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EC number: 231-907-1 | CAS number: 7778-53-2
- 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: Two in vivo studies are available for skin irritation. The study reported by Warren (2012) 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 study (Freeman, 1987) is provided to support this conclusion.
Eye irritation: Four studies of varying reliability exist for the endpoint 'eye irritation'. As all available studies were considered to be deficient in some way a weight of evidence approach is used to address this endpoint for tripotassium orthophosphate.
Respiratory tract irritation: No studies exist to show the effects of tripotassium phosphate on the respiratory tract. However, workplace observations suggest the material is irritating to the respiratory tract.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 June 2012 - 18 June 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 19-21 July 2011, signed 31 August 2011
- Species:
- other: reconstituted human epidermis model
- Strain:
- other: reconstituted human epidermis model
- Type of coverage:
- other: Topical
- Preparation of test site:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Control animals are not applicable, however controls were used in the study.
- Amount / concentration applied:
- The test item was used as supplied.
- Amount(s) applied (volume or weight with unit):
10 ± 2 mg of the test material was applied to the epidermis surface pre-moistened with 5 µl of sterile distilled water.
- Concentration (if solution):
The test material was used as supplied.
VEHICLE
No vehicle used - Duration of treatment / exposure:
- 15 minutes and 42 hours post-exposure incubation.
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
At the end of the exposure period, each tissue was removed from the well using forceps and rinsed using a wash bottle containing PBS with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS to gently remove any residual test material.
- Time after start of exposure:
15 Minutes post exposure
SCORING SYSTEM:
Quantitative MTT Assessment (percentage tissue viability)
For the test material the relative mean tissue viabilities obtained after the 15 minute treatment followed by the 42 hour post-exposure incubation period were compared to the mean of the negative control treated tissues (n=3). The relative mean viabilities were calculated in the following way:
mean OD540 of test material / mean OD540 of negative control x 100 = Relative mean tissue viability (percentage of negative control)
Classification of irritation potential is based upon relative tissue viability following the 15 minute exposure period followed by the 42 hour post-exposure incubation period according to the following:
Mean tissue viability is ≤50% : Irritant (I) R38
Mean tissue viability is >50% : Non-Irritant (NI) - Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value - all three tissues
- Value:
- 81.6
- Remarks on result:
- other:
- Remarks:
- Basis: mean viability of cells (%). Time point: day 6. Max. score: 100.0. Reversibility: other: not applicable. Remarks: %. (migrated information)
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study tripotassium orthophosphate is considered to be a non-irritant.
This study is conducted according to an appropriate validated in vitro 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 (Regulation (EC) No. 1907/2006; REACH) as a key study for this endpoint. In addition, the data is considered to be adequate and reliable for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). Tripotassium orthophosphate is not considered to be classified in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
Reference
Test Item, Positive Control Item and Negative Control Item
The mean OD540values, standard deviations and tissue viabilities for the test item, negative control item and positive control item are given in Table 1. The mean viabilities and standard deviations of the test item and positive control, relative to the negative control are also given in Table 1.
The relative mean viability of the test item treated tissues was 81.6% after a 15-Minute exposure period.
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was 8.6% relative to the negative control treated tissues and the standard deviation value of the percentage viability was 1.0%. The positive control acceptance criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was 0.659 and the standard deviation value of the percentage viability was 6.2%. The negative control acceptance criterion was therefore satisfied.
The standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues was 5.2%. The test item acceptance criterion was therefore satisfied.
Table 1. Mean OD540Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
OD540of tissues |
Mean OD540of triplicate tissues |
± SD of OD540 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of relative mean viability (%) |
Negative control item |
0.666 |
0.659 |
0.041 |
101.1 |
100* |
6.2 |
0.696 |
105.6 |
|||||
0.615 |
93.3 |
|||||
Positive control item |
0.059 |
0.056 |
0.006 |
9.0 |
8.6 |
1.0 |
0.061 |
9.3 |
|||||
0.049 |
7.4 |
|||||
Test item |
0.560 |
0.538 |
0.034 |
85.0 |
81.6 |
5.2 |
0.499 |
75.7 |
|||||
0.555 |
84.2 |
SD = Standard deviation
*= The mean viability of the negative control tissues is set at 100%
Control group shared with Harlan Laboratories Ltd Project numbers 41200853, 41200861,
41200866, 41200871, 41200880, 41200884 and 41201543
The relative mean viability of the test item treated tissues was 81.6% after the 15-minute exposure period.
