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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 807-085-0 | CAS number: 1004297-30-6
- 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 (EpiDerm): irritating (aqueous sollution 50 wt%)
Skin Irritation (EpiDerm): not corrosive (pure substance)
Eye Irritation (BCOP + EpiOcular): not irritating (aqueous sollution 50 wt%)
Eye Irritation (EpiOcular): irritating (pure substance)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: in vitro
- Strain:
- other: in vitro
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 μL (corrosion test) or 30 μL (irritation test) of the undiluted test substance - Duration of treatment / exposure:
- Corrosion test: 3 min and 1 h
Irritation test: 1h followed by a 42-hours post.incubation period - Details on study design:
- The EpiDermTM model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDermTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm ∅) and commercially available as kits (EpiDerm™ 200), containing 24 tissues on shipping agarose.
Corrosion test:
From the day of arrival in the laboratory, tissues were kept in the refrigerator. At least 1 hour but not more than 1.5 hours before test-substance application, tissues were transferred to 6- well plates with 0.9 mL assay medium and preconditioned in the incubator at 37°C. The preincubation medium was replaced with fresh medium immediately before application.
Two tissues per exposure time (3 minutes at room temperature or 1 hour in the incubator, as a rule) and test group (test material, negative control and positive control; 12 tissues per test) were used.
Fifty microliter (50 μL) of the undiluted liquid test substance was applied using a pipette. A nylon mesh was placed carefully onto the tissue surface afterwards.
Control tissues were concurrently treated with 50 μL of de-ionized water (negative control, NC) or with 50 μL of 8 N potassium hydroxide (positive control, PC). A nylon mesh was placed carefully onto the tissue surface afterwards (negative control, only).
The tissues were washed with PBS to remove residual test material 3 minutes or 1 hour after start of the application treatment. Rinsed tissues were kept in 24-well plates (holding plates) at room temperature on assay medium until all tissues per application time were dosed and rinsed. The assay medium was then replaced by MTT solution and tissues were incubated for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 6 microtiter wells filled with isopropanol for each microtiter plate.
Irritation test:
On the day of arrival in the laboratory, the tissues were transferred to sterile 6-well plates with 0.9 mL assay medium and preconditioned in the incubator at 37°C. After 1 hour the preincubation medium was replaced with fresh medium and preconditioning continued for 18 ± 3 hours.
Three tissues were treated with the test substance, the PC and NC, respectively. Thirty microliter (30 μL) of the undiluted liquid test substance was applied using a pipette. A nylon mesh was placed carefully onto the tissue surface afterwards.
Control tissues were concurrently treated with 30 μL of sterile PBS (negative control, NC) or with 30 μL of 5% SDS (positive control, PC). A nylon mesh was placed carefully onto the tissue surface afterwards.
The tissues were kept under the laminar flow hood at room temperature for 25 minutes overall and for 35 minutes in the incubator.
The tissues were washed with sterile PBS to remove residual test material 1 hour after start of application. Rinsed tissues were blotted on sterile absorbent paper and transferred into new 6-well plates, pre-filled with 0.9 mL fresh medium. When all tissues were rinsed, the surface of each tissue was carefully dried with a sterile cotton swab.
Subsequently, the tissues were placed into the incubator at 37°C for 24 ± 2 hours. After 24 ± 2 hours the tissues were transferred into new 6-well plates pre-filled with 0.9 mL of fresh medium and placed into the incubator for additional 18 ± 2 hours post-incubation period.
After the post-incubation period, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated in the incubator for 3 hours.
After incubation, the tissues were washed with PBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 6 microtiter wells filled with isopropanol for each microtiter plate.
Reference
Corrosion test: The mean viability of the test-substance treated tissues determined after an exposure period of 3 minutes was 101%, and it was 66% after an exposure period of 1 hour. Irritation test: The mean viability of the test-substance treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 11%.
Based on the observed results and applying the evaluation criteria it was concluded, that Trimethylcyclohexylammonium sulfate , aqueous solution 50 wt.% shows a skin irritation potential in the EpiDerm™ in vitro skin irritation and corrosion test strategy under the test conditions chosen.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- 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:
- other: OECD (2014a) Draft Proposal for a New Test Guideline: Reconstructed Human Cornealike Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage
- GLP compliance:
- yes (incl. QA statement)
- Species:
- other: in vitro
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- a bulk volume of 50 μL (about 24 mg) of the test material was applied covering the whole tissue surface.
