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EC number: 280-734-8 | CAS number: 83763-48-8
- 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
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- Flash point
- Auto flammability
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- Explosiveness
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- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
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- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Endpoint summary
- Stability
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Sediment toxicity
- Terrestrial toxicity
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- 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:
- From 23 February 2017 to
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- Deviation 1
General Study Plan Number 1107 version 07 was withdrawn prior to the start of the study therefore General Study Plan Number 1107 version 09 was followed.
Deviation 2
An assessment found the test item was able to directly reduce MTT. Therefore, an additional procedure using water killed tissues was performed. However, the results obtained showed that negligible interference due to direct reduction of MTT occurred. It was therefore considered unnecessary to use the results of the water killed tissues for quantitative correction of results or for reporting purposes.
These deviations were considered to have not affected the integrity or validity of the study - Deviations:
- yes
- Remarks:
- See "Version / remarks" above
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (3-ammonio-4-methoxyphenyl)(2-hydroxyethyl)ammonium sulphate
- EC Number:
- 280-734-8
- EC Name:
- (3-ammonio-4-methoxyphenyl)(2-hydroxyethyl)ammonium sulphate
- Cas Number:
- 83763-48-8
- Molecular formula:
- C9H14N2O2.H2O4S
- IUPAC Name:
- (3-ammonio-4-methoxyphenyl)(2-hydroxyethyl)ammonium sulphate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: supplied by the Sponsor, batch no. 7215603732
- Expiration date of the lot/batch: 31 January 2018 (retest date)
- Purity test date: 21.08.2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: not applicable
- Solubility and stability of the test substance in the solvent/vehicle: not vehicle was used
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not applicable, the test substance was used as supplied
- Preliminary purification step (if any): not applicable
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: highly differentiated and stratified epidermis
- Cell source:
- other: not appicable
- Source strain:
- other: adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen
- Justification for test system used:
- Following a full validation study the EpiSkinTM reconstructed human epidermis model showed evidence of being a reliable and relevant stand-alone test for predicting rabbit skin irritation when the endpoint is measured by MTT reduction and for being used as a replacement for the Draize Skin Irritation Test for the purpose of distinguishing between Irritating and Non-Irritating test items.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKINTM reconstructed human epidermis model
- Tissue batch number(s): 17-EKIN-050
- Production date: not detailed
- Shipping date: not detailed
- Delivery date: 12 December 2017
- Date of initiation of testing: 12 December 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 °C, 5% CO2
- Temperature of post-treatment incubation (if applicable): 37 °C, 5% CO2 in air
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: each tissue was removed from the well using forceps and rinsed using a wash bottle containing DPBS with Ca++ and Mg++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft stream of DPBS to gently remove any residual test item
- Observable damage in the tissue due to washing: no observable damage
- Modifications to validated SOP: no modification of SOP
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 hours at 37°C
- Spectrophotometer: Labtech LT-4500 microplate reader
- Wavelength: 570 nm
- Filter: no filter
- Filter bandwidth: not specified
- Linear OD range of spectrophotometer: not detailed
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
No reference to historical data was mentionned
NUMBER OF REPLICATE TISSUES: triplicate were used
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Water- killed tissues
- Procedure used to prepare the killed tissues (if applicable): Water-killed tissues were prepared prior to the study by placing untreated EPISKINTM tissues in a 12 well plate containing 2.0 mL of sterile distilled water in each well. The tissues were incubated at 37 °C, 5% CO2 in air for a minimum of 48 hours. At the end of the incubation the water was discarded. Once killed the tissues were stored in a freezer (-14 to -30 °C) for up to 6 months
- N. of replicates : triplicate
- Method of calculation used: True viability = Viability of treated tissue - direct MTT interferance from test item = OD treated viable tissue - (mean OD treated killed tissue - mean OD untreated killed tissue) OD = opical density
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: two independant sequences : pretest and main test (including MTT assay)
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the viability after 15 minutes exposure and 42 hours post incubation period is less than or equal to 50%.
