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EC number: 231-834-5 | CAS number: 7758-11-4
- 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:
- Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From: 12/05/1986 To: 15/05/1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- minor deviation: The range over which room temperature was maintained was lower than the recommended 20±3°C.
- Qualifier:
- according to guideline
- Guideline:
- other: FIFRA: Pesticide Assessment Guidelines, Subdivision F; Hazard Evaluation: Human and Domestic Animals; Office of Pesticide and Toxic Substances, November 1982; Section 81-4, Primary Eye Irritation Study,
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: TSCA; Health Effects Test Guidelines; Office of Toxic Substances, Office of Pesticides and Toxic Substances, US EPA, August 1982, Acute Exposure, Primary Eye Irritation Primary eye irritation
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Study predates GLP
Test material
- Reference substance name:
- Dipotassium hydrogenorthophosphate
- EC Number:
- 231-834-5
- EC Name:
- Dipotassium hydrogenorthophosphate
- Cas Number:
- 7758-11-4
- Molecular formula:
- H3O4P.2K
- IUPAC Name:
- dipotassium hydrogen phosphate
- Details on test material:
- - Name of test material (as cited in study report): Potassium Phosphate Diibasic, K2HPO4 50% Solution (aqueous)
- Substance type: Clear, colourless
- Physical state: Liquid
- Analytical purity: no data
- Lot/batch No.: Carondelet Lab #1
- Storage condition of test material: Room temperature
- Receipt of test material: The test material was received 06/05/1986 from Monsanto Company.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton-Dutchland, Inc. Denver, Pennsylvania
- Age at study initiation: Young adults (atleast 8 weeks old at study initiation)
- Weight at study initiation:
- Housing: Individually housed, suspended stainless steel cages.
- Diet (e.g. ad libitum): Lab Rabbit Chow HF (Purina # 5326), ad libitum.
- Water (e.g. ad libitum): Automatic watering system, ad libitum. Municipal water supply (Elizabethtown Water Co.)
- Acclimation period: 21 days, with checks for viability twice daily.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature was maintained within the range of 60-70°F to the maximum extent possible. (15.5°C-21.1°C)
- Humidity (%): Humidity was kept within the range of 30-70% to the maximum extent possible.
- Air changes (per hr): No data.
- Photoperiod (hrs dark / hrs light): Light cycle: 12 hours light, 12 hours dark (controlled by automatic timer)
IN-LIFE DATES: From: Date of receipt on 21/04/1986 To: Termination 15/05/1986
Test system
- Vehicle:
- other: The test material was received and administered as 50% solution
- Controls:
- other: The untreated eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 50%
VEHICLE
- No data. - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 3 days.
- Number of animals or in vitro replicates:
- Six (3 males, 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were rinsed to remove any residual test material.
- Time after start of exposure: 24 h
STUDY DESIGN
- Evaluation of ocular irritation: At 1, 24, 48 and 72 h after treatment
SCORING SYSTEM: At each interval the treated control eyes were examined and scored according to Draize J.H. 1959, The Appraisal of Chemicals in Foods. Drugs and Cosmetics, p 51. Association of Food and Drug Officials of the United States, Austin, Texas. Scores were considered positive under 16 CFR 1500.42.
TOOL USED TO ASSESS SCORE: fluorescein dye was used to confirm presence or absence of corneal ulceration.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- iris score
- Basis:
- other: All 6 animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all 6 animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- 50% Potassium Phosphate Solution produced mild, transient ocular irritation. Irritation consisted primarily of conjunctival irritation (redness, chemosis, discharge) and iridial changes or iritis, with the most severe effects ocurring at one hour. No significant corneal changes were seen. All six animals were free of ocular irritation within 48 to 72 hours after instillation of the test material.
- Other effects:
- Animals vocalizing after instillation of the test material are identified in Table 2.
Any other information on results incl. tables
Table 1 - Eye irritation in rabbits, summary of responses.
Animal # / Sex |
Cornea |
Iris |
Conjunctivae |
|||
Opacity |
Ulceration |
|
Redness |
Chemosis |
Necrosis or Ulceration |
|
1 F |
- |
- |
- |
- |
+ |
- |
2 F |
- |
- |
+ |
+ |
+ |
- |
3 M |
- |
- |
+ |
+ |
+ |
- |
4 F |
- |
- |
+ |
+ |
+ |
- |
5 M |
- |
- |
- |
+ |
+ |
- |
6 M |
- |
- |
+ |
+ |
+ |
- |
Table 2 - Individual ocular scores.
