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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 908-081-2 | 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 corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 July 2016 - 15 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:
- 2016
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:
- The purity reported is different to the Study Plan due to a new Certificate of Analysis being provided by the sponsor.
- Deviations:
- yes
- Remarks:
- this fact has no impact on the results or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008, Annex Part B, B.40.Bis: “In Vitro Skin Corrosion: Human Skin Model Test”, Official Journal of the European Union No. L142 (31 May 2008)
- Version / remarks:
- The purity reported is different to the Study Plan due to a new Certificate of Analysis being provided by the sponsor.
- Deviations:
- yes
- Remarks:
- this fact has no impact on the results or integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2λ⁵,11,20,29,38,39λ⁵,40,41-octaaza-1-cupradodecacyclo[19.17.1.1¹,¹².1³,³⁷.0²,¹⁰.0⁴,⁹.0¹³,¹⁸.0²²,²⁷.0²⁸,³⁹.0³⁰,³⁸.0³¹,³⁶.0¹⁹,⁴¹]hentetraconta-2,4,6,8,10,12,14,16,18,20,22,24,26,28(39),29,31,33,35,37(40)-nonadecaene-2,39-bis(ylium)-1,1-diuide
- EC Number:
- 908-081-2
- IUPAC Name:
- 2λ⁵,11,20,29,38,39λ⁵,40,41-octaaza-1-cupradodecacyclo[19.17.1.1¹,¹².1³,³⁷.0²,¹⁰.0⁴,⁹.0¹³,¹⁸.0²²,²⁷.0²⁸,³⁹.0³⁰,³⁸.0³¹,³⁶.0¹⁹,⁴¹]hentetraconta-2,4,6,8,10,12,14,16,18,20,22,24,26,28(39),29,31,33,35,37(40)-nonadecaene-2,39-bis(ylium)-1,1-diuide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch number: 150205
Description: Blue powder
Manufacture date: 05 February 2015
Expiry date: 05 February 2019
Purity: As a UVCB, purity is considered as 100%
Storage conditions: Controlled room temperature (15-25°C, below 70% RH%).
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: main basal, supra basal, spinous and granular layers and a functional stratum corneum
- Source strain:
- not specified
- Details on animal used as source of test system:
- Manufactured tissues, reconstructed epidermis
- Justification for test system used:
- The model has been validated for corrosivity testing in an international trial (Fentem, 1998) and its use is recommended by the relevant OECD guideline for corrosivity testing (OECD No. 431); therefore, it was considered to be suitable for this study.
- Vehicle:
- physiological saline
- Details on test system:
- SKIN DISC PREPARATION
- Procedure used: supplied by manufacturer
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 25.2-26.4°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 1
- Observable damage in the tissue due to washing: no
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: yes
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if both disks have mean viability of <35% and the variability is less than 50%
- The test substance is considered to be non-corrosive to skin if both disks have mean viability of ≥35% and the variability is less than 50% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- - 20 mg of test item was applied evenly to the epidermal surface of each of two test units and then 100 μL physiological saline was added to the test item to ensure good contact with the epidermis.
- 50 μL of physiological saline was added to each of the two negative control skin units.
- 50 μL of glacial acetic acid was added to each of the two positive control skin units. - Duration of treatment / exposure:
- 4 hours (±10 min)
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 108.8
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 112.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- After receipt, the two indicators of the delivered kits were checked. Based on the observed colours, the epidermis units were in proper conditions in each case.
The mean OD value of the two negative control tissues was in the recommended range (0.834).
The positive control treated tissues showed 1.9% viability demonstrating the proper performance of the assay.
The difference of viability between the two test item-treated tissue samples in the MTT assay was 3.3%.
The mean OD value of the blank samples (acidified isopropanol) was 0.046.
All these parameters were within acceptable limits and therefore the study was considered to be valid.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following exposure with the test item, the mean cell viability was 110.6% compared to the negative control (after adjustment for non-specific MTT reduction). This is above the threshold of 35%, therefore the test item was considered as being non-corrosive. The experiment met the validity criteria, therefore the study was considered to be valid.
In conclusion, in this in vitro model test with the test item, the results indicate that the test item is 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.