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Diss Factsheets
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EC number: 232-221-5 | CAS number: 7790-76-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 - 29 July 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dicalcium pyrophosphate
- EC Number:
- 232-221-5
- EC Name:
- Dicalcium pyrophosphate
- Cas Number:
- 7790-76-3
- Molecular formula:
- Ca2O7P2
- IUPAC Name:
- dicalcium pyrophosphate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Source strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN™ in vitro reconstructed human epidermis model
- Tissue batch number(s): not specified
- Production date: not specified
- Shipping date: not specified
- Delivery date: 27 July 2010
- Date of initiation of testing: the study was performed between 27 and 29 July 2010
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
REMOVAL OF TEST MATERIAL AND CONTROLS
Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of PBS with Ca++ an Mg++ to gently remove any residual test material. Each rinsed tissue was placed into the third column of the 12-well plate until all tissues were rinsed.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 hours ± 5 minutes
- Spectrophotometer: Anthos 2001 microplate reader
- Wavelength: 540 nm
- Filter: without reference filter
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability:
- Barrier function:
- Morphology:
- Contamination:
- Reproducibility:
NUMBER OF REPLICATE TISSUES: 2
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 35%, or if the viability after 3 minutes exposure is greater than or equal to 35% and the viability after 1 hour exposure is less than 35%. The test substance is considered to be corrosive to skin if the viability after 60 minutes exposure is greater than or equal to 35% and the viability after 240 minutes exposure is less than 35%.
- The test substance is considered to be non-corrosive to skin if viability after 240 minutes exposure is greater than or equal to 35%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 20 mg
- Other: 100 µl of 0.9% w/v sodium chloride solution was added for wetting of the test item.
VEHICLE
no vehicle used
NEGATIVE CONTROL
- Amount(s) applied: 50 µL
- Concentration: 0.9% (w/v) sodium chloride solution
POSITIVE CONTROL
- Amount(s) applied: 50 µL glacial acetic acid - Duration of treatment / exposure:
- Test material: 3, 60 and 240 min
Negative and positive controls: 240 min - Duration of post-treatment incubation (if applicable):
- not applicable
- Number of replicates:
- duplicates
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- 117.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min
- Value:
- 135.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 240 min
- Value:
- 105.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: not specified
- Direct-MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: not specified
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: not specified
Mean OD540 values and viabilities for the negative control, positive control and test material are given in Table 1.
The qualitative evaluation of tissue viability is given in Table 2. Following the 3, 60 and 240 min exposure periods the test material treated tissues appeard blue which was considered to be indicative of viable tissue.
Any other information on results incl. tables
Table1 :Mean OD540Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
Exposure period |
Mean OD540of duplicate tissues |
Relative mean viability (%) |
Negative control** |
240 minutes |
0.161 |
100* |
Positive control** |
240 minutes |
0.005 |
3.1 |
Test substance |
240 minutes |
0.170 |
105.6 |
60 minutes |
0.218 |
135.4 |
|
3 minutes |
0.189 |
117.4 |
* = The mean viability of the negative control tissues is set at 100%
** = Control group shared with Harlan Laboratories Ltd Project numbers 2920/0150, 2920/0151, 2920/0153, 2920/0154 and 2920/0155
Table2 : Qualitative Evaluation of Tissue Viability (MTT uptake visual evaluation)
Item |
Exposure period |
Mean OD540of duplicate tissues |
Relative mean viability (%) |
Negative control* |
240 minutes |
- |
- |
Positive control* |
240 minutes |
++ |
++ |
Test substance |
240 minutes |
- |
- |
60 minutes |
- |
- |
|
3 minutes |
- |
- |
- = Blue tissue (viable)
+ = Blue/white tissue (semi-viable)
++ = Tissue completely white (dead)
* = Control group shared with Harlan Laboratories Ltd Project numbers 2920/0150, 2920/0151, 2920/0153, 2920/0154 and 2920/0155
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was 3.1% relative to the negative control treated tissues following the 240-Minute exposure period. The positive control acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The relative mean cell viability of the test material treated tissues was 117.4, 135.4 and 105.5% after 3, 60 and 240 min exposure, respectively. Under the conditions of this study, the test material is thus considered to be not corrosive in vitro. Therefore, the test material does not meet the criteria for classification for Skin corrosion Category 1 according to Regulation (EC) No 1272/2008 (CLP) or the Globally Harmonized System (GHS).
CLP: not classified
GHS: not classified
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