- Details on study design:
- Direct MTT reduction
To assess the ability of the test material to directly reduce MTT a pretest was performed. The test substance was added to 0.9 mL of the MTT solution. The mixture was incubated in the dark at about 37 °C for 3 hours. A negative control (de-ionized water) was tested concurrently. If the MTT solution color or, in case of water-insoluble test substances the border to the water-phase, turned blue / purple, the test substance was presumed to directly reduce MTT.
The direct reduction of MTT by a test substance interferes with the color density produced by metabolic capacity of the tissue and would falsify the test results.
In case where direct MTT reduction occurred, two freeze-killed control tissues each were treated with the test article and the negative control, in the same way as described in the following section.
Basic procedure
Several test substances were tested in parallel within the present test (test no. 59) using the same control tissues (NC and PC). Two tissues were treated with each, the test substance, the PC and the NC. There are two separate protocols for liquids and solids, differing in exposure time and postincubation
period. Due to the physical condition of the test substance the protocol for solids was applied.
Pre-incubation of the tissues
On the day of arrival in the laboratory, the tissues were transferred to sterile 6-well plates with 1 mL assay medium and preconditioned in the incubator at 37°C. After 1 hour the preincubation medium was replaced with fresh medium and preconditioning continued in the incubator at standard culture conditions for 16 – 24 hours.
Pretreatment of the tissues
After the pre-incubation the tissues were pre-treated with 20 μL of PBS in order to wet the tissue surface. The tissues were incubated at standard culture conditions for 30 minutes.
Application of the test substance
Using a sharp spoon, a bulk volume of 50 μL of the test material was applied covering the whole tissue surface. Control tissues were concurrently applied with 50 μL of sterile de-ionized water (NC) or with 50 μL of methyl acetate (PC). After application, the tissues were placed into the incubator until the total exposure time of 6 hours was completed.
Removal of the test substance and postincubation period
To remove the test substance, the tissues were washed with sterile PBS. For this purpose the tissues were immersed and swiveled three times in each of three beakers filled with PBS. Washed tissues were immediately immersed into 12-well plates, pre-filled with 5 mL/well prewarmed medium (post-soak immersion) in order to remove residual test substance. After 25 minutes of post-soak immersion, each tissue was dried on absorbent paper and transferred to fresh 6-well plates filled with 1 mL/well pre-warmed medium. Subsequently, the tissues were incubated at standard culture conditions for 18 hours (postincubation period).
MTT incubation
After the post-incubation period, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated in the incubator for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol at room temperature overnight or for at least 2 hours on a plate shaker. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 4 microtiter wells filled with isopropanol for each microtiter plate.
Reference
Test substance |
|
tissue 1 |
tissue 2 |
mean |
inter-tissue variability [%] |
NC |
mean OD570 |
1.709 |
1.691 |
1.700 |
|
viability [% of NC] |
100.5 |
99.5 |
100.0 |
1.1 |
|
14/0711-1 |
mean OD570 |
0.378 |
0.268 |
0.323 |
|
viability [% of NC] |
22.3 |
15.8 |
19.0 |
6.5 |
|
PC |
mean OD570 |
0.427 |
0.550 |
0.489 |
|
viability [% of NC] |
25.1 |
32.4 |
28.7 |
7.3 |
Based on the observed results and applying the evaluation criteria, it was concluded, that Trimethylcyclohexylammonium sulfate shows an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
There are studies available for Trimethylcyclohexylammonium sulfate as aqueous solution 50 wt.% and for the pure substance.
Skin irritation (in vitro):
EpiDerm
The potential of Trimethylcyclohexylammonium sulfate to cause dermal corrosion was assessed by a single topical application of 25
μL bulk volume (about 17 mg) of the undiluted test substance to a reconstructed three dimensional human epidermis model
(EpiDerm™). Two EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, each. Viability of the
test-substance treated tissues determined after an exposure period of 3 minutes was 105.4%. Viability of the test-substance treated
tissues determined after an exposure period of 1 hour was 90.5%. Based on the observed results and applying the evaluation criteria
it was concluded, that Trimethylcyclohexylammonium sulfate does not show a corrosion potential in the EpiDerm™ skin corrosion
test under the test conditions chosen.
