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EC number: 269-537-8 | CAS number: 68298-05-5
- 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:
- 2020-01-21 to 2020-03-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Version / remarks:
- version 2015-07-28
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (2-hydroxy-1,1-dimethylethyl)ammonium toluene-4-sulphonate
- EC Number:
- 269-537-8
- EC Name:
- (2-hydroxy-1,1-dimethylethyl)ammonium toluene-4-sulphonate
- Cas Number:
- 68298-05-5
- Molecular formula:
- C7H8O3S.C4H11NO
- IUPAC Name:
- (2-hydroxy-1,1-dimethylethyl)ammonium toluene-4-sulphonate
- Test material form:
- solid
- Details on test material:
- (2-hydroxy-1,1-dimethylethyl)ammoniumtoluene-4-sulphonate from Evonik, Batch: NC19B11650
Constituent 1
In vitro test system
- Test system:
- artificial membrane barrier model
- Remarks:
- In vitro Membrane Test Corrositex™- Assay
- Justification for test system used:
- The CORROSITEX™ Assay is a standardized, quantitative in vitro test for skin corrosivity and has been validated by the ECVAM for testing acids, bases and their derivatives [11]. The bio-barrier membrane is constructed to have physico-chemical properties similar to rat skin.
- Details on test system:
- CORROSITEX™ Assay Kit (Invitro International; Irvine, CA 92614, Lot No.: CT040119
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 100 mg of the test substance were addes to Tube A & B
500 mg of the test item were applied on top of the BIOBARRIER - Duration of treatment / exposure:
- Table 1: Packing Group Designation
Category Time [min.] Time [min.] Time [min.] Time [min.]
1 0 – 3 > 3 - 60 > 60 - 240 > 240
2 0 - 3 > 3 - 30 > 30 - 60 > 60 - Number of replicates:
- 4x BIOBARRIER discs
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- The corresponding BIOBARRIER has been treated with
- negative control: 500 µl of 10% Citric acid (in ddH2O)
- positive control: 500 µl of 85% Phosphoric Acid
- 500 g of solid test item - Duration of treatment / exposure:
- based on the confirm experiment in the CORROSITX™, the chemical has been categorized in category 2. Therefore, the CDS solution was observed for 1 h. B
- Observation period:
- 1 h
- Details on study design:
- BIOBARRIER Prepartion:
-The content of the BIOBARRIER diluent was added to the vial of BIOBARRIER matrix powder.
-The vial was heated to 68°C (± 1°C) in a water bath under smooth agitation.
-After complete dissolution the solution was allowed to sit for 5 min.
-200 µL of the BIOBARRIER were pipetted into each membrane disc.
-The BIOBARRIERS were set on the tray and kept in the cold (2 - 8°C) for at least 2 h before the test was conducted
Categorization Test:
- 100 mg of the test substance were added to the tubes A and B.
- After shaking a colour change was observed in either of the tubes and colour was matched to the corresponding colour charts on the CORROSITEX™ Testing Protocol Poster.
- If no colour change had been observed in either tube, CONFIRM reagent was added to Tube B. After shaking, the resulting colour was matched to the colour chart on the CORROSITEX™ Testing Protocol Poster.
If the test item has a strong inherent colour or shows other characteristics impairing a clear categorization according to the colour chart, the pH value can be measured in tubes A and B and is used to confirm/determine the category of the test item, according to the Corrositex® Reference Manual .
Classification Test:
- The CDS vials were warmed to room temperature
- Vials 1 - 4: sample replicate testing
- Vial labelled (+): positive control sample,
-Vial labelled (-) :negative control.
- Vial labelled C: CDS colour control.
- 1x BIOBARRIER disc was added on top of the first vial
- 500 mg of the test item were applied evenly on the top of the BIOBARRIER disc and starting time was recorded, this was repeated for the remaining vials, staggering each start time by e.g. 10 seconds.
The start time difference for each vial was subtracted from the final time to determine the net response time.
As soon as a reaction had been observed, the time was recorded.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- Corrositex™
- Value:
- > 60
- Negative controls validity:
- valid
- Remarks:
- n.a. for 10% Citrix Acid
- Positive controls validity:
- valid
- Remarks:
- 26.08 min for 85% Phosphoric Acid
Any other information on results incl. tables
Table2: Results of the Test Item Propan-1-ol, 2-amino-2-methyl-, 4-methylbenzenesulphonate
|
CORROSITEX™ Time [min] |
Colour Change |
Replicate 1 |
n.a. |
no |
Replicate 2 |
n.a. |
no |
Replicate 3 |
n.a. |
no |
Replicate 4 |
n.a. |
no |
Mean ± SD |
n.a. |
|
|
|
|
Positive control |
26.08 |
yes |
Negative control |
n.a. |
no |
During the observation period of 1 h the CDS was not activated.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not corrosive to skin.
- Executive summary:
The potential of the test substance to induce skin corrosion was analysed by using the “In VitroMembrane Barrier Test (CORROSITEX™ Assay)”, comprising a Chemical Detection System covered by a bio-barrier membrane.
The test substance Propan-1-ol, 2-amino-2-methyl-, 4-methylbenzenesulphonate proved its ability to activate the CDS and was subsequently subjected to the timescale category test. The test substance was applied undiluted on top the bio-barrier membraneand the timerequired to activate the CDSwas measured in four replicates. The mean time was compared to the given thresholds (see Table 1).
The test substance was compatible with the CORROSITEX™ Assay, as assessed in the qualification step. The categorization step and the classification step could be performed.
A direct colour change was not observed. CONFIRM reagent was added to tube B and the category was read from the CORROSITEX™ colour chart. The chemical has been categorized to category 2.
In this study under the given conditions the test substance showed no corrosive effects as the mean time, required to activate the CDS, was > 60 min. (category 2).
The controls confirmed the validity of the study. The positive control activated the CDS between 3 - 60 min. (26.08 min.), the negative control did not activate the CDS before 60 min.
This in vitro study was performed to assess the corrosive potential of test item by means of the in vitro Membrane Barrier Test for
Skin Corrosion (OECD TG 435) using the Corrositex™ test kit.
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