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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
Both hydrogen peroxide and carbamide peroxide are used for hair bleaching, oral antiseptics, dentifrices, oxidation of permanent waves, hair relaxer, ear drops, and tooth bleaching. Small quantities are used for such purposes as disinfection of eye contact lenses, disinfection of wounds and mouth washing.
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) in tooth whitening 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 tooth-whitening products permissible?
* Does the SCCNFP propose any restrictions or conditions for use of these cosmetic products?
3. Toxicological Evaluation & Characterisation
3.1. Acute toxicity (dermal, oral, i.v., i.p.) : Exposure to tooth whitener containing 10% carbamide will be 0.084 mg/kg/day corresponding to 0.028 mg/kg/day hydrogen peroxide. No risk for acute toxicity.
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. MOS = 26/0.028 = 929.
3.3 Reproductive toxicity : Data on the teratogenic potential and reproductive toxicity are limited and do not allow a complete evaluation.
3.4 Irritation and corrosivity : Stomach gavage of 15 mg/kg b.w. carbamide peroxide produced ulceration of gastric mucosa in rats after 1 hour. MOS = 15/0.084 = 179.
3.5 Allergenicity and sensitisation : Not detected to be allergenic.
3.6 Genotoxicity/carcinogenicity : Hydrogen peroxide in genotoxic in vitro, but not in vivo. It is unlikely that a tooth whitener containing hydrogen peroxide (carbamide peroxide) 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.
3.7 Other effects of concern : Information on possible pathophysiological effects on oral and pulpal tissues from long-term treatment and effects of overuse are lacking.
4. Opinion
The content of hydrogen peroxide in tooth whitening products should not exceed 3.6% (10% carbamide peroxide). Tooth whitening products containing more than 0.1% hydrogen peroxide (0.3% carbamide peroxide) should exclusively be administered under supervision of a dentist ("take home"). The products should contain a printed warning against overuse or reuse of tooth whitening products several times and that they should not be used during pregnancy or by habitual tobacco and alcohol users.
5. 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
Both hydrogen peroxide and carbamide peroxide are used for hair bleaching, oral antiseptics, dentifrices, oxidation of permanent waves, hair relaxer, ear drops, and tooth bleaching. Small quantities are used for such purposes as disinfection of eye contact lenses, disinfection of wounds and mouth washing.
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) in tooth whitening 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 tooth-whitening products permissible?
* Does the SCCNFP propose any restrictions or conditions for use of these cosmetic products?
3. Toxicological Evaluation & Characterisation
3.1. Acute toxicity (dermal, oral, i.v., i.p.) : Exposure to tooth whitener containing 10% carbamide will be 0.084 mg/kg/day corresponding to 0.028 mg/kg/day hydrogen peroxide. No risk for acute toxicity.
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. MOS = 26/0.028 = 929.
3.3 Reproductive toxicity : Data on the teratogenic potential and reproductive toxicity are limited and do not allow a complete evaluation.
3.4 Irritation and corrosivity : Stomach gavage of 15 mg/kg b.w. carbamide peroxide produced ulceration of gastric mucosa in rats after 1 hour. MOS = 15/0.084 = 179.
3.5 Allergenicity and sensitisation : Not detected to be allergenic.
3.6 Genotoxicity/carcinogenicity : Hydrogen peroxide in genotoxic in vitro, but not in vivo. It is unlikely that a tooth whitener containing hydrogen peroxide (carbamide peroxide) 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.
3.7 Other effects of concern : Information on possible pathophysiological effects on oral and pulpal tissues from long-term treatment and effects of overuse are lacking.
4. Opinion
The content of hydrogen peroxide in tooth whitening products should not exceed 3.6% (10% carbamide peroxide). Tooth whitening products containing more than 0.1% hydrogen peroxide (0.3% carbamide peroxide) should exclusively be administered under supervision of a dentist ("take home"). The products should contain a printed warning against overuse or reuse of tooth whitening products several times and that they should not be used during pregnancy or by habitual tobacco and alcohol users.
5. 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.
