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EC number: 238-961-5 | CAS number: 14887-42-4
- 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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: One key study is provided. The key study (Moore, 2006) has been conducted according to a current guideline (OECD 420) and under the conditions of GLP. The acute oral median dose (LD50) of potassium pentahydrogen bis(phosphate) in the female Wistar strain rat was estimated to be > 2000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP).
Acute inhalation toxicity: In accordance with Annex VIII, section 8.5.2, column 2 of Regulation (EC) No. 1907/2006, testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Potassium pentahydrogen bis(phosphate) is a solid with a low vapour pressure. The particle size distribution data concludes that ca. 10% of particles have a particle size of <254.4 µm and therefore potassium pentahydrogen bis(phosphate) is not considered to present an inhalation risk and as such testing via the inhalation route is not scientifically justified.
Acute dermal toxicity: One key study is provided. The key study (Moore, 2006) is conducted to an appropriate guideline and under the conditions of GLP. Potassium pentahydrogen bis(phosphate) has been found to have an LD50 of >2,000 mg /kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 24 - April 18, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA.
- Age at study initiation: young adults 9 - 10 weeks
- Weight at study initiation: 165 - 220 g
- Fasting period before study: overnight by removing the feed from their cages. Feed was replaced approximately 3 - 4 h after dosing.
- Housing: singly in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least 3 times per week.
- Water: ad libitum
- Acclimation period: 6 - 17 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23 ºC
- Photoperiod: 12 h light/dark cycle.
IN-LIFE DATES: From: 2005-09-27 To:2006-05-24 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg administered as a 50 % w/w mixture.
DOSAGE PREPARATION: a tissue homogeniser was used ot facilitate the preparation of a homogenous mixture. Preliminary solubility tests indicated that mixtures in excess of 50 % were too viscous to be administered properly.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 females only
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: individual body weights were recorded prior to test substance administration and again on Days 7 and 14 (termination) following dosing. Animals were observed for mortality, signs of gorss toxicity and behavioural changes during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing. Observations included gross evaluation of skin an fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systmes, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea and coma.
- Necropsy of survivors performed: necropsies were performed on all animals. Tissues and organs of hte thoracic and abdominal cavities were examined. - Statistics:
- No data
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no mortalities
- Clinical signs:
- other: All animals appeared active and healthy during the study.
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied.
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the condiitons of the study, the acute oral LD50 pf PeKacid was greater than 2000 mg/kg of body weight in female rats. According to Regulation (EC) No 1272/2008 (EU CLP) potassium pentahydrogen bis(phosphate) (also known as PeKacid) is not considered to be classified.
This study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement for this endpoint and is therefore submitted as a key study. In addition, The study is deemed reliable for classification and labelling according to Regulation (EC) No 1272/2008 (EU CLP).
Reference
Table 2. Individual body weights and doses
Animal No. |
Sex |
Dose level (mg/kg) |
Body weight (g) |
Dose1 (mL) |
||
Initial |
Day 7 |
Day 14 |
||||
9096 |
F |
2000 |
192 |
219 |
250 |
0.55 |
9137 |
F |
2000 |
177 |
201 |
243 |
0.51 |
9262 |
F |
2000 |
165 |
189 |
240 |
0.47 |
9289 |
F |
2000 |
173 |
192 |
240 |
0.50 |
9335 |
F |
2000 |
220 |
233 |
256 |
0.63 |
1: the test substance was administered as a 50 % w/w mixture in distilled waster. Specific gravity - 1.393 g/mL.
Table 3. Individual cage-side observations
Animal No. |
Findings |
Day of occurrence |
All animals |
Active and healthy |
0 - 14 |
Table 4. Individual necropsy observations
Animal No. |
Tissues |
Findings |
All animals |
All tissues and organs |
No gross abnormalities |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- LD50 >2000 mg/kg bw. Study is performed to an appropriate guideline and under the conditions of GLP (Klimisch 1).
Acute toxicity: via inhalation route
Endpoint conclusion
- Quality of whole database:
- No data available, data adaptation submitted.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-09-27 to 2006-07-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA.
- Age at study initiation: 9 - 10 weeks (young adult)
- Weight at study initiation: Males 298 - 320 g; females 206 - 220 g.
