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Directorate-General for Health and Food Safety
Executive Summary
1. General data
1.1 Identity of the ingredient
Hydrogen peroxide [H2O2]
Carbamide peroxide [CO(NH2)2 . H2O2]
1.2 CAS n°
Hydrogen peroxide : CAS No.: 7722-84-1
EINECS No.: 231-765-0
Carbamide peroxide : CAS No.: 124-43-6
EINECS No.: 204-701-4
1.3 Use
The main usage of hydrogen peroxide is in production of chemicals and bleaching of cellulose pulp and textiles. Small quantities are used for such purposes as disinfection of eye contact lenses, and disinfection of wounds. Both hydrogen peroxide and carbamide peroxide are used for hair bleaching, oral hygiene, dentifrices and tooth bleaching, oxidation of permanent waves, hair relaxer, ear drops, and crank sores.
2. Terms of reference
2.1 Context of the question
The adaptation to technical progress of the Annexes to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products.
Request to change Annex III, part 1, n° 12 to Council Directive 76/768/EEC to increase the limit concentration of hydrogen peroxide (and equivalent) to 3.6% in oral hygiene products.
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Is an increase of the limit concentration of hydrogen peroxide (and equivalent) to 3.6% in oral hygiene products (tooth-whiteners, certain mouth-rinses or toothpastes) permissible?
* Does the SCCNFP propose any restrictions or conditions for use of these cosmetic products?
SCCNFP has recently prepared an opinion (SCCNFP/0058/98) based on another request for a maximum threshold of hydrogen peroxide and equivalent in tooth whitening products be fixed at 3.6%. The present opinion will cover the use of hydrogen peroxide and hydrogen peroxide releasing substances in oral care products such as toothpastes and mouth-rinses.
3. Toxicological Evaluation & Characterisation
3.1 Acute toxicity (dermal, oral, i.v., i.p.) : Exposure to toothpastes and mouth-rinses containing 3.6% hydrogen peroxide will be 0.3 and 1.8 mg/kg/day hydrogen peroxide, respectively. No risk for acute toxicity is expected with ordinary use. However, a 16-month-old boy died after ingestion of a 3% hydrogen peroxide solution.
3.2 Chronic/sub-chronic toxicity : NOAEL of hydrogen peroxide from a rat study (repeated dose oral toxicity was 30 mg/kg b.w./day and from a mice study was 26 mg/kg/day. Toothpastes; MOS = 26/0.3 = 87. Mouth-rinses; MOS = 26/1.8 = 14.4
Based on experiments with tooth whiteners it is unlikely that hydrogen peroxide in toothpastes or mouth-rinses will have any adverse effects on the teeth.
3.3 Irritation and corrosivity : Stomach gavage of 15 mg/kg b.w. carbamide peroxide (corresponding to 5.4 mg/kg b.w. of hydrogen peroxide) produced ulceration of gastric mucosa in rats after 1 hour. Toothpastes; MOS = 5.4/0.3 = 18. Mouth-rinses; MOS = 5.4/1.8 = 3.0
3.4 Allergenicity and sensitisation : Not detected to be allergenic.
3.5 Genotoxicity/carcinogenicity : Hydrogen peroxide is genotoxic in vitro, but not in vivo. It is unlikely that a oral care product containing hydrogen peroxide or hydrogen peroxide releasing products will enhance a cancer risk in persons that do not have an increased risk of oral cancer due to tobacco use, alcohol abuse or genetic predisposition.
3.6 Toxicity to reproduction : Data on teratogenic potential and reproductive toxicity are limited and do not allow a complete evaluation.
3.7 Other effects of concern : No studies seem to be available concerning people that have used hydrogen peroxide containing toothpastes or mouth-rinses for long periods. Conditions such as genetically determined traits (acatalasaemia, glucose-6-phosphate dehydrogenase deficiency) and pre-existing tissue injury or the use of alcohol and/or tobacco may exacerbate the toxic effect hydrogen peroxide in toothpastes or mouth-rinses.
3.8 Classification and opinion : An increase of hydrogen peroxide (and equivalent) in toothpastes and mouth-rinses to 3.6% is not permissible. The margin of safety for chronic/subchronic toxicity and for irritation and corrosivity are not sufficiently large for an oral hygiene product. No studies seem to be available concerning longterm use of hydrogen peroxide containing toothpastes or mouth-rinses. A 16-month-old boy has died after ingestion of a 3% solution of hydrogen peroxide. The content of hydrogen peroxide (and equivalent) in oral hygiene products should not exceed 0.1%.
4. Statement on the toxicological evaluation
The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.
The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.
SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.
