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EC number: 696-139-5 | CAS number: 19895-48-8
- 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
Skin irritation: corrosive
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- artificial membrane barrier model
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The experimental design of this study consisted of a qualification screen with the CDS (to determine if a color change can be detected) and a categorization screen (to categorize weak acids/bases and strong acids/bases), which were performed as a pretest, and a definitive Corrositex® assay.
The Corrositex® assay was evaluated on the basis of the color change of the CDS. The time that a color change was observed was recorded manually and the break through times of the four replicates was used to determine the corrosive potential of the test substance.
For the qualification screen, 150 μL of the test substance was added to the CDS screening tube. If the test substance failed to produce a color change in the CDS within one minute, the test substance could not be analyzed in this system, and no further testing was required.
test substance. Four vials containing the CDS were used for the test substance. In addition, one vial was used for the PC, NC and for the color (blank) control, each. A membrane disc coated with the biobarrier matrix was placed into one vial containing the CDS and approximately 500 μL of the test substance was added onto the membrane disc. An electronic time clock was started with the application. The vial was observed for three minutes for any change in the CDS. If no color change was observed within three minutes, the remaining membranes were treated with the test substance. An electronic time clock was started with each application. The vials were observed continuously for the first ten minutes. Thereafter the vials were
observed for approximately ten minutes around the time points relevant for evaluation (see table in section 3.8) or until break through of the test substance occurred. The elapsed time between test-substance application and the first change in the indicator solution (i.e. barrier penetration) was recorded. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl - Duration of treatment / exposure:
- up to 4 hours or unitl break through
- Duration of post-treatment incubation (if applicable):
- Test substance: 3 min to 4 hours or until break through
Negative control: 60 min
Positive control: continuosly until break through - Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- mean
- Value:
- 15.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Reference
Breakthrough times of the test substance and the PC and NC
Test substance |
Break Through Time[min:s] |
||||
Vial 1 |
Vial 2 |
Vial 3 |
Vial 4 |
Mean |
|
14/0211-1 |
19 min |
14 min |
15 min |
14 min |
15:30 |
Controls: |
|
||||
PC: Sodium hydroxide, solid |
11:20 |
- |
- |
- |
- |
NC: 10% citric acid |
NB |
- |
- |
- |
- |
NB = no breakthrough within maximum observation period (60 min)
Based on the observed results and applying the evaluation criteria it was concluded, that Trimethylcyclohexylammonium hydroxid, aqueous solution 50 wt.% shows a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen. The mean break through time determined in the in vitro membrane barrier test was 15 minutes and 30 seconds.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro skin irritation:
The potential of Trimethylcyclohexylammonium hydroxid, aqueous solution 50 wt.% to cause dermal corrosion was assessed by a single topical application of 500 μL of the test substance to the Corrositex® Biobarrier Membrane (Corrositex® assay). The Corrositex® Biobarrier Membrane is the test system consisting of a reconstituted collagen matrix. The assay is based on the time that is required for the test substance to penetrate through the Corrositex® Biobarrier Membrane and produce a change in the Chemical Detection System (CDS). In the main test four Corrositex® Biobarrier Membranes were treated with the test substance. The mean break through time of the test substance, determined in the actual Corrositex® assay, was 15 minutes and 30 seconds. Based on the observed results and applying the evaluation criteria it was concluded, that Trimethylcyclohexylammonium hydroxid, aqueous solution 50 wt.% shows a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen.
Effects on skin irritation/corrosion: corrosive
Justification for classification or non-classification
Based on the results of the skin irritation porpertie, the test item is classified as skin corrosive cat. 1B (H314) according to Regulation (EC) No 1272/2008 (CLP).
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