- Housing: Singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent guide for the care and use of laboratory animals DHEW (NIH). Litter paper was placed beneath the case and was changed at least three times per week.
- Diet: Purina rodent chow #5012
- Water: Filtered tap water supplied ad libitum by automatic water dispenser.
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23 ºC
- Photoperiod (hrs dark / hrs light): 12-h light/dark cycle - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal area and trunk.
- % coverage: Approximately 10 % (2 inches by 3 inches)
- Type of wrap if used: A gauze pad and 3 inch Durapore tape.
REMOVAL OF TEST SUBSTANCE
- Washing: Test site was gently cleansed of any residual test substance.
- Time after start of exposure: After 24 h.
TEST MATERIAL
- Amount applied: 2000 mg/kg bw. Individual doese were calculated based on the initial body weights and concentration of the test mixture.
- Concentration: 90 % w/w
- For solids, paste formed: Yes the test substance was moistened with distiled water to acheive a dry paste.
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weights of the animals were recorded prior to test substance application (initial) and again on Days 7 and 14 (termination). Cage side observations for mortality, signs of gross toxicity and behavioural changes during the first several hours after application and at least once daily thereafter for 14 days. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea and coma.
- Necropsy of survivors performed: Yes gross necropsies were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined. - Statistics:
- No data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: The test substance was applied as a 90 % w/w mixture in distilled water.
- Mortality:
- All animals survived.
- Clinical signs:
- other: All animals appeared healthy and active during the study. There were no signs of gross toxicity, dermal irritation, adverse pharmacologic effects or abnormal behaviour.
- Gross pathology:
- No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period.
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the single dose acute dermal LD50 of PeKacid is greater than 2000 mg/kg bw in male and female rats.
This study is conducted according to the appropriate guidelines (EU AND US) and under the conditions of GLP and therefore 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.
In addition, this study is suitable to fulfill the requirements for classification and labelling according to Regulation (EC) No 1272/2008 (EU CLP).
Reference
Table 2. Individual body weights and doses:
Animal No. |
Sex |
Body weight |
Dose* |
||
Initial |
Day 7 |
Day 14 |
|||
9342 |
M |
307 |
363 |
400 |
0.68 |
9343 |
M |
320 |
348 |
388 |
0.71 |
9344 |
M |
312 |
338 |
376 |
0.69 |
9345 |
M |
298 |
345 |
390 |
0.66 |
9346 |
M |
307 |
369 |
416 |
0.68 |
9347 |
F |
212 |
227 |
239 |
0.47 |
9348 |
F |
215 |
239 |
248 |
0.48 |
9349 |
F |
214 |
243 |
253 |
0.48 |
9350 |
F |
220 |
236 |
254 |
0.49 |
9351 |
F |
206 |
242 |
261 |
0.46 |
* The test substance was applied as a 90 % w/w mixture in distilled water.
Table 3. Individual cage-side observations:
Animal No. |
Findings |
Day of occurrence |
Males |
||
9342 – 9346 |
Active and healthy |
0 - 14 |
Females |
||
9347 - 9351 |
Active and healthy |
0 - 14 |
Table 4. Individual necroscopy observations:
Animal No. |
Tissue |
Findings |
Males |
||
9342 – 9346 |
All tissues and organs |
No gross abnormalities |
Females |
||
9347 - 9351 |
All tissues and organs |
No gross abnormalities |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- LD50 >2000 mg/kg bw. Study is performed to an appropriate guideline and under the conditions of GLP (Klimisch 1).
Additional information
Justification for classification or non-classification
Acute toxicity: oral: The acute oral median dose (LD50) of potassium pentahydrogen bis(phosphate) in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP).
Acute toxicity: dermal: The acute dermal median dose (LD50) of potassium pentahydrogen bis(phosphate) in rabbits was estimated to be greater than 2000 mg /kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP).
Acute toxicity, inhalation: As potassium pentahydrogen bis(phosphate) is not considered to pose an inhalation risk not testing has been performed. However, on the basis of the results obtained in acute oral and acute dermal studies, no classification is proposed for acute toxicity via the inhalation route in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
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