1. General data
1.1 Identity of the ingredient
Hydrogen peroxide [H2O2]
Carbamide peroxide [CO(NH2)2 . H2O2]
1.2 CAS n°
Hydrogen peroxide : CAS No.: 7722-84-1
EINECS No.: 231-765-0
Carbamide peroxide : CAS No.: 124-43-6
EINECS No.: 204-701-4
1.3 Use
The main usage of hydrogen peroxide is in production of chemicals and bleaching of cellulose pulp and textiles. Small quantities are used for such purposes as disinfection of eye contact lenses, and disinfection of wounds. Both hydrogen peroxide and carbamide peroxide are used for hair bleaching, oral hygiene, dentifrices and tooth bleaching, oxidation of permanent waves, hair relaxer, ear drops, and crank sores.
2. Terms of reference
2.1 Context of the question
The adaptation to technical progress of the Annexes to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products.
Request to change Annex III, part 1, n° 12 to Council Directive 76/768/EEC to increase the limit concentration of hydrogen peroxide (and equivalent) to 3.6% in oral hygiene products.
2.2 Request to the SCCNFP
The SCCNFP is requested to answer the following questions :
* Is an increase of the limit concentration of hydrogen peroxide (and equivalent) to 3.6% in oral hygiene products (tooth-whiteners, certain mouth-rinses or toothpastes) permissible?
* Does the SCCNFP propose any restrictions or conditions for use of these cosmetic products?
SCCNFP has recently prepared an opinion (SCCNFP/0058/98) based on another request for a maximum threshold of hydrogen peroxide and equivalent in tooth whitening products be fixed at 3.6%. The present opinion will cover the use of hydrogen peroxide and hydrogen peroxide releasing substances in oral care products such as toothpastes and mouth-rinses.
3. Toxicological Evaluation & Characterisation
3.1 Acute toxicity (dermal, oral, i.v., i.p.) : Exposure to toothpastes and mouth-rinses containing 3.6% hydrogen peroxide will be 0.3 and 1.8 mg/kg/day hydrogen peroxide, respectively. No risk for acute toxicity is expected with ordinary use. However, a 16-month-old boy died after ingestion of a 3% hydrogen peroxide solution.
3.2 Chronic/sub-chronic toxicity : NOAEL of hydrogen peroxide from a rat study (repeated dose oral toxicity was 30 mg/kg b.w./day and from a mice study was 26 mg/kg/day. Toothpastes; MOS = 26/0.3 = 87. Mouth-rinses; MOS = 26/1.8 = 14.4
Based on experiments with tooth whiteners it is unlikely that hydrogen peroxide in toothpastes or mouth-rinses will have any adverse effects on the teeth.
3.3 Irritation and corrosivity : Stomach gavage of 15 mg/kg b.w. carbamide peroxide (corresponding to 5.4 mg/kg b.w. of hydrogen peroxide) produced ulceration of gastric mucosa in rats after 1 hour. Toothpastes; MOS = 5.4/0.3 = 18. Mouth-rinses; MOS = 5.4/1.8 = 3.0
3.4 Allergenicity and sensitisation : Not detected to be allergenic.
3.5 Genotoxicity/carcinogenicity : Hydrogen peroxide is genotoxic in vitro, but not in vivo. It is unlikely that a oral care product containing hydrogen peroxide or hydrogen peroxide releasing products will enhance a cancer risk in persons that do not have an increased risk of oral cancer due to tobacco use, alcohol abuse or genetic predisposition.
3.6 Toxicity to reproduction : Data on teratogenic potential and reproductive toxicity are limited and do not allow a complete evaluation.
3.7 Other effects of concern : No studies seem to be available concerning people that have used hydrogen peroxide containing toothpastes or mouth-rinses for long periods. Conditions such as genetically determined traits (acatalasaemia, glucose-6-phosphate dehydrogenase deficiency) and pre-existing tissue injury or the use of alcohol and/or tobacco may exacerbate the toxic effect hydrogen peroxide in toothpastes or mouth-rinses.
3.8 Classification and opinion : An increase of hydrogen peroxide (and equivalent) in toothpastes and mouth-rinses to 3.6% is not permissible. The margin of safety for chronic/subchronic toxicity and for irritation and corrosivity are not sufficiently large for an oral hygiene product. No studies seem to be available concerning longterm use of hydrogen peroxide containing toothpastes or mouth-rinses. A 16-month-old boy has died after ingestion of a 3% solution of hydrogen peroxide. The content of hydrogen peroxide (and equivalent) in oral hygiene products should not exceed 0.1%.
4. Statement on the toxicological evaluation
The SCCNFP is the scientific advisory body to the European Commission in matters of consumer protection with respect to cosmetics and non-food products intended for consumers.
The Commission's general policy regarding research on animals supports the development of alternative methods to replace or to reduce animal testing when possible. In this context, the SCCNFP has a specific working group on alternatives to animal testing which, in co-operation with other Commission services such as ECVAM (European Centre for Validation of Alternative Methods), evaluates these methods.
SCCNFP opinions include evaluations of experiments using laboratory animals; such tests are conducted in accordance with all legal provisions and preferably under chemical law regulations. Only in cases where no alternative method is available will such tests be evaluated and the resulting data accepted, in order to meet the fundamental requirements of the protection of consumer health.