Quality criteria: The quality criteria required for acceptance of results in the test were satisfied.
Direct MTT Reduction
An assessment found the test item was able to directly reduce MTT. Therefore, an additional procedure using water-killed tissues was performed during the determination of skin irritation potential. However, the results obtained showed a negligible degree ofinterference due to direct reduction of MTT occurred. It was therefore considered unnecessary to use the results of the water-killed tissues for quantitative correction of results or for reporting purposes.
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:
- weight of evidence
- 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: Code of Federal Regulation, Section 1500.42
- Deviations:
- not specified
- GLP compliance:
- not specified
- Remarks:
- Study pre-dates GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Zartman Farms, Douglassville, Pa.
- Weight at study initiation: 2.0 to 2.5 kg
- Housing: Housed and fed individually - Vehicle:
- not specified
- Controls:
- other: The untreated right eye served as a control for each animal.
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- No data
- Number of animals or in vitro replicates:
- 7
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Not done
SCORING SYSTEM: according to the Federal Register 38 (187) 27019 an animal should be considered as exhibiting a positive reasion if the test stubstace produced at any of the readings, ulceration of the cornea (other than a fine stippling); or opacity of the cornea (other than a slight duling of the normal lustre); or inflammation of the iris (other than a slight deepening of the folds, or rugae, or a slight circumcorneal injection of the blood vessels); or if such substances produce in the conjunctivae (excluding the cornea and iris) an obvious swelling with partial eversion or the lids or a diffuse crimson red with vessles not easily discernible. - Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- other: all animals tested (#1-6)
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- other: all animals tested (#1-6)
- Time point:
- 24/48/72 h
- Score:
- 2.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- other: all animals tested (#1-6)
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- other: animal #1, 3, 4 and 6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 3.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritant / corrosive response data:
- All of the test animals exhibited severe irritation at 24, 48 and 72 h. At 4 days, four animals exhibited moderate irritation and two animals exhibited severe irritation. All animals exhibited moderate irritation at 7 days.
- Other effects:
- No data
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test material produced moderate to severe irritation for 7 days when instilled into the eye and not washed out.
The study meets generally accepted scientific standards; however substance identity is not adequately reported (although company records indicate the substance to be tripotassium orthophosphate) and as such this study is not considered to be acceptable for use as a stand-alone source of data but is considered acceptable for use as part of a weight of evidence approach in accordance with Annex XI, section 1.2 of Regulation (EC) No. 1907/2006 (REACH). - 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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No details on methodology included within study report.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 10 mg - Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2 per treatment
- Details on study design:
- No data
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- based on total scores from 2 animals
- Time point:
- 24 h
- Score:
- 10
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Response noted in 1 animal
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- based on total scores from 2 animals
- Time point:
- 24 h
- Score:
- 5
- Max. score:
- 10
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Response noted in 1 animal
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- based on total scores from 2 animals
- Time point:
- 24 h
- Score:
- 18
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Response recorded in 2 animals
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- based on total scores from 2 animals
- Time point:
- 24 h
- Score:
- 16
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Response noted in 2 animals
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- based on total scores from 2 animals
- Time point:
- 24 h
- Score:
- 15
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Response noted in 1 animal
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- based on total scores from 2 animals
- Time point:
- 24 h
- Score:
- 13
- Max. score:
- 20
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: Response noted in 2 animals
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 2 animals
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 2 animals
- Time point:
- 24/48/72 h
- Reversibility:
- fully reversible
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 2 animals
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 2 animals
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Erythema, oedema and discharge were recorded as local effects.
- Other effects:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The paper concludes that the irritant rating of tripotassium orthophosphate in rabbits in a moderate irritant. Observations were only recorded for 72 hours and as such an indication of the reversibility of the effects is not available.
