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EC number: 225-555-8 | CAS number: 4926-55-0
- 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:
- From 27 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:
- The test item was found to have the potential to cause color interference with the MTT endpoint, therefore additional color correction tissues were incorporated into the testing procedure. However, the results obtained showed that no color interference occurred. It was therefore considered unnecessary to use the results of the color correction tissues for quantitative correction of results or for reporting purposes.
This deviation was considered to have not affected the integrity or validity of the study. - Deviations:
- yes
- Remarks:
- See "Version / remarks" section above
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-[(2-nitrophenyl)amino]ethanol
- EC Number:
- 225-555-8
- EC Name:
- 2-[(2-nitrophenyl)amino]ethanol
- Cas Number:
- 4926-55-0
- Molecular formula:
- C8H10N2O3
- IUPAC Name:
- 2-[(2-nitrophenyl)amino]ethanol
- Test material form:
- solid
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. 98893196L-1
- Expiration date of the lot/batch: 01 October 2018
- Purity test date: 15.12.2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
at room temperature in the dark
- Stability under test conditions: not applicable
- Solubility and stability of the test substance in the solvent/vehicle:
not applicable, no vehicule was used
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
no
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Not appliacle, the test item 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
FORM AS APPLIED IN THE TEST (if different from that of starting material)
The test substance was used as supplied
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: three-dimensional reconstructed human epidermis model consisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen
- Cell source:
- other: not applicable
- Source strain:
- other: not applicable
- 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
- Tissue batch number(s): 17-EKIN-021
- Production date: not detailed
- Shipping date:not detailed
- Delivery date: 23 May 2017
- Date of initiation of testing: 22 May 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: At the end of the exposure period, 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
- Modifications to validated SOP: No modification was performed
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Labtech LT-4500 microplate reader
- Wavelength: 570 nm
- Filter: no filter was used
- Filter bandwidth: no filter was used
- Linear OD range of spectrophotometer: not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
No historical data was mentionned in the report
NUMBER OF REPLICATE TISSUES: triplicates were used per condition
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- water killed tissue
- Procedure used to prepare the killed tissues (if applicable): not detailed
- N. of replicates : triplicates
- Method of calculation used: Relative mean viability (%) = [( mean OD570 of test item) / (mean OD570 of negative control)] x 100
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: two independant tests : Assessments for direct test item reduction of MTT and Color interference ; 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-exposure incubation is equal or less than 50%.
- The test substance is considered to be non-irritant to skin if the viability after 15 minutes exposure and 42 hours post-exposure incubation is greater than 50% .
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: no different cut off point - 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 (corresponding to 26.3 mg/cm2)
- Concentration (if solution): pure (used as supplied)
VEHICLE
No vehicle was used, but 5µL 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): 10µL
- Concentration (if solution): pure
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10µL
- 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 - Negative control
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test - Positive control
- Value:
- 4.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test - Test item
- Value:
- 79.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: No
- Colour interference with MTT: The solution containing the test item was an orange color therefore additional color correction tissues were incorporated into the testing procedure. However, the results obtained showed that no color interference occurred. It was therefore considered unnecessary to use the results of the color correction tissues for quantitative correction of results or for reporting purposes.
DEMONSTRATION OF TECHNICAL PROFICIENCY: The positive control showed the profiency of the test sytem to measure the decrease of cellular viability
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The mean OD570 for the negative control treated tissues was 0.802 and the standard deviation value of the viability was 10.2%. 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 4.9% relative to the negative control treated tissues and the standard deviation value of the viability was 0.8%. 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 15.5%. The test item acceptance criterion was therefore satisfied.
- Range of historical values if different from the ones specified in the test guideline: not applicable
Any other information on results incl. tables
Table1 :Mean OD570Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
OD570of tissues |
Mean OD570of triplicate tissues |
±SDof OD570 |
Relative individual tissue viability(%) |
Relative mean viability(%) |
± SD of Relative mean viability (%) |
Negative Control ItemÅ |
0.721 |
0.802 |
0.082 |
89.9 |
100* |
10.2 |
0.800 |
99.8 |
|||||
0.885 |
110.3 |
|||||
Positive Control ItemÅ |
0.033 |
0.039 |
0.007 |
4.1 |
4.9 |
0.8 |
0.039 |
4.9 |
|||||
0.046 |
5.7 |
|||||
Test Item |
0.636 |
0.639 |
0.124 |
79.3 |
79.7 |
15.5 |
0.517 |
64.5 |
|||||
0.765 |
95.4 |
OD= Optical Density
SD= Standard deviation
*= The mean viability of the negative control tissues is set at 100%
Å= Control group shared withEnvigo -Shardlowstudy number QT69YC and BN48LN
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental condition of the study, The test item HC YEllow No 2 did not induce irritant effect to EpiSkin model. Hence, the test item was classified as non-irritant : EU CLP Not classified for Irritation according to CLP criteria.
- Executive summary:
The purpose of this GLP-compliant in vitro test was to evaluate the skin irritation potential of the test item HC yellow No 2 using the EPISKINTM reconstructed human epidermis model after a treatment period of 15 minutes according to OECD TG 439 method.
Triplicate tissues were treated with the test item for an exposure period of 15 minutes. The test item was found to have the potential to cause color interference with the MTT endpoint therefore additional tissues were incorporated into the testing to correct for this. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. At the end of the post exposure incubation period each tissue was taken for MTT-assay. DPBS was used as negative control and SDS5% w/v was used as positive control. Optical density was measured at 570nm to determine cellular viability.
The relative mean viability of the test item treated tissues was 79.7% after the 15 Minute exposure period and 42 Hours post exposure incubation period.
Under the experimental condition of the study, The test item HC YEllow No 2 did not induce irritant effect to EpiSkin model. Hence, the test item was classified as non-irritant : EU CLP Not classified for Irritation according to CLP criteria
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