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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
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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: no data
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Dipotassium phosphate at dosage levels of 300 and 20 mg/kg was in contact with the skin for 24 h under an occlusive wrap. Observations were conducted at approximately 3 h on the day of dosing and daily thereafter for 14 days.
- GLP compliance:
- yes
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: dipotassium phosphate
- Molecular formula: K2HPO4
- Substance type: solid
- Physical state: white granules
- Purity test date: > 99 % based on H2O content
- Lot/batch No.: 275B30202
- Other: FMC# 426
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Researach Animals, Inc., Denver, Pennsylvania.
- Age at study initiation: young adult
- Weight at study initiation: 2.10 to 2.65 kg
- Housing: individually housed in stainless steel rabbit cages with DACB cageboard bedding used in litter pans.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68 - 77 ºF
- Humidity (%): 28 - 44 %
- Photoperiod (hrs dark / hrs light): 12 h fluorescent light and 12 h dark
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- physiological saline
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 300 mg/kg and 20 mg/kg - Duration of treatment / exposure:
- 24 h
- Observation period:
- 14 days
- Number of animals:
- 5 animals
- Details on study design:
- TEST SITE
- Area of exposure: the trunk from the scapular to the pelvic floor.
- Type of wrap if used: 8 ply 4 x 4 inch gauze pad held in place with hypoallergenic tape. The test site was occluded with impervious plastic sheeting.
REMOVAL OF TEST SUBSTANCE
- Washing: the test site was wiped with clean gauze moistened with methanol, then rinsed with tap water.
- Time after start of exposure: approximately 24 h after application.
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:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- edema score
- Basis:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Slight erythema was noted on the test sites of three rabbits in the 300 mg/kg group. All irritation resolved by day 4.
- Other effects:
- There were no treatment-related deaths, clinical signs, changes in body weight or treatment-related observations at necropsy.
Any other information on results incl. tables
Individual scores (300 mg/kg bw)
Animal # |
ER |
ED |
O |
24 hr |
|||
B5917M |
0 |
0 |
0 |
B5918M |
0 |
0 |
0 |
B5851M |
1 |
0 |
0 |
B5905M |
1 |
0 |
0 |
B5888M |
1 |
0 |
0 |
Irritation score: 0.6/8.0 |
|||
48 hr |
|||
B5917M |
0 |
0 |
0 |
B5918M |
0 |
0 |
0 |
B5851M |
1 |
0 |
0 |
B5905M |
1 |
0 |
0 |
B5888M |
0 |
0 |
0 |
Irritation score: 0.4/8.0 |
|||
72 hr |
|||
B5917M |
0 |
0 |
0 |
B5918M |
0 |
0 |
0 |
B5851M |
1 |
0 |
0 |
B5905M |
0 |
0 |
0 |
B5888M |
0 |
0 |
0 |
Irritation score: 0.2/8.0 |
|||
Day 4 |
|||
B5917M |
0 |
0 |
0 |
B5918M |
0 |
0 |
0 |
B5851M |
0 |
0 |
0 |
B5905M |
0 |
0 |
0 |
B5888M |
0 |
0 |
0 |
Irritation score: 0.0/8.0 |
Primary skin irritation scores for each group:
Scoring interval |
Dosage level |
|
300 mg/kg |
20 mg/kg |
|
24 h |
0.6 / 8.0 |
0 / 8.0 |
48 h |
0.4 / 8.0 |
0 / 8.0 |
72 h |
0.2 / 8.0 |
0 / 8.0 |
Day 4 |
0 / 8.0 |
0 / 8.0 |
Day 7 |
0 / 8.0 |
0 / 8.0 |
Day 14 |
0 / 8.0 |
0 / 8.0 |
Primary irritation Index |
0.4 / 8.0 |
0.8 / 8.0 |
Mean body weights ± SD
Dosage level (mg/kg) |
Body weights ± SD (kg) |
||
Day |
|||
0 |
7 |
14 |
|
300 |
2.26 ± 0.223 |
2.31 ± 0.179 |
2.38 ± 0.169 |
20 |
2.23 ± 0.094 |
2.19 ± 0.218 |
2.15 ± 0.063 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study the authors concludes that the test material is temporarily approximated to be minimally irritating (300 mg/kg) and non-irritating (20.0 mg/kg).
This study has been selected as the key study because the results are sufficient in order to derive a reliable conclusion on classification and labelling in accordance with Regulation EC (No.) 1272/2008 (EU CLP). Dipotassium hydrogenorthophosphate 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.
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