In accordance with Regulation (EC) No. 1272/2008 (EU CLP) it is not possible to reliably assign a classification on the basis of the results reported in this study report, however the study indicates that tripotassium orthophosphate is potentially corrosive to the eyes and as such this study is considered acceptable for use as part of a weight of evidence approach in accordance with Annex XI, section 1.2 of Regulation (EC) No. 1907/2006 (REACH). - 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:
- weight of evidence
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: No data
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Test substance was applied as a finely ground sample equivalent to 0.1 mL - 40 mg sample to the eyes of rabbits for 1 minute and for 24 h.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No data
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: dosage equivalent to 0.1 mL / volume - 40 mg sample - Duration of treatment / exposure:
- 1 min or 24 h
- Observation period (in vivo):
- 1 minute exposure: 10 days
24 h exposure: 24 h - Number of animals or in vitro replicates:
- Three
- Details on study design:
- No data
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Max. score:
- 110
- Reversibility:
- not reversible
- Remarks on result:
- other: 24 h exposure: Corrosive
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 21.3
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1 minute exposure
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- other: corrosive
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- other: corrosive
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- other: corrosive
- Irritation parameter:
- chemosis score
- Basis:
- animal: All animals
- Time point:
- 24/48/72 h
- Reversibility:
- not reversible
- Remarks on result:
- other: corrosive
- Irritant / corrosive response data:
- 1 minute exposure
Immediate: discomfort was severed with pawing, squealing, thrashing about the stocks, and eyes tightly closed.
10 min: Slight erythema, copious discharge.
1 h: severe erythema, very slight edema, copious discharge.
24 h: Area of barely perceptible corneal dullness in one instance, iris congestion, severe erythema (necosis in conjunctival sac), very slight to slight edema, copious discharge containing white exudate.
40 - 168 h: gradual improvement.
168 h - 10 d: all scored zero.
24 h exposure
Immediate: discomfort was severe with pawing, squealing, thrashing about the stocks, and eyes tightly closed.
10 min: severe erythema, very slight edema, copious discharge.
1 h: severe erythema, very slight to slight edema, copious discharge.
24 h: corrosive - Other effects:
- No data
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The study report indicates that tripotassium phosphate was corrosive when applied as a finely ground sample to rabbits eyes at a dosage equivalent to 0.1 mL/ volume - 40 mg sample for 24 h. After an application of 1 minute the author concluded the material was a mild irritant.
In accordance with Regulation (EC) No. 1272/2008 (EU CLP) it is not possible to reliably assign a classification on the basis of the results reported in this study report, however the study indicates that tripotassium orthophosphate is potentially corrosive to the eyes and as such this study is considered acceptable for use as part of a weight of evidence approach in accordance with Annex XI, section 1.2 of Regulation (EC) No. 1907/2006 (REACH). - 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:
- other: Reported in secondary literature (review paper)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: no data
- Deviations:
- not specified
- Principles of method if other than guideline:
- 4 New Zealand White rabbits were dosed with 0.1g of test material (neat) in the right eye. The left eye was used as the control eye.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- No data
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- Washed: 20-30 seconds
Unwashed: 22 days - Observation period (in vivo):
- 22 days
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the right eyes of 2 out of the 4 tested animals were washed with 100 mL of tap water
- Time after start of exposure: 20-30 seconds after treatment
SCORING SYSTEM: Draize JH, Woodward Fand Calvery HO (1944) J Pharmacol. Exp. ther. 83: 387. - Irritation parameter:
- overall irritation score
- Remarks:
- Draize score
- Basis:
- other: unwashed (2 animals)
- Time point:
- 24 h
- Score:
- 75
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 22 days
- Irritation parameter:
- overall irritation score
- Remarks:
- Draize score
- Basis:
- other: unwashed (2 animals)
- Time point:
- 48 h
- Score:
- 85
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 22 days
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The authors conclude that tripotassium orthophosphate is extremely irritating to the unwashed eyes of New Zealand White rabbits. As the study does not provide individual eye scores or detailed results and as only 2 animals were tested, it is not sufficient to conclude on classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). However, this study is considered acceptable for use as part of a weight of evidence approach in accordance with Annex XI, section 1.2 of Regulation (EC) No. 1907/2006 (REACH).