v- animal vocalised after test material administration
f - observation confirmed with fluorescein
Animal 1 - Femalev |
Time After Administration (hours) |
Positive scores per 16 CFR 1500.42 |
|||
Conjunctivae scores |
1 |
24 |
48 |
72 |
|
Redness |
1 |
1 |
1 |
0 |
No |
Chemosis |
2 |
1 |
0 |
0 |
Yes |
Discharge |
2 |
0 |
0 |
0 |
- |
Necrosis (N) / Ulceration (U) |
0 |
0 |
0 |
0 |
No |
|
|||||
Iris scores |
+ |
0 |
0 |
0 |
No |
|
|||||
Cornea scores |
|
|
|
|
|
Opacity |
0 |
0 |
0 |
0 |
No |
Area |
0 |
0 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
|
Ulceration |
0 |
0f |
0f |
0 |
No |
Other |
- |
- |
- |
- |
|
Table 2 - continued
Animal 2 - F |
Time After Administration (hours) |
Positive scores per 16 CFR 1500.42 |
|||
Conjunctivae scores |
1 |
24 |
48 |
72 |
|
Redness |
2 |
1 |
0 |
0 |
Yes |
Chemosis |
2 |
0 |
0 |
0 |
Yes |
Discharge |
1 |
0 |
0 |
0 |
- |
Necrosis (N) / Ulceration (U) |
0 |
0 |
0 |
0 |
No |
|
|||||
Iris scores |
1 |
0 |
0 |
0 |
Yes |
|
|||||
Cornea scores |
|
|
|
|
|
Opacity |
+ |
0 |
0 |
0 |
No |
Area |
4 |
0 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
|
Ulceration |
0 |
0f |
0f |
0 |
No |
Other |
- |
- |
- |
- |
|
Table 2 - continued
Animal 3 - Male |
Time After Administration (hours) |
Positive scores per 16 CFR 1500.42 |
|||
Conjunctivae scores |
1 |
24 |
48 |
72 |
|
Redness |
2 |
1 |
1 |
0 |
Yes |
Chemosis |
2 |
1 |
0 |
0 |
Yes |
Discharge |
2 |
0 |
0 |
0 |
- |
Necrosis (N) / Ulceration (U) |
0 |
0 |
0 |
0 |
No |
|
|||||
Iris scores |
1 |
0 |
0 |
0 |
Yes |
|
|||||
Cornea scores |
|
|
|
|
|
Opacity |
0 |
0 |
0 |
0 |
No |
Area |
0 |
0 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
|
Ulceration |
0 |
0f |
0f |
0 |
No |
Other |
- |
- |
- |
- |
|
Table 2 - continued
Animal 4 - Female |
Time After Administration (hours) |
Positive scores per 16 CFR 1500.42 |
|||
Conjunctivae scores |
1 |
24 |
48 |
72 |
|
Redness |
2 |
2 |
1 |
0 |
Yes |
Chemosis |
2 |
1 |
0 |
0 |
Yes |
Discharge |
3 |
0 |
0 |
0 |
- |
Necrosis (N) / Ulceration (U) |
0 |
0 |
0 |
0 |
No |
|
|||||
Iris scores |
1 |
0 |
0 |
0 |
Yes |
|
|||||
Cornea scores |
|
|
|
|
|
Opacity |
+ |
0 |
0 |
0 |
No |
Area |
4 |
0 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
|
Ulceration |
0 |
0f |
0f |
0 |
No |
Other |
- |
- |
- |
- |
|
Table 2 - continued
Animal 5 - Malev |
Time After Administration (hours) |
Positive scores per 16 CFR 1500.42 |
|||
Conjunctivae scores |
1 |
24 |
48 |
72 |
|
Redness |
2 |
1 |
1 |
0 |
Yes |
Chemosis |
2 |
1 |
0 |
0 |
Yes |
Discharge |
3 |
0 |
0 |
0 |
- |
Necrosis (N) / Ulceration (U) |
0 |
0 |
0 |
0 |
No |
|
|||||
Iris scores |
+ |
0 |
0 |
0 |
No |
|
|||||
Cornea scores |
|
|
|
|
|
Opacity |
+ |
+ |
0 |
0 |
No |
Area |
4 |
4 |
0 |
0 |
|
Stippling |
1 |
1 |
0 |
0 |
|
Ulceration |
0 |
0f |
0f |
0 |
No |
Other |
- |
- |
- |
- |
|
Table 2 - continued
Animal 6 - Male |
Time After Administration (hours) |
Positive scores per 16 CFR 1500.42 |
|||
Conjunctivae scores |
1 |
24 |
48 |
72 |
|
Redness |
2 |
2 |
1 |
0 |
Yes |
Chemosis |
2 |
1 |
0 |
0 |
Yes |
Discharge |
2 |
0 |
0 |
0 |
- |
Necrosis (N) / Ulceration (U) |
0 |
0 |
0 |
0 |
No |
|
|||||
Iris scores |
1 |
+ |
0 |
0 |
Yes |
|
|||||
Cornea scores |
|
|
|
|
|
Opacity |
+ |
+ |
0 |
0 |
No |
Area |
4 |
4 |
0 |
0 |
|
Stippling |
0 |
0 |
0 |
0 |
|
Ulceration |
0 |
0f |
0f |
0 |
No |
Other |
- |
- |
- |
- |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Author's conclusion: 50% Potassium Phosphate Solution produced mild, transient ocular irritation. Irritation consisted primarily of conjunctival irritation (redness, chemosis, discharge) and iridial changes or iritis, with the most severe effects ocurring at one hour. No significant corneal changes were seen. All six animals were free of ocular irritation within 48 to 72 hours after instillation of the test material.
This study considered to be sufficient for classification and labelling due to the minimal effects noted and is therefore submitted as a key study with supporting data also provided to support the conclusions on classification and labelling. Dipotassium hydrogenorthophosphate is not considered to be classified for eye irritation in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
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