Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 264-731-9 | CAS number: 64216-15-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data available
- Reliability:
- other: not rated acc. to Klimisch
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well-documented study on Ca supplementation to young pregnant women to prevent preterm delivery. In the current study, calcium was supplemented to humans in the form of calcium carbonate. The carbonate ion is released as CO2 following reaction with gastric juice and is therefore toxicologically not relevant. The objective of the study was the evaluation of any effects of calcium.
Data source
Reference
- Reference Type:
- publication
- Title:
- Calcium supplementation during pregnancy may reduce preterm delivery in high-risk populations
- Author:
- Villar, J.; Repke, J.T.
- Year:
- 1 990
- Bibliographic source:
- Am. J. Obstet. Gynecol, Vol. 163, No. 4, Part 1, 1124-1131
Materials and methods
- Study type:
- medical monitoring
- Endpoint addressed:
- developmental toxicity / teratogenicity
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Medical monitoring, double-blind controlled clinical trial of calcium supplementation during pregnancy
- GLP compliance:
- no
Test material
- Reference substance name:
- Calcium carbonate
- EC Number:
- 207-439-9
- EC Name:
- Calcium carbonate
- Cas Number:
- 471-34-1
- Molecular formula:
- CaCO3
- IUPAC Name:
- calcium carbonate
- Details on test material:
- - Name of test material (as cited in study report): Calcium carbonate
- Physical state: solid
No further details are given.
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Details on study design:
- All participants were 17 years of age or less and clinically healthy. Patients were enrolled by the 21st week of gestation. The mean duration of supplementation with 2.0 g Ca or placebo was approximately 14 weeks. The Ca tablets contained 500 mg of elemental Ca as CaCO3. 94 women received 3.0 (±1.4) tablets per day in the Ca group and 95 women received 2.8 (±1.5) tablets per day in the placebo group. Dietary Ca intake was similar in both groups at about 1200 mg/day.
Results and discussion
- Results:
- The Ca group had a lower incidence of preterm delivery (< 27 weeks; 7.4% vs. 21.1%; p=0.007); spontaneous labour and preterm delivery (6.4% vs. 17.9%; p=0.01), and low birth weight (9.6% vs. 21.1%; p=0.03). This effect was also present after stratified analysis by level of treatment compliance, urinary tract infection, and chlamydial infection. Life-table analysis demonstrated an overall shift to a higher gestational age in the Ca group compared with the placebo group.
Applicant's summary and conclusion
- Conclusions:
- The calcium group had a lower incidence of preterm delivery, spontaneous labour and preterm delivery, and low birth weight. This effect was also present after stratified analysis by level of treatment compliance, urinary tract infection, and chlamydial infection. Life-table analysis demonstrated an overall shift to a higher gestational age in the calcium supplemented group compared with the placebo group.
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.