Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 237-574-9 | CAS number: 13845-36-8
- 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: A single in vivo study is available for skin irritation. The key study is comparable to the OECD Guideline No 404 and performed in a GLP accredited facility.
Eye irritation: Two in vivo studies are available for eye irritation. The protocol for the key study is comparable to modern day guidelines and was performed in a GLP accredited facility. The supporting study provides additional support for the conclusions reached in the key study.
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:
- June 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- A GLP study which is comparable to OECD Guideline 404.
- Qualifier:
- according to guideline
- Guideline:
- other: FMC Non-Definitive Primary Skin Irritation Protocol (Number 10)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- please see additional information on materials and methods.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania on June 6, 1990.
- Age at study initiation: Young
- Weight at study initiation: 2.23 - 2.52 kg
- Housing: individually housed in stainless steel cages. DACB cageboard bedding was used in the litter pans.
- Diet (e.g. ad libitum): ad libitum; Purina High Fiber Rabbit Chow 5326
- Water (e.g. ad libitum): ad libitum; fresh tap water
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68 - 72°F
- Humidity (%): 51 - 66 %
- Photoperiod (hrs dark / hrs light): 12 hour fluorescent light: 12 hour dark cycle.
IN-LIFE DATES: From June 6, 1990 - termination, ca. 31st June 1990 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: The test material was moistened with physiological saline.
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 gram - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3 animals, each with two test sites.
1 female, 2 males. - Details on study design:
- TEST SITE
- Area of exposure: 2" x 2"
- % coverage: no data
- administration of test material: The test material, moistened with saline, was applied to an 8-ply gauze pad and secured with hypoallergenic tape. The entire trunk of the animal was wrapped with semi-occlusive cheesecloth bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were wiped with a gauze moistened with methanol, then rinsed with tap water.
- Time after start of exposure: 4 h post application of the test material.
- Other: The test sites were allowed to 'rest' for 30 minutes after the wrapping and pads were removed.
SCORING SYSTEM: Approximately 30 minutes after unwrapping, the test sites of each rabbit were scored for irritation using the method of:
Draize J. H., G. Woodard and H. O. Calvery, J. Pharmacol. Exp. Ther., 83, 384 (1944). The 30 minute delay was instituted to allow for regression of pressure and hydration effects.
RATING SYSTEM:
- Non Irritating: No irritation observed in any animal at any scoring interval.
- Slightly irritating: Any animal exhibiting scores of 1 or less at any scoring interval and irritation clearing within 72 hours.
- Mildly irritating: Any animal exhibiting scores of 2 or less at any scoring interval and irritationg clearing within 7 days.
- Moderately irritating: Any animal exhibiting scores of 3 or less at any scoring interval and irritation clearing within 7 days.
- Severely irritating: Any animal exhibiting scores of 4 or less at any scoring interval - Irritation parameter:
- erythema score
- Basis:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- other: all animals tested
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Zero scores were recorded at all time points for all test sites.
- Other effects:
- All animals remained healthy throughout the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study and based on the FMC rating system, the test material is temporarily approximated to be non-irritating to intact skin when applied topically to New Zealand White rabbits.
This study is conducted according to an appropriate guideline 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. Therefore according to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances the test material is not considered to be classified for skin irritation. - Executive summary:
no data
Reference
Zero scores were recorded at all time points and at all test sites.
Results of skin irritation study:
Animal No. |
Left |
Right |
||
Oedema |
Erythema |
Oedema |
Erythema |
|
4.5 hours |
||||
B7871F |
0 |
0 |
0 |
0 |
B7860M |
0 |
0 |
0 |
0 |
B7861M |
0 |
0 |
0 |
0 |
24 hours |
||||
B7871F |
0 |
0 |
0 |
0 |
B7860M |
0 |
0 |
0 |
0 |
B7861M |
0 |
0 |
0 |
0 |
48 hours |
||||
B7871F |
0 |
0 |
0 |
0 |
B7860M |
0 |
0 |
0 |
0 |
B7861M |
0 |
0 |
0 |
0 |
72 hours |
||||
B7871F |
0 |
0 |
0 |
0 |
B7860M |
0 |
0 |
0 |
0 |
B7861M |
0 |
0 |
0 |
0 |
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:
- From 07/08/1986 to 12/08/1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Only two animals were tested per category (washed/unwashed eyes) not the three animals stipulated in the guideline. Effects were not severe in those animals tested.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania on July 16th, 1986
- Age at study initiation: The animals were young.