- The test substance is considered to be non-irritant to skin if ithe viability after 15 minutes exposure and 42 hours post incubation period is higher than 50%.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: not different cutpoint - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg (26.3 mg/cm2)
- Concentration (if solution): not applicable, used as supplied
VEHICLE
No vehicle was sued, however, 5 µL of sterile distilled water was topically applied to the epidermal surface in order to improve contact between the test item and the epidermis
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL of DPBS
- Concentration (if solution): pure
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL of SDS
- Concentration (if solution): 5% w/v - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- triplicates were used per condition
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test - Test item
- Value:
- 86.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test - Negative control
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test - Positive control
- Value:
- 6.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: An assessment found the test item was able to directly reduce MTT. Therefore, an additional procedure using water killed tissues was performed. However, the results obtained showed that negligible interference due to direct reduction of MTT occurred. It was therefore considered unnecessary to use the results of the water killed tissues for quantitative correction of results or for reporting purposes.
- Colour interference with MTT: The solution containing the test item was a pale grey color. This color was attributed to the intrinsic color of the test item itself. It was therefore unnecessary to run color correction tissues.
DEMONSTRATION OF TECHNICAL PROFICIENCY: The positive control condition showed the ability of the test system to quantify decrease of tissue viability
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD570 for the negative control treated tissues was 0.910 and the standard deviation value of the viability was 3.0%. The negative control acceptance criteria were therefore satisfied.
- Acceptance criteria met for positive control: The relative mean tissue viability for the positive control treated tissues was 6.8% relative to the negative control treated tissues and the standard deviation value of the viability was 2.8%. The positive control acceptance criteria were therefore satisfied.
- Acceptance criteria met for variability between replicate measurements: The standard deviation calculated from individual tissue viabilities of the three identically test item treated tissues was 6.3%. The test item acceptance criterion was therefore satisfied.
- Range of historical values if different from the ones specified in the test guideline: Not specified
Any other information on results incl. tables
Table & : Mean OD570Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
OD570of tissues |
Mean OD570of triplicate tissues |
± SD of OD570 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative Control Item |
0.880 |
0.910 |
0.028 |
96.7 |
100* |
3.0 |
0.916 |
100.6 |
|||||
0.935 |
102.7 |
|||||
Positive Control Item |
0.042 |
0.062 |
0.026 |
4.6 |
6.8 |
2.8 |
0.053 |
5.8 |
|||||
0.091 |
10.0 |
|||||
Test Item |
0.772 |
0.784 |
0.057 |
84.8 |
86.1 |
6.3 |
0.734 |
80.6 |
|||||
0.846 |
92.9 |
SD= Standard deviation
*= The mean viability of the negative control tissues is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- other: Not skin irritant
- Conclusions:
- Under the experimental condition of the study, the registered substance was applied on EpiSkinTM model and the relative mean viability of treated tissues was 86.1% after the 15 Minute exposure period and 42 Hours post exposure incubation period. Hence, according to CLP criteria, the test item 2-Amino-4-Hydroxyethylaminoanisole Sulfate was not classified for skin irritation.
- Executive summary:
The purpose of this GLP-compliant in vitro test was to evaluate the skin irritation potential of the test item 2-Amino-4-Hydroxyethylaminoanisole Sulfate using the EPISKINTM reconstructed human epidermis model.
Triplicate tissues of EPISKINTM model were treated with the test item for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. DPBS was used as negative control and SDS as positive control condition. The test item was found to directly reduce MTT and therefore additional non-viable tissues were incorporated into the testing for correction purposes. At the end of the post exposure incubation period each tissue was taken for MTT-loading.
The relative mean viability of the test item treated tissues was 86.1% after the 15 Minute exposure period and 42 Hours post exposure incubation period.
Under the experimental condition of the study, the registered substance did not indeuced adverse effect on EpiSkinTM model. Hence, according to CLP criteria, the test item 2-Amino-4-Hydroxyethylaminoanisole Sulfate was not classified for skin irritation.
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.
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