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

Species and strain Type of study Measured endpoint Exposure data Test conditions Result Remark Reference a
a The full references of the articles in Tables 3.1 and 3.2 are given separately at the end of the Opinion
Mouse Swiss HIM/OG1 Host mediated assay with intraperitoneally inoculated Salmonella typhimurium strains TA1530, G46 dosing: 0.003, 0.3 or 3.0% H2O2 in milk for one week. 0.5 ml 0.3% H2 >O2 twice by gavage with a 2 h interval negative; H2O2 in milk positive; pure H2O2 a strong positive response for TA1530, a weak one for G46. Keck & Binder (1980)
Mouse inbread strain AB Jena Gat. cytogenetic assay with intraperitoneally inoculated tumour cells (S2 sarcoma, Ehrlich ascites, sarcoma 180) dosing: 1 ml of 0.01, 0.05, 0.1 or 0.5 M H2O2 i.p. 48 h after the implantation of the tumour cells. chromosomes were studied 48 h after the treatment. increased chromatid aberrations local effect; response presumed to depend on the presence or absence of RBCs. Schöneich (1967)
Rat Wistar, male In vivo - in vitro hepatocyte unscheduled DNA synthesis (UDS) H2O2 dosing: 0, 25 or 50 mg/kg by intravenous infusion of 0%, 0.1% or 0.2% water solution at a rate of 0.2 ml/min during approximately 30 min (=MTD) Negative exposure duration limited to 30 min. CEFIC (1997)
Mouse Swiss HIM/OF1 micronucleus assay of bone marrow polychromatic erythrocytes dosing: 0.003, 0.3 or 3.0% H2O2 in milk for 32 h (apparently also in water, % not given) Negative oral route, reporting unclear and incomplete. Keck & Binder (1980)
Mouse strain unkown micronucleus assay of bone marrow polychromatic erythrocytes single intraperitoneal injection of ½, 1/5, 1/25 or 1/100 LD50 dose of H2O2 Negative no experimental details given Liarskii et al. (1983)
Mouse C57BL/6NCr1BR micronucleus assay of bone marrow polychromatic erythrocytes H2O2 in drinking water at 0, 200, 1,000, 3,000 or 6,000 ppm for 2 weeks. Doses males: 0, 42.4, 164, 415 or 536 mg/kg negative, P/N ratio was not changed oral route Du Pont (1995)
    bw/day; females: 0, 48.5, 198, 485 or 774 mg/kg bw/day.      
Mouse Swiss OF1/ICO:OF1 (IOPS Caw) micronucleus assay of bone marrow polychromatic erythrocytes dosing: 0, 250, 500 or 1,000 mg/kg i.p. (25 ml/kg: 0, 1, 2 or 4% H2O2, respectively) Time of harvest 24 or 48 h negative, P/N was lower at 24 h, and at 48 h in the 250 and 1,000 mg/kg groups single i.p. injection CEFIC (1995)
Drosophila melanogasterr Drosophila SLRL test single dose of 3% H2O2 injected into male larvae Negative    DiPaolo (1952)
Mouse SencarFemale Pre-screen forcarcinogenicity in target tissue (mouse skin) quantity of 8-OH-2’deoxyguanosine (DNA damage) mutations in codon 61 of cHa-ras gene epidermal hyperplasia and dermal cellularity changes Hydrogen peroxide 70% was applied to the skin of 10 female Sencar mice per dose group at dose levels of 10, 100, or 200 µmol in 200 µl of ethanol (i.e. 0.2-3.2% solutions) twice weekly for 4 weeks. Mice treated under the same conditions with DMBA (10 or 100 µmol/animal) or ethanol (200 µl) acted as positive and negative controls, respectively. The animals wer killed on days 2 or 4 after the last administration (5 mice on each day). The application sites were removed and after fixation and staining, epithelial and dermal thickness and dermal cellularity were determined visually by light microscopy. Non-phenol extraction of fresh frozen tissue was used to isolate DNA from animals killed 2 days after last dosing, and following digestion to nucleosides, 8-OH-2’deoxyguanosine (8-OH-dG) was quantified by HPLC. mutations in codon 61 of c-Ha-ras gene were determined using DNA isolated from paraffin blocks of whole skin. negative for all enpoints at the relatively low concentrations used hydrogen peroxide did not induce local in vivo genotoxicity and mutagenicity in the skin. Society for Plastic Industry (1997)

Source: SCCP  Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products (2007), p.25-26

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.