- Weight at study initiation: 2.36-2.77 kg
- Housing: Individual stainless steel cages, DAGB cageboard bedding was used in litter pans.
- Diet (e.g. ad libitum): Purina High Fiber Rabbit Chow 5326, ad libitum
- Water (e.g. ad libitum): fresh tap water ad libitum
- Acclimation period: July 16th 1986 - August 7th 1986
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68 - 75 °F
- Humidity (%): 56 - 61 %
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light, 12 hours dark cycle.
IN-LIFE DATES: From: 16/07/1986 To: 12/08/1986 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes, the untreated left eyes served as controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.10 gram - Duration of treatment / exposure:
- washed eyes: exposure was 20-30 seconds before the eye were rinsed.
not washed: The test material was not removed by any external processes. - Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 2 of the 4 animals had their eye washed, the remaining 2 did not.
- Time after start of exposure: 20-30 seconds after treatment.
- The washed eyes were rinsed with 100 mL of tap water for 1 minute.
SCORING SYSTEM: Eyes were assessed for irritation using the method of Draize.
TOOL USED TO ASSESS SCORE: The eyes were examined with the aid of 2% fluorescein dye - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- See Table 1. One hour after dosing mild conjunctivitis was noted in all eyes. Washed eyes recovered within 24 hours of dosing, at which time both of the unwashed eyes had slight conjunctivitis. At the 48 and 72 hour scoring, one unwashed rabbit still had slight conjunctivitis. By day 4, all irritation had resolved and the test was terminated.
Washing the eyes with tap water shortly after exposure decreased both the severity and duration of the irritation observed. - Other effects:
- All animals remained healthy throughout the study, except one of the rabbits subject to eye washing, this rabbit had diarrhea at 72 hours and on day 4.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 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. This study is therefore submitted as a key study to provide the relevant classification according to Regulation (EC) No. 1272/2008 (EU CLP)
Reference
Table -1. Eye scores per animal.
Animal |
Time point (hours) |
Cornea opacity/area |
Iris Iritis |
Conjunctiva |
Other comments |
||
Redness |
Chemosis |
Discharge |
|||||
1 |
1 |
0 |
0 |
1 |
1 |
3 |
0 |
24 |
0 |
0 |
1 |
0 |
1 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|||||||
2 |
1 |
0 |
0 |
1 |
1 |
2 |
Cb* |
24 |
0 |
0 |
1 |
1 |
1 |
0 |
|
48 |
0 |
0 |
1 |
0 |
1 |
0 |
|
72 |
0 |
0 |
1 |
0 |
0 |
0 |
|
96 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|||||||
3 washed eyes |
1 |
0 |
0 |
0 |
1 |
3 |
0 |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|||||||
4 washed eyes |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
96 |
0 |
0 |
0 |
0 |
0 |
0 |
*Cb- conjunctiva red (bloody spots)
Table 2 - Primary eye irritation indexes
Scoring intervals |
Unwashed |
Washed |
1h |
9.0 |
8.0 |
24 h |
5.0 |
0 |
48 h |
2.0 |
0 |
72 h |
1.0 |
0 |
96 h (day 4) |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to Regulation (EC) No. 1272/2008 (EU CLP) the available data indicate that no classification is necessary for pentapotassium triphosphate with regards to skin or eye irritation.
There are no data (study or workplace observations) to suggest that pentapotassium triphosphate is a respiratory irritant.
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.