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Diss Factsheets
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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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: no data
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Rabbits were treated topically on each of two test sites and coverd with gauze patches and the trunk of the animal was wrapped with a piece of cheesecloth for 4 h after which the animals were unwrapped and the test material removed. Approximately 30 min after the end of the exposure period, the test sites were scored for irritation using the method of Draize.
- 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 (as cited in study report): monopotassium phosphate
- Molecular formula (if other than submission substance): no data
- Molecular weight (if other than submission substance): no data
- Smiles notation (if other than submission substance): no data
- InChl (if other than submission substance): no data
- Structural formula attached as image file (if other than submission substance): no data
- Substance type: solid
- Physical state: white powder
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: purity not determined
- Lot/batch No.: reference no. 483B3015A
- Expiration date of the lot/batch: no data
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not determined
- Storage condition of test material: room temperature
- Other: FMC-T# 862
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Haxleton Research Animals, Inc., Denver, Pennsylvania.
- Age at study initiation: young adult
- Weight at study initiation: 2.6 to 2.75 kg
- Housing: individually housed in stainless steel cages wiht DACB cageboard bedding in the litter pans
- Diet: no data
- Water: no data
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68 to 72 ºC
- Humidity (%): 51 - 66 %
- Air changes (per hr): no data
- Photoperiod: 12 h fluorescent light and 12 h dark cycle
IN-LIFE DATES: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped free of hair
- Vehicle:
- physiological saline
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of test material moistened with physiological saline
- Concentration (if solution): no data
VEHICLE
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution):no data
- Lot/batch no. (if required): no data
- Purity:no data - Duration of treatment / exposure:
- 4 h
- Observation period:
- 3 days
- Number of animals:
- Three
- Details on study design:
- TEST SITE
- Area of exposure: the clipped area extended from the scapular to the pelvic region. One test site was located on each side of the spinal column.
- % coverage: no data
- Type of wrap if used: 8 ply 2x 2 inch gauze pad secured to each test site with hypoallergenic tape. The entire trunk of the animal was wrapped with a semi-occlusive cheesecloth bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test sites were wiped with clean gauze moistened with methanol and then rinsed with tap water.
- Time after start of exposure:
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No irritation was noted on any of the test sites during any of hte scoring intervals, and the test was terminated following the 72-h scoring.
- Other effects:
- All animals remained healthy throughout the study.
Any other information on results incl. tables
Group irritation scores for each scoring interval
Scoring interval |
Irritation score |
4.5 h |
0 |
24 h |
0 |
48 h |
0 |
72 h |
0 |
Primary irritation index |
0/8.0 |
Pretest examination
Animal # |
Body weight (kg) |
Test sites |
B7853F |
2.70 |
N |
B7854F |
2.75 |
N |
B7843M |
2.60 |
N |
N - normal
Individual skin scores
Animal # |
Left |
Right |
||||
ER |
ED |
O |
ER |
ED |
O |
|
4.5 h |
||||||
B7853F |
0 |
0 |
0 |
0 |
0 |
0 |
B7854F |
0 |
0 |
0 |
0 |
0 |
0 |
B7843M |
0 |
0 |
0 |
0 |
0 |
0 |
Irritation score |
0 / 8.0 |
|||||
24 h |
||||||
B7853F |
0 |
0 |
0 |
0 |
0 |
0 |
B7854F |
0 |
0 |
0 |
0 |
0 |
0 |
B7843M |
0 |
0 |
0 |
0 |
0 |
0 |
Irritation score |
0 / 8.0 |
|||||
48 h |
||||||
B7853F |
0 |
0 |
0 |
0 |
0 |
0 |
B7854F |
0 |
0 |
0 |
0 |
0 |
0 |
B7843M |
0 |
0 |
0 |
0 |
0 |
0 |
Irritation score |
0 / 8.0 |
|||||
72 h |
||||||
B7853F |
0 |
0 |
0 |
0 |
0 |
0 |
B7854F |
0 |
0 |
0 |
0 |
0 |
0 |
B7843M |
0 |
0 |
0 |
0 |
0 |
0 |
Irritation score |
0 / 8.0 |
ER - erythema/eschar
ED - edema
O - other comments
F - female
M - male
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the test material is non-irritating to intact skin when applied topically to rabbits.
This study is conducted according protocols comparable to the appropriate guidelines (EU ) and under the conditions of GLP. Minor deviations are noted however, the study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement as a key study for this endpoint.
Potassium dihydrogenorthophosphate is not considered to be classified according to 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.
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