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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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-12-22
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline study reliable with restrictions - The purity and stability was not given in the test report. Minor deviation with no effect on the study results: - According to the guideline, any effects other than ocular which are observed should be stated. It was not mentioned in this study if other than ocular effects were observed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- , adopted 1987-02-24
- Deviations:
- yes
- Remarks:
- , see "rationale for reliability"
- GLP compliance:
- yes
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 (from Laboratoire Central Balthazar et Cotte)
- Physical state: White powder
- Batch No.: 3542
- Storage condition of test material: At ambient temperature
- pH: The pH of the product, at 10 % concnetration in distilled water, measured at the International Toxicology Centre, was about 9.
No further information on the test material was stated.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Weight at study initiation: 2708 g
- Housing: polystyrene cage (35 X 55 X 32 cm or 48.2 X 58 X 36.5 cm) equipped with a trough and bottle.
- Diet (ad libitum): Food in the form of granules " Rabbit maintenance, Reference 112 C" (UAR, 91360 Villemoisson-sur-Orge, France).
- Water (ad libitum): Drinking water
- Acclimation period: 5 days before the start of the study
ENVIRONMENTAL CONDITIONS
- Temperature: 18 +/- 3 °C
- Humidity: 30 to 70 %
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animal was stated.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: The lower eyelid was delicately opened, and a single dose of 100 mg of the product as such was introduced in the conjuctival cul-de-sac of the left eye of the animal. The lower and upper lids were maintained in contact for a second to prevent any loss of product. The right eye was administered no product and served as control.
No further information on amount/concentration applied was stated. - Observation period (in vivo):
- The eyes were examined 1 hour after the administration of the product.
- Number of animals or in vitro replicates:
- one male rabbit
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
The eyes were not rinsed after the administration of the product.
SCORING SYSTEM: Draize scoring system
All other damage observed was recorded.
TOOL USED TO ASSESS SCORE: If necessary the cornea was examined with an ultra-violet lamp. In the case of doubt as to the presence of corneal opacity, the eye was subjected to UV examination (the areas of corneal impairment are distinguished by a very clear fluorescence).
No further information on the study design was stated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 hour after administration
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: Given the seriousness of the eye lesions observed, the animal was put down for humanitarian reasons, and the product was not tested on the other 2 rabbits.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 hour after administration
- Score:
- 3
- Max. score:
- 3
- Remarks on result:
- other: Given the seriousness of the eye lesions observed, the animal was put down for humanitarian reasons, and the product was not tested on the other 2 rabbits.
- Irritant / corrosive response data:
- Very severe eye reactions were observed 1 hour after the treatment, with pronounced chemosis (score:3), necrotised appearance of the conjunctiva, whitish watering and total opacity of the cornea, showing nacreous appearance. The iris was no longer visible.
Given the seriousness of the eye lesions observed, the animal was put down for humanitarian reasons, and the product was not tested on the other 2 rabbits.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the given experimental conditions, the product, calcium hydroxide, is considered as an irritant to the eye in rabbits.
According to the Directive 67/548/EEC and subsequent regulations, the classification of the product, calcium hydroxide, should be irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as Category 1.
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