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EC number: 231-826-1 | CAS number: 7757-93-9
- 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:
- 19 January 2011 - 22 January 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- Specific information related to the characterisation of the test substance as received and as tested is the responsibility of the study Sponsor.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Specific information related to the characterisation of the test substance as received and as tested is the responsibility of the study Sponsor.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Specific information related to the characterisation of the test substance as received and as tested is the responsibility of the study Sponsor.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Calcium hydrogenorthophosphate
- EC Number:
- 231-826-1
- EC Name:
- Calcium hydrogenorthophosphate
- Cas Number:
- 7757-93-9
- Molecular formula:
- CaHPO4
- IUPAC Name:
- calcium hydrogen phosphate
- Reference substance name:
- 231-827-1
- IUPAC Name:
- 231-827-1
- Reference substance name:
- Calcium bis(dihydrogenorthophosphate)
- EC Number:
- 231-837-1
- EC Name:
- Calcium bis(dihydrogenorthophosphate)
- Cas Number:
- 7758-23-8
- Molecular formula:
- CaH4O8P2
- IUPAC Name:
- calcium dihydrogen phosphate
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services, Inc. Clemmons, NC
- Age at study initiation: Young adult
- Housing: Animals were singly housed in suspended stainless steel caging with mesh floors, which conform to the size recommendations in the most recent guide for the care and use of laboratory animals (Natl. Res. Council, 1996). Litter paper was placed beneath the cage and was changed at least 3 times a week.
- Diet: ad libitum; Pelleted Purina Rabbit Chow #5326
- Water: ad libitum, filter tap water was dispensed by an automatic dispensing system.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%):31-45
- Air changes (per hr): 14
- Photoperiod (hrs dark / hrs light): 12 hr light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The left eye of each rabbit was left untreated and served as a control.
SCORING SYSTEM: Ocular irritation was evaluated using a high intensity white light (Mag Lite) in accordance with Draize et al (1944) at 1, 24, 48 and 72 hours post-installation. A fluorescein dye procedure was used in the treated eye at 24 hours to evaluate the absence of corneal damage.
TOOL USED TO ASSESS SCORE: fluorescein and high-intensity white light.
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
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- There was no irititis observed in any treated eye during this study. One hour post-instillation, all three rabbits exhibited corneal opacity and ‘positive’ conjunctivitis. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation by 72 hours.
- Other effects:
- Apart from the ocular irritation noted above, the animals appeared active and healthy during the study. There were no signs of acute toxicity, abnormal behaviour or adverse pharmacologic effects.
Any other information on results incl. tables
Table 1. Individual scores for ocular irritation
|
Rabbit No. 3401 (F) |
Rabbit No. 3402 (F) |
Rabbit No. 3403 (F) |
|||||||||
Observation time |
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
Cornea |
|
|
|
|
|
|
|
|
|
|
|
|
Opacity |
1 |
01 |
0 |
0 |
1 |
01 |
0 |
0 |
1 |
01 |
0 |
0 |
Area |
2 |
4 |
4 |
4 |
1 |
4 |
4 |
4 |
1 |
4 |
4 |
4 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
Redness |
2 |
1 |
1 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
Chemosis |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Discharge |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
12% ophthalmic fluorescein sodium used to evaluate the absence of corneal opacity
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study dicalcium phosphate (with 10% monocalcium phosphate) was determined to be not classified in accordance with the Guidance on the application of Regulation (EC) No. 1272/2008 (EU CLP).
This study is considered to be acceptable and reliable for use as a key study and for classification and labelling in accordance with 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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