Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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:
- 19 FEB 2021 - 2 JUN 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
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)
- Version / remarks:
- adopted 18. Jun. 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt Rheinland-Pfalz 15 May 2018
Test material
- Reference substance name:
- Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, zinc sodium salts
- Molecular formula:
- non specified (UVCB substance)
- IUPAC Name:
- Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, zinc sodium salts
- Test material form:
- solid: particulate/powder
1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method (e.g. ICE, EIT, RhCE) and considerations regarding applicability:
This study was performed in order to evaluate the eye hazard potential of ManganeseEDDHA sodium salts in a Reconstructed human Cornea-like Epithelium (RhCE) model in an in vitro study (e.g. EpiOcularTM Eye Irritation Test). The EpiOcular™ Eye Irritation Test (EIT) predicts the acute eye hazard potential of chemicals by measurement of tissue damage caused by cytotoxic effects in the reconstructed
human cornea-like tissue model. Within a testing strategy, the EpiOcular™ EIT can be used as a replacement of the in vivo Draize Eye Irritation Test. It is utilized for the classification and labelling of chemicals concerning their eye hazard potential. The EpiOcular™ EIT can be used to identify chemicals that do not require classification for eye irritation or serious eye damage according to the UN GHS classification system. A limitation of this guideline is that it neither allows discrimination between eye irritation/reversible effects on the eye (Category 2) and serious eye damage/irreversible effects on the eye (Category 1), nor between eye irritants (optional Category 2A) and mild eye irritants (optional Category 2B). For these purposes, further testing with other suitable test methods is required The solid test item was applied topically to a three-dimensional RhCE tissue construct in duplicate for an exposure time of 6 hours. Eye hazard materials are identified by their ability to produce a decrease in cell viability as determined. The cell viability is measured by dehydrogenase conversion of MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide), present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percentage reduction of cell viability in comparison of untreated negative controls is used to predict the eye irritation potential. The test substance falls within the applicaility domain of this model.
- Description of the cell system used, incl. certificate of authenticity and the mycoplasma status of the cell live: No bacteria, yeast and other fungi were detected, Tissue viability and Barrier function were within the acceptance criteria
- Cell line used, its source, passage number and confluence of cells used for testing: Keratinocyte strain 4F1188
- RhCE tissue or hCE cell construct used, including batch number: EpiOcular™ Tissue (Lot No. 34901)
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): 50.5mg - Duration of treatment / exposure:
- 6 h
- Duration of post- treatment incubation (in vitro):
- 18 h
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- - Details of the test procedure used
:
The solid test item was applied topically to a three-dimensional RhCE tissue construct in duplicate for an exposure time of 6 hours. Eye hazard materials are identified by their ability to produce a decrease in cell viability as determined. The cell viability is measured by dehydrogenase conversion of MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide), present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percentage reduction of cell viability in comparison of untreated negative controls is used to predict the eye irritation potential
- Doses of test chemical and control substances used :
test item: 50 mg, positive and negative control: 50 µL
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable) : 6 h exposure 37 ± 1 °C, 18 h post-exposure incubation at 37 ± 1 °C
- Number of tissue replicates used per test chemical and controls (positive control, negative control) : 2
- For hCE cells: number of runs and of hCE models used within each run : 1 run, 2 tissues per test item/controls
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer) : 570 nm
- Description of the method used to quantify MTT formazan, if applicable : The inserts were removed from the 6-well plate and discarded. 1 mL isopropanol was added and the content of each well was thoroughly mixed in order to achieve homogenisation.
From each well, two replicates with 200 µL solution (each) were pipetted into a 96-wellplate. The plate was read in a plate spectrophotometer at 570 nm. In addition, eight wells of the 96-well-plate were filled with 200 µL isopropanol each, serving as blank
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model : according to OECD TG 492
- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria :
negative control OD: historical range 1.047 - 2.340 (mean 1.660) - study 1.618
positive control viability: historical range 20.4 - 47.8% (mean 34.1%) - study 26.4%
- Complete supporting information for the specific RhCE tissue construct or hCE cells used :
EpiOcularTM tissues were procured from MatTek In Vitro Life Science Laboratories, Mlynské Nivy 73, 82105 Bratislava, Slovakia.
