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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 Jun - 20 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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted July 26, 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Gesundheit und Verbraucherschutz
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
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Hubert Bahlmann GmbH & Co. Versandschlachterei Spezialmischfutterwerk KG, Lindern, Germany
- Characteristics of donor animals: 6 - 12 months old
- Storage, temperature and transport conditions of ocular tissue: The isolated eyes were transported in Hank's Buffered Salt Solution (HBSS) containing penicillin (100 IU/mL) and streptomycin (100 µg/mL).
- Time interval prior to initiating testing: The corneae were isolated on the same day after delivery of the eyes and directly used in the BCOP test.
- indication of any existing defects or lesions in ocular tissue samples: Upon arrival at the laboratory, the eyes were examined for defects such as but not limited to increased opacity, scratches, and neovascularisation. Only corneas from eyes free of defects were used.
- Indication of any antibiotics used: Penicillin (100 IU/mL) and streptomycin (100 µg/mL)
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 750 µL
- Concentration: 20% suspension
VEHICLE
- Amount(s) applied: 750 µL
- Concentration: 0.9%
- Lot/batch no.: 170518002
POSITIVE CONTROL
- Amount(s) applied: 750 µL
- Concentration: 20%
- Lot/batch no.: SLBK9670V - Duration of treatment / exposure:
- 240 min
- Number of animals or in vitro replicates:
- triplicates for each treatment and control group
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The corneas were dissected with a 2 to 3 mm rim of sclera and mounted in corneal holders with anterior (epithelium) and posterior (endothelium) chambers. Beginning with the posterior chambers, the chambers were filled to excess with pre-warmed Eagle’s Minimum Essential Medium (EMEM), while preventing bubble formation. The corneal holder was equilibrated at 32 °C ± 1 °C for at least one hour.
QUALITY CHECK OF THE ISOLATED CORNEAS
After the equilibration period, fresh pre-warmed EMEM was added to both chambers and baseline opacity readings were taken for each cornea. Corneas exhibiting macroscopic tissue damage (e.g. scratches, pigmentation, neovascularisation) or an opacity >7 opacity units were discarded. The mean opacity of all equilibrated corneas was calculated by use of an opacitometer. A minimum of three corneas with opacity values close to the median value for all corneas were selected as negative control corneas. The remaining corneas were then distributed into treatment, solvent and positive control groups.
TREATMENT METHOD: closed chamber
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: The epithelium was washed with EMEM containing phenol red at least three times. Washing was repeated until no test item or discolouration (yellow or purple) of phenol red was visible. The corneas were rinsed a final time with EMEM only to remove any remaining phenol red from the chamber. The chamber was then filled with EMEM without phenol red.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer (BASF, Ludwigshafen am Rhein, Germany).
- Corneal permeability: The passage of sodium fluorescein dye was measured with the aid of a microplate reader (Tecan Sunrise Magellan Version 7.2, Crailsheim, Germany) at 490 nm.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA
Test substance with an IVIS > 55 was regarded as severe irritant/corrosive and labelled Category 1.
Test substance with an IVIS ≤ 3 was regarded as non-irritant and labelled in no category.
Test substance with an IVIS > 3; ≤ 55: no prediction can be made.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean value of 3 corneas
- Value:
- 0.627
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The corneas treated with the negative control item 0.9 % sodium chloride solution revealed a mean opacity value of 1.209 ± 0.807 and a mean permeability value of 0.031 ± 0.011. The calculated IVIS value of 1.669 ± 0.956 was well below the cut-off value of 3 (UN GHS no category).
- Acceptance criteria met for positive control: The corneas treated with the positive control item 20 % Imidazole in 0.9 % NaCl solution revealed a mean opacity value of 59.694 ± 7.591 and a mean permeability value of 3.011 ± 0.100 compared to the solvent control. The calculated IVIS value of 104.864 ± 8.811 was within two standard deviations of the current historical mean and well above the cut-off value of 55. Hence, the acceptance criteria for the test were fulfilled.
