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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 208-865-8 | CAS number: 544-19-4
- 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:
- 2019-07-02 to 2019-07-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40bis (In Vitro Skin Corrosion: Reconstructed Human Epidermis Test Method (RHE))
- Version / remarks:
- 30 May 2008
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Copper diformate
- EC Number:
- 208-865-8
- EC Name:
- Copper diformate
- Cas Number:
- 544-19-4
- Molecular formula:
- CH2O2.1/2Cu
- IUPAC Name:
- copper diformate
- Test material form:
- solid: particulate/powder
- Details on test material:
- blue in color
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™
- Tissue lot number(s): 30804
- Delivery date: 02 July 2019
- Date of initiation of testing: 02 July 2019
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure and post-treatment incubation: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps:
3-Minute exposure: Rinsing was achieved by filling and emptying each tissue under a constant soft stream of Dulbecco’s Phosphate Buffered Saline (DPBS) (without Ca++ Mg++) for approximately 40 seconds, to gently remove any residual test item. Excess DPBS was removed by blotting the bottom of the tissue insert with tissue paper. Each tissue was placed into the prepared holding plate until all tissues were rinsed. They were then blotted and transferred to the 24-well plate prepared for MTT-loading. The plate was incubated (37 °C, 5% CO2) for 3 hours. Once the 60-Minute exposure period was complete, the same rinsing and MTT-loading procedure was repeated.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Optical Density (OD): OD was read in a microplate reader (Labtech LT-4500 microplate reader and LT-com analysis software)
- Filter bandwidth: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: mean OD of two tissues is >=0.8 <=2.8
NUMBER OF REPLICATE TISSUES: 2
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
-Test for direct MTT reduction:
25 mg of the test item was added to 1 mL of a freshly prepared 1.0 mg/mL MTT solution. The solution was incubated in the dark at 37 °C, 5% CO2 in air for 60 minutes. Untreated MTT solution was tested concurrently to act as a control. The MTT solution containing the test item turned a green color as opposed to a blue/purple colour. A blue/purple color is considered to be a positive and therefore indicative of a direct MTT reducer. The green colored MTT solution was considered to be inconclusive and therefore, as a precaution, an additional procedure using freeze-killed tissues was performed. There was a possibility that if the test item could not be totally rinsed off the tissues, any residual test item present on or in the tissue may directly reduce MTT and could have given rise to a false negative result. Therefore, the determination of skin corrosion potential was performed in parallel on viable and freeze-killed tissues.
Freeze-killed tissues: Freeze-killed tissues were prepared prior to the study by placing untreated EPIDERMTM tissues in an empty 12-well plate and storing in a freezer (-35 to -10 °C) for a minimum of 24 hours. Before use each tissue was thawed by placing in 0.9 mL of assay medium for approximately 1 hour at room temperature. In addition to the normal test procedure, the test item was applied to two freeze-killed tissues per exposure period. In addition, two freeze-killed tissues per exposure period remained untreated. The untreated freeze-killed control normally show a small amount of MTT reduction due to residual reducing enzymes within the killed tissues.
-Assessment of Color Interference with the MTT Endpoint:
25 mg of test item was added to 300 µL of sterile water. The solution was incubated in the dark at 37 °C, 5% CO2 in air for 60 minutes. A visual assessment of the color was then made.
The test item was found to produce a colored solution which may interfere with the MTT assay. Therefore, viable color correction tissues were incorporated into the test to correct for this possibility. These tissues were treated the same as the main test with the exception of being placed into assay medium for 3 hours post-exposure instead of MTT. Two tissues were dosed with the test item and two remained untreated to act as negative controls for the 3 minute exposure group. The same was also performed for the 60 minute exposure group.
-Double Correction Check:
A third set of controls was also used to prevent a double correction from a colored test item that also reduces MTT using killed tissues.
Two freeze-killed tissues were dosed with the test item and two freeze-killed tissues remained untreated to act as the negative control for the 3 minute exposure, with the same number being used for the 60 minute exposure group. These tissues were incubated with assay medium instead of MTT post-exposure.
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- For the test item the relative mean tissue viabilities obtained after the 3 and 60-Minute exposure periods, compared to the mean of the negative control tissues (n=2) treated with sterile distilled water.
- Classification of corrosivity potential is based on relative viabilities for both exposure times
- The test substance is considered to be corrosive to skin if relative mean tissue viability is <50% after 3 min exposure or >= 50% after 3 min exposure AND < 15% after 60 min exposure.
- The test substance is considered to be non-corrosive to skin if relative mean tissue viability is >= 50% after 3 min exposure AND >= 15% after 60 min exposure. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- other: Assessment of Color Interference with the MTT endpoint
- Duration of treatment / exposure:
- 3 min and 60 min
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 min exposure
- Run / experiment:
- mean of 2 replicates
- Value:
- 84.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: non-corrosive to the skin
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 min exposure
- Run / experiment:
- mean of 2 replicates
- Value:
- 31.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: non-corrosive to the skin
Any other information on results incl. tables
During the assessment of direct reduction of MTT the MTT solution containing the test item turned a green color as opposed to a blue/purple colour. A blue/purple color is considered to be a positive and therefore indicative of a direct MTT reducer. The green colored MTT solution was considered to be inconclusive and therefore, as a precaution, an additional procedure using freeze-killed tissues was performed. However, the results obtained showed that no or negligible interference due to direct reduction of MTT occurred. It was therefore considered unnecessary to use the results of the freeze-killed tissues for quantitative correction of results.
The solution containing the test item turned a blue color, therefore additional viable color correction tissues were incorporated into the testing procedure. However, the results obtained showed that no color interference occurred. It was therefore considered unnecessary to use the results of the viable color correction tissues for quantitative correction of results.
As it was unnecessary to use the results of the viable color correction tissues for quantitative correction it was therefore also unnecessary to use the results of the killed color correction tissues as no double correction for color interference would have occurred.
Table 1: Mean OD570 Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Tissue |
|
Exposure Period |
Mean OD570 of individual tissues |
Mean OD570 of duplicate tissues |
Standard Deviation |
Coefficient of Variation (%) |
Relative Mean Viability (%) |
Negative Control
|
|
3 Minutes |
1.898 |
1.775
|
0.174
|
9.8
|
100*
|
|
1.652 |
||||||
|
60 Minutes |
1.832 |
1.788
|
0.063
|
3.5
|
||
|
1.743 |
||||||
Positive Control
|
|
3 Minutes |
0.096 |
0.085
|
0.016
|
na
|
4.8
|
|
0.074 |
||||||
|
60 Minutes |
0.079 |
0.067
|
0.018
|
na
|
3.7
|
|
|
0.054 |
||||||
Test Item
|
|
3 Minutes |
1.644 |
1.499
|
0.206
|
13.7
|
84.4
|
|
1.353 |
||||||
|
60 Minutes |
0.603 |
0.561
|
0.060
|
10.7
|
31.3
|
|
|
0.518 |
OD = Optical density
* = The mean percentage viability of the negative control tissue is set at 100%
na = Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be non-corrosive to the skin.
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.