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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 205-287-8 | CAS number: 137-29-1
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 December 2017 - 13 February 2018
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Supplied from romachem batch number 37160906201
- Expiration date of the lot/batch:September 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room Temperature
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None
- Preliminary purification step (if any):none
- Final dilution of a dissolved solid, stock liquid or gel:Neat
- Final preparation of a solid:
OTHER SPECIFICS: - Test system:
- human skin model
- Cell type:
- other: Noormal human-derived epidermal keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- SKIN DISC PREPARATION
- Procedure used: tested for its potential for MTT interference and water colouration
- Quality control for skin discs: Electrical resistance obtained with two of the isolated skin discs was [complete, e.g. 10 kΩ]
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 10minues +/-1 minute (25mines at RT and 35 mins at 37C, 5% carbon dioxide >= 95% relative humidity)
- Temperature of post-treatment incubation (if applicable): 42 +/- 4hours
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps:
- Observable damage in the tissue due to washing:
- Modifications to validated SOP:
DYE BINDING METHOD
- Dye used in the dye-binding assay: [none / MTT / Sulforhodamine B / other:] MTT
- Spectrophotometer: BMG Latech Fluostar Optima
- Wavelength: 570nm
- Filter:no
-
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be non-corrosive to skin if the skin model viability after exposure and post treatment incubation >50%
- Justification for the selection of the cut-off point(s) if different than recommended in TG 430: - Control samples:
- yes, concurrent positive control
- other: concurrent negative control 30uL DPBS
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25mg
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
NEGATIVE CONTROL
- Amount(s) applied (volume or weight):30uL
- Concentration (if solution): neat
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30uL
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 60 +/-1 minutes (25 minutes at room temperature and 35 minutes at 37C, 5% CO2, >=95% Relative humidity
- Duration of post-treatment incubation (if applicable):
- 42 +/- 4 hours post does incubation at 37C, 5% CO2, >= 95% relative humidity.
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- In vitro assessment of skin irritation potential of copper dimethyldithiocarbamate according to OECD Test Guideline 439 (reconstructed Human Epidermis Test Method)
- Value:
- >= 50 - < 100
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- 93.91%
Reference
Condition | Tissue | Raw data | Blank corrected date | Mean OD | % of Viability |
Aliquot 1/Aliquot 2 | Aliquot 1/Aliquot 2 | ||||
Negative conrol NC | Tissue 1 | 2.041/2.995 | 1.889/1.843 | 1.866 | 111.226 |
NC | Tissue 2 | 1.759/1.79 | 1.607/1.638 | 1.623 | 96.712 |
NC | Tissue 3 | 1.701/1.692 | 1.549/1.540 | 1.545 | 92.062 |
Positive control PC | Tissue 1 | 0.25/0.235 | 0.098/0.083 | 0.091 | 5.394 |
PC | Tissue 2 | 0.217/0.22 | 0.065/0.068 | 0.067 | 3.964 |
PC | Tissue 3 | 0.216/0.225 | 0.064/0.073 | 0.069 | 4.083 |
TA1 | Tissue 1 | 1.772/1.72 | 1.620/1.568 | 1.594 | 95.013 |
TA1 | Tissue 2 | 1.666/1.662 | 1.514/1.510 | 1.512 | 90.125 |
TA1 | Tissue 3 | 1.82/1.771 | 1.658/1.619 | 1.639 | 97.665 |
Name/Code | Mean of OD | SD of OD | Mean of viability(%) | SD of viability (%) | CV (%) | Classification |
DPBS/NC | 1.678 | 0.168 | 100.000 | 9.996 | 9.996 | Non-irritant |
SDS 5%/PC | 0.075 | 0.013 | 4.480 | 0.794 | I7.716 | Irritant |
Copper dithiodicarbamate/TA1 | 1.582 | 0.064 | 94.268 | 3.825 | 4.058 | Non-irritant |
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 May 2018- 30 May 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- SOP LOO69 @EpiOcular Eye Irritation test Using XcellR8 form FOO68
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: Reconstructed Human Cornea-like Epithelium
- Details on test animals or tissues and environmental conditions:
- The EpiOcular tissue model (OCL-200-MatTek corporation) is composed of stratified human keratinocytes in a three dimensional structure, reflecting the morphology and funcion of the human corneal epithelium found in vivo.
On the day f receipt, pre-incubation of EpiOcular tissues overnight at 37C 5%CO2 >=95% relative ,humidity. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50mg
- Duration of treatment / exposure:
- 6 hours+/-15 minutes
- Duration of post- treatment incubation (in vitro):
- 25+/-2 minute post treatment immersion, and 18 hours +/-15 minutes post treatment incubation
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- other: Optical density
- Run / experiment:
- Optical density
- Value:
- ca. 2.219
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
Reference
Additional information
Justification for classification or non-classification
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.