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Description of key information

No data are available on the substance identified as reaction mass of calcium fluoride (47.5% w/w), calcium sulfate (ca 22.3%) and calcium carbonate (ca 12.09%).

The absorption, the distribution, the metabolism and the excretion of the registered substance is based on the basic toxicokinetics of its three main constituents, as reported in the 3 corresponding registration dossiers.

Key value for chemical safety assessment

Additional information

Absorption :

Calcium fluoride :

- It is absorbed by oral route following dissolution in the stomach and dissociation into calcium and fluoride. However, the absorption of fluoride appears to be variable and is strongly influenced by the concentration and form in which it is administered orally.

- The dermal absorption of calcium fluoride is considered likely to be negligible due to its low water solubility and ionic nature.

 

Calcium sulfate :

- It is absorbed by oral route following dissolution in the stomach and dissociation into calcium and sulfates. Moreover, as other calcium salts, solubility will affect the absorption. Oral ingestion via food and drinking water is the primary route of exposure for sulfates, including calcium sulfate. Both calcium and sulfate ions are necessary nutritional elements for animals and they are derived from a variety of sources with an average daily intake of around 500 mg sulfate per day.

- As with other calcium salts dermal and inhalation absorption are likely to be limited.

 

Calcium carbonate:

- It is absorbed by oral route following slow dissolution in the stomach and dissociation into calcium and carbonate ions then absorbed from the intestines via both an active transport and a passive diffusion.

- It has the potential to be inhaled depending on its particle distribution and then absorbed based on its nature as physiological substance.

- It is expected to be absorbed at very low rate by dermal route based on the inorganic nature of calcium and itsthe physico-chemical properties.

 

Based on the absorption characteristics of its three constituents, it can be concluded that the substance is absorbed by all routes of exposure without induced toxicity as demonstrated by the acute toxicity studies. However, the absorption may be very limited following exposure by dermal route and by inhalation.

Distribution :

Following absorption of the calcium containing constituents, the calcium ions are distributed in the serum and then throughout the body. The majority of calcium is stored in the skeleton.

Calcium, as a bulk metal is found in a variety of proteins and enzymes and is important in the transmission of signals in nerves. At the cellular level, metal ions, such as calcium are used in biology in communication roles to trigger cellular responses.

At the macroscopic level, solid calcium compounds also play a structural role as a major component of bones, teeth and shells.

As calcium ions are indispensable to life their distribution is tightly regulated systemically as well as intra-cellular.

Metabolism:

Calcium ions are inorganic and stable to reduction or oxidation in biological systems. Calcium carbonate plays a wide variety of roles in biological processes, for example acting as a catalytic site for reactions and or transferring atoms or groups to catalytic sites. Calcium is also complexed to important biological molecules such as calmodulin, calbindin.

Moreover, fluoride, carbonate and sulfate ions are necessary nutritional elements included in physiological processes into the organism.

 

Excretion

Assuming homeostasis of this indispensable nutrient, the same amount is excreted as taken up. Calcium is generally excreted mainly via kidneys but also via faeces and sweat. 

 

Overview

In general, calcium levels in the body are regulated by homeostatic processes. These homeostatic processes are able to deal with moderate increases in calcium intake: either by storage in bone or by excretion via urine, faeces or sweat. Therefore, calcium and calcium carbonate are not toxic to humans but are essential elements to life and serious disorders, such as retarded skeletal growth may result from calcium deficiency.