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EC number: 692-731-2 | CAS number: 76950-43-1
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 - 24 Feb 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted 26 Jul 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 20 Jul 2012
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- {1,4-diazabicyclo[2.2.2]octan-2-yl}methanol
- EC Number:
- 692-731-2
- Cas Number:
- 76950-43-1
- Molecular formula:
- C7H14N2O
- IUPAC Name:
- {1,4-diazabicyclo[2.2.2]octan-2-yl}methanol
- Details on test material:
- - Name of test material (as cited in study report): [trade name]
- Substance type: off-white powder with lumps
- Analytical purity: 90.7%
- Impurities (identity and concentrations): 1,5-diazabicyclo[3.2.2]nonane-3-ol 8.9%
- Expiration date of the lot/batch: 20 Dec 2014
- Storage condition of test material: at room temperature in the dark in a well-sealed container
- Other: pH: 11.0 at concentration of 10%
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: EPISKIN-SM™; three-dimensional human epidermis model
- Details on test animals or test system and environmental conditions:
- TEST SKIN MODEL
- Source: SkinEthic Laboratories, Lyon, France
TEST METHOD
EPISKIN Small Model™ (EPISKIN-SM™):
This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
Irritant materials are identified by their ability to penetrate the stratum corneum and to damage the underlaying cell layers which is determined through a decrease in cell viability as determined by MTT reduction assay.
ADAPTATION TO CELL CULTURE CONDITIONS
On the day of receipt, tissues were transferred into 12-well plates and preincubated with prewarmed Maintenance Medium for approx. 26 h at 37 °C.
INCUBATION CONDITIONS
- Temperature (°C): 37 ± 1 (acutal range: 36.6 - 37.5)
- CO2 gas concentration (%): 5 ± 0.5
- Humidity (%): 80 - 100 (actual range: 84 - 88)
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: intact human epidermis model
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent control tissues treated with PBS served as negative controls, positive controls were exposed to 5% (aq) SDS
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 12.9 to 16.4 mg
The skin was moistened with 5 µl Milli-Q water (Millipore Corp., Bedford, Mass., USA) to ensure close contact of the test substance to the tissue.
POSITIVE CONTROL SUBSTANCE:
- Positive control substance: 5% (aq) sodium dodecyl sulphate (SDS) in PBS
The positive control was re-spread after 7 minutes contact time. - Duration of treatment / exposure:
- 15 min
- Observation period:
- not applicable
- Number of animals:
- not applicable
The test was performed in triplicates for each test or control group. - Details on study design:
- TEST SITE
- Area of exposure: 0.38 cm²
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test item was washed from the skin surface with phosphate buffered saline.
- Time after start of exposure: 15 min
After rinsing, the cell culture inserts were each dried carefully and moved to a new well on 2 mL pre-warmed maintenance medium until all tissues were dosed and rinsed. Subsequently the skin tissues were incubated for approximately 42 h at 37°C.
CELL VIABILITY MEASUREMENTS
For determining alterations in cell viability, MTT reduction assays were performed. Therefore, after incubating tissues in maintenance medium for 42 h, tissues were transferred into a 12-wells plate and incubated in 2 mL MTT-medium (0.3 mg/mL) for 3 h at 37 °C. Thereafter the tissues were placed on blotting paper to dry the tissues. Total biopsy was made by using a biopsy punch. Epidermis was separated from the collagen matrix and both parts were placed in prelabeled microtubes and extracted with 500 µl isopropanol. Tubes were stored refrigerated and protected from light for approximately 69 hours. The amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate with the TECAN Infinite® M200 Pro Plate Reader. The absorption was corrected for the background absorption.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of negative controls (PBS). Time point: 15 min. Reversibility: other: not applicable.
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 22
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of positive controls (5% (aq) SDS). Time point: 15 min. Reversibility: other: not applicable.
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 93
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of the test item. Time point: 15 min. Reversibility: other: not applicable.
- Other effects / acceptance of results:
- The relative mean tissue viability obtained after 15 minutes treatment with the test substance compared to the negative control tissues was 93%. Since the mean relative tissue viability for the test substance was above 50% after 15 minutes treatment, the test substance is considered to be non-irritant.
Any other information on results incl. tables
Table 1. Mean absorption in the in vitro skin irritation test
|
A (OD570) |
B (OD570) |
C (OD570) |
Mean (OD570) ± SD |
Mean tissue viability (percentage of control) |
Negative control |
1.315 |
0.979 |
1.114 |
1.136 ± 0.169 |
100 |
Test substance |
1.006 |
0.997 |
1.152 |
1.052 ± 0.087 |
93 |
Positive control |
0.173 |
0.404 |
0.186 |
0.254 ± 0.130 |
22 |
OD = optical density
SD = standard deviation
Triplicate exposures are indicated by A, B and C.
The test substance was checked for possible direct MTT reduction by adding the test substance to MTT medium. Because no colour change was observed it was concluded that the test substance did not interact with MTT.
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
DSD: not classified
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