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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 261-235-4 | CAS number: 58398-71-3
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- no data available
- Reliability:
- other: high
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well-documented study on Ca supplementation to pregnant women to increase foetal bone mineralisation. Under physiological conditions, the hydroxyl-ions released from lime following oral adminstration have been neutralised in the GI tract and are therefore not relevant for consideration of systemic toxicity. Therefore for assessment of any systemic effects of lime following administration via the oral route, the calcium ion Ca2+ is the chemical species of interest. 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. In view of the the limited relevance of the anionic counter-ions discussed here, calcium released both from calcium hydroxide and calcium carbonate can be considered as structurally equivalent, and the results of the study can be used by read-across.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Maternal calcium supplementation and fetal bone mineralization
- Author:
- Koo, W.W.K.; et al.
- Year:
- 1 999
- Bibliographic source:
- Obstetrics Gynecology, Vol. 94, No. 4, 577-582
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:
- Prospective double-blind, randomised, controlled 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:
- CH2O3.Ca
- 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:
- Healthy women (19-20 years of age) with early ultrasound confirmation of dates and singleton pregnancies were enrolled in a double-masked study and randomised before 22 weeks of gestation to 2 g calcium per day or placebo until delivery (128 women per group). The calcium tablets contained 500 mg of elemental Ca as CaCO3. Maternal dietary intake at randomisation and at 32-33 weeks gestation was recorded with 24-hour dietary recalls. Dual-energy X-ray absorptiometry measurements of the whole body and lumbar spine of the neonates were performed before hospital delivery.
Results and discussion
- Results:
- The infants of all women had dual-energy X-ray absorptiometry measurements during the first week of life. There were no significant differences between the treatment groups in gestational age, birth weight, or length of the infants or in the total-body or lumbar spine bone mineral content.
However, when bone mineral content was analyzed by treatment group quintiles of maternal Ca intake, total-body bone mineral content was significantly greater in infants born to calcium-supplemented mothers in the lowest quintile of dietary Ca intake (less than 600 mg/day). The effect of calcium supplementation remained significant after adjustment for maternal age and maternal body mass index and after normalisation for skeletal area and body length of the infant.
Applicant's summary and conclusion
- Conclusions:
- The results indicate that maternal calcium supplementation of 2 g per day during the 2nd and 3rd trimester can increase foetal bone mineralisation in women with lower dietary calcium intake.
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.