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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 908-084-9 | 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:
- 15 January 2015 - 16 January 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This method is approved by international regulatory agencies as a replacement for the identification of corrosives in the in vivo Rabbit skin assay (OECD No. 404) and is specifically approved (OECD 431) as a replacement for the in vivo skin corrosivity test.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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:
- Due to technical reason (upgrade of the plate reader), plate was measured at 540 and 570 nm, instead of 540 nm as indicated in the Study Plan. As the maximum of the absorption peak is at 570 nm, those results are reported, however all the data will be kept and archived in the raw data binder. The measurements on the two different wavelength resulted identical conclusion.
Due to unscheduled delay of reporting, the Draft Report was issued two days later than indicated in the Study Plan. However, this fact had no impact on the results or integrity of the study. - Deviations:
- yes
- Remarks:
- This fact was considered not to adversely affect the results or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- Due to technical reason (upgrade of the plate reader), plate was measured at 540 and 570 nm, instead of 540 nm as indicated in the Study Plan. As the maximum of the absorption peak is at 570 nm, those results are reported, however all the data will be kept and archived in the raw data binder. The measurements on the two different wavelength resulted identical conclusion.
Due to unscheduled delay of reporting, the Draft Report was issued two days later than indicated in the Study Plan. However, this fact had no impact on the results or integrity of the study. - Deviations:
- yes
- Remarks:
- This fact was considered not to adversely affect the results or integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- bis((9Z,26Z,35Z)-9,18,27,36,37,39,40,41-octaaza-38-cupradecacyclo[17.17.3.1¹⁰,¹⁷.1²⁸,³⁵.0²,⁷.0⁸,³⁷.0¹¹,¹⁶.0²⁰,²⁵.0²⁶,³⁹.0²⁹,³⁴]hentetraconta-1,3,5,7,9,11,13,15,17(41),18,20,22,24,26,28(40),29,31,33,35-nonadecaene); dodecan-1-amine; sulfonylideneoxidane
- EC Number:
- 908-084-9
- IUPAC Name:
- bis((9Z,26Z,35Z)-9,18,27,36,37,39,40,41-octaaza-38-cupradecacyclo[17.17.3.1¹⁰,¹⁷.1²⁸,³⁵.0²,⁷.0⁸,³⁷.0¹¹,¹⁶.0²⁰,²⁵.0²⁶,³⁹.0²⁹,³⁴]hentetraconta-1,3,5,7,9,11,13,15,17(41),18,20,22,24,26,28(40),29,31,33,35-nonadecaene); dodecan-1-amine; sulfonylideneoxidane
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch number: 141016
- Appearance: Blue powder
- Purity: ≥85.5%
- Expiry date: 19 November 2018
- Storage conditions: Controlled Room Temperature (15-25°C, below 70 RH%)
In vitro test system
- Test system:
- human skin model
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Main basal, supra basal, spinous and granular layers and a functional stratum corneum
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN-SM
- Tissue batch number(s): 15 MAIN3 002
- Expiration date: 21 Jan 2015
KILLED EPIDERMIS
- Tissue batch number(s): 14-EKIN-043
- Expiration date: 17 November 2014
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 25.1-26.4°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 25 mL PBS solution
- Observable damage in the tissue due to washing: N/A
- Modifications to validated SOP:
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Batch no: 10175554
- Expiration date: 02 May 2023
- Wavelength:
NUMBER OF REPLICATE TISSUES:
In this assay, two replicates per test item per time point were used. Two negative controls and two positive controls were also run in the assay. As the test item was coloured, two additional test item-treated tissues were used for the non specific OD evaluation. Furthermore, as the test item had an MTT interacting potential, two additional test item-treated killed epidermis and two negative control treated killed epidermis were used in the study. - Control samples:
- yes, concurrent negative control
- yes, concurrent no treatment
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20mg
- applied as is, but 100 μL physiological saline was added to the test item to ensure good contact with the epidermis.
NEGATIVE CONTROL
Physiological saline
- Amount(s) applied (volume or weight): 50 μL
- Concentration (if solution): 0.9% (w/v) NaCl solution
- Batch no: 19GI12GF
- Expiry Date: 31 Aug 2018
POSITIVE CONTROL
Glacial acetic acid
- Amount(s) applied (volume or weight): 50 μL
- Batch no: 12D120031
- Expiry date: 30 Apr 2015 - Duration of treatment / exposure:
- 4h at room temperature
- Duration of post-treatment incubation (if applicable):
- 3h
- Number of replicates:
- 2 per control group (plus 2 positive and negative control on killed epidermis)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 94.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Following exposure with test item, the mean cell viability was 94.7% 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 EPISKIN model test with test item, the results indicate that the test item is not 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.