Designation of the kit: OCL-200-EIT
Day of delivery: 16. Mar. 2021
Batch no.: 34901
- Demonstration of proficiency in performing the test method before routine use by testing of the proficiency chemicals : All 15 proficiency chemicals of the OECD TG 492 were correctly classified.
- Acceptable variability between tissue replicates for positive and negative controls : <20%
- Acceptable variability between tissue replicates for the test chemical: <20%
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- Tissue 1
- Value:
- 43.9
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent tissue viability
- Run / experiment:
- Tissue 2
- Value:
- 40.4
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
The pre-test showed, that the test item was intensely coloured (OD > 0.08), but the mean viability of the tissues treated with test item was 42.2% (≤ 60%) and therefore the additional test was not necessary.
DEMONSTRATION OF TECHNICAL PROFICIENCY: demonstrated on the 15 proficiency chemicals indicated in the OECD TG 492
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: demanded OD > 0.8 < 2.8 - found OD 1.618
- Acceptance criteria met for positive control: demanded < 50 % of negative control - found 26.4 %
Any other information on results incl. tables
Table 1: Absorbance Values Negative Control, Positive Control and Test Item (OD at 570 nm)
Designation |
Measurement |
Negative Control |
Positive Control |
Test Item |
Tissue 1 |
1 |
1.740 |
0.442 |
0.744 |
2 |
1.750 |
0.443 |
0.745 |
|
Tissue 2 |
1 |
1.561 |
0.479 |
0.687 |
2 |
1.558 |
0.482 |
0.688 |
Table 2: Mean Absorbance Negative Control, Positive Control and Test Item
Designation |
Negative Control |
Positive Control |
Test Item |
Mean – blank (Tissue 1) |
1.711 |
0.409 |
0.711 |
Mean – blank (Tissue 2) |
1.526 |
0.447 |
0.654 |
Table 3: % Viability Positive Control and Test Item
Designation |
Positive Control |
Test Item |
% Viability (Tissue 1) |
25.2% |
43.9% |
% Viability (Tissue 2) |
27.6% |
40.4% |
% Viability Mean |
26.4% |
42.2% |
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- After treatment with the test item, the mean value of relative tissue viability was 42.2%. This value is below the threshold for eye irritation potential (≤ 60%). Test items that induce values below the threshold are considered either eye irritant or inducing serious eye damage.
- Executive summary:
The registered substance was tested for eye irritation in a GLP compliant in vitro study according to OECD Guideline 492. The test item was applied to a three-dimensional human cornea tissue model in duplicate for an exposure time of 6 hours. The solid test item was applied to two tissue replicates. After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to formazan. The formazan production was evaluated by measuring the optical density (OD) of the resulting solution. Demineralised water was used as negative control and methyl acetate was used as positive control. The controls showed the following results: After treatment with the negative control, the absorbance values were within the required acceptability criterion of mean OD > 0.8 and < 2.8, OD was 1.618. The positive control showed clear eye irritating effects, the mean value of the relative tissue viability was 26.4% (< 50%). The variation within tissue replicates of the controls and the test item was acceptable (< 20%). After treatment with the test item, the mean value of relative tissue viability was 42.2%. This value is below the threshold for eye irritation potential (≤ 60%). Test items that induce values below the threshold are considered either eye irritant or inducing serious eye damage. According to the OECD Guideline 492, the EpiOcularTM Eye Irritation Test does not allow discrimination between eye irritation/reversible effects on the eye (Category 2) and serious eye damage/irreversible effects on the eye (Category 1). In this case no prediction can be made and further testing with other suitable test methods is required. Under the conditions of the test, Zinc-EDDHA sodium salts is considered either eye irritant or inducing serious eye damage in the EpiOcularTM Eye Irritation Test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.