Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 932-084-8 | CAS number: -
Endpoint summary
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
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.
