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Diss Factsheets
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EC number: 215-137-3 | CAS number: 1305-62-0
- 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:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable publication. Purity of the test material unknown.
Data source
Reference
- Reference Type:
- publication
- Title:
- Development and Interlaboratory Evaluation of an in Vitro Human Cell-Based Test to Aid Ocular Irritancy Assessments
- Author:
- Osborne R, Perkins MA and Roberts DA
- Year:
- 1 995
- Bibliographic source:
- Fundamental and Applied Toxicology 28: 139-153
Materials and methods
- Principles of method if other than guideline:
- A human cell-based in vitro method was developed to screen for ocular irritancy potential of aqueous compatible and incompatible test agents, such as liquids, insoluble solids, powders, granulars, emulsions, and acids/alkalis.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Calcium dihydroxide
- EC Number:
- 215-137-3
- EC Name:
- Calcium dihydroxide
- Cas Number:
- 1305-62-0
- Molecular formula:
- CaH2O2
- IUPAC Name:
- calcium dihydroxide
- Details on test material:
- - Name of test material (as cited in study report): Calcium hydroxide powder
- Analytical purity: no data given
Constituent 1
Test system
- Vehicle:
- not specified
- Amount / concentration applied:
- The substances were tested at the same concentration (undiluted) tested previously in vivo.
- Duration of treatment / exposure:
- up to 30 min
- Details on study design:
- Cell cultures used in this work were cocultured human foreskin-derived dermal fibroblasts and epidermal keratinocytes, grown on a nylon mesh substrate. The final cultures were noncornified stratified squamous epithelium and resemble the outermost stroma and epithelium of the cornea.
The hypothesis tested and confirmed in this work was that the rate of cytotoxicity induced by topical application of the test material to the stratified epithelial cell cultures would correlate with ocular irritancy.
The test materials were applied to the cell system for up to 30 min., and cytotoxicity was measured as decreased 3-[4,5-dimethylthiazol-2-yl]2,5-diphenyltetrazolium bromide (MTT) vital dye metabolism. The time (in minutes) of exposure to test agent that reduced MTT metabolism to 50 % of control levels (the t50 value) was calculated.
These values were compared to historic rabbit low-volume eye test maximum average scores (LVET MAS).
Results and discussion
In vivo
Results
- Irritation parameter:
- other: irritation
- Basis:
- other: not applicable
- Time point:
- other: not applicable
- Score:
- > 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: The potential of the test substance to cause serious damage to the eye is evident.
- Irritant / corrosive response data:
- The test material calcium hydroxide was a highly irritating substance and damaged the cultures very rapidly. The t50 value was 0.29 +/- 0.01 min (n=2). This result was in good correlation with the results obtained in an in-vivo LVET-MAS (46.3 +/- 1.7), (n=3).
For comparison, a non-irritating material which was also tested in this study (a skin care product), had a t50 value of >30 min and a LVET-MAS of 0.0 +/- 0.0.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information
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