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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
Skin irritation: One key study is available. The study is conducted according to appropriate 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).
Eye irritation: One key study is available. The study is conducted according to appropriate 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).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Remarks:
- In vivo. 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:
- From: 19/04/2006 To: 22/04/2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (2002)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- (1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Part B.4 (Skin Irritation), Directive 2004/73/EC (2004)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services, Inc. Clemmons, NC on April 12, 2006.
- Age at study initiation: The animals are described as young adult rabbits
- Weight at study initiation:
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum):Filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 7 days
- Other: 1 male and 2 females were tested. Females assigned to test were nulliparous and non-pregnant.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs light/ dark cycle.
IN-LIFE DATES: From: 12/04/2006 To: 22/04/2006 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.56 gram
- Concentration (if solution): 90% w/w
VEHICLE
- The vehicle was distilled water
- A dry paste was formed. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours after removal of patches containing the test material.
- Number of animals:
- Three (1 male and 2 females)
- Details on study design:
- TEST SITE
The test material (moistened to a 90% w/w aqueous suspension) was placed on a 1"x1", 4-ply gauze pad and applied to one 6cm² intact dose site on each animal. The pad and the entire trunk of the animal were then wrapped with semi-occlusive 3-inch micropore tape. Elizabethan collars were placed on each rabbit.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The pads and collars were removed and the test sites were gently cleansed of any residual test substance.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize, J.H., Woodard, G. and Calvery, H.O. Methods for the study of irritation and toxicity of susbtances applied topically to the skin and mucous membranes. J. Pharm. Exp. Ther. 1944; 82:377-390. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- 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:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- See Tables 1 and 2.
Within one hour after patch removal, all three treated sites exhibited very slight erythema. The overall incidence and severity of irritation decreased with time. All animals were free of dermal irritation by 48 hours. - Other effects:
- None - all animals appeared active and healthy during the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The author reports that under the conditions of this study, PeKacid is classified as slightly irritating to the skin according to U.S. EPA Addendum 3 on data reporting to pesticide assessment guidelines; Dermal Irritation, January 1988.
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) No1272/2008 (EU CLP). Potassium pentahydrogen bis(phosphate) is not considered to be irritating to the skin.
Reference
Table 1 - Individual skin irritation scores
Results given in the format 'erythema/edema'
Animal # |
Sex |
Time after patch removal |
|||
30-60 min |
24 hrs |
48 hrs |
72 hrs |
||
16475 |
F |
1/0 |
1/0 |
0/0 |
0/0 |
16476 |
M |
1/0 |
0/0 |
0/0 |
0/0 |
16477 |
F |
1/0 |
0/0 |
0/0 |
0/0 |
Total |
3/0 |
1/0 |
0/0 |
0/0 |
|
Mean |
1.0/0 |
0.3/0 |
0/0 |
0/0 |
Table 2: Summary of primary skin irritation scores (average value for three rabbits)
|
Time after patch removal |
|||
Erythema |
1.0 |
0.3 |
0 |
0 |
Edema |
0 |
0 |
0 |
0 |
Total (PDI)a |
1.0 |
0.3 |
0 |
0 |
a– PDI = Average Erythema + average Edema
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Remarks:
- In vivo. 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:
- 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services, Inc. Clemmons, NC.
- Age at study initiation: Young adult
- Housing: The animals were 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 cage and was changed at least 3 times per week.
- Diet: Pelletted Purina Rabbit Chow #5326
- Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23 ºC
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: 2006-04-27 To: 2006-05-04 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye of each rabbit remained untreated with the test substance and served as a control.
- Amount / concentration applied:
- one-tenth of a gram
- Duration of treatment / exposure:
- Test substance was not removed
- Observation period (in vivo):
- 7-days post instillation
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- SCORING SYSTEM: scored according to Draize. The classification of eye scores was by the system of Kay and Calandra.
TOOL USED TO ASSESS SCORE: High-intensity white light (Mag Lite) and the fluorescein dye evaluation procedure described below. - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Within 24 h of test substance instillation, all three treated eyes exhibited corneal opacity, iritis and conjuncitvitis. The overall incidence and severity of irritation decreased gradually thereafter. All animals were free of ocular irritation by Day 7 (study termination).
- Other effects:
- All animals appeared active and healthy during the study. Apart from the eye irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the conditions of the study, Pekacid is classified as irritating to the eyes, in accordance with Regulation (EC) No. 1272/2008. 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).
