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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 15 March 1999 to 20 March 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- This non GLP-compliant study was performed with method equivalent to OECD 429 method. However, the test item was used diluted at 0.25, 0.5, 1 and 2% instead of pure recommended by REACh regulation. A sensitisation effect cannot be excluded at higher dose. No test item purity, solubility and stability were provided. No details on test item (purity, batch) and no radiolabelled thymidine information were provided.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- The test item was used diluted instead pure required by REACh regulation
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
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: 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 : Bristol-Myers squibb Worldwide Beauty Care
- Expiration date of the lot/batch: not specified
- Purity test date: not specified
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: not specified
- Specific activity:not specified
- Locations of the label: 3H-thymidine was used in this study
- Expiration date of radiochemical substance: not specified
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Not specified
- Solubility and stability of the test substance in the solvent/vehicle: not specified
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test articles will be prepared daily in vehicle at 0.25, 0.50, 1.0 and 2.0% (2wgt/vol)
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:Jackson laboratories or Harlan Sprague Dawley
- Females (if applicable) nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: not specified
- Age at study initiation:8-12 weeks
- Weight at study initiation: 18-25g
- Housing: housed in shoebox-type cages with a filter cover which provides a filtered microenvironment.
- Diet (e.g. ad libitum): Certified Rodent Chow #7012C Teklad, ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 7 days
- Indication of any skin lesions: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 26 deg Celsius
- Humidity (%): 30 to 70%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours
- IN-LIFE DATES: From: 15 March 1999 To: 20 March 1999
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 0, 0.25, 0.5, 1 and 2 % were used
- No. of animals per dose:
- 5 females were used per dose
- Details on study design:
- PRE-SCREEN TESTS:
No pre-screen test was performed before the main study.
MAIN STUDY
Mice were treated on dorsal surfaces of both ears, once per day for 3 days. On day 5 the mice were injected with 20µC of 3H-thymidine in 250 µL. Five hours later the mice were euthanazied with C02 and the draining auricular lymph nodes removed. A single cell suspension was prepared from lymph nodes of each mouse. Cells were washed twice with phosphate buffered saline (PBS) and precipitated with 5% trichloro-acetic acid (TCA) overnight at 2-8 deg Celsius. The pellets were recovered by centrifugation and resuspended in 1 mL of TCA and transferred to 10 mL of scintillation fluid. Incorporation of 3H-thymidine was measured with Beta-scintillation counter.
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: Increases of 3H-thymidine incorporation relative to vehicle-treated control were derived for each group and recorded as stimulation indices (Test/Control ratio). THe criterion for a positive response is that one or more concentration of a test article elicits a 3-fold or greater increase in isotope incorporation relative to the vehicle control.
TREATMENT PREPARATION AND ADMINISTRATION:
The test articles will be prepared daily in vehicle at 0.25; 0.5, 1 and 2% (wgt/vol) in vehicle (DMSO). The test articles were applied daily on the dorsal surfaces of both ears for 3 days at a volume of 25 µL. - Positive control substance(s):
- other: p-phenylenediamine
- Statistics:
- Descriptive statistics and an analysis of variance (ANOVA) will be performed. If a statistically significant difference is detected, a Dunnett's test will be performed.
Results and discussion
- Positive control results:
- The positive control, PPD, at1.0 and 2.0% resulted in test/control ratios greater than 3 (5.06 and 13.79, respectively) indicating a positive response. Only the response at the high dose was statistically significant compared to the vehicle control.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.19
- Test group / Remarks:
- Test Item at 0.25%
- Key result
- Parameter:
- SI
- Value:
- 0.79
- Test group / Remarks:
- Test Item at 0.5%
- Key result
- Parameter:
- SI
- Value:
- 1.03
- Test group / Remarks:
- Test Item at 1.0%
- Key result
- Parameter:
- SI
- Value:
- 1.28
- Test group / Remarks:
- Test Item at 2.0%
Any other information on results incl. tables
Table 1 :Summary of Results
|
Treatment Group |
DPM (mean±sem) |
Test/control Ratio |
Result |
DMSO |
0 |
735±216 |
- |
|
Test Item |
0.25 |
875±172 |
1.19 |
- |
Test Item |
0.5 |
577±137 |
0.79 |
- |
Test Item |
1 |
756±376 |
1.03 |
- |
Test Item |
2 |
942±146 |
1.28 |
- |
PPD |
0.25 |
990±313 |
1.35 |
- |
PPD |
0.5 |
1388±281 |
1.89 |
- |
PPD |
1 |
3720±663 |
5.06 |
- |
PPD |
2 |
10134±4853* |
13.79 |
+ |
*statistically significant difference (p>0.001) compared to vehicle control
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the experimental conditions of this study, the test item HC Yellow No. 2 did not induced delayed contact hypersensitivity to mice after skin contact. However, the study cannot be used for classification because the test item was used diluted at 0.25, 0.5, 1 and 2% instead of pure recommended by REACh regulation. A sensitisation effect cannot be excluded at higher dose. No test item purity, solubility and stability were provided. No details on test item (purity, batch) and radiolabelled thymidine information were provided.
- Executive summary:
The purpose of this no GLP compliant study was to evaluate the potential sensitising effect of the test substance HC Yellow No. 2 in mice on a Local Lymph Node Assay (LLNA) which was performed with a method equivalent to OECD Guideline 429 method.
25 μL test preparation applied to dorsal aspect of ear lobe of CBA/Ca mice daily for 3 days. 5 days after the first application, 250 μL of a solution containing 20 μCi/mL 3H-thymidine was injected intravenously. 5 hours later the animals were euthanized and the draining auricular lymph nodes were removed. Incorporation of 3H-thymidine was measured by beta-scintillation counting. The compound is not positive (>3) at any concentration and it is not sensitizer in this test.
Under the experimental conditions of this study, the test item HC Yellow No. 2 did not induced delayed contact hypersensitivity to mice after skin contact. However, the study cannot be used for classification because the test item was used diluted at 0.25, 0.5, 1 and 2% instead of pure recommended by REACh regulation. A sensitisation effect cannot be excluded at higher dose.No test item purity, solubility and stability were provided. No details on test item (purity, batch) and radiolabelled thymidine information were provided.
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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