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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
Endpoint summary
Administrative data
Description of key information
Skin irritation: Three in vivo studies are available for skin irritation. The study reported by Freeman (1990) as the key study is conducted according to modern guidelines and performed in a GLP accredited facility. The results of this study are sufficient for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). The additional studies (Birch, 1972 and Birch, 1973) are provided to support this conclusion.
Eye irritation: Two in vivo studies are available for eye irritation. The key study (Freeman C, 1986) is conducted to a protocol similar to modern day guidelines and was performed in a GLP accredited facility. Despite only having assessed the eyes of two animals, the results are deemed sufficient for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). The supporting study (Birch MD, 1973) supports the use of the key study.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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
- 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 - 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 - 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.
- 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).
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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
- 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 - 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. - 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.
- 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).
Reference
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
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
The data available for skin and eye irritation of potassium dihydrogenorthophosphate conclude that no classification is required according to regulation (EC) No. 1272/2008 (EU CLP). It is not considered scientifically justified on ethical grounds to repeat in vivo studies for these endpoints as the data provided is sufficient.
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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