The objective was to assess the potential for corrosive activity and skin irritation of Trimethylcyclohexylammonium sulfate , aqueous
solution 50 wt.%. Two in vitro assays were part of this in vitro skin irritation and corrosion test strategy: The Skin Corrosion Test
(SCT) and Skin Irritation Test (SIT). The potential of Trimethylcyclohexylammonium sulfate , aqueous solution 50 wt.% to cause
dermal corrosion/irritation was assessed by a single topical application of 50 μL (corrosion test) or 30 μL (irritation test) of the
undiluted test substance to a reconstructed three dimensional human epidermis model (EpiDerm™). For the corrosion test two
EpiDerm™ tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. The irritation test was
performed with three EpiDerm™ tissue samples, which were incubated with the test substance for 1 hour followed by a 42-hours
post-incubation period. Corrosion test: The mean viability of the test-substance treated tissues determined after an exposure period
of 3 minutes was 101%, and it was 66% after an exposure period of 1 hour. Irritation test: The mean viability of the test-substance
treated tissues determined after an exposure period of 1 hour with about 42 hours post-incubation was 11%.
Based on the observed results and applying the evaluation criteria it was concluded, that Trimethylcyclohexylammonium sulfate ,
aqueous solution 50 wt.% shows a skin irritation potential in the EpiDerm™ in vitro skin irritation and corrosion test strategy under the
test conditions chosen.
Eye irritation (in vitro):
EpiOcular
The potential of Trimethylcyclohexylammonium sulfate to cause ocular irritation was assessed by a single topical application of 50 μL bulk volume (about 24 mg) of the undiluted test substance to a reconstructed three dimensional human cornea model (EpiOcular™).
Two EpiOcular™ tissue samples were incubated with the test substance for 6 hours followed by a 18-hour post-incubation period.
Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The ratio of the values indicates the relative tissue viability. The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues was 19%. Based on the observed results and applying the evaluation criteria it was concluded, that Trimethylcyclohexylammonium sulfate shows an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.
BCOP
The potential of Trimethylcyclohexylammonium sulfate , aqueous solution 50 wt.% to cause ocular irritation or serious damage to the
eyes was assessed by a single topical application of 750 μL of the undiluted test substance to the epithelial surface of isolated bovine
corneas. Three corneas were treated with the test substance for 10 minutes followed by a 2-hours post-incubation period.
In addition to the test substance a negative control (NC; de-ionized water) and two positive controls (PC1 and PC2; 100% ethanol
and 100% dimethylformamide) were applied to three corneas each. Corneal opacity was measured quantitatively as the amount of
light transmitted through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes
across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance. In
addition H&E-stained cross sections of the corneas were evaluated in addition to the assessment of opacity and permeability.
The mean IVIS (In Vitro Irritancy Score) was 5.5. Histological evaluation revealed changes indicating minimal eye damage in all
corneas treated with the test substance.
EpiOcular
The potential of Trimethylcyclohexylammonium sulfate , aqueous solution 50 wt.% to cause ocular irritation was assessed by a single topical application of 50 μL of the undiluted test substance to a reconstructed three dimensional human cornea model (EpiOcular™). Two EpiOcular™ tissue samples were incubated with the test substance for 30 minutes followed by a 2-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The ratio of the values indicates the relative tissue viability. The EpiOcular™ eye irritation test showed the following results:
The test substance is not able to reduce MTT directly. The mean viability of the test-substance treated tissues was 81%. Based on the results for BCOP and EpiOcular™ Test and applying the evaluation criteria, Trimethylcyclohexylammonium sulfate , aqueous solution 50 wt.% does not show an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen.
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: irritating
Justification for classification or non-classification
Based on the available studies data on skin and eye irritating properties the test item is classified as Xi, R36/28 (according to Directive 67/548/EEC (DSD) and as eye and skin irritating (H315/H319) according to Regulation (EC) No 1272/2008 (CLP).
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.