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EC number: 231-837-1 | CAS number: 7758-23-8
- 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): irreversible effects on the eye
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
- Study period:
- 20/8/1984 to 7/11/1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- Reactions at abraded skin sites were also observed, observations were not recorded at 48 hr
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive dressing, also abraded skin tested, 48 hour reading is mising
- Principles of method if other than guideline:
- Study states protocols were consitent with or exceeded the requirements of EPA and OECD guidelines at the time of the study.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: Stauffland albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, California
- Weight at study initiation: 1.642 - 2.146 kg - Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and non-abraded (shaved) sites
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4 hours, 24 hours and 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 1 inch²
- % coverage: no data
- Type of wrap if used: rubber damming
SCORING SYSTEM: Draize, 1965 - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24/72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24/72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation was observed either in intact or abraded skin.
- Other effects:
- Not applicable
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Monocalcium phosphate was considered to be non-irritating. Calcium bis(dihydrogenorthophosphate) is not considered to be classified according to Regulation (EC) No. 1272/2008 (EU CLP).
Reference
Table 1: Results of a primary skin irritation study
Rabbit No |
Skin |
Erythema-eschar observation |
Edema observation |
Sum total |
Score* |
||||
4 hr |
24 hr |
72 hr |
4 hr |
24 hr |
72 hr |
||||
84-M-1084
|
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
84-M-1085 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
84-M-1086 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
84-M-1087 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
84-M-1088 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
84-M-1089 |
Intact |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Abraded |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
*score = sum of individual values for each rabbit divided by six
Primary Irritant Score = 0
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:
- The study was performed between 06 May 2010 and 02 June 2010.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Due to the low pH value of the test material a Rabbit Enucleated Eye Test (REET) was performed prior to the in vivo test. The results are given in Appendix 3 and indicated that the test material was unlikely to cause severe ocular irritancy.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:
Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation:
Twelve to twenty weeks old
- Weight at study initiation:
2.0 to 3.5 kg
- Housing:
The animals were individually housed in suspended cages. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Diet (e.g. ad libitum):
ad libitum (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK)
- 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 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
A volume of 0.1 mL of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball.
- Concentration (if solution):
Undiluted and used as supplied - Duration of treatment / exposure:
- Test material was administered once on day 1. Observations continued until day 21. The test material was not removed from the eye of the test animal.
- Observation period (in vivo):
- Approximately 1 hour and 24, 48 and 72 hours following treatment. Additional observations were made on Days 7, 14 and 21 to assess the reversibility of the ocular effects.
- Number of animals or in vitro replicates:
- 1 animal was tested in total. Due to the severity of the ocular responses produced in the first treated animal, and in accordance with UK Home Office guidelines, no additional animals were treated.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Not applicable
- Time after start of exposure:
Not applicable
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).
TOOL USED TO ASSESS SCORE:
Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 69201 Male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 69201 Male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 Days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 69201 Male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- Haemorrhage scattered over the majority of the nictitating membrane Day 7 to Day 14, Off white appearance covering one quarter of the upper conjunctival membrane Day 7 to Day 21.
- Irritation parameter:
- chemosis score
- Basis:
- animal: 69201 Male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- Ocular Reactions
Individual scores for ocular irritation are given in Table 1.
Scattered or diffuse corneal opacity was noted in the treated eye at the 24, 48 and 72 hour observations with translucent corneal opacity noted at the 7, 14 and 21 Day observations.
Iridial inflammation was noted in the treated eye one hour after treatment and at the 24, 48, 72 Hour observations.
Moderate conjunctival irritation was noted in the treated eye one hour after treatment and at the 24, 48, 72 Hour, 7 and 14 Day observations with minimal conjunctival irritation at the 21 Day observations.
Haemorrhage scattered over the majority of the nictitating membrane was noted in the treated eye at the 7 and 14 Day observations. Off white appearance covering one quarter of the upper conjunctival membrane was noted in the treated eye at the 7, 14 and 21 Day observations.
The persistence of reactions in the treated eye at the 21 Day observation was considered to be indicative of irreversible ocular damage. - Other effects:
- The animal showed expected gain in bodyweight during the study.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test material produced irreversible ocular damage and was considered to be CORROSIVE to the rabbit eye (based on one rabbit only). In accordance with the Guidance on the application of Regulation (EC) No. 1272/2008 (EU CLP) the test substance meets the criteria for classification as corrosive to the eyes and no further testing is required.
- Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
OECD Guidelines for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 24 April 2002)
Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008
Initial considerations. Due to the low pH value of the test material a Rabbit Enucleated Eye Test (REET) was performed prior to the in vivo test. The results are given in Appendix 3 and indicated that the test material was unlikely to cause severe ocular irritancy.
