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

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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)