Any other information on results incl. tables
Table 2: Opacity values
Cornea No. | Opacity [Opacity Units] | Corrected Opacity | ||||||||||||||||||||||||||||||
Mean of group | Standard deviation | |||||||||||||||||||||||||||||||
0.9 % NaCl | 1 | 0.558 | 1.209 | 1.209 | 0.807 | |||||||||||||||||||||||||||
2 | 0.956 | |||||||||||||||||||||||||||||||
3 | 2.112 | |||||||||||||||||||||||||||||||
20 % Imidazol | 4 | 53.386 | 52.177 | 59.694 | 7.591 | |||||||||||||||||||||||||||
5 | 60.757 | 59.548 | ||||||||||||||||||||||||||||||
6 | 68.566 | 67.357 | ||||||||||||||||||||||||||||||
20 % Test substance |
7 | 2.710 | 1.501 | 1.062 | 0.900 | |||||||||||||||||||||||||||
8 | 2.868 | 1.659 | ||||||||||||||||||||||||||||||
9 | 1.236 | 0.027 |
Table 3: Permeability OD values (490 nm)
Corne a no. | Permeability [OD] | Mean of Tripli- cates | Corrected Permeability [OD] | |||||||||||||||||||||||||||||||||
Per Cornea | Per Group | |||||||||||||||||||||||||||||||||||
Mean | SD | Mean | SD | |||||||||||||||||||||||||||||||||
0.9 % NaCl | 1 | 0.028 | 0.027 | - | 0.027 | 0.001 | 0.031 | 0.011 | ||||||||||||||||||||||||||||
0.027 | - | |||||||||||||||||||||||||||||||||||
0.027 | - | |||||||||||||||||||||||||||||||||||
2 | 0.022 | 0.022 | - | 0.022 | 0.001 | |||||||||||||||||||||||||||||||
0.023 | - | |||||||||||||||||||||||||||||||||||
0.022 | - | |||||||||||||||||||||||||||||||||||
3 | 0.042 | 0.043 | - | 0.043 | 0.002 | |||||||||||||||||||||||||||||||
0.042 | - | |||||||||||||||||||||||||||||||||||
0.045 | - | |||||||||||||||||||||||||||||||||||
20 % Imidazol | 4 | 2.908 | 2.928 | 2.877 | 2.897 | 0.018 | 3.011 | 0.100 | ||||||||||||||||||||||||||||
2.934 | 2.903 | |||||||||||||||||||||||||||||||||||
2.942 | 2.911 | |||||||||||||||||||||||||||||||||||
5 | 3.054 | 3.113 | 3.023 | 3.082 | 0.051 | |||||||||||||||||||||||||||||||
3.142 | 3.111 | |||||||||||||||||||||||||||||||||||
3.142 | 3.111 | |||||||||||||||||||||||||||||||||||
6 | 3.010 | 3.086 | 2.979 | 3.055 | 0.070 | |||||||||||||||||||||||||||||||
3.100 | 3.069 | |||||||||||||||||||||||||||||||||||
3.148 | 3.117 | |||||||||||||||||||||||||||||||||||
20 % Test substance |
7 | 0.007 | 0.004 | -0.024 | -0.027 | 0.003 | -0.029 | 0.002 | ||||||||||||||||||||||||||||
0.004 | -0.027 | |||||||||||||||||||||||||||||||||||
0.002 | -0.029 | |||||||||||||||||||||||||||||||||||
8 | 0.000 | 0.001 | -0.031 | -0.030 | 0.001 | |||||||||||||||||||||||||||||||
0.002 | -0.029 | |||||||||||||||||||||||||||||||||||
0.001 | -0.030 | |||||||||||||||||||||||||||||||||||
9 | 0.000 | 0.001 | -0.031 | -0.030 | 0.001 | |||||||||||||||||||||||||||||||
0.002 | -0.029 | |||||||||||||||||||||||||||||||||||
0.001 | -0.030 |
SD: Standard deviation
OD: Optical density
Table 4: IVIS
Cornea No. | Opacity | Permeability | IVIS | |||||||||||||||||||||||||||||||||
Per Cornea | Per Group | |||||||||||||||||||||||||||||||||||
Mean | SD | |||||||||||||||||||||||||||||||||||
0.9 % NaCl | 1 | 0.558 | 0.027 | 0.963 | 1.669 | 0.956 | ||||||||||||||||||||||||||||||
2 | 0.956 | 0.022 | 1.286 | |||||||||||||||||||||||||||||||||
3 | 2.112 | 0.043 | 2.757 | |||||||||||||||||||||||||||||||||
20 % Imidazol | 4 | 52.177 | 2.897 | 95.632 | 104.864 | 8.811 | ||||||||||||||||||||||||||||||
5 | 59.548 | 3.082 | 105.778 | |||||||||||||||||||||||||||||||||
6 | 67.357 | 3.055 | 113.182 | |||||||||||||||||||||||||||||||||
20 % Test substance |
7 |
1.501 |
-0.027 |
1.096 |
0.627 |
0.911 |
||||||||||||||||||||||||||||||
8 |
1.659 |
-0.030 |
1.209 |
|||||||||||||||||||||||||||||||||
9 |
0.027 |
-0.030 |
-0.423 |
SD: Standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
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