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Diss Factsheets
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EC number: - | CAS number: -
- 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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a sub-chronic toxicity study (90 days) does not need to be conducted because a reliable chronic toxicity study is available, conducted with an appropriate species and route of administration
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
According to Annex IX, section 8.6.2, column 2 of Regulation No. 1907/2006, repeated dose toxicity testing by the dermal route is appropriate if 1) inhalation of the substance is unlikely, 2) skin contact in production and/or use is likely and 3) one of the following conditions is met: toxicity is observed in the acute dermal toxicity test at lower doses than in the oral toxicity test; or, systemic effects or other evidence of absorption is observed in skin and/or eye irritation studies; or, in vitro tests indicate significant dermal absorption; or, significant dermal toxicity or dermal penetration is recognised for structurally-related substances. Although skin contact during production and use is possible, inhalation is expected to be the primary route of exposure. The substance is an inorganic ionic solid. It is expected to partition strongly to water rather than organic media. While it is not possible to measure or accurately predict an octanol/water partition coefficient for inorganic ionic substances, such a value would be expected to be very low. Electrolytes are also known not to penetrate the skin in any significant quantity. Given the physico-chemical properties of calcium carbonate (a component of the substance), it is not expected that the substance would penetrate the skin in any significant quantity and so would therefore not cause any toxic effects following repeated dermal exposure. Acute oral (Bradshaw, 2008) and dermal toxicity (Bradshaw, 2010) studies were performed in the rat using test concentrations of 2000 mg/kg of calcium carbonate and calcium carbonate (nano), respectively. No mortalities or signs of systemic toxicity were observed in either study and no irritation was observed in the dermal study. Hence, calcium carbonate is not acutely toxic via the oral and dermal routes. Furthermore, a 28 day repeat dose oral toxicity study in rats was performed according to OECD Guideline 422 and GLP with concentrations of calcium carbonate (nano) of 0, 100, 300 and 1000 mg/kg bw/day (Dunster, 2010). Treatment-related effects were observed at all dose levels. However, these effects were considered not to represent an adverse effect of treatment. Hence, the NOAEL for systemic toxicity was considered to be 1000 mg/kg bodyweight/day and calcium carbonate is not considered to be toxic following repeated oral exposure for a period of 28 days. In addition, there was no evidence of systemic toxicity or absorption of the test material observed in the skin irritation and eye irritation studies (Sanders, 2004). In a study similar to OECD 452 rats have received the test item silicic acid, calcium salt (read-across substance) via feed (1, 5, 7.5 and 10% nominal in diet). No difference in survival from the control and no gross signs of toxicity have been reported. In the highest dose group growth suppression and slightly elevated pH of the urine but no tumours have been observed. The NOEL is considered to be the 5% dietary level, which is estimated to correspond to about 2500 – 3200 mg/kg bw/day, based on reduction in body-weight gain and isolated cases of calculi and brittle in kidney and urinary bladder, respectively, as well as a few cases of cholangitis-like lesions at the higher dose levels (Columbia, 1956).
Based on this information, repeated dose toxicity studies via the dermal route are therefore scientifically unjustified also due to animal welfare reasons.
Data source
Materials and methods
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.
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