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Diss Factsheets
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EC number: 231-203-4 | CAS number: 7446-26-6
- 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:
- 20 Jun-14 Jul 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Adopted 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Department of Health and Consumer Protection, Hamburg, Germany
Test material
- Reference substance name:
- Dizinc pyrophosphate
- EC Number:
- 231-203-4
- EC Name:
- Dizinc pyrophosphate
- Cas Number:
- 7446-26-6
- Molecular formula:
- H4O7P2.2Zn
- IUPAC Name:
- dizinc(2+) (phosphonooxy)phosphonate
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The reconstructed human epidermis model showed evidence of being a reliable and relevant stand-alone test for predicting rabbit skin irritation being used as a replacement for the Draize Skin irritation test. Test items are applied topically as the dermal route is the most likely exposure route and the results of the study are believed to be of value in predicting the likely skin irritancy potential to man.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: The EpiDerm™ model
- Tissue batch number(s): EPI-200, Lot no. 25829
- Date of initiation of testing: 20 June 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment/exposure: 37 °C
- Temperature of post-treatment incubation: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: All tissues were washed carefully with DPBS after the exposure period.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: Tecan Sunrise Magellan Version 7.2
- Wavelength: 540 nm
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Fresh tissues/killed tissues: killed tissues
- Procedure used to prepare the killed tissues: incubating in distilled water at 37 °C for 42 h
- N. of replicates: 3
- Method of calculation used: direct comparison of treated to untreated water-killed tissues
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: one
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be a non-irritant to skin if the viability of three individual tissues after 60 minutes exposure period to the test substance followed by 42 hours post-exposure incubation is greater than 50% of the mean viability of the negative controls. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- - OTHER EFFECTS:
- Direct-MTT reduction: The results of the direct interference evaluation procedure showed that no interference due to direct reduction of MTT by the test substance occurred.
- Colour interference with MTT: An assessment found the test item had no potential to cause colour interference with the MTT endpoint. It was therefore considered unnecessary to use the results of the colour correction tissues for quantitative correction of results or for reporting purposes
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg applied uniformly over an area of 0.63 cm²
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): DPBS 30 µL
- Concentration (if solution): 100%
POSITIVE CONTROL
- Amount(s) applied (volume or weight): aqueous sodium dodecyl sulphate 30 µL
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 35 min at 37 °C and 25 min at RT
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60-min exposure followed by 42-hour post-exposure incubation period
- Value:
- 101.6
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 6.5%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD540 for the negative control treated tissues was 1.396 and the standard deviation determined for all triplicates was below 18%. The negative control acceptance criteria were therefore satisfied.
- Acceptance criteria met for positive control: The relative mean tissue viability for the positive control treated tissues was 6.5% relative to the negative control treated tissues. The positive control acceptance criteria was therefore satisfied.
- Acceptance criteria met for variability between replicate measurements: The relative mean tissue viability for the test item treated tissues was 101.6% of the negative controls after a 60-min exposure period and 42-hour post-exposure incubation period. The standard deviation calculated from individual tissue viabilities of the three identically test item treated tissues was <18%. The test item acceptance criteria was therefore satisfied.
Any other information on results incl. tables
Mean OD540 Values and Viabilities for the Negative Control, Positive Control, and Test Items
Item |
OD540 of tissues |
Mean OD540 of triplicate tissues |
%CV of mean OD540 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
%CV of Relative mean viability (%) |
Negative Control |
1.313 |
1.396 |
7.6 |
94.1 |
100* |
7.6 |
1.360 |
97.4 |
|||||
1.516 |
108.6 |
|||||
Positive Control |
0.083 |
0.092 |
10.4 |
5.9 |
6.5 |
10.9 |
0.090 |
6.4 |
|||||
0.102 |
7.3 |
|||||
Test Item |
1.349 |
1.418 |
5.3 |
96.6 |
101.6 |
5.2 |
1.408 |
100.9 |
|||||
1.497 |
107.2 |
* = The mean viability of the negative control tissues is set at 100%
OD = Optical density
CV = Coefficient ovf variation
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
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