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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

Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The test site area was larger at 2"x2" than the recommened 1"x1".
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- May 12, 1981
- Deviations:
- yes
- Remarks:
- minor deviations as test site larger than recommended; for more detail see "Further information on Material and Methods"
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. E.P.A. Pesticide Assessment Guidelines; Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984; 81-5 Primary Dermal Irritation Study.
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Commission of the European Communities, Council Directive 67/548/EEC, Annex V, Part B.4; May 1, 1987,
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: FMC Primary Skin Irritation Protocol (Number 16)
- Deviations:
- no
- GLP compliance:
- yes
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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HRP, Inc., Denver, PA on May 12, 1993
- Age at study initiation: The rabbits are referred to as 'young'.
- Weight at study initiation: 2.67 - 2.85 kg
- Housing: The animals were inidividually housed in stainless steel cages. Deosorb indirect bedding was used in the litter pans.
- Diet (e.g. ad libitum): Purina High Fiber Rabbit Chow 5326 was provided
- Water (e.g. ad libitum): Fresh tap water was provided
- Acclimation period: The animals were acclimated for a minimum of 5 days prior to study start.
ENVIRONMENTAL CONDITIONS
- Temperature: 65 - 69°F (18.3 - 20.6°C)
- Humidity (%): 45 - 66 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hour dark cycle.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: The test material was moistened with physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 gram - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- Six animals were used in this study, three males and three females. Per animal 2 test sites were prepared and dosed.
- Details on study design:
- TEST SITE
- Other: Per animal there were 2 test sites either side of the spinal column.
- Area of exposure: each site was approximately 26 square cm
- % coverage: no data
- Test material administration: The test material was weighed onto an 8-ply, 2"x2" gauze pad and moistened with physiological saline. The gauze pad was secured with hypoallergenic tape. The entire trunk of the animal was wrapped with a semi-occlusive cheesecloth bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: test sites were wiped with gauze moistened with methanol and then rinsed with tap water.
- Time after start of exposure: 4 h
SCORING SYSTEM: Approximately 30 minutes after unwrapping, the test sites of each rabbit were scored for irritation using the method of:
Draize J. H., G. Woodard and H. O. Calvery, J. Pharmacol. Exp. Ther., 83, 384 (1944). The 30 minute delay was instituted to allow for regression of pressure and hydration effects.
RATING SYSTEM: The FMC rating system.
- Non Irritating: No irritation observed in any animal at any scoring interval.
- Slightly irritating: Any animal exhibiting scores of 1 or less at any scoring interval and irritation clearing within 72 hours.
- Mildly irritating: Any animal exhibiting scores of 2 or less at any scoring interval and irritationg clearing within 7 days.
- Moderately irritating: Any animal exhibiting scores of 3 or less at any scoring interval and irritation clearing within 7 days.
- Severely irritating: Any animal exhibiting scores of 4 or less at any scoring interval.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- other: all 6 animals tested
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- other: all 6 animals tested
- Time point:
- other: mean 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No irritation was noted on any of the test sites during the study.
- Other effects:
- All animals remained healthy throughout the study.
Any other information on results incl. tables
Zero scores were recorded at all test sites at all time points, i.e. at 4.5, 24, 48 and 72 hours post exposure.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test material is judged to be non-irritating to intact skin when applied topically to New Zealand White rabbits.
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