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Diss Factsheets
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EC number: 251-410-3 | CAS number: 33229-34-4
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline 429 in compliance to GLP.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
- Reference Type:
- other: Published secondary source
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2,2'-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol
- EC Number:
- 251-410-3
- EC Name:
- 2,2'-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol
- Cas Number:
- 33229-34-4
- Molecular formula:
- C12H19N3O5
- IUPAC Name:
- 2-({4-[bis(2-hydroxyethyl)amino]-2-nitrophenyl}amino)ethan-1-ol
- Details on test material:
- Test item : 2-[(4-N,N-bis-(2'-hydroxyethyl)amino-2-nitrophenyl)amino]ethanol
EC number : 252-410-3
Batch number : 114B5
Content : 98.7%
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 25uL of 0.5, 1.0, 2.5, 5 and 10% in dimethylformamide.
- No. of animals per dose:
- 4 females per dose
- Details on study design:
- Range Finding Test : No information available
Main Study
In two independent experients, 25uL HC Blue No2 in dimethylformamide was applied to the dorsal surface of both ears at the followinh concentrations : 0.5%, 1.0%, 2.5%, 5.0%, 10.0%. A positive control group received 25% alpha-hexylcinnamicaldehyde (HCA) in dimethylformamide and the negative control the vehicle alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Positive control induced a positive response. The stimulation indices were 9.97 and 5.70 at the concentration of 25%.
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- In each experiment, during the induction phase, the test item, vehicle or positive control was applied over the ears (25uL per ear) for 3 conecutive days. After 2 days of resting, the proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of tritiated thymidine (day 6). The obtained values were used to calculate stimulation indices (SI). In the first experiment, an increase in stimulation index was observed at 5% only. In the second experiment, a dose related increase in the stimulation index was noted at concentrations between 1 and 10%, but the threshold positove value of 3 was not reached at any of the tested concentrations.
Any other information on results incl. tables
Experiment 1
Treatment | Concentration (%) | Signs of Local Irritation | Stimulation Index (SI) |
B37 | 0.5 | no | 1.37 |
B37 | 1 | no | 1.03 |
B37 | 2.5 | no | 1.30 |
B37 | 5 | no | 3.92 |
B37 | 10 | no | 1.55 |
HCA | 25 | - | 9.97 |
Experiment 2
Treatment | Concentration (%) | Signs of Local Irritation | Stimulation Index (SI) |
B37 | 0.5 | no | 1.60 |
B37 | 1.0 | no | 0.90 |
B37 | 2.5 | no | 1.35 |
B37 | 5 | no | 1.50 |
B37 | 10 | no | 2.01 |
HCA | 25 | - | 5.70 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Conclusions:
- While the data is equivocal, the test substance HC Blue No 2 is considered to have a skin sensitising potential.
- Executive summary:
The potential of HC Blue no 2 to induce contact hypersensitivity was examined using the local lymph node assay (OECD guideline 429). Groups of 4 female mice in each were treated with 0.5%, 1%, 2.5%, 5% and 10% of the test substance in vehicle (dimethylformamide) for 3 daily treatments. After 2 days of resting, the proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of tritiated methyl thymidine (day 6). While the data is equivocal, the test substance HC Blue No 2 is considered to have a skin sensitising potential.
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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