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EC number: 235-330-6 | CAS number: 12167-74-7
- 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:
- 02/02/1982 to 29-05-1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study not conducted to current guideline, however study is scientifically sound and acceptable for assessment. This study has been selected as the key study because the results are sufficient in order to derive a reliable conclusion on classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). Pentacalcium hydroxide tris(orthophosphate) is not considered to be classified according to Regulation (EC) No. 1272/2008 (EU CLP).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA Guidelines(24/05/1982) FR22405), OECD Guidelines (1981), and PR Notice 81-3
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- however, study predates the introduction of GLP
Test material
- Reference substance name:
- Pentacalcium hydroxide tris(orthophosphate)
- EC Number:
- 235-330-6
- EC Name:
- Pentacalcium hydroxide tris(orthophosphate)
- Cas Number:
- 12167-74-7
- Molecular formula:
- Ca5HO13P3
- IUPAC Name:
- Calcium hydroxycalcium(1+) phosphate (4:1:3)
- Reference substance name:
- tricalcium phosphate
- IUPAC Name:
- tricalcium phosphate
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Stauffland albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, CA
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: two in a cage in suspended steel cages (24" x 16.5 " x 14").
- Diet: ad libitum; Special Mixture, Gunter Bros., Morgan Hill, CA.
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature: 65-70°F (18.3 - 21.1°C)
- no other data pertinent to environmental conditions.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
The solid test material was passed through a #300 mesh screen and the fines were used. 100mg of the test material was used.
VEHICLE
No vehicle used. The test material was not moistened before being placed in the eye. - Duration of treatment / exposure:
- Three animals had their eyes washed 20-30 seconds after application and a further six animals did not.
- Observation period (in vivo):
- 1, 24, 48 and 72 hours and then at 4 and 7 days post application.
If after 7 days irritation was present then additional observations would be made every 3-4 days. - Number of animals or in vitro replicates:
- 9
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
20-30 seconds after application three animals had their eyes washed with luke warm water for one minute, the remaing six animals did not.
SCORING SYSTEM: The guidelines described by Draize (1965) were used to assign numerical scored to the observed effects.
TOOL USED TO ASSESS SCORE: fluorescein
Fluorescein staining was graded using a modified procedure outlined by the National Research Council (1977)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Unwashed eyes: Three of the six animals exhibited a redness of the conjuctiva on day 1 after administration. No other effects were observed.
Washed eyes: All zero scores at all timepoints.
Any other information on results incl. tables
Individual eye scores for rabbits whose eyes were unwashed:
Animal No. |
Irritation |
Pre-dose |
Day 1 |
Day 2 |
Day 3 |
Day 4 |
Day 7 |
82-M-341 |
Cornea: opacity |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea: area |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: redness |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
82-M-342 |
Cornea: opacity |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea: area |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: redness |
0 |
1 |
0 |
0 |
0 |
0 |
|
Conjuctiva: chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
82-M-343 |
Cornea: opacity |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea: area |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: redness |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
82-M-344 |
Cornea: opacity |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea: area |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: redness |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
82-M-345 |
Cornea: opacity |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea: area |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: redness |
0 |
1 |
0 |
0 |
0 |
0 |
|
Conjuctiva: chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: discharge |
0 |
0 |
0 |
0 |
0 |
0 |
|
82-M-346 |
Cornea: opacity |
0 |
0 |
0 |
0 |
0 |
0 |
Cornea: area |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: redness |
0 |
1 |
0 |
0 |
0 |
0 |
|
Conjuctiva: chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjuctiva: discharge |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was classed as a mild conjuctival irritant to the eyes of stauffland rabbits. Three of the six animals whose eyes were not washed after application exhibited a redness of the conjuctiva. All effects were reversed by day 2. Pentacalcium hydroxide tris(orthophosphate) is has not to be classified according to Regulation (EC) No. 1272/2008 (EU CLP).
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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