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EC number: - | CAS number: -
- 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:
- From 2022-10-28 to 2022-10-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 023
- Report date:
- 2023
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EU) No 2017/735 amending, for the purpose of its adaptation to technical progress, the Annex to Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 (Reach).
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997.
- Version / remarks:
- April 1997
- 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:
- 26th June 2020
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- 09 Dec 2010
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2‐aminoacetate, hydron, zinc(2+) sulfate hydrate
- Molecular formula:
- C2H7NO7SZn
- IUPAC Name:
- 2‐aminoacetate, hydron, zinc(2+) sulfate hydrate
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: AB Schlachthof GmbH & Co. KG, 63739 Aschaffenburg, Germany
- Characteristics of donor animals (e.g. age, sex, weight): The slaughterhouse did not confirm the age of the donor cattle despite repeated requests.
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Freshly isolated bovine eyes of donor cattle were collected from the abattoir. Excess tissue was removed from the excised eyes. The isolated eyes were stored in HBSS (Hank’s Balanced Salt Solution) containing 1% (v/v) penicillin/streptomycin (100 units/mL penicillin and 100 μg/mL streptomycin) in the cooled slaughter house and during transportation on the same morning to the laboratory using a Styrofoam box.
- Time interval prior to initiating testing: The corneas were isolated on the same day after delivery of the eyes.
- Indication of any existing defects or lesions in ocular tissue samples:
All eyes were carefully examined macroscopically for defects. Those presenting defects such as vascularization, pigmentation, opacity and scratches were discarded. The cornea was carefully removed from the eye using scalpel and rounded scissors. A rim of about 2 mm of tissue (sclera) was left for stability and handling of the isolated cornea.
- Indication of any antibiotics used: 100 units penicillin per mL medium, and 100 µg streptomycin per mL medium)
- Selection and preparation of corneas: Each isolated cornea was mounted in a specially designed cornea holder according to the description given in OECD guideline 437, which consists of anterior and posterior compartments, which interface with the epithelial and the endothelial sides of the cornea, respectively. The endothelial side of the cornea was positioned against the sealing ring (O-ring) of the posterior part of the holder. The cornea was gently flattened over the O-ring but stretching was avoided. The anterior part of the holder was positioned on top of the cornea and fixed in place with screws. Both compartments of the holder were filled with incubation medium. The posterior compartment was filled first to return the cornea to its natural convex position. Care was taken to assure that no air bubbles were present within the compartments.
For equilibration, the corneas in the holder were incubated in a vertical position for about one hour at 32 ± 1 °C in a water-bath. At the end of the incubation period, the medium was changed before basal opacity measurement (t0).
- Quality check of the isolated corneas: Only corneas with a value of the basal opacity < 7 were used.
Test system
- Vehicle:
- physiological saline
- Remarks:
- (0.9% NaCl in deionised water)
- Controls:
- yes
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: The test item was tested as a 20% solution (w/v) in saline.
VEHICLE
- Amount(s) applied: 0.75 mL - Duration of treatment / exposure:
- The incubation period was 240 minutes.
- Duration of post- treatment incubation (in vitro):
- The anterior compartment was filled with 1 mL of a 0.5% (w/v) sodium fluorescein solution in HBSS. Corneas were incubated again in a horizontal position for 90 ± 5 minutes in a water-bath at 32 ± 1 °C. Incubation medium from the posterior compartment was removed, well mixed and transferred into a 96 well plate.
- Number of animals or in vitro replicates:
- Number of Corneas:
15 corneas where used for the experiment (three per group):
Negative Control I: 3
Negative Control II: 3
Positive Control I: 3
Positive Control II: 3
Test Item: 3 - Details on study design:
- NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: deionised water
SOLVENT CONTROL USED: Saline (0.9% NaCl in deionised water)
POSITIVE CONTROL USED
Positive Control 1: 10% (w/v) Benzalkonium chloride (purity not indicated by the producer) in saline using sonication.
Positive Control 2: 20 % (w/v) Imidazole in saline
APPLICATION DOSE AND EXPOSURE TIME
The test item was tested as a 20% solution (w/v) in saline.
The incubation period was 240 minutes.