Referenceopen allclose all
Eye irritation in rabbits:
Animal No. |
Cornea A x B x 5 |
Iris A x 5 |
Conjunctivae (A + B + C) x 2 |
Total score per animal |
|||
A |
B |
A |
A |
B |
C |
||
24 h |
|||||||
1 |
3 |
4 |
2 |
3 |
3 |
2 |
85 |
2 |
4 |
4 |
2 |
3 |
3 |
2 |
106 |
3 |
3 |
4 |
2 |
3 |
3 |
2 |
86 |
4 |
3 |
4 |
2 |
3 |
3 |
2 |
86 |
5 |
4 |
4 |
2 |
3 |
3 |
2 |
106 |
6 |
3 |
4 |
2 |
3 |
3 |
2 |
86 |
48 h |
|||||||
1 |
3 |
4 |
2 |
3 |
3 |
2 |
86 |
2 |
4 |
4 |
2 |
3 |
3 |
2 |
106 |
3 |
3 |
4 |
2 |
3 |
3 |
2 |
86 |
4 |
3 |
4 |
2 |
3 |
3 |
2 |
86 |
5 |
3 |
4 |
2 |
3 |
3 |
2 |
86 |
6 |
3 |
4 |
2 |
3 |
3 |
2 |
86 |
72 h |
|||||||
1 |
3 |
4 |
2 |
3 |
2 |
3 |
86 |
2 |
3 |
4 |
2 |
3 |
2 |
3 |
86 |
3 |
3 |
4 |
2 |
3 |
2 |
3 |
86 |
4 |
3 |
4 |
2 |
3 |
2 |
3 |
86 |
5 |
3 |
4 |
2 |
3 |
2 |
3 |
86 |
6 |
3 |
4 |
2 |
3 |
2 |
3 |
86 |
4 days |
|||||||
1 |
2 |
4 |
2 |
3 |
2 |
3 |
66 |
2 |
3 |
4 |
2 |
3 |
2 |
3 |
86 |
3 |
2 |
4 |
2 |
3 |
2 |
2 |
64 |
4 |
2 |
4 |
2 |
3 |
2 |
2 |
64 |
5 |
3 |
4 |
2 |
3 |
2 |
2 |
84 |
6 |
2 |
4 |
2 |
2 |
2 |
2 |
62 |
7 days |
|||||||
1 |
2 |
4 |
2 |
2 |
2 |
2 |
62 |
2 |
2 |
4 |
2 |
2 |
2 |
2 |
62 |
3 |
2 |
4 |
2 |
2 |
2 |
2 |
62 |
4 |
2 |
4 |
2 |
2 |
2 |
2 |
62 |
5 |
2 |
4 |
2 |
2 |
2 |
2 |
62 |
6 |
2 |
4 |
2 |
2 |
2 |
2 |
62 |
Table 1: In vivo eye irritation results in rabbits for tripotassium phosphate
Dose/Response Data |
|||
Eye Structure |
Number Responding/Mean Score for 2 Rabbits |
||
24 Hours |
48 Hours |
72 Hours |
|
Cornea |
1/10 |
1/10 |
1/15 |
Iris |
1/5 |
1/5 |
0/0 |
Conjunctivae |
2/18 |
2/16 |
2/13 |
One minute exposure:
Hour |
1 |
24 |
48 |
72 |
120 |
168 |
||||||||||||
Structure |
Cornea |
Iris |
Conjunctivae |
Cornea |
Iris |
Conjunctivae |
Cornea |
Iris |
Conjunctivae |
Cornea |
Iris |
Conjunctivae |
Cornea |
Iris |
Conjunctivae |
Cornea |
Iris |
Conjunctivae |
Animal No. |
||||||||||||||||||
1 |
0 |
0 |
14 |
0 |
5 |
14 |
0 |
0 |
10 |
0 |
0 |
10 |
0 |
0 |
6 |
0 |
0 |
4 |
2 |
0 |
0 |
14 |
0 |
5 |
14 |
0 |
0 |
10 |
0 |
0 |
10 |
0 |
0 |
6 |
0 |
0 |
4 |
3 |
0 |
0 |
14 |
5 |
5 |
16 |
5 |
5 |
16 |
0 |
5 |
14 |
0 |
5 |
8 |
0 |
0 |
6 |
Mean / 110 |
14.0 |
21.3 |
15.3 |
13.0 |
8.3 |
4.6 |
No data for 24 h exposure.
Table 1. Results
Test compound |
Treatment |
Eye irritancy |
Draize scores (110 maximum) |
||
24 hr |
48 hr |
22 days |
|||
Tripotassium phosphate |
Unwashed |
Extreme |
75 |
85 |
16 |
Washed |
Moderate |
46 |
48 |
9 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Skin irritation: In accordance with Regulation (EC) No 1272/2008 (EU CLP) tripotassium orthophosphate is not considered to be classified for skin irritation.
Eye irritation: All available studies indicate that tripotassium orthophosphate is corrosive to the eyes and therefore classification as a category 1 corrosive is proposed in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
Respiratory irritation: Respiratory irritation has been noted in worker populations exposed to tripotassium orthophosphate via the inhalation route and therefore a classification of STOT-SE category 3 for respiratory tract irritation is proposed in accordance with Regulation (EC) No. 1272/2008 (EU CLP).
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