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EC number: 255-940-6 | CAS number: 42783-06-2
- 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:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- OECD guideline reference 429 (2002): Skin sensitisation: Local Lymph Node Assay
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- United States Environmental Protection Agency, Health Effects Test Guidelines, OPPTS 870.2600 (1998): Skin Sensitisation.
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-[4-[N-(4-acetoxybutyl)-N-ethyl]amino-2-methylphenylazo]-3-acetyl-5-nitrothiophene
- EC Number:
- 404-830-8
- EC Name:
- 2-[4-[N-(4-acetoxybutyl)-N-ethyl]amino-2-methylphenylazo]-3-acetyl-5-nitrothiophene
- Cas Number:
- 122063-39-2
- Molecular formula:
- C21H26N4O5S
- IUPAC Name:
- 4-({4-[2-(3-acetyl-5-nitrothiophen-2-yl)diazen-1-yl]-3-methylphenyl}(ethyl)amino)butyl acetate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Disperse Blue 369
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Barriered Animal Breeding Unit at ICI Pharmaceuticals, Alderley Park, Cheshire, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation:8-12 week
- Housing: group housing
- Diet (ad libitum): SDS PCD 5/8" pelleted diet
- Water (ad libitum): tap water
- Acclimation period: at least 2 days housed in groups of 10 as on delivery from the Breeders and at least 2 days in their study groups of 4 animals.
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2°C
- Humidity (%): 55+/-10
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 14 January 1990 to 23 January 1990
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 3%, 10%, 30% and 50% w/v
- No. of animals per dose:
- Four female mice per dose.
- Details on study design:
- Justification for test system selection
The CBA/Ca mouse is the species of choice because previous examination of strain differences in lymphocyte proliferation responses to contact sensitisers showed the CBA/Ca mice to exhibit the most vigorous response (Kimber and Weisenberger (1989)).
Test method
Groups of four female mice were used for this study. Approximately 25 μl of the vehicle or the different test substance preparations was applied, using a variable volume micro-pipette, to the dorsal surface of each ear. The procedure was repeated daily for 3 consecutive days.
Five days following the initial dosing all mice were injected I.V. with approximately 250 µL of phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine (specific activity 2.0 Ci/mmol). Approximately 5 hours later mice were sacrificed (inhalation of anaesthetic ['Fluothane'] followed by cervical dislocation) and the draining auricular lymph nodes were removed and pooled for each experimental group.
A single cell suspension was prepared by mechanical disaggregation of lymph nodes through a 200-mesh stainless steel gauze. The cell suspensions were then washed three times by centrifugation with approximately 10 ml of PBS. Approximately 3 ml of 5% w/v trichloroacetic acid (TCA) was added and, after overnight precipitation at 4 °C, the samples were pelleted by centrifugation and the supernatant was discarded. The cells were then resuspended in approximately 1 ml of TCA.
The lymph node suspensions were transferred to scintillation vials and 10 ml of scintillant (Optiphase) was added prior to β-scintillation counting using a Packard Tri-Carb 2500TR Liquid Scintillation Counter.
The results are expressed as mean counts per minute (cpm) per lymph node for each experimental group. The activity of each test group was divided by the activity of the vehicle only (control) group to give a test/control ratio for each concentration tested.
Criteria for Positivity
For a chemical to be designated a potential sensitiser in the Local Lymph Node Assay it has to fulful two criteria:
1) The increase in isotope incorporation for at least one concentration tested must be 3-fold or more compared to the control (vehicle treated) mice.
2) The data generated must not be incompatible with a biological dose response.
If a chemical does not fulfil the above criteria it is designated as showing no evidence of sensitising potential - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The results are expressed as a counts per minute (cpm) value per lymph node for each group.
The activity of each test group is then divided by the activity of the vehicle control group to give a test: control ratio for each concentration.
The criterion for a positive response is that one or more concentrations of the test substance should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group.
Results and discussion
- Positive control results:
- The application of hexylcinnamaldehyde at concentrations of 2.5%, 5% and 10% w/v in acetone resulted in a greater than 3-fold increase in isotope incorporation at all three concentrations. Therefore, hexylcinnamaldehyde was shown to be a skin sensitiser, confirming the validity of the protocol used for the study.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.08
- Test group / Remarks:
- 3%
- Key result
- Parameter:
- SI
- Value:
- 1.63
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 1.63
- Test group / Remarks:
- 30%
- Key result
- Parameter:
- SI
- Value:
- 1.32
- Test group / Remarks:
- 50%
Any other information on results incl. tables
Test results
Concentration of test substance (% w/v) |
Number of lymph nodes assayed |
Counts per minute (cpm) |
cpm per lymph node |
Test control ratio |
0 (vehicle only) |
8 |
1580 |
197.5 |
N/A |
3% w/v |
8 |
1711 |
213.88 |
1.08 |
10% w/v |
8 |
2570 |
321.25 |
1.63 |
30% w/v |
8 |
2576 |
322 |
1.63 |
50% w/v | 8 | 2080 | 260 | 1.32 |
N/A – not applicable
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance showed no evidence of sensitising potential in the Local Lymph Node assay in mice
- Executive summary:
The test substance was assessed for its skin sensitisation potential using the Local Lymph Node assay. The assay determines the level of T lymphocyte proliferation in the lymph node draining the site of chemical application,
by measuring the amount of radiolabelled thymidine incorporated into the dividing cells. The increase in isotope incorporation at all concentrations tested did not reach 3 times that of the control (vehicle treated) mice. Therefore under
the conditions of this assay the test substance showed no evidence of sensitising potential.
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