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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 214-307-4 | CAS number: 1120-44-1
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11. May- 13. July 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Version 439, 28. July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- dated 24. Aug. 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Copper dioleate
- EC Number:
- 214-307-4
- EC Name:
- Copper dioleate
- Cas Number:
- 1120-44-1
- Molecular formula:
- C18H34O2.1/2Cu
- IUPAC Name:
- copper(2+) bis((9Z)-octadec-9-enoate)
- Test material form:
- solid
- Remarks:
- paste
- Details on test material:
- Solid green paste. Batch number 21092015
Constituent 1
- Specific details on test material used for the study:
- Name: Copper dioleate
Batch no.: 21092015
Appearance: Green, solid/paste
Composition: Cu-dioleate.
Purity: > 99 %, IR.
Homogeneity: homogeneous
Expiry date: 21. Sep. 2018
Storage: Room Temperature (20 ± 5°C)
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDermTM
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDermTM tissue consists of human-derived epidermal keratinocytes
- Source strain:
- other: Human derived keratinocytes
- Details on animal used as source of test system:
- The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have
been cultured to form a multi-layered, highly differentiated model of the human epidermis.
It consists of organized basal, spinous and granular layers, and a multi-layered stratum
corneum containing intercellular lamellar lipid layers representing main
lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially
prepared cell culture inserts. - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test system is a commercially available EpiDermTM-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have
been cultured to form a multi-layered, highly differentiated model of the human epidermis.
It consists of organized basal, spinous and granular layers, and a multi-layered stratum
corneum containing intercellular lamellar lipid layers representing main
lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially
prepared cell culture inserts. EpiDermTM tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.
MTT assay:
3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazoliumbromide (=MTT), which can be reduced
to a blue formazan.
A MTT stock solution of 5 mg/mL in DPBS buffer was prepared and stored in aliquots of
2 mL in the freezer (– 20 ± 5 °C).
2 mL of the stock solution were thawed and diluted with 8 mL of medium. This MTTsolution
with the resulting concentration of 1 mg/mL was used in the test.
For the pre-test (testing the ability of direct formazan reduction), the concentrate was
thawed and diluted with serum-free MEM directly before use.
For the main tests, the concentrate was thawed and diluted with assay medium directly
before use.
The following instruments and devices were used in the performance of the study.
Autoclave, 3870 ELV-B
Stop watches
96-well-plate photometer, Anthos Reader
Precision scales, Sartorius CPA8201
Precision scales, Mettler Toledo PB 5001-S
Analytical scales, Mettler Toledo XS 205 DU
Incubation chamber Binder, adjustable to 37 °C, 5% CO2
Table water bath, neoLab
Glass thermometer
Adjustable pipettes with sterile tips
Clean bench, category 2 (Axo Safe, MARS 12000)
Forceps, sterile
Orbital shakers, GFL 3005
Nylon mesh circles 8 mm diameter (200 μm pore (EPI-MESH))
Pipetting device, Accu Jet
Freezer
Weighing funnels - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- Tissue Amount
1.exp Add test 2. exp 3. exp
1 24.4 mg 26.4 mg 25.7 mg 25.4 mg
2 26.7 mg -- 25.8 mg 25.9 mg
3 26.0 mg -- 25.4 mg 25.9 mg - Duration of treatment / exposure:
- three tissues of the human skin model EpiDermTM were treated with Copper dioleate for 60 min.
The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm2; as indicated by the supplier). - Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other:
- Remarks:
- % photometric absorbance
- Run / experiment:
- 3 experiments
- Value:
- 63.2
- Negative controls validity:
- valid
- Remarks:
- In all experiments, the optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8
- Positive controls validity:
- valid
- Remarks:
- The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system
- Remarks on result:
- positive indication of irritation
- Remarks:
- In the first experiment the mean value lead to the classification “non-irritant to skin”, in the second experiment the result was “skin irritant” and in the third experiment the result was again “non-irritant to skin”. Therefore, Copper dioleate cannot be classified with the Human Skin Model Test because of the discrepant results of the three experiments.
- Other effects / acceptance of results:
- All validity criteria were met.
Values for negative control and for positive control were within the range of historical data of the test .
