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Diss Factsheets
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EC number: 946-103-2 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- TNO Triskelion, Utrechtseweg 48, 3700 AV, Zeist
Test material
- Reference substance name:
- Calcium hydrosilicate, reaction product of natural quartz sand and technical lime by a hydrothermal and tribochemical process
- EC Number:
- 946-103-2
- IUPAC Name:
- Calcium hydrosilicate, reaction product of natural quartz sand and technical lime by a hydrothermal and tribochemical process
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Celitement
- Chemical name: Calcium hydrosilicate
- Physical state: White powder
- pH-value: 10.5
- Expiration date of the lot/batch: 12/2015
- Stability under test conditions: Hydration reaction with water
- Storage condition of test material: Room temperature protected from light, in original container in evacuated desiccator
Constituent 1
Test animals / tissue source
- Species:
- other: eyes of male or female chickens (ROSS, spring chickens)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: slaughterhouse, v.d. Bor, Nijkerkerveen, The Netherlands
- Age at study initiation: approximately 7 weeks
- Weight at study initiation: approximately 1.5 - 2.5 kg
- Heads of the animals were cut off immediately after sedation of the animals by electric shock and incision of the neck for bleeding, and before they reached the next station on the process line. The heads were placed in small plastic boxes on a bedding of paper tissues moistened with isotonic saline. Next they were transported to the testing facility. During transportation, the heads were kept at ambient temperature.
- The preparation and validation of the eyes prior to the ICE-test were all according to OECD guideline 438.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 30 mg - Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- 0, 30, 75, 120, 180, and 240 minutes
- Number of animals or in vitro replicates:
- 3 eyes
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The eyes were rinsed with 20 mL saline
- Time after start of exposure: 10 seconds
SCORING SYSTEM: According to OECD 438 guideline.
TOOL USED TO ASSESS SCORE: All examinations were carried out with the hand-slit lamp microscope. Fluorescein retention was only scored at approximately 30 minutes after treatment.
CONTROLS: A negative control (30 µL physiological saline) and 3 positive controls (30 mg Imidazole) were included.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- swelling (%)
- Basis:
- mean
- Time point:
- other: 240 min
- Score:
- 7
- Remarks on result:
- other: Maximum value during the test
- Irritation parameter:
- cornea opacity score
- Remarks:
- opacity
- Basis:
- mean
- Time point:
- other: 120, 180, and 240 min
- Score:
- 1.8
- Max. score:
- 4
- Remarks on result:
- other: Maximum value during the test
- Irritation parameter:
- cornea opacity score
- Remarks:
- fluorescein retention
- Basis:
- mean
- Time point:
- other: 30 min
- Score:
- 2.2
- Max. score:
- 3
- Irritant / corrosive response data:
- Slit-lamp examination: After rinsing of the cornea, remnants of the test substance were present on the cornea and could not be removed. The test substance caused slight corneal swelling (7%), slight to moderate or moderate corneal opactiy (1.8) and moderate or moderate to severe fluorescein retention (2.2). In addition, spots with erosion of epithelium was observed in one eye. The negative control eye did not show any corneal effect and demonstrated that the general conditions during the test were adequate. The positive control eyes showed severe corneal effects and demonstrated the ICE test valid to detect severe eye irritants.
MIcroscopic examination: Microscopic examination of the corneas treated with the test substance revealed very slight erosion of the epithelium. Microscopic examination of the cornea treated with the negative control (saline) did not reveal any abnormalities. The positive control Imidazole caused severe erosion and necrosis of the epithelium.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions (OECD 438 and GLP) the test substance is considered to be an eye irritant.
- Executive summary:
In accordance to OECD guideline 438 and GLP the test substance was examined for its in vitro eye irritating potential using the Isolated Chicken Eye (ICE) Test. In the ICE test, 3 eyes were exposed to 30 mg test substance for 10 seconds. In addition, one negative control eye (30 µL saline) and three positive control eyes (30 mg imidazole) were tested. After the exposure the eyes were rinsed with 20 mL saline and were examined at approximately 0, 30, 75, 120, 180, and 240 minutes after treatment. The test substance caused slight corneal swelling (7%), slight to moderate or moderate corneal opactiy (1.8) and moderate or moderate to severe fluorescein retention (2.2). In addition, spots with erosion of epithelium was observed in one eye. The negative control eye did not show any corneal effect while the positive control eyes showed severe corneal effects. Microscopic examination of the corneas treated with the test substance revealed very slight erosion of the epithelium. Microscopic examination of the cornea treated with the negative control did not reveal any abnormalities. The positive control caused severe erosion and necrosis of the epithelium. Based on the results obtained in the present study, the test substance is considered to be irritating to eyes. Based on GHS and CLP, the test substance can be classified as category 2A and category 2 substance, respectively.
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