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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
Skin irritation / corrosion
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- Tripotassium orthophosphate
- EC Number:
- 231-907-1
- EC Name:
- Tripotassium orthophosphate
- Cas Number:
- 7778-53-2
- Molecular formula:
- H3O4P.3K
- IUPAC Name:
- tripotassium orthophosphate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Sponsor's identification : Tripotassium orthophosphate
Description : white powder
Batch number : 1136181
Purity : 96.9%
Date received : 14 March 2012
Expiry date : 01 December 2013
Storage conditions : room temperature in the dark
Constituent 1
Test animals
- Species:
- other: reconstituted human epidermis model
- Strain:
- other: reconstituted human epidermis model
Test system
- 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)
Results and discussion
In vitro
Results
- 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)
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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).
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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