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EC number: 244-842-9 | CAS number: 22205-45-4
- 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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with Good laboratory Practice and internationally accepted guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dicopper sulphide
- EC Number:
- 244-842-9
- EC Name:
- Dicopper sulphide
- Cas Number:
- 22205-45-4
- Molecular formula:
- Cu2S
- IUPAC Name:
- Copper(I) sulphide
- Details on test material:
- - Name of test material (as cited in study report): Dicopper sulphide.
- Analytical purity: >99%
- Lot/batch No.: CM25005
- Storage condition of test material: room temperature in the dark.
Constituent 1
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: Relative mean viability
- Remarks on result:
- other: Reconstructed human epidermis model. Time point: 15 Minute exposure period. Remarks: The relative mean viability of the test item treated tissues was 57.6% after a 15 Minute exposure period.
Any other information on results incl. tables
RESULTS
Direct MTT Reduction
The MTT solution containing the test item did not turn blue which indicated that the test item did not directly reduce MTT. Quantitative correction of the results was therefore unnecessary.
Test Item, Positive Control Item and Negative Control Item
The individual and mean OD540 values, standard deviations and tissue viabilities for the test item, negative control item and positive control item are given in Table 1. The mean viabilities and standard deviations of the test item and positive control, relative to the negative control are also given in Table 1.
Table 1: Mean OD540 Values and Percentage Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
OD540of tissues |
Mean OD540of triplicate tissues |
±SDof OD540 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative Control Item |
0.976 |
0.829 |
0.129 |
117.7 |
100* |
15.6 |
0.734 |
88.5 |
|||||
0.776 |
93.6 |
|||||
Positive Control Item |
0.093 |
0.088 |
0.005 |
11.2 |
10.6 |
0.5 |
0.085 |
10.3 |
|||||
0.085 |
10.3 |
|||||
Test Item |
0.542 |
0.477 |
0.068 |
65.4 |
57.6 |
8.2 |
0.406 |
49.0 |
|||||
0.483 |
58.3 |
SD= Standard deviation
*= The mean viability of the negative control tissues is set at 100%
The relative mean viability of the test item treated tissues was57.6% after a 15‑Minute exposure period.
Quality Criteria
The relative mean tissue viability for the positive control treated tissues was 10.6% relative to the negative control treated tissues and the standard deviation value of the percentage viability was 0.5%. The positive control acceptance criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was 0.829 and the standard deviation value of the percentage viability was 15.6%. The negative control acceptance criterion was therefore satisfied.
The standard deviation calculated from individual percentage tissue viabilities of the three identically treated tissues was 8.2%. The test item acceptance criterion was therefore satisfied.
CONCLUSION
The test item was considered to be Non-Irritant.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Dicopper sulphide was considered to be Non-Irritant.
- Executive summary:
A GLP-compliant in-vitro study was conducted using the EPISKIN reconstructed human epidermis modelin accordance with the requirements of OECD Guideline 439 and EU Method B.46. Triplicate tissues were treated with the test item for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre‑labelled micro tubes and stored in a freezer for possible inflammatory mediator determination. After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT‑loaded tissues. At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µl samples were transferred to the appropriate wells of a pre-labelled 96 -well plate. The optical density was measured at 540 nm. The findings were assessed in terms of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
The relative mean viability of the test item treated tissues was 57.6% after the 15-Minute exposure period. The quality criteria required for acceptance of results in the test were satisfied. Dicopper sulphide was considered to be Non-Irritant.
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