Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Instead of conducting new in vivo tests, available data on the constituents of the reaction mass of calcium carbonate and calcium dihydroxide and silicon dioxide were used to evaluate the potential of the substance to cause adverse effects on fertility. The available data indicate that the substance does not cause a toxic effect on fertility. Systemic effects of any constituent(s) are not expected, because they all are inorganic salts which have a low solubility in water and thus low bioavailability or which dissociate in ions which are efficiently regulated in the human body, i.e.OH-and Ca2+. Moreover, both calcium carbonate and calcium dihydroxide are approved additives to food (respectively E 170 and E 526, Annex 1 of EU directive No 92/2/EC) and calcium which is an essential element necessary for good growth and health.

Information sources:

European chemical Substances Information System http://ecb.jrc.ec.europa.eu/esis/

International Programme on Chemical Safety, Concise international chemical assessment document No.24, Crystalline silica, Quartz, 09-21-10, http://www.inchem.org/documents/cicads/cicads/cicad24.htm

International chemical Safety Cards, National Instutute for occupational Safety and Health http://www.cdc.gov/niosh/ipcsneng/neng0808.html

International chemical Safety Cards, National Instutute for occupational Safety and Health http://www.cdc.gov/niosh/ipcsneng/neng0408.html

International chemical Safety Cards, National Instutute for occupational Safety and Health 

http://www.cdc.gov/niosh/ipcsneng/neng0409.html

IMA-Europe Position Paper (February 2010) on the classification and labelling of respirable crystalline silica (RCS) http://www.ima-reach-hub.eu/index.php?option=com_docman&task=doc_download&gid=141&Itemid=26

Recommendation from the Scientific Committee on Occupational Exposure Limits for Calcium oxide (CaO) and Calcium Hydroxide (Ca(OH)2), European Commission, DG Employment, social Affairs and Equal Opportunities, SCOEL/SUM/137, February 2008

Threshold Limit Values & Biological Exposure Indices for Chemical Substances and Physical Agents, ACGIH®, Signature Publications, 2010

Opinion of the Scientific Committee on Food on the tolerable upper intake level of calcium European Commission,SCF/CS/NUT/UPPLEV/64 Final, 2003-04-23

 


Short description of key information:
Instead of conducting new in vivo tests, available data on the constituents of the reaction mass of calcium carbonate and calcium dihydroxide and silicon dioxide were used to evaluate the potentialof the substance to cause toxic effects on fertility . The available data indicate that the substance does not cause a toxic effect on fertility.

Effects on developmental toxicity

Description of key information
Instead of conducting new in vivo tests, available data on the constituents of the reaction mass of calcium carbonate, calcium dihydroxide and silicon dioxide were used to evaluate the potential of the substance to cause developmental toxicity or teratogenicity.
Additional information

Instead of conducting new in vivo tests, available data on the constituents of the reaction mass of calcium carbonate, calcium dihydroxide and silicon dioxide were used to evaluate the potential of the substance to cause developmental toxicity or teratogenicity. The available data indicate that the substance does not cause developmental toxicity or teratogenicity. Systemic effects of any constituent(s) are not expected, because they all are inorganic salts which have a low solubility in water and thus low bioavailability or which dissociate in ions which are efficiently regulated in the human body, i.e.OH-and Ca2+. Moreover, both calcium carbonate and calcium dihydroxide are approved additives to food (respectively E 170 and E 526, Annex 1 of EU directive No 92/2/EC) and calcium which is an essential element necessary for good growth and health.

 

Information sources:

European chemical Substances Information System http://ecb.jrc.ec.europa.eu/esis/

International Programme on Chemical Safety, Concise international chemical assessment document No.24, Crystalline silica, Quartz, 09-21-10, http://www.inchem.org/documents/cicads/cicads/cicad24.htm

International chemical Safety Cards, National Instutute for occupational Safety and Health http://www.cdc.gov/niosh/ipcsneng/neng0808.html

International chemical Safety Cards, National Instutute for occupational Safety and Health http://www.cdc.gov/niosh/ipcsneng/neng0408.html

International chemical Safety Cards, National Instutute for occupational Safety and Health 

http://www.cdc.gov/niosh/ipcsneng/neng0409.html

IMA-Europe Position Paper (February 2010) on the classification and labelling of respirable crystalline silica (RCS) http://www.ima-reach-hub.eu/index.php?option=com_docman&task=doc_download&gid=141&Itemid=26

Recommendation from the Scientific Committee on Occupational Exposure Limits for Calcium oxide (CaO) and Calcium Hydroxide (Ca(OH)2), European Commission, DG Employment, social Affairs and Equal Opportunities, SCOEL/SUM/137, February 2008

Threshold Limit Values & Biological Exposure Indices for Chemical Substances and Physical Agents, ACGIH®, Signature Publications, 2010

Opinion of the Scientific Committee on Food on the tolerable upper intake level of calcium European Commission,SCF/CS/NUT/UPPLEV/64 Final, 2003-04-23

 

 

Justification for classification or non-classification

Instead of conducting new in vivo tests, available data on the constituents of the reaction mass of calcium carbonate, calcium dihydroxide and silicon dioxide were used to evaluate the reprotoxic potential of the substance.The available data indicate that the substance is not reprotoxic. Systemic effects of any constituent(s) are not expected, because they all are inorganic salts which have a low solubility in water and thus low bioavailability or which dissociate in ions which are efficiently regulated in the human body, i.e.OH-and Ca2+. Therefore, based on the available data on the constituents of the reaction mass of calcium carbonate, calcium dihydroxide and silicon dioxide, a classification for toxicity to reproduction was not considered justified.

Additional information