Criterion: OD of negative control
Demanded: ≥ 0.8 and ≤ 2.8
1. Experiment 1.4
2. Experiment 1.9
3. Experiment 1.8
Criterion: % Formazan production of positive control
Demanded: ≥ 20% of negative control
1. Experiment 3.6%
2. Experiment 3.5%
3. Experiment 3.4%
Criterion: SD of mean viability of the tissue replicates(%)
Demanded: ≤ 18%
1. Experiment
3.0% (negative control)
0.5% (positive control)
8.7% (test item)
2. Experiment
4.3% (negative control)
0.2% (positive control)
1.6% (test item)
3. Experiment
7.1% (negative control)
0.2% (positive control)
3.6% (test item)
Any other information on results incl. tables
All validity criteria were met.
Values for negative control and for positive control were within the range of historical data
of the test facility .
The first experiment was insufficient for classification of the test item, because the three
replicates lead to a discrepant classification, the mean value would lead to “non-irritant to
skin”. Therefore a second experiment was performed. In the second experiment the test
item showed skin irritation potential. This was a deviating value compared to the first experiment.
Therefore a third experiment was performed. The result was “non-irritant to
skin”.
Due to the equivocal results of the three experiments, no prediction can be made and the
test item cannot be classified for skin irritation with this test method.
Experiment 1 %Formazanproduction
Designation |
Copperdioleate |
PositiveControl |
% Formazanproduction(tissue1) |
62.1% |
3.9% |
% Formazanproduction(tissue2) |
55.7% |
3.1% |
% Formazanproduction(tissue3) |
44.9% |
3.8% |
%Formazan production (mean) |
54.2% |
3.6% |
±SD ofmean Formazan production (%) |
8.7% |
0.5% |
Designation |
Copperdioleate |
PositiveControl |
% Formazanproduction(tissue1) |
37.6% |
3.3% |
% Formazanproduction(tissue2) |
37.0% |
3.6% |
% Formazanproduction(tissue3) |
34.6% |
3.6% |
%Formazan production (mean) |
36.4% |
3.5% |
±SD ofmean Formazan production (%) |
1.6% |
0.2% |
Experiment 2 %Formazanproduction
Designation |
Copperdioleate |
PositiveControl |
% Formazanproduction(tissue1) |
37.6% |
3.3% |
% Formazanproduction(tissue2) |
37.0% |
3.6% |
% Formazanproduction(tissue3) |
34.6% |
3.6% |
%Formazan production (mean) |
36.4% |
3.5% |
±SD ofmean Formazan production (%) |
1.6% |
0.2% |
Experiment 3 %Formazanproduction
Designation |
Copperdioleate |
PositiveControl |
% Formazanproduction(tissue1) |
61.6% |
3.7% |
% Formazanproduction(tissue2) |
60.6% |
3.3% |
% Formazanproduction(tissue3) |
67.3% |
3.3% |
%Formazan production (mean) |
63.2% |
3.4% |
±SD ofmean Formazan production (%) |
3.6% |
0.2% |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The results were equivocal. They showed test substance to be irritant and non irritant. Invivo study may be neccessery to verify. However considering to avoid undue animal testing a precautionary classification will be applied.
- Executive summary:
Three experiments plus an additional test on colour binding capacity of the test item were
performed. The first experiment was not sufficient for classification, because the three replicates
lead to different classification results, the mean value was above the threshold for
skin irritation. The second experiment showed a discrepant result compared to the first
experiment, the mean value was below the threshold for skin irritation. Therefore a third
experiment was performed. In the third experiment the mean value was again above the
threshold for skin irritation.
After the treatment with the test item, the relative absorbance values were reduced to
54.2 % (1. experiment), 36.4% (2. experiment) and 63.2% (3. experiment).
Therefore in the first experiment the mean value lead to the classification “non-irritant to
skin”, in the second experiment the result was “skin irritant” and in the third experiment the
result was again “non-irritant to skin”.
Therefore, Copper dioleate cannot be classified with the Human Skin Model Test because
of the discrepant results of the three experiments.
In all experiments, the optical density of the negative control was well within the required
acceptability criterion of 0.8 ≤ mean OD ≤ 2.8.
The positive control has met the acceptance criterion too, for thus ensuring the validity of
the test system.
Variation within replicates was within the accepted range for negative control, positive control
and test item (required: ≤ 18%).
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.