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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-906-2 | CAS number: 22450-96-0
- 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:
- 07 to 13 May 2013 (in-life dates)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline (OECD 439) compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- 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)
Test material
- Reference substance name:
- 4,4'-dioxo-4H,4'H-2,2'-spirobi[[1,3,2]benzodioxaborinin]-2-uide; tributylazanium
- EC Number:
- 700-906-2
- Cas Number:
- 22450-96-0
- Molecular formula:
- C26H36BNO6
- IUPAC Name:
- 4,4'-dioxo-4H,4'H-2,2'-spirobi[[1,3,2]benzodioxaborinin]-2-uide; tributylazanium
- Reference substance name:
- SABoTBA
- IUPAC Name:
- SABoTBA
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): SABoTBA
- Purity: 98.77%
- Purity test date: 08 April 2014
- Lot/batch No.: 12342
- Expiration date of the lot/batch: Stable under recommended storage conditions
- Storage condition of test material: Room temperature in the dark
Constituent 1
Constituent 2
Test animals
- Species:
- human
- Strain:
- other: human epidermis skin constructs
- Details on test animals or test system and environmental conditions:
- The 'EPISKIN™ Skin Irritation Test 15 Min - 42 Hours' using human epidermis skin constructs, supplied by SkinEthic Laboratories, Lyon, France, has been accepted as a replacement to the in vivo test, Draize Skin Irritation Test, by the European Centre for the Validation of Alternative Methods (ECVAM, 2007). The test was conducted in accordance with the Standard Operating Procedure, In Vitro Skin Irritation Test: Human Epidermis Model (L’Oreal 2009), supplied by L’Oreal (leading laboratory in the validation of the test for ECVAM) and the OECD 439 Guideline For The Testing of Chemicals: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (OECD 439).
The test involves the application of the test substance for 15 minutes to the EPISKIN™ three-dimensional human skin model. The model consists of normal, human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type 1 matrix coated with type IV collagen. After 13 days in culture a multilayered, highly differentiated model of the human epidermis with a functional multi-layered stratum corneum has formed. The epidermis surface area supplied is 0.38cm2. The EPISKIN™ kits include assay medium, maintenance medium, 12 well plates and the tissues which are shipped on nutritive agar.
The principle of the assay is that irritant substances are sufficiently cytotoxic to cause cell death in the cell layers. The cell viability was determined by mitochondrial dehydrogenase activity, assessed by the reduction of MTT (3-(4,5-dimethylthiazol-2-yl)-2, 5 diphenyltetrazolium bromide) to a soluble, coloured, formazan product. The prediction model (OECD 439) uses the percentage viability values (compared to negative control viability) to identify irritant and non-irritant substances. The test includes acceptance criteria for both negative and positive controls.
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: surface wetted prior to application
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ± 2mg was dispensed over each tissue
VEHICLE
- Amount(s) applied (volume or weight with unit): 5 µL of purified water prior to application of the test substance. - Duration of treatment / exposure:
- 15 min (±0.5min) contact time with the test substance, followed by rinsing and then 42 h (±1 h) incubation time at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air.
- Details on study design:
- Tissue
The tissues are received as a kit, the kit contents were checked and the inserts with tissues on agarose were stored at room temperature until use. The kit was used within the expiry date indicated by the supplier (expiry date: 13 May 2013). The maintenance medium was pre-warmed to 37ºC. The tissues were removed from the agar and placed into wells of 12 well plates containing 2 mL pre-warmed maintenance medium per well. The tissues were incubated for a minimum of 24 hours at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air.
Application
A weight of 10 ± 2mg was dispensed over each tissue, the tissues were wetted with 5 µL of purified water prior to application of the test substance. The positive (5% Sodium Dodecyl Sulphate (SDS) in purified water) and negative (sterile Dulbecco’s Phosphate Buffered Saline (DPBS) with magnesium and calcium) controls were in liquid form and were applied by dispensing a volume of 10 µL over each tissue using a positive displacement pipette.
