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EC number: 908-343-6
CAS number: -
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.
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
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)
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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