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Diss Factsheets

Administrative data

Description of key information

A human patch test performed with sodium percarbonate (York et al. 1996) and a valid and reliable skin irritation test performed with rabbits Glaza 1990c) shows that sodium percarbonate is not irritating to the skin. A series of valid and reliable eye irritation tests performed with rabbits (Glaza 1990d, Driscoll 1995 a,b,c) show that sodium percarbonate is highly irritating to the rabbit eye with the risk of serious damage to eyes. In a well-reported, non-GLP respiratory irritation test in the mouse (Janssen et al. 2001) sodium percarbonate appeared to be a respiratory irritant at relatively high aerosol concentrations.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

The available animal data show that the skin irritation potential of sodium percarbonate depends on the concentration that is applied to the skin and on the conditions of exposure. Aqueous solutions containing 1 % sodium percarbonate were practically non-irritating to the skin of rats (Chater 1978). Also the application of 0.5 g of the test material (purity >88 %, moistened with 0.9 % saline, exposure under semi-occlusion for four hours) to the skin of rabbits caused only slight to moderate irritation that was fully reversible within a period of 14 days after exposure (Glaza 1990c). The application of the test material to rabbit skin under occlusion for 24 hours (2 g/kg body weight, purity > 88 %, moistened with 0.9 % saline) caused severe irritation and possibly corrosive effects (Glaza 1990b). The conditions of dermal exposure in the dermal toxicity test are not realistic with regard to the identified uses of sodium percarbonate and are not taken into account when assessing the skin irritation potential of the substance. Indeed, the human patch (skin irritation) test carried out under realistic human exposure conditions for up to four hours (York et al. 1996) indicated that sodium percarbonate is not a human skin irritant. For eye irritation, a set of reliable GLP and standard guideline studies are available (Glaza 1990d, Driscoll 1995a, b, c). Sodium percarbonate instilled into the rabbit eye in amounts of 0.01 to 0.1 g was highly irritating. Corrosivity was not investigated in animals receiving 0.05 or 0.1 g of sodium percarbonate. The substance produced an irreversible corrosive effect in one eye that was treated with 0.01 g sodium percarbonate and was not rinsed (Driscoll 1995c). The eye irritation potential of sodium percarbonate is in accordance with the eye irritation potential of hydrogen peroxide and sodium carbonate formed during the dissociation of sodium percarbonate. Sodium percarbonate contains 32.5 % hydrogen peroxide and 67.5 % sodium carbonate. Such a concentration of hydrogen peroxide is highly irritating and causes irreversible effects in the rabbit eye (European Commission 2003). Sodium carbonate will add to the eye irritation effect of sodium percarbonate. The extent of eye irritation will depend on the sodium percarbonate content of a mixture: when the calculation method described in Annex II (part A) of Directive 1999/45/EC is used mixtures containing 25 % sodium percarbonate or more can cause serious damage to eyes. Mixtures containing 10 % sodium percarbonate or more but less than 25 % have to be considered as irritating to eyes. In a well-reported, non-GLP study with mice (Janssen et al. 2001), sodium percarbonate appeared to be a respiratory irritant at relatively high aerosol concentrations, which decreased the respiratory rate and minute volumes at concentrations equal to or greater than 309 mg/m3. No clinical signs and no abnormalities of the lungs were observed at the tested exposure concentrations indicating that the sodium percarbonate did not adversely affect the lung tissues. The respiratory irritation can be explained by the elevated particle concentration in the breathing air and the formation of hydrogen peroxide and sodium carbonate from the dissociation of sodium percarbonate in the upper respiratory tract. The RD50 was approximately 700 mg/m³.


Effects on eye irritation: highly irritating

Effects on respiratory irritation: irritating

Justification for classification or non-classification

It is concluded that sodium percarbonate will dissociate into hydrogen peroxide and sodium carbonate in contact with skin, eyes or human body fluids in the lungs or the gastrointestinal tract. The local irritating effects thus can be explained by the presence of the two dissociation products. Sodium percarbonate is only slightly irritating to the skin of rats and rabbits and is not irritating to the human skin. No classification for skin irritation is required. Sodium percarbonate is severely irritating to the rabbit eye and can cause irreversible effects. The substance is classified as eye irritant Category 1 according to the CLP Regulation (EC) No 1272/2008 and as irritant, risk of serious damage to eyes in accordance with the Dangerous Substance Directive (67/548/EEC). Sodium percarbonate appears to be a respiratory irritant with an RD50 value of approximately 700 mg/m3, which does not warrant classification in accordance with the CLP Regulation (EC) No 1272/2008 or the Dangerous Substances Directive (67/548/EEC).