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Description of key information

A reliable and valid acute toxicity study is available for the oral route (Glaza 1990a) resulting in an LD50 value for male and female Alderley Park albino rats of 1034 mg/kg body weight. The reliable and valid acute dermal toxicity study performed with rabbits resulted in a LD50 value of greater 2000 mg/kg body weight and did not produce mortality nor clinical signs related to the test material in the test animals. No valid study on acute inhalation toxicity of sodium percarbonate is available. As sodium percarbonate will rapidly dissociate into hydrogen peroxide in the respiratory tract, information on the acute inhalation toxicity can be considered. The LC50 value of hydrogen peroxide (49.3 % aqueous solution) was > 170 mg/m3 (European Commission 2003) and the LC50 value of sodium carbonate was 1200 mg/m3 in the mouse and 2300 mg/m3 in the rat (OECD 2002). The existing animal data on acute toxicity show that sodium percarbonate has a local effect and that systemic effects are not to be expected.

Key value for chemical safety assessment

Additional information

Standard acute oral toxicity studies in the rat and acute dermal toxicity studies in rabbits with a high reliability are available. Acute oral exposure to undiluted or diluted sodium percarbonate causes local effects in the gastrointestinal tract and can lead to death. The Alderley Park albino rats were most susceptible with regard to oral exposure to sodium percarbonate and the combined acute oral LD50 value for male and female rats was 1034 mg/kg body weight (Glaza 1990a). The magnitude of the LD50 value and the local gastrointestinal effects are supported by the findings of less reliable acute toxicity studies. The local effects are due to the formation of hydrogen peroxide and sodium carbonate: hydrogen peroxide is a known irritant of the gastrointestinal tract and this effect may be supported by the increase in alkalinity caused by the formation of sodium carbonate. The acute dermal LD50 was >2000 mg/kg body weight in the available guideline-conform study (Glaza 1990b). No mortality or clinical signs related to the test material were observed during the observation period of 14 days. Animals in the dermal toxicity test on sodium percarbonate were exposed under occlusion for 24 hours and under these conditions the substance caused severe skin irritation and possibly corrosive effects. The relevance of these effects will be further discussed in section 5.3.4. The acute inhalation toxicity of sodium percarbonate has not been studied. Inhaled sodium percarbonate will dissociate into hydrogen peroxide and sodium carbonate in the respiratory tract and the acute inhalation toxicity of sodium percarbonate can be explained by the presence of the two dissociation products. The acute inhalation LD50 value for hydrogen peroxide in the rat was > 170 mg/m3 based on the maximal attainable vapour concentration of 49.3 % hydrogen peroxide and the LD50 value for sodium carbonate was 1200 mg/m3 in mice and 2300 mg/m3 in rats (European Commission 2003, OECD 2002). Hydrogen peroxide and sodium carbonate cause local irritation effects in the respiratory tract, which is further discussed in section 5.3.4.

Justification for classification or non-classification

It can be concluded that the existing animal data on acute toxicity show that sodium percarbonate exhibits local irritation effects in the gastrointestinal and respiratory tracts and on the skin. Systemic effects are not to be expected. Sodium percarbonate should be classified for acute oral toxicity, Category 4 based on the criteria of the CLP Regulation (EC) No 1272/2008. In accordance with the Dangerous Substances Directive (67/548/EEC) the substance should be classified as harmful if swallowed. No classification for the acute dermal and inhalation toxicity of sodium percarbonate is required.

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