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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-12-09 to 2020-03-13
- 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 18th June 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Bis(glycinato)copper
- EC Number:
- 236-783-2
- EC Name:
- Bis(glycinato)copper
- Cas Number:
- 13479-54-4
- Molecular formula:
- C4H8CuN2O4
- IUPAC Name:
- copper;2-aminoacetate
- Test material form:
- solid: granular
- Details on test material:
- Appearance Grey to bluish powder/granule
Homogeneity homogeneous
Storage room temperature (20 ± 5 °C)
Stability stable under storage conditions
CAS No. 13479-54-4
EC-No. 236-783-2
Chemical Class organometallic chelate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Justification for test system used:
- This in vitro study was performed in order to evaluate the potential of Copper bisglycinate to evoke skin irritation in a reconstructed human epidermis (RhE) test method. The test method can diskriminate between non-classification and classification in Cat 1 or Cat 2 according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Tissues wetted with DPBS buffer
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: The test system is a commercially available EpiDerm™-Kit. The EpiDerm™ 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.
- Tissue batch number(s): Kit: 30851
- Delivery date: 2020-03-10
- Date of initiation of testing: 2020-03-11
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 1 hour after the first application, the inserts were removed from the plates using sterile forceps and rinsed immediately in 1-minute-intervals.
- Observable damage in the tissue due to washing: not observed
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Anthos Reader 2010 Flexi (Anthos Microsysteme GmbH)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: MTT QC assay, 4 hours, n=3: OD (540-570 nm)[1.0 - 3.0], Result: 1.771 ± 0.07
- Barrier function: ET-50 assay, 100 µL 1% Triton-X-100, 4 time-points, n=3, MTT assay; ET-50 [4.77 - 8.72 h];, Results: 5.13 h
- Contamination: Long term antibiotic and antimycotic free culture; no contamination, Result Sterile
NUMBER OF REPLICATE TISSUES: three tissues were used for each treatment
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
-The test chemical is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after 1h exposure and post-treatment incubation is less than or equal (≤) to 50%.
- The test chemical may be considered as non-irritant to skin in accordance with UN GHS No Category if the tissue viability after 1h exposure and post-treatment incubation is more than (>) 50%. - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Tissue 1: 26.4 mg, Tissue 2: 26.1 mg, Tissue 3: 25.1 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL DPBS
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µL SDS solution
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 1 h
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 1
- Value:
- 34
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- OD between 0.8 and 2.8
- Positive controls validity:
- valid
- Remarks:
- < 20% of negative control
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 2
- Value:
- 30.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- OD between 0.8 and 2.8
- Positive controls validity:
- valid
- Remarks:
- < 20% of negative control
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- tissue 3
- Value:
- 35.6
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Remarks:
- OD between 0.8 and 2.8
- Positive controls validity:
- valid
- Remarks:
- < 20% of negative control
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: Not reported
- Direct-MTT reduction: not observed
- Colour interference with MTT: not observed
DEMONSTRATION OF TECHNICAL PROFICIENCY: The validity of the skin irritation study at LAUS GmbH was demonstrated in a proficiency study. For this purpose, 10 proficiency chemicals (indicated by the OECD 439 guideline) were tested.
All of the 10 proficiency chemicals were correctly categorized. Therefore, the proficiency of the skin irritation study was demonstrated.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, OD should be between 0.8 and 2.8, mean OD for the negative control was 1.411
- Acceptance criteria met for positive control: yes, The viability should be < 20% of the negative control, the mean viability was 3.3%
- Acceptance criteria met for variability between replicate measurements: yes, the variability should be < 18%, the variability were 3.0% for the negative control, 0.1% for the positive control and 10.2% for the test item
- Range of historical values if different from the ones specified in the test guideline: No
Any other information on results incl. tables
Historical data
Parameter |
Negative Control |
Positive Control Negative Control) |
Substance |
DPBS buffer |
Sodium Dodecyl Sulphate Solution 5% |
Mean |
1.779 |
4.2% |
Standard deviation |
0.310 |
2.9% |
Range |
0.476 – 2.471 |
1.7% - 17.1% |
Study |
1.411 |
3.3% |
Applicant's summary and conclusion
- Interpretation of results:
- other: based on the conditions used in the present test the substance is at least classified as Category 2, irritant to skin
- Conclusions:
- In the present test the skin irritation potential of bis(glycinato)copper was evaluated according to OECD guideline 439 (2019). Human keratinocytes, 3 tissues, were exposed to 25 mg test item for 1h. After a postincubation time of 42 h the viability was determined using the MTT assay. The mean viability of three tissues was < 50% (33.4%), thus the test item is considered to be at least irritating to the skin accoding to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classifcation and Labelling of Chemicals (GHS).
- Executive summary:
In a dermal irritation study performed in accordance with OECD Guideline 439 (In Vitro Skin Irritation) (2019), bis(glycinato)copper (100% a.i.) was applied to the three-dimensional human epidermis model tissue for an exposure period of 1 h in triplicates. 25 μL of DPBS buffer were topically applied to the epidermal surface in order to improve further contact between the solid and the epidermis. Each approximately 25 mg of the test item were applied to the wetted tissues. The test item was spread to match the surface of the tissue.
After dosing the last tissue the plates were transferred to an incubator for 35 minutes exposure at 37±1°C and 5.0±1% CO2, the tissues were then washed with phosphate buffered saline to remove any residual test material after 60 minutes after the first application. Subsequently the tissue constructs were incubated for 42 h at 37°C. Cytotoxicity (irritancy) was expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
The positive (5% SDS) and negative (DPBS buffer) control gave responses that were within the acceptance criteria and as such demonstrated the validity of the study.
The relative mean tissue viability obtained after 60 minutes treatment with bis(glycinato)copper compared to the negative control tissues was 33.4%. Since the mean relative tissue viability for the test substance was below 50%, Bis(glycinato)copper is identified to be at least irritating to the skin under the described test conditions.
Thus, based on OECD guideline, the test item is considered to be at least irritating to the skin according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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