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EC number: 914-172-8 | CAS number: -
- 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
- Remarks:
- Carried out before the entry into force of the amendments to Annexes VII and VIII
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- In vivo study was carried out before the entry into force of the amendments to Annexes VII and VIII
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- reaction mass of calcium bis(dihydrogenorthophosphate) and calcium hydrogenorthophosphate
- EC Number:
- 914-172-8
- Molecular formula:
- not available
- IUPAC Name:
- reaction mass of calcium bis(dihydrogenorthophosphate) and calcium hydrogenorthophosphate
- Details on test material:
- Sponsor's identification : a reaction mass of monocalcium phosphate and dicalcium phosphate
Description : cream coloured granular solid
Batch number : not supplied
Date received : 05 May 2010
Expiry date : 05 May 2012
Storage conditions : room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd., Loughborough, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.63 kg
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL, weighing approximately 93 mg. - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): None
SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix 2, (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49). Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope. Any clinical signs of toxicity, if present, were also recorded. Additional observations were made on Days 7 and 11 to assess the reversibility of the ocular effects. The animal’s bodyweight was recorded on Day 0 (the day of dosing) and at the end of the observation period.
TOOL USED TO ASSESS SCORE: ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: a score of 3 for corneal opacity was recorded on day 11
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 11 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 11 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 11 days
- Other effects:
- Individual scores for ocular irritation are given in Table 1. Opalescent areas of the cornea were noted in the treated eye at the 11-Day observation.
Iridial inflammation and moderate conjunctival irritation were noted in the treated eye one hour after treatment and at the 24, 48, 72-Hour, 7 and 11-Day observations.
A pale area on the nictitating membrane, approximately 5 mm x 5 mm in size, was noted in the treated eye at 7-Day observation. Additional ocular effects noted in the treated eye at the 11-Day observation were vascularisation, with a generalised ingrowth of vessels for approximately 3 mm, over lower half of cornea, pale areas on the remainder of the nictitating membrane and lower conjunctival membrane, blood stained discharge, a white area on the nictitating membrane, approximately 10 mm x 10 mm in size, and also scattered areas on the lower conjunctival membrane, and a small area of sloughing on lower edge of the nictitating membrane, approximately 1 mm x 4 mm in size, which had almost completely detached. The reactions noted were considered to be indicative of irreversible ocular damage. Due to worsening reactions the animal was killed for humane reasons immediately after the 11-Day observation in accordance with current UK Home Office guidelines.
Any other information on results incl. tables
Table 1: Individual scores for ocular irritation
Rabbit number and sex |
69653 male |
|||||
IPR = 2 |
||||||
Time after treatment |
1 hour |
2 hours |
48 hours |
72 hours |
7 days |
11 days K |
CORNEA |
||||||
Degree of opacity |
0 |
0 |
0 |
0 |
0 |
3 |
Area of cornea involved |
0 |
0 |
0 |
0 |
0 |
2 |
IRIS |
1 |
1 |
1 |
1 |
1 |
1 |
CONJUNCTIVA |
||||||
Redness |
2 |
2 |
2 |
2 |
2 |
2 |
Chemosis |
2 |
2 |
2 |
2 |
2 |
2 |
Discharge |
2 |
3 |
3 |
3 |
1 |
2 |
Other reactions |
- |
- |
- |
- |
P |
VBsWP*Sl |
IPR = Initial pain reaction V = Vascularisation, with a generalised ingrowth of vessels for approximately 3 mm, over lower half of cornea
P = Pale area on nictitating membrane, approximately 5 mm x 5 mm in size
Bs = Blood stained discharge
P* = Pale area on remainder of nictitating membrane and lower conjunctival membrane
W = White area on nictitating membrane, approximately 10 mm x 10 mm in size, and scattered areas on lower conjunctival membrane
Sl = Sloughing, small area on lower edge of nictitating membrane approximately 1 mm x 4 mm in size, almost completely detached
K = Due to the persistence of severe reactions, animal killed for humane reasons in accordance with current UK Home Office guidelines
- = Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In accordance with Regulation (EC) No. 1272/2008 the reaction mass of calcium bis(dihydrogenorthophosphate) and calcium hydrogenorthophosphate is classified as Category 1: irreversible effects on the eye/serious damage to eyes due to the severe reactions noted at day 7 which led to the animal being euthanized for humane reasons.
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