Registration Dossier

Administrative data

Key value for chemical safety assessment

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.

 

 

Hydrogen peroxide

In the EU Risk Assessment Report (2003) a thorough assessment on the genotoxic properties of hydrogen peroxide has been performed. It was concluded that hydrogen peroxide is a mutagen and genotoxicant as positive results were obtained in a variety of in vitro test systems, including Ames, gene mutation, DNA damage and repair and chromosomal aberrations testing.

In contrast, the available in vivo studies are not in support of a significant genotoxicity/mutagenicity for hydrogen peroxide under in vivo conditions. It is suggestes that cells are adapted to repair DNA damage caused by oxidants. In the EU Risk Assessment Report it is therefore concluded that hydrogen peroxide is not classified as a mutagen.

 

 

Calcium dihydroxide

Reliable in vitro studies are available that assess the different genotoxicity aspects of calcium dihydroxide (bacterial gene mutation, mammalian cell gene mutation and DNA damage (comet test, available in section 7.12 of IUCLID). There is no indication for genotoxic or mutagenic effects in these tests.

 

This is further substantiated by the fact that calcium is an essential mineral nutrient that is omnipresent in the human body, with daily dietary requirements for adults of approx. 1000 mg, varying by developmental status and age.

Based on the above information, it can be concluded that the reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide will not exert any genotoxic effects in vivo.


Endpoint Conclusion: No adverse effect observed (negative)

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 genotoxicity based on the available information for read-across substances hydrogen peroxide and calcium hydroxide.