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EC number: 951-963-7 | 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:
- 24.06.2020-17.07.2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Type:
- Constituent
- Test material form:
- other: wet sticky solid
- Specific details on test material used for the study:
- Test Item Zinc chlorohydroxy sulphate and copper sulphide, precipitation Synonym: „Sulphide precipitate“
Lot No. 20190601
CAS No. Not provided
EINECS-No . 951-963-7
Molecular Formula Not provided
Molecular Weight Not provided
Composition Solid
Purity 100 % (UVCB), Multi-constituent substance.
Main components
Zinc Chloride Sulphate Hydroxide Hydrate (Zn12(OH)15(SO4)3Cl3 x H2O)
Sodium Sulphate (Na2SO4)
Copper Sulfide (CuS)
Sodium Chloride (NaCl)
Appearance blackish-green, wet sticky solid
Solubility Water - poor
Homogeneity homogenous
Production Date Not known
Expiry Date 31st December 2025
Storage Room temperature 25±5°C
Test Item Handling and Storage Protect from light, protect from humidity
Test animals / tissue source
- Species:
- other: in vitro study
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
- Protocol: In vitro EpiOcularTM eye irritation test (OCL-200-EIT)
- Source: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Cell line: The EpiOcular™ human cell construct
- Lot: 30667
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37±1°C
- Cell Culture Conditions: a humidified atmosphere of 5±0.5% CO2 in air
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 mg
- Duration of treatment / exposure:
- 6 ± 0.25 minutes
- Duration of post- treatment incubation (in vitro):
- post-exposure of 18±0.25 hours + tissues were incubated with MTT for 3 hours ± 5 min
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- - Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods
Exposure lasted 6±0.25 hours (37±1ºC, 5±1% CO2 and 90±10% RH), followed by post-exposure of 18±0.25 hours (37±1ºC, 5±1% CO2 and 90±10% RH).
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals (if applicable)
The test item may interfere with the MTT endpoint if it is coloured and/or able to directly reduce MTT and at the same time is present in the tissues when the MTT viability test is performed. Some non-coloured test items may change into coloured material in wet or aqueous conditions and thus stain tissues during the 60 min exposure.
To identify these possible interferences, a functional check was performed. The 50mg of a test item was added into 0.3 mL of purified water as well as isopropanol. The mixture was incubated in a glass test tube in the incubator at 37±1°C in a humidified atmosphere of 5±1% CO2 in air for 60 min. At the end of the exposure time, the presence of the staining was evaluated. To evaluate direct interference of the test item with the MTT, 50 mg of the test item was added to 1 mL of the MTT medium and incubated in the incubator (37±1°C in a humidified atmosphere of 5±1% CO2 in air) for 60 min. MTT medium was used as visual control.
- Description of the method used to quantify MTT formazan
After the completion of the post-exposure period, tissue were blot and moved into the 24-well plate prefilled with 300 µL of the MTT-media (c = 1mg/mL). Tissues were incubated with MTT for 3 hours ± 5 min at a humidified incubator (37±1ºC, 5±1% CO2 and 90±10% RH). After the MTT incubation, the blue formazan salt formed by cellular mitochondria was extracted from the tissue with 2 mL/tissue of isopropanol. Extraction was performed overnight at room temperature. Plates were sealed with parafilm to prevent evaporation of isopropanol. On the following day, 200 μL of each extraction solution was transferred to a 96-well plate, and the optical density of extracted formazan was determined using a spectrophotometer at 570 nm. Isopropanol was used as blank.
-The assay was considered valid if the following criteria were met:
Negative Control (NC):
The absolute optical density (OD) of negative control tissues (treated with sterile DI H2O) in the MTT-test is an indicator of tissue viability obtained under specific conditions of the assay. Tissue viability is meeting the acceptance criterion if the mean OD of the NC tissues is ≥ 0.8 and ≤ 2.8.
Positive Control (PC):
The assay meets the acceptance criterion if the mean viability of tissues treated with PC (Methyl acetate) and expressed as % of the negative control tissues is ≤ 50%.
Standard Deviation (SD or Diff):
Per OECD TG 492, Difference of viability between two tissue replicates should be less than 20% or the Standard deviation (SD) between three tissue replicates should not exceed 18%.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- The mean tissue viability (%)
- Value:
- 2.9
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- 100 % viability
- Positive controls validity:
- valid
- Remarks:
- 33.8 % viability
- Remarks on result:
- not determinable
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes, the Optical density (OD) of Negative control treated tissues was 2.011
- Acceptance criteria met for positive control: Yes, the viability of the tissues exposed for 6 hours to the positive control was 33.8%
Any other information on results incl. tables
Results obtained with the test item, PC and NC in the OECD Test Guideline No. 492.
|
OD |
Diff of OD |
Viability [%] |
Diff [%] |
QC |
Prediction |
NC |
2.011 |
0.004 |
100.0 |
0.2 |
qualified |
Not cat |
PC |
0.680 |
0.165 |
33.8 |
8.2 |
qualified |
Positive |
TA |
0.059 |
0.006 |
2.9 |
0.3 |
qualified |
Positive, no prediction can be made |
OD – Optical density, Diff – Difference, QC – quality criteria
NC – Negative control, PC – Positive Control, TA – Test article
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the experimental data conducted according to the OECD TG 492 and strictly adhering to the prediction model of the guideline, it can be concluded that no prediction of eye irritating effect can be made for the test item “Zinc chlorohydroxy sulphate and copper sulphide, precipitation”.
- Executive summary:
The purpose of the study was to evaluate the eye irritation potential of “Zinc chlorohydroxy sulphate and copper sulphide, precipitation” in In Vitro Eye Irritation Test utilising the Reconstructed Human Cornea-like Epithelial (RhCE) model (OECD TG 492).
The eye irritation potential of “Zinc chlorohydroxy sulphate and copper sulphide, precipitation” was examined in the in vitro eye irritation test using the reconstructed human epidermal model EpiOcularTM. Two tissue replicates were used for each treatment (exposure time 6 hours, postexposure time 18 hours). Concurrent positive (Methyl acetate) and negative (DI H2O) controls were used to ensure the adequate performance of the experimental model.
The Optical density (OD) of Negative control treated tissues was2.011 and the viability of the tissues exposed for 6 hours to the positive control was 33.8% (see Table 6 and Appendix 3). The Positive and Negative controls met the acceptance criteria set by the OECD TG 492.
The viability of cultures treated by “Zinc chlorohydroxy sulphate and copper sulphide, precipitation” was 2.9 % with a Diff of 0.3 %. Since the material did not reduce MTT, nor it interacted with water, and was very easily removed from the tissue surface during the washing procedure, no additional steps were necessary to correct the result obtained on viable tissues in the main experiment.
On the basis of the prediction model given by the OECD TG 492, for the test item “Zinc chlorohydroxy sulphate and copper sulphide, precipitation” no prediction could be made, and the test material requires further testing and clarification its eye irritating or corrosive effects.
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