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EC number: 300-491-4 | CAS number: 93940-93-3
- 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2016-12-126 to 2017-01-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 29 July, 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- May 30, 2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis[N-(2-hydroxyethyl)-N-methylglycinato-N,O,ON]copper
- EC Number:
- 300-491-4
- EC Name:
- Bis[N-(2-hydroxyethyl)-N-methylglycinato-N,O,ON]copper
- Cas Number:
- 93940-93-3
- Molecular formula:
- C10H20CuN2O6
- IUPAC Name:
- bis[N-(2-hydroxyethyl)-N-methylglycinato-N,O,ON]copper
- 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
- Cell source:
- other: human-derived epidermal keratinocytes
- Source strain:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- To ensure good contact with the skin the test item was moistened with 25 µL H2O.
- Details on test system:
- - Source: MatTek Corporation
- The EpiDerm™ tissue: normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis
- Surface: 0.63 cm2
- Pre-incubation: 60 minutes in the incubator (37 ± 1 °C, 5% CO2, 95% RH) in 6-well plates - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg of the test item
- Duration of treatment / exposure:
- 3 min and 60 min
- Number of replicates:
- 2
Test system
- Details on study design:
- Details of the test procedure used:
- EpiDerm™ tissue of human-derived epidermal keratinocytes was used (MatTek, EPI-200-SCT)
- Conditions of exposure: 37 ± 1 °C, 5% CO2, 95% RH
- Washing: inserts gently rinsed with PBS about 20 times (3 min and 60 min exposure time)
- The test was performed on a total of 4 tissues per dose group, 2 replicates for each treatment period (3 min and 60 min exposure time).
- MTT assay: incubation with 0.3 mL of MTT solution for 60 minutes, 3 minutes and 60 minutes at 37 ± 1 °C, 5% CO2
- Data evaluation:
The following was calculated: Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after 3 min and 60 min treatment compared to the negative control tissues concurrently treated with Aqua dest (= 100%)
- Description of evaluation criteria:
In step 1
The mean tissue viability (% negative control)
< 50% after 3 min exposure: predicted as corrosive
≥ 50% after 3 min exposure AND < 15% after 60 min exposure: predicted as corrosive (a combination of optional sub-categories 1B and 1C)
≥ 50% after 3 min exposure AND ≥ 15% after 60 min exposure: predicted as Non-Corrosive
In step 2:
The mean tissue viability (% negative control)
< 25% after 3 min exposure: optional Sub-category 1A
≥ 25% after 3 min exposure: a combination of optional Sub-categories 1B and 1C
- Historical data positive control: Relative Tissue Viability [%] (60 min experiment): 6.1%; Rel. Standard Deviation: 1.99%
- Historical data negative control: Mean Absorption (60 min experiment): 1.867; Rel. Standard Deviation: 0.261
- Acceptability of the Assay:
- mean OD570 nm of the two negative control tissues of the 3 min and 60 min treatment period is between 0.8 and 2.8,
- mean relative tissue viability of the two positive control tissues of the 60 min treatment period is < 15%,
- coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is <= 30%..
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- for the 3 min treatment
- Run / experiment:
- 4 tissues per dose group, 2 replicates
- Value:
- >= 84.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no corrosive effect
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- for the 60 min treatment
- Run / experiment:
- 4 tissues per dose group, 2 replicates
- Value:
- >= 90.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- no corrosive effect
- Other effects / acceptance of results:
- The acceptance criteria were met
Any other information on results incl. tables
Pre-experiments:
The MTT-reducing capacity was tested. The mixture turned blue/purple. Therefore the part of absorption due to non-specific reductin of MTT (NSMTT) was determined:
3 min: NSMTT = 1.3 %
60 min: NSMTT = -1.5 %
This means that the test item was washed away almost completely before the addition of MTT solution.
The non-specific colour (NSC living) was determined using MTT-free assay medium:
3 min: NSC = 0.1 %
60 min: NSC = 0.1 %
Since the outcome is < 5 % no correction of the results was necessary.
Main experiment
Summary results after 3 min and 60 min exposure:
Negative control | Test item | Positive control | |||||
Exposure | 1 | 2 | 1 | 2 | 1 | 2 | |
3 min | Mean OD 570 (blank corrected) | 1.984 | 1.706 | 1.809 | 1.256 | 0.055 | 0.141 |
Total mean OD570 (blank corrected) | 1.845 | 1.533 | 0.098 | ||||
Mean relative tissue viability (%) | 100 | 83.1 | 5.3 | ||||
NSMTT-corrected tissue viability (%) | - | 81.8 | - | ||||
CV (%) | 10.7 | 25.5 | 62.2 | ||||
60 min | Mean OD 570 (blank corrected) | 1.997 | 2.241 | 1.946 | 1.817 | 0.101 | 0.1 |
Total mean OD570 (blank corrected) | 2.119 | 1.882 | 0.1 | ||||
Mean relative tissue viability (%) | 100 | 88.8 | 4.7 | ||||
NSMTT-corrected tissue viability (%) | - | 90.3 | - | ||||
CV (%) | 8.1 | 4.9 | 0.7 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was found to be not corrosive to skin.
- Executive summary:
This in vitro study was performed to assess the corrosivity potential of the test item by means of the Human Skin Model Test. The test was according to OECD guideline 431 and in compliance to GLP.
The test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 3 min and 60 min exposure period and compared to those of the concurrent negative controls.
The test item showed MTT-reducing capability. Since the substance was classified as “non-corrosive” in the main experiment, NSMTT (non specific reduction of MTT) was determined and calculated to 1.3% after 3 min treatment, and – 1.5% after 60 min treatment. Moreover, the test item showed colouring potential after mixture with water and isopropanol in the relevant range of 570 ± 30 nm. Therefore, NSCliving (non-specific colour of additional viable tissues) was determined and calculated to 0.1% for both treatment periods. Since NSClivingwas ≤ 5% relative to the negative control of living epidermis, no correction of the results and no determination of NSCkilled was necessary.
The corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after 3 min and 60 min treatment compared to the negative control tissues concurrently treated with Aqua dest (= 100%). The mean relative tissue viability (% negative control) was 84.4 % (NSMTT corrected), which is ≥ 50% after 3 min treatment and was 90.1 % (90.1%, NSMTT-corrected) ≥ 15 % after 60 min. Therefore it is concluded that the substance shows no corrosive effects.
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