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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
Eye irritation
Administrative data
- 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
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:
- 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)
Test material
- 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
Test animals / tissue source
- 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
Test system
- 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.
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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).
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