinese hamster ovary CHO-K1 cells in vitro + NT 3.4 Tsuda (1981)
CIC, Chromosomal aberrations, Chinese hamster lung V79 cells in vitro + NT 3.4 Tsuda (1981)
CIC, Chromosomal aberrations, Chinese hamster ovary CHO cells in vitro (+) NT 340 Wilmer & Natarajan
CIC, Chromosomal aberrations, Chinese hamster ovary CHO cells in vitro (+) NT 1 Hanham et al. (1983)
CIM, Chromosomal aberrations, newborn BALB/c mouse back-skin cells in vitro + NT 0.34 Tsuda (1981)
CIS, Chromosomal aberrations, Syrian hamster lung cells in vitro + NT 3.4 Tsuda (1981)
DIH, DNA single-strand breaks, transformed human WI-38 & XP (+) NT 3.4 Hoffmann & Meneghini
cells in vitro       (1979)
DIH, DNA single-strand breaks, human D98/AH2 cells in vitro + NT 2 Wang et al. (1980)
DIH, DNA single-strand breaks, human epithelioid P3 cells in vitro + NT 0.21 Peak et al. (1991)
DIH, DNA single-strand breaks, human cells in vitro + NT 0.85 Meyers et al. (1993)
DIH, DNA single-strand breaks, human leukocytes in vitro + NT 17 Rueff et al. (1993)
DIH, DNA damage, human bronchial epithelium (HBEI) cells in vitro + NT 1.7 Spencer et al. (1995)
DIH, DNA damage, human bronchial epithelium (BEAS and NHBE) cells in vitro + NT 0.68 Lee et al. (1996)
DIH, DNA damage, human lymphobastoid (GM1899A) cells in vitro +e NT 0.34 Duthie & Collins (1997)
UHF, Unscheduled DNA synthesis, human fibroblasts in vitro + NT 20 Stich et al. (1978)
UHF, Unscheduled DNA synthesis, human fibroblasts in vitro + NT 9 Coppinger et al. (1983) 
SHL, Sister chromatid exchange, human lymphocytes in vitro + (+) 2.7 Mehnert et al. (1984b) 
CHF, Chromosomal aberrations, human fibroblasts in vitro + NT 0.07 Parshad et al. (1980) 
CHL, Chromosomal aberrations, human lymphocytes in vitro – NT 0.17 Smith et al. (1990) 
CIH, Chromosomal aberrations, human embryonic fibroblasts in vitro + NT 0.34 Oya et al. (1986) 
CIH, Chromosomal aberrations, human lymphocytes in vitro + NT 510 Rueff et al. (1993) 
AIH, Aneuploidy, human lymphocytes in vitro ? NT 0.17 Smith et al. (1990) 
CBA, Chromosomal aberrations, rat bone-marrow cells in vivo –   NG Kawachi et al. (1980) 
CVA, Chromosomal aberrations, mouse ascites tumour cells in vivo +   340 μg/mouse Schöneich (1967) 
CVA, Chromosomal aberrations, mouse ascites tumour cells in vivo +   170 μg/mouse Schöneich et al. (1970) 
BID, DNA binding (covalent), 8-hydroxydeoxyguanosine, BALB/c mouse keratinocytes in vitro – NT 680 Beehler et al. (1992)
ICR, Inhibition of cell communication, WB-Fischer 344 rat liver epithelial cells in vitro + NT 3.4 Upham et al. (1997)

Source: SCCP  Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products (2007), p.22-24

Related publication:
Tooth Whiteners homeTooth Whiteners & Oral Hygiene Products containing hydrogen peroxide
Other Figures & Tables on this publication:

Table 3.1: Summary of in vitro genotoxicity of hydrogen peroxide (IARC, 1999)

Table 3.2. Summary of in vivo genotoxicity of hydrogen peroxide (ECB, 2003)

Table 3.3. Incidence of gastro-duodenal lesions in C57BL/6J mice after receiving hydrogen peroxide in the drinking water (Ito et al., 1981)

Table 3.4. Incidence of duodenal tumours in 4 strains of female mice treated with 0.4% H2O2 in drinking water (Ito et al., 1984)

Table 3.5. Effect on gastro-duodenal carcinogenesis induced by MNNG (Takahashi et al, 1986)

Table 3.6: Hydrogen peroxide exposure in mouse dermal and hamster check pouch tumour promotion assays following initiation by with DMBA

Table 3.7: Summary of clinical studies using hydrogen peroxide toothpastes

Table 3.8: Adverse events in clinical trials with toothpastes containing up to 3% hydrogen peroxide (unpublished company data)

Table 3.9: Unfavourable reports received to marketed toothpaste with 0.75% hydrogen peroxide in the period 1995-1997(unpublished company data)

Table 3.10: Summary of human safety data of hydrogen peroxide in mouth-rinses

Table 3.11: Unfavourable reports received to marketed mouth-rinse with 0.75% hydrogen peroxide in the period 1995-1997 (unpublished company data)

Table 3.12. Available hydrogen peroxide in the saliva during the first 30 and 60 minutes

Table 3.13. Concentration of hydrogen peroxide in the strip, at the teeth, at the gingival, and in the saliva during the first 60 minutes.

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