TREATMENT METHOD: closed chamber
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period:
After exposure, the test item or the control items, respectively, were each rinsed off from the according application sides with EMEM containing phenol red for at least three times or more until phenol red was still discoloured (yellow or purple), or the test item was still visible. Once the medium was free of the test item the corneas were given a final rinse with cMEM without phenol red. Fresh cMEM was added into both compartments and opacity was measured (t240).
- POST-EXPOSURE INCUBATION:
After the final opacity measurement was performed, the incubation medium was removed from both chambers. The posterior chamber was filled with fresh cMEM first. Then the anterior compartment was filled with 1 mL of a 0.5% (w/v) sodium fluorescein solution in HBSS. Corneas were incubated again in a horizontal position for 90 ± 5 minutes in a water-bath at 32 ± 1 °C. Incubation medium from the posterior compartment was removed, well mixed and transferred into a 96 well plate.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity:
The opacitometer determines changes in the light transmission passing through the corneas and displays a numerical opacity value. The opacitometer (OP_KiT opacitometer (Electro Design, 63-Riom, France)) was calibrated as described in the manual and the opacity of each of the corneas was determined by reading each holder placed in the photoreceptor compartment for treated cornea.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490).
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
IVIS GHS
≤ 3 No Category
> 3; ≤ 55 No prediction can be made
> 55 Category 1
DECISION CRITERIA: according to guideline
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1 Experiment with five groups (two negative controls, two positive controls, one test item)
- Value:
- 1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Test Group | Opacity value = Difference (t240-t0) of Opacity | Permeability at 490 nm (OD490) | IVIS | Mean IVIS | Standard Deviation | Proposed Category | ||
|
| Mean |
| Mean |
|
|
|
|
Negative Control (Saline) | 0 | 0.33 | 0.071 | 0.067 | 1.07 | 1.34 | 0.58 | No Category |
1 | 0.067 | 2.01 | ||||||
0 | 0.064 | 0.96 | ||||||
Negative Control (deionised water) | 1 | 0.065 | 1.98 | 1.29 | 0.60 | No Category | ||
0 | 0.060 | 0.90 | ||||||
0 | 0.066 | 0.99 | ||||||
Positive Control | 76.67* | 0.768* | 88.18 | 91.70 | 3.05 | Category 1 | ||
82.67* | 0.710* | 93.31 | ||||||
85.67* | 0.529* | 93.60 | ||||||
Positive Control (20 % Imidazole) | 88.67* | 0.769* | 100.20 | 101.15 | 4.74 | Category 1 | ||
80.67* | 1.086* | 96.95 | ||||||
87.67* | 1.242* | 106.29 | ||||||
Test Item | 1.67* | 0.00** | 1.67 | 1.00 | 0.58 | No Category | ||
0.67* | 0.00** | 0.67 | ||||||
0.67* | 0.00** | 0.67 |
* corrected values
** Value was set to zero since the calculated value was negative
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, according to the current study and under the experimental conditions reported, the test item is not categorized (EU CLP/GHS No Category).
- Executive summary:
This in vitro study was performed to assess the corneal irritation and damage potential of Zinc Monoglycinate Sulfate Hydrate by means of the BCOP assay using fresh bovine corneas (OECD 437, 2013-07-26).
After a first opacity measurement of the fresh bovine corneas (t0), the 20% (w/v) solution in saline (0.9% (w/v) NaCl in deionised water) of the test item Zinc Monoglycinate Sulfate Hydrate as well as the positive and the negative controls were each applied to different corneas fixed in an incubation chamber in horizontal position and incubated for 240 minutes at 32 ± 1 °C. The posterior chamber contained incubation medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneas and opacity was measured again (t240).
After the opacity measurements, permeability of the corneas was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C.
With the negative controls saline and deionised water, neither an increase of opacity nor permeability of the corneas could be observed (saline mean IVIS = 1.34; deionised water mean IVIS = 1.29).
The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity and distinctive permeability of the corneas (mean IVIS = 91.70) corresponding to a classification as serious eye damaging (EU CLP/GHS (Category 1) as well as the positive control imidazole (mean IVIS = 101.15).
Based on these results, zinc monoglycinate sulfate dihydrate does not require classification according to Regulation (EC) No. 1272/2008 (CLP) or the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) with respect to eye irritation.
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