Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-913-4 | CAS number: 7778-77-0
- 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:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: no data
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The test substance was instilled into the test eyes of 4 New Zealand white rabbits at a dose of 0.1 g. Two rabbits remained unwashed, while the eyes of the remaining rabbits were washed with tap water 20 - 30 sec after treatment. Eyes were assessed for irritation using the method of Draize up to 72 h after instillation.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium dihydrogenorthophosphate
- EC Number:
- 231-913-4
- EC Name:
- Potassium dihydrogenorthophosphate
- Cas Number:
- 7778-77-0
- Molecular formula:
- H3O4P.2K
- IUPAC Name:
- potassium dihydrogen phosphate
- Details on test material:
- - Name of test material: monopotassium phosphate
- Substance type: solid
- Physical state: white granules
- Analytical purity: > 99 % based on water and insoluble matter
- Lot/batch No.: Reference no. 483B 3114W
- Storage condition of test material: room temperature (stable indefinitely)
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 Reseach Animals, Inc., Denver, Pennsylvania.
- Age at study initiation: young adult
- Weight at study initiation: 2.53 to 3.09 kg
- Housing: individually housed in stainless steel cages. DACB cageboard bedding was used in the litter pans.
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 71 to 74 ºF
- Humidity (%): 61 %
- Photoperiod (hrs dark / hrs light): 12 h dark / 12 h light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye of each rabbit served as a control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g per test eye - Duration of treatment / exposure:
- The eyes were washed 20 - 30 seconds after instillation for 2 rabbits
The eyes of two rabbits remained unwashed - Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: gently washed with 100 mL of tap water at a rate of approximately 100 mL/min.
- Time after start of exposure: 20 - 30 sec after instillation of the test substance
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: after 24 h examination with a penlight type light, the eyes were examined with the aid of 2 % sodium fluorescein dye.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: both animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- other: both animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- other: both animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- other: both animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- 1 h after dosing, all eyes exhibited slight chemosis and / or severe discharge. Within 24 h, all irritation had resolved and the test was terminated following the 72 h scoring. Washing the eyes with tap water shortly after exposure had no significant effect on the irritation observed at the 1-h scoring.
- Other effects:
- All animals remained healthy throughout the study.
Any other information on results incl. tables
The primary irritation indexes for the unwashed and washed eyes at each time interval
Scoring interval |
Unwashed |
Washed |
1 h |
8.0 |
7.0 |
24 h |
0 |
0 |
48 h |
0 |
0 |
72 h |
0 |
0 |
Eye examination individual eye scores
Animal No. |
Cornea |
Iris |
Conjunctiva |
||
Opacity/Area |
Iritis |
Redness |
Chemosis |
Discharge |
|
1 hour |
|||||
B5504F |
0/0 |
0 |
0 |
1 |
3 |
B5506F |
0/0 |
0 |
0 |
1 |
3 |
B5508F (w) |
0/0 |
0 |
0 |
0 |
3 |
B5509F (w) |
0/0 |
0 |
0 |
1 |
3 |
Primary eye irritation index – unwashed 8.0/110, washed 7.0/110. |
|||||
24 hour |
|||||
B5504F |
0/0 |
0 |
0 |
0 |
0 |
B5506F |
0/0 |
0 |
0 |
0 |
0 |
B5508F (w) |
0/0 |
0 |
0 |
0 |
0 |
B5509F (w) |
0/0 |
0 |
0 |
0 |
0 |
Primary eye irritation index – unwashed 0.0/110, washed 0.0/110. |
|||||
48 hour |
|||||
B5504F |
0/0 |
0 |
0 |
0 |
0 |
B5506F |
0/0 |
0 |
0 |
0 |
0 |
B5508F (w) |
0/0 |
0 |
0 |
0 |
0 |
B5509F (w) |
0/0 |
0 |
0 |
0 |
0 |
Primary eye irritation index – unwashed 0.0/110, washed 0.0/110. |
|||||
72 hour |
|||||
B5504F |
0/0 |
0 |
0 |
0 |
0 |
B5506F |
0/0 |
0 |
0 |
0 |
0 |
B5508F (w) |
0/0 |
0 |
0 |
0 |
0 |
B5509F (w) |
0/0 |
0 |
0 |
0 |
0 |
Primary eye irritation index – unwashed 0.0/110, washed 0.0/110. |
(w) - washed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Authors conclusion: Under the conditions of this study the test material is non-irritating to both unwashed and washed eyes.
Although the study has only been conducted on two animals (unwashed eyes) it is 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. Potassium dihydrogenorthophosphate is not considered to be classified for eye irritation in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.