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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
Endpoint summary
Administrative data
Description of key information
Skin irritation (similar to OECD 404, RL2): not irritating
Eye irritation (OECD 405, RL1): not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Animals were examined at 24 and 72 hours only. No data reported on reversibility of effects. Study uses intact and abraded skin. No controls were included in the study.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Animals were examined at 24 and 72 hours only. No data reported on reversibility of effects. Study uses intact and abraded skin. No controls were included in the study.
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- occlusive
- Preparation of test site:
- other: Shaved, abraded and intact
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.5 g
VEHICLE
Used as received. - Duration of treatment / exposure:
- 24 hours
- Observation period:
- Up to 72 hours
- Number of animals:
- 6, 3 males and 3 females.
- Details on study design:
- TEST SITE
- Type of wrap if used: Rubber (occlusive)
REMOVAL OF TEST SUBSTANCE
No data
SCORING SYSTEM:
The Draize dermal method of testing primary irritant substance as described in the Code of Federal Refulations under the Federal Hazardous Substances Labelling Act, Part 191.11, Chapter 1, Title 21.
Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; indexes from 2 to 5 are moderate irritants and those with scores above 5 are considered severe or primary irritants. - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Other effects:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No effects were noted throughout the study. Dicalcium phosphate is a non-irritant to both intact and abraded skin.
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). Calcium hydrogenorthophosphate is not considered to be classified according to Regulation (EC) No. 1272/2008 (EU CLP) as no effects for the parameters erythema/eschar or oedema are noted.
Reference
Table 1: Results for Dicalcium phosphate
Exposure time Hours |
Rabbit No. |
Mean |
||||||
|
8M |
15M |
16M |
32F |
33F |
34F |
||
|
Score |
Score |
Score |
Score |
Score |
Score |
||
Erythema |
||||||||
24 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
72 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
24 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
72 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Subtotal |
0.0 |
|||||||
Oedema |
||||||||
24 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
72 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
24 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
72 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
Subtotal |
0.0 |
|||||||
Total score |
0.0 |
|||||||
(Total/4) Primary Irritation Index |
0.0 |
|||||||
Result |
Non-Irritant |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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
- 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 - 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. - 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.
- 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). - Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 December 2010 - 16 December 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- This study is conducted according to an appropriate guideline and under the conditions of GLP, the study is therefore considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement for this endpoint. However as a key study is already available (and this data was provided from a source outside of the EU) it is not required as a key study and therefore the Inorganic Phosphates Consortium have not paid for a letter of access to this data but has agreed with the data owner that a summary can be included in the IUCLID.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- yes
- Remarks:
- No in process inspection was performed due to early termination of the study. 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:
- No in process inspection was performed due to early termination of the study. 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:
- No in process inspection was performed due to early termination of the study. 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
- 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 (e.g. ad libitum): ad libitum; Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): ad libitum, filter tap water was dispensed by an automatic dispensing system.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-22°C
- Humidity (%):21-40%
- Air changes (per hr): 11 or 14
- Photoperiod (hrs dark / hrs light): 12 hr light/dark cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- 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. - 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
- Basis:
- mean
- Time point:
- other: mean score following grading at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- There was no corneal opacity or irititis observed in any treated eye during this study. One hour post-instillation, two animals exhibited positive conjunctivitis and one animal exhibited minimal conjunctivitis. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation by 24 hours.
- Other effects:
- Apart from the ocular irritation noted at 1 hour post-instillation, the animals appeared active and healthy during the study. There were no signs of acute toxicity, abnormal behaviour or adverse pharmacologic effects.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study dicalcium phosphate (with 3% monocalcium phosphate) was determined to be not classified in accordance with the Guidance on the application of Regulation (EC) No. 1272/2008 (EU CLP). As such no further testing is required.
Referenceopen allclose all
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
Table 1. Individual scores for ocular irritation
|
Rabbit No. 3401 (M) |
Rabbit No. 3402 (M) |
Rabbit No. 3403 (M) |
|||||||||
Observation time |
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
1h |
24h |
48h |
72h |
Cornea |
|
|
|
|
|
|
|
|
|
|
|
|
Opacity |
0 |
01 |
0 |
0 |
0 |
01 |
0 |
0 |
0 |
01 |
0 |
0 |
Area |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
|
|
|
|
|
|
|
|
|
|
|
|
Redness |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
Chemosis |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Discharge |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
12% ophthalmic fluorescein sodium used to evaluate the absence of corneal opacity
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
In order to evaluate the skin irritating potential of calcium hydrogenorthophosphate one reliable in vivo skin irritation study is available. The study performed by Bullock & Kamienski in 1972 similar to OECD 404. This skin irritation test was performed with six albino rabbits (3 per sex). A 4-hour occlusive exposure to ca. 0.5 g of the unchanged test material, produced no effects during the whole observation period on the treated sites of the animals. The mean score for the 24, 48 and 72 h reading for erythema and edema, respectively, was 0. Under the conditions of the study, the test substance is considered to be non-irritating to skin. This result is supported by a further study done in 1974. This study is not sufficient for assessment because individual scores are not given in the study report. Nevertheless, no irritating effects were observed at any time point indicating that the test substance does not have an irritating potential.
Eye Irritation:
Three in vivo eye irritation tests are available for calcium hydrogenorthophosphate. Two eye irritation tests were performed in 2011 and 2012. Both studies serve as key study because they were performed according to OECD Guideline 405 just with test material of different purities. The test substance used in the study done in 2012 contained 10% calcium bis (dihydrogenorthophosphate) which is classified as Eye Dam. Cat. 1. Three New Zealand White rabbits were tested with 0.1 mL of the test material, which was placed into the conjunctival sac of the right eye. After application the animals were observed for 72 hours. The study done in 2011 with 95% calcium hydrogenorthophosphate showed mean scores for the 24, 48 and 72 hour reading for cornea opacity, iritis, conjunctivae redness and chemosis were all 0.0. The study done in 2012 with 90% calcium hydrogenorthophosphate showed mean scores for the 24, 48 and 72 hour reading for cornea opacity, iritis, conjunctivae redness and chemosis were 0.0, 0.0, 0.44 and 0.0, respectively.Conjunctivae redness was fully reversible after 48 hours in 2 of the 3 animals and after 72 hours for 1 of 3 animals. Both results conclude a non-irritating potential for calcium hydrogenorthorphosphate although containg the impurity of up to 10% calcium bis(dhydrogenorthophosphate) which has eye damaging potential.
The non-irritating potential of the test material is supported by further studies done in 1974 and 1973. These studies are not sufficient for assessment because individual scores are not given in the study report. Nevertheless, no irritating effects were observed at any time point indicating that the test substance does not have an irritating potential.
Conclusion
Taken together, the available data on irritation/corrosion with calcium hydrogenorthophosphate (CAS 7757 -93 -9) do not indicate any hazardous potential on skin and eye. Thus, the test substance is not to be classified regarding skin and eye irritation.
Justification for classification or non-classification
The available data on skin irritation with calcium hydrogenorthophosphate do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.
The available data on eye irritation with calcium hydrogenorthophosphate do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification. In addition, calcium hydrogenorthophosphate containing up to 10% calcium bis(dihydrogenorthophosphate) (classified as Eye Damage, Category 1) is also not classified in accordance with Regulation (EC) No. 1272/2008.
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