Reference
Individual scores for ocular irritation:
Rabbit No. 16540 (male) |
||||||
|
Hours |
Days |
||||
|
1 |
24 |
48 |
72 |
4 |
7 |
I.Cornea |
||||||
A. Opacity |
1 |
1* |
1 |
0* |
0 |
0 |
B. Area |
1 |
1 |
1 |
4 |
4 |
4 |
(A x B) x 5 |
5 |
5 |
5 |
0 |
0 |
0 |
II. Iris |
||||||
A. Values |
1 |
1 |
1 |
1 |
0 |
0 |
A x 5 |
5 |
5 |
5 |
5 |
0 |
0 |
III. Conjunctivae |
||||||
A. Redness |
2 |
2 |
2 |
2 |
1 |
0 |
B. Chemosis |
2 |
2 |
2 |
1 |
0 |
0 |
C. Discharge |
3 |
3 |
2 |
1 |
1 |
0 |
(A + B + C) x 2 |
14 |
14 |
12 |
8 |
4 |
0 |
Total |
24 |
24 |
22 |
13 |
4 |
0 |
Rabbit No. 16541 (female) |
||||||
I.Cornea |
||||||
A. Opacity |
1 |
1* |
1 |
0* |
0 |
0 |
B. Area |
1 |
1 |
1 |
4 |
4 |
4 |
(A x B) x 5 |
5 |
5 |
5 |
0 |
0 |
0 |
II. Iris |
||||||
A. Values |
1 |
1 |
1 |
1 |
0 |
0 |
A x 5 |
5 |
5 |
5 |
5 |
0 |
0 |
III. Conjunctivae |
||||||
A. Redness |
2 |
2 |
2 |
2 |
1 |
0 |
B. Chemosis |
2 |
2 |
2 |
2 |
1 |
0 |
C. Discharge |
2 |
2 |
1 |
1 |
0 |
0 |
(A + B + C) x 2 |
12 |
12 |
10 |
10 |
4 |
0 |
Total |
22 |
22 |
20 |
15 |
4 |
0 |
Rabbit No. 16542 (male) |
||||||
I.Cornea |
||||||
A. Opacity |
1 |
1* |
1 |
0* |
0 |
0 |
B. Area |
1 |
1 |
1 |
4 |
4 |
4 |
(A x B) x 5 |
5 |
5 |
5 |
0 |
0 |
0 |
II. Iris |
||||||
A. Values |
0 |
1 |
1 |
0 |
0 |
0 |
A x 5 |
0 |
5 |
5 |
0 |
0 |
0 |
III. Conjunctivae |
||||||
A. Redness |
2 |
2 |
2 |
1 |
1 |
0 |
B. Chemosis |
2 |
2 |
2 |
1 |
0 |
0 |
C. Discharge |
3 |
2 |
1 |
1 |
1 |
0 |
(A + B + C) x 2 |
14 |
12 |
10 |
6 |
4 |
0 |
Total |
19 |
22 |
20 |
6 |
4 |
0 |
* 2 % ophthalmic fluorescein sodium used to evaluate the extent or verify the absene of corneal opacity.
Classification of eye irritation scores:
MMTS |
Irritation classification |
Requirement for maintenance of classification |
0.0 – 0.5 |
Non |
Up to 0.5 at 1 h with zeros at 24 h; otherwise increase 1 level. |
0.6 – 2.5 |
Practically non |
with zeros at 24 h; otherwise increase 1 level. |
2.6 – 15.0 |
Minimally |
with zeros at 48 h; otherwise increase 1 level. |
15.1 – 25.0 |
Mildly |
with zeros at 96 h; otherwise increase 1 level. |
25.1 – 50.0 |
Moderately |
With 7 day mean ≤ 20 and individual total scores ≤ 10 in at least 60 % of the rabbits with no total score > 30; otherwise increase 1 level. |
50.1 – 80.0 |
Severely |
With 7 day mean ≤ 40 and individual total scores ≤ 30 in at least 60 % of the rabbits with no total score > 60; otherwise increase 1 level. |
80.1 – 100.0 |
Extremely |
With 7 day mean ≤ 80 and individual total scores ≤ 60 in at least 60 % of the rabbits with no total score > 100; otherwise increase 1 level. |
100.1 - 110 |
Maximally |
With 7 day mean > 80 and individual total scores > 60 in at least 60 % of the rabbits; otherwise decrease 1 level. |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
Skin irritation: The data available to assess the skin irritation potential of potassium pentahydrogen bis(phosphate) concludes 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 this endpoint as the data provided is sufficient.
Eye irritation: The data available to assess the eye irritation potential of potassium pentahydrogen bis(phosphate) concludes that the substance is classified as irritating to eyes, category 2 in accordance with Regulation (EC) No. 1272/2008 (EU CLP). It is not considered scientifically justified on ethical grounds to repeat in vivo studies for this endpoint 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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