Procedure
After incubation for at least 24 hours in maintenance medium, triplicate tissues were dosed for 15 ± 0.5 minutes with the test substance, negative or positive control at room temperature. The test substance was spread over the surface of the tissues with a curved spatula. A maximum of four samples were applied in a block with a minimum of 1 minute intervals between each application of substance. On application of 10 µL, the positive control was spread over the tissue for approximately 30 seconds and then respread with a curved flat spatula after 7 minutes (actual time 8 minutes) application time.
After 15 ± 0.5 minutes, each tissue was rinsed with 25 mL sterile Dulbecco’s Phosphate Buffered Saline (DPBS) to remove residual test substance. Inserts were then blotted on absorbent paper to remove remaining DPBS. Each insert was then transferred to a well containing 2 mL maintenance medium and incubated for 42 ± 1 hour at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air.
After 42 ± 1 hour, each insert was transferred to a well containing 2 mL of 0.3 mg/mL MTT ((3-(4,5-dimethylthiazol-2-yl)-2, 5 diphenyltetrazolium bromide)) and incubated for 3 hours ± 5 minutes at 37 ± 2°C in a humidified atmosphere of 5% CO2 in air.
At the end of 3 hours ± 5 minutes, the triplicate inserts were blotted on absorbent paper. The epidermis was removed from the insert using a biopsy punch, the epidermis separated from the collagen matrix using forceps and both parts placed in a micro tube.
When all tissues had been punched, the tissues were vortexed with 500 µL of acidic isopropanol (0.04 N HCl final concentration).
The tissues were extracted by storing at 2-8 ºC, protected from light, for 48 - 70 hours.
After formazan extraction, duplicate 200 µL aliquots of the extractant from each micro tube were pipetted into the wells of flat-bottomed 96-well plates. The extractant was mixed by vortexing prior to taking the aliquots. The absorbance was read at 540 nm, with six wells containing acidified isopropanol (0.04 N HCl final concentration) as a blank.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 97.2
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Table 1: EPISKIN study data
Sample |
Tissue replicate |
Optical Density (OD) |
OD - blank |
% Negative Control |
Negative control |
a |
1.071 1.054 |
0.927 0.910 |
100.6 |
b |
1.059 1.018 |
0.915 0.874 |
97.9 |
|
c |
1.087 1.055 |
0.942 0.911 |
101.5 |
|
|
Mean SD |
0.913 0.023 |
100.0 1.8 |
|
Positive control |
a |
0.569 0.542 |
0.425 0.398 |
45.0 |
b |
0.431 0.445 |
0.286 0.301 |
32.2 |
|
c |
0.510 0.470 |
0.366 0.326 |
37.9 |
|
|
Mean SD |
0.350 0.055 |
38.4 6.5 |
|
SABoTBA |
a |
1.072 1.027 |
0.928 0.883 |
99.1 |
b |
1.014 0.952 |
0.870 0.808 |
91.9 |
|
c |
1.093 1.033 |
0.949 0.888 |
100.6 |
|
|
Mean SD |
0.887 0.049 |
97.2 4.7 |
|
Blank |
|
0.135 0.149 0.150 0.140 0.145 0.146 |
|
|
Mean SD |
0.144 0.006 |
The mean Optical Density (OD) for the six replicate blanks was subtracted from the individual substance and control tissues OD.
The viability of each tissue was expressed as a percentage of the mean negative control value.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It was concluded that the test substance, SABoTBA, with a mean tissue viability of 97.2 ± 4.7%, was predicted as non-irritant to the skin.
- Executive summary:
The study was performed to assess the skin irritation potential, in vitro, of the test substance,SABoTBA in accordance with the OECD Guideline 439.
The test substance was applied to EPISKIN™human epidermis skin constructs. The constructs consisted of normal, human-derived epidermal keratinocytes, which had been cultured to form a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum. The cell viability was determined by mitochondrial dehydrogenase activity, assessed by the reduction of MTT (3-(4,5-dimethylthiazol-2-yl)-2, 5‑diphenyltetrazolium bromide) to a soluble, coloured, formazan product. The prediction model (OECD Guideline 439) uses the percentage viability values (compared to negative control viability) to identify irritant and non-irritant substances.
The test substance,SABoTBA, elicited a mean tissue viability of 97.2 ± 4.7% and was predicted as non-irritant 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.