Result. A single application of the test material to the non-irrigated eye of one rabbit produced translucent corneal opacity, iridial inflammation and moderate conjunctival irritation. Other ocular effects noted were off white appearance covering one quarter of the upper conjunctival membrane and haemorrhage scattered over the majority of the nictitating membrane. The persistence of reactions in the treated eye at the 21‑Day observation was considered to be indicative of irreversible ocular damage.
Conclusion. The test material produced irreversible ocular damage and was considered to be CORROSIVE to the rabbit eye (based on one rabbit only).
Reference
Table1 IndividualScores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex |
69201Male |
||||||
IPR= 2 |
|||||||
Time After Treatment |
1 Hour |
24 Hours |
48 Hours |
72 Hours |
7 Days |
14 Days |
21 Days |
CORNEA |
|
|
|
|
|
|
|
Degree of Opacity |
0 |
1 |
1 |
1 |
2 |
2 |
2 |
Area of Cornea Involved |
0 |
2 |
2 |
2 |
2 |
1 |
1 |
IRIS |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
CONJUNCTIVA |
|
|
|
|
|
|
|
Redness |
2 |
2 |
2 |
2 |
2HP |
2HP |
1P |
Chemosis |
2 |
2 |
2 |
2 |
1 |
1 |
0 |
Discharge |
2 |
2 |
2 |
2 |
1 |
1 |
0 |
IPR= Initial pain reaction
H = Haemorrhage scattered over the majority of the nictitating membrane
P = Off white appearance covering one quarter of the upper conjunctival membrane
Table2 Individual Bodyweights and Bodyweight Change
Rabbit Number |
Individual Bodyweight (kg) |
Bodyweight Change (kg) |
|
Day 0 |
Day 21 |
||
69201Male |
2.39 |
2.79 |
0.40 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
In order to evaluate the skin irritating potential of calcium bis(dihydrogenorthophosphate) one in vivo skin irritation study is available. The study performed in 1985 similar to OECD 404. This skin irritation test was performed with six male Stauffland albino rabbits. 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.
Eye Irritation:
Three eye irritation tests are available for calcium bis(dihydrogenorthophosphate). In vivo eye irritation tests were performed in 2010 and 1985. The study from 2010 served as key study since it was performed according to OECD Guideline 404. The in vivo test was initially performed with one male New Zealand white rabbit. A volume of 0.1 mL of the test material, which was found to weigh approximately 88 mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye. After application the animal was observed 21 days. Evaluation of the animal resulted in mean scores for the 24, 48 and 72 hour reading for cornea opacity, iritis, conjunctivae redness and chemosis were 1.0, 1.0, 2.0 and 2.0, respectively. Conjunctivae redness and corneal opacity were not reversible until day 21 after treatment. Haemorrhage scattered over the majority of the nictitating membrane and off white appearance covering on quarter of the upper conjunctival membrane was observed until 14 or 21 days after treatment, respectively. These effects leading to the conclusion that calcium bis(dihydrogenorthophosphate) has an eye damaging potential and no further animal was tested.
This result is supported by another in vivo study performed in 1985 similar to OECD 405. Six female Stauffland albino rabbits were used to evaluate the irritating potential of calcium bis(dihydrogenorthophosphate). 100 mg of the test material was placed in one eye and the eyes were observed until day 24 after treatment. Evaluation the animals with unwashed eyes, the means scores for the 24, 48 and 72 hour reading for cornea opacity, iritis, conjunctivae redness and chemosis were 2.78, 1.61, 2.67 and 1.5, respectively. Conjunctivae redness and chemosis and corneal opacity were not reversible until day 24 after treatment. This results lead also to the conclusion that calcium bis(dihydrogenorthophosphate) has irreversible effects on the eyes.
Before the in vivo test was done in 2010, an in vitro Rabbit Enucleated Eye test was performed due to the low pH value of the test material. This test was performed before guidelines for in vitro tests were available. As OECD guideline 492 is available since 2015 and the test was performed in 2010 a major deficiency is the too short incubation time of 10 minutes instead of 6 hours for solids. Furthermore, 30 mg instead of 50 mg were used for the test. The relative mean viability of the test material treated tissue was 76.6% after a 10-minute exposure which leads to the conclusion that the test material has no irritating potential. Due to the major deficiencies described above and a negative result this study was devalidated and not used for classification.
Conclusion
Taken together, the available data on irritation/corrosion with calcium bis(dihydrogenorthophosphate) (CAS 7758-23-8) do not indicate any hazardous potential on skin but shows eye damaging potential. Therefore, the test substance is not to be classified regarding skin irritation but has to be classified as Eye Dam. Category 1 (H318).Justification for classification or non-classification
The available data on skin irritation with calcium bis(dihydrogenorthophosphate) 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 bis(dihydrogenorthophosphate) meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore classified as Eye Damage Category 1 (H318).
There are no data (study or workplace) to support a classification for respiratory irritation.
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