Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

In order to be systemically available, a chemical needs to be absorbed, either via the oral, inhalatory or dermal route. Dissolution of solids is generally assumed to be a prerequisite for absorption. As the reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide is a solid inorganic multi-constituent substance, this means that Ca2 +, OH- and hydrogen peroxide are the species to be taken into account when assessing its toxicity.

 

Due to its reactivity and rapid metabolism in the body (scavenging by catalase) it can reasonably be assumed that hydrogen peroxide will not reach inner organs such as ovaries and testes, nor foetuses. As a consequence, hydrogen peroxide is considered not to be toxic for reproduction.

 

The primary effect of calcium dihydroxide is characterised by primary local irritation at the site of first contact. Furthermore, calcium cations are physiologically essential elements and nutrients for all mammals including humans. The tolerable upper intake level (UL) that is proposed by the Scientific Committee on Food (SCF; Anonymous, 2003) is considered as sufficient and adequate for risk characterisation, and this value is furthermore considered to also cover any potential reproductive effects.

Effects on developmental toxicity

Additional information

In order to be systemically available, a chemical needs to be absorbed, either via the oral, inhalatory or dermal route. Dissolution of solids is generally assumed to be a prerequisite for absorption. As the reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide is a solid inorganic multi-constituent substance, this means that Ca2 +, OH- and hydrogen peroxide are the species to be taken into account when assessing its long-term systemic toxicity.

 

Due to its reactivity and rapid metabolism in the body (scavenging by catalase) it can reasonably be assumed that hydrogen peroxide will not reach inner organs such as ovaries and testes, nor foetuses. As a consequence, hydrogen peroxide is considered not to be toxic for reproduction.

 

The primary effect of calcium dihydroxide is characterised by primary local irritation at the site of first contact. Furthermore, calcium cations are physiologically essential elements and nutrients for all mammals including humans. The tolerable upper intake level (UL) that is proposed by the Scientific Committee on Food (SCF; Anonymous, 2003) is considered as sufficient and adequate for risk characterisation, and this value is furthermore considered to also cover any potential reproductive effects.

Justification for classification or non-classification

In accordance to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification is not necessary for toxicity to reproduction, because the substance is not systemically available.