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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well-documented publication. Under physiological conditions the carbonate contained in the test substance calcium carbonate is released as CO2 upon contact with the acid environment in the stomach and is therefore not relevant for consideration of systemic toxicity. The study allows the derivation of a NOAEL value for effects of Ca regarding developmental toxicity.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Foetal development in rats fed AIN-76A diets supplemented with excess calcium
- Author:
- Shackelford, M.E.; et al.
- Year:
- 1 993
- Bibliographic source:
- Fd Chem. Toxicol. 31, 953-961
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not specified
- GLP compliance:
- no
- Limit test:
- 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
- Purity: 98.62%
- Physical state: solid
No further details are given.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD/VAF Plus
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc. (Wilmington, MA, USA)
- Age at study initiation: when received, the females were 52 days old and the males were 44 days old
- Weight at study initiation: 217 g (females)
- Housing: Animals, identified by numbered metal ear tags, were housed in stainless-steel cages.
- Diet: ad libitum; females received powdered AIN-76A diet for 6 weeks before and throughout mating and for 20 days of gestation; male rats were fed pelleted Purina Rodent Chow except during mating, when they also received one of the four experimental diets.
- Water: ad libitum, deionised water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-27
- Humidity (%): 25-72
- Photoperiod: 12 hour light/dark cycle
No further details are given.
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with laboratory diet: The formulation of powdered AIN-76A diet is recommended as nutritionally adequate for rats by the American Institute of Nutrition. The mineral mix of the AIN-76a diet was slightly modified. The copper content was inceased from 6 to 9 mg/kg diet by seperate addition of cupric carbonate. Dietary calcium was adjusted with calcium carbonate.
- Storage temperature of food: During the duration of the study, the diets were stored in a walk-in refrigerator (-1 to -6°C) to maintain nutrient stability. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The diets were assayed for homogeneity and concentrations of Ca, P, Mg, Mn, Zn, Fe and Cu by the New Jersey Feed Laboratory, Inc., using the methods of the Association of Official Analytical Chemists.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: female rats were mated to males at a 2:1 ratio
- Length of cohabitation: approximately 24 hours
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy
- Any other deviations from standard protocol: no
No further details are given. - Duration of treatment / exposure:
- Rats were given calcium rations in diet for 6 weeks before mating, during mating and for 20 days of gestation.
- Frequency of treatment:
- continuously
- Duration of test:
- until day 20 of gestation
- No. of animals per sex per dose:
- - 156 male rats
- From the total of 291 female animals, 276 female rats were divided into 4 groups of 69 animals
- 15 female rats were randomly selected for evaluation of tissue mineral status and histopathology before assignment to the 4 dietary groups - Control animals:
- yes
- Details on study design:
- no further details given
Examinations
- Maternal examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: Female animals were weighed every 3 days for 6 weeks before mating and during gestation, but not during mating.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Time schedule: Feed consumption was measured every 3 days for 6 weeks before mating and during gestation, but not during mating.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data; not applicable
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: Laparotomy was performed on each dam, and the major organs were examined. In each case, the uterus was opened and examined in situ for the presence and position of resorption sites and foetuses (dead or alive) and the number of implantation sites.
OTHER:
- 135 female rats were randomly selected for determination of tissue mineral level at three time points during the study: 15 animals before assignment of diet groups, 15 animals per group (total of 60) after 6wks on the diet, and 15 animals per group (total of 60) at Caesarian section. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes
- Other: Yes, uterine position, sex, weight and crown-rump lenght of each foetus - Fetal examinations:
- - External examinations: Yes: Foetuses were examined individually for gross abnormalities. The uterine position, sex, weight and crown-rump length of each foetus were recorded.
- Soft tissue and skeletal examinations: Yes: Foetuses were assigned to skeletal or visceral analysis. Approximately half of the foetuses were fixed and stained and examined microscopically for skeletal variations. The remaining half were fixed and microscopically examined for internal variations of the soft tissues.
- Head examinations: Yes
- Other: Yes, from 12 litters in each group two foetuses were randomly selected for whole body mineral determinations. - Statistics:
- All statistical analyses were performed by the Division of Methematics, US FDA.
- Indices:
- Implantation efficiency
- Historical control data:
- no data given
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
Both the non-pregnant and pregnant rats in the 0.75, 1.0 and 1.25 % groups ate slightly more than the control group, but this increase was not statistically significant. There was no consistent pattern of increase or decrease in weight gain.
No dose-related changes were found in maternal clinical findings, the average number of implantations and resorptions.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1.25 other: % Ca in diet
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No dose-related changes were found in the average number of viable foetuses or foetal length or weight. Under the conditions of the study, there were no statistically significant increases as compared with the control group in the litter incidence regarding specific external, visceral or skeletal variations of the foetuses.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Dietary calcium was neither foetotoxic nor teratogenic at the concentrations used. The highest dietary dose of 1.25 % Ca is considered to be the NOAEL for developmental effects in this study.
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