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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 266-340-9 | CAS number: 66402-68-4 This category encompasses the various chemical substances manufactured in the production of ceramics. For purposes of this category, a ceramic is defined as a crystalline or partially crystalline, inorganic, non-metallic, usually opaque substance consisting principally of combinations of inorganic oxides of aluminum, calcium, chromium, iron, magnesium, silicon, titanium, or zirconium which conventionally is formed first by fusion or sintering at very high temperatures, then by cooling, generally resulting in a rigid, brittle monophase or multiphase structure. (Those ceramics which are produced by heating inorganic glass, thereby changing its physical structure from amorphous to crystalline but not its chemical identity are not included in this definition.) This category consists of chemical substances other than by-products or impurities which are formed during the production of various ceramics and concurrently incorporated into a ceramic mixture. Its composition may contain any one or a combination of these substances. Trace amounts of oxides and other substances may be present. The following representative elements are principally present as oxides but may also be present as borides, carbides, chlorides, fluorides, nitrides, silicides, or sulfides in multiple oxidation states, or in more complex compounds.@Aluminum@Lithium@Barium@Magnesium@Beryllium@Manganese@Boron@Phosphorus@Cadmium@Potassium@Calcium@Silicon@Carbon@Sodium@Cerium@Thorium@Cesium@Tin@Chromium@Titanium@Cobalt@Uranium@Copper@Yttrium@Hafnium@Zinc@Iron@Zirconium
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented study on Ca supplementation to prevent the recurrence of colorectal adenomas.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Calcium supplements for the preventation of colorectal adenomas
- Author:
- Baron, J.A.; et al.
- Year:
- 1 999
- Bibliographic source:
- New England J. Med., Vol. 340, No. 2, 101-107
Materials and methods
- Study type:
- medical monitoring
- Endpoint addressed:
- carcinogenicity
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Medical monitoring, double-blind placebo controlled trial for prevention of recurrence of colorectal adenomas
- GLP compliance:
- no
Test material
- Reference substance name:
- Calcium carbonate
- EC Number:
- 207-439-9
- EC Name:
- Calcium carbonate
- Cas Number:
- 471-34-1
- IUPAC Name:
- calcium carbonate
- Details on test material:
- - Name of test material (as cited in study report): Calcium carbonate
No further details are given.
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- 930 subjects (mean age, 61 years; 72 % men) with a recent history of colorectal adenomas were randomly assigned to receive either calcium carbonate (3 g [1200 mg of elemental calcium] daily) or placebo, with follow-up colonoscopies 1 and 4 years after the qualifying examination. The primary endpoint was the proportion of subjects in whom at least one adenoma was detected after the first follow-up endoscopy but up to (and including) the second follow-up examination. Risk ratios for the recurrence of adenomas before the study, clinical center, and length of the surveillance period.
Results and discussion
- Results:
- The subjects in the calcium group had a lower risk of recurrent adenomas. Among the 913 subjects who underwent at least one study colonoscopy, the adjusted risk ratio for any recurrence of adenoma with calcium as compared with placebo was 0.85 (95 % CI: 0.74 to 0.98; P=0.03). The main analysis was based on the 832 subjects (409 in the calcium group and 423 in the placebo group) who completed both follow-up examinations. At least one adenoma was diagnosed between the first and second follow-up endoscopies in 127 subjects in the calcium group (31%) and 159 subjects in the placebo group (38%); the adjusted risk ratio was 0.81 (95 % CI: 0.67 to 0.99; P=0.04). The adjusted ratio of the average number of adenomas in the calcium group to that in the placebo group was 0.76 (95 % CI: 0.6 to 0.96; P=0.02). The effect of calcium was independent of initial dietary fat and calcium intake.
Applicant's summary and conclusion
- Conclusions:
- Calcium supplementaion is associated with a significant - though moderate - reduction of the risk of recurrent colorectal adenomas.
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