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EC number: 700-222-4 | CAS number: 1065519-44-9
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N-(4-{[3-(dimethylamino)propyl]sulfamoyl}phenyl)-2-[(2-methoxy-4-nitrophenyl)diazenyl]-3-oxobutanamide
- EC Number:
- 700-222-4
- Cas Number:
- 1065519-44-9
- Molecular formula:
- C22H28N6O7S
- IUPAC Name:
- N-(4-{[3-(dimethylamino)propyl]sulfamoyl}phenyl)-2-[(2-methoxy-4-nitrophenyl)diazenyl]-3-oxobutanamide
- Reference substance name:
- No. 408 Yellow
- IUPAC Name:
- No. 408 Yellow
- Details on test material:
- - Name of test material (as cited in study report): No. 408 Yellow
- Physical state: yellow powder
- Analytical purity: 98.6%
- Purity test date: 07 November 2008
- Lot/batch No.: 081105-1
- Expiration date of the lot/batch: 04 November 2009
- Stability under test conditions:
- Storage condition of test material: room temperature, dark, sealed container
- Other: Source: TOYO INK MFG. CO. LTD.; pH of 33% w/v dispersion was 9.3
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Bicester.
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 18 - 23 g
- Housing: individual
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No 1, Special Diets Services Ltd, Witham, UK
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 - 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0.5, 1.0, 2.5 % (w/v)
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Formulation trials were carried out with the test article using 80% v/v acetone in olive oil, dimethyl formamide, methyl ethyl ketone and dimethylsulphoxide. At the start of each trial, 500 mg of test article was added to 1 mL of vehicle. At this concentration, all formulations were thick suspensions. A further 1 mL of vehicle was added to each formulation and left stirring overnight. The resulting suspensions were then further diluted with 0.5 mL of vehicle. A visual inspection confirmed that the formulation in dimethyl formamide appeared to be the most suitable, therefore a series of dilutions were carried out until a solution was obtained. This occurred at approximately 3%.
As no toxicological information was available regarding the systemic toxicity/irritancy potential of the test article, the preliminary screening test was performed with one mouse. The mouse was treated by daily application of 25 μL of the test article at the maximum attainable concentration (2.5% w/v in dimethyl formamide) to the dorsal surface of each ear for three consecutive days (Days 1, 2 and 3). The mouse was observed daily for five days from the initiation of treatment. Any signs of toxicity or irritation during this period were recorded.
- Irritation: Death or signs of systemic toxicity/excessive irritation were not noted.
- Lymph node proliferation response: Not reported
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
Groups of five female mice were assigned to study according to the table given below. Doses were selected from the concentration series 2.5%, 1.0%, 0.5% etc. Three consecutive concentrations were selected based on the preliminary screening test so that the highest concentration maximised exposure whilst avoiding systemic toxicity and excessive local irritation.
- Name of test method: Individual Method
- Criteria used to consider a positive response: The test article is regarded as a sensitiser when the maximum value of the SI is 3.0 or above.
TREATMENT PREPARATION AND ADMINISTRATION:
Doses were selected from the concentration series 2.5%, 1.0%, 0.5% etc. Three consecutive concentrations were selected based on the preliminary screening test so that the highest concentration maximised exposure whilst avoiding systemic toxicity and excessive local irritation.Formulations were freshly prepared as required, on Days 1, 2 and 3. The formulations were mixed by multiple inversion of the containers prior to administration to ensure homogeneity. The formulations were stored at room temperature, in sealed, air-tight containers prior to dosing. All formulations were used within two hours of preparation.
The five groups of five female mice were subjected to application of the vehicle control, positive control or one of the test formulations to the outer aspect of the auditory pinnae, once daily on Days 1, 2 and 3. On Day 6 0.25 mL phosphate buffered saline incorporating 20 μCi of 3HTdR were administered into a tail vein of each mouse by slow bolus injection. Approximately five hours after intravenous injection of the 3HTdR, all mice were killed by exposure to a rising concentration of carbon dioxide. Killing was organised to minimise the interval between death and the recovery of the auricular lymph nodes to no more than fifteen minutes.
The isolated lymphocytes of individual animals were subsequently subject to scintillation counting after the preparation procedure. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The scintillation counter data included the DPM value (disintegrations per minute during a ten minute period) for each individual animal. The DPM value was transformed into a mean DPM value for each group. The mean DPM value for each test group was divided by the mean DPM for the control group to provide the Stimulation Index (SI) value for each test group.
Results and discussion
- Positive control results:
- The positive control article produced a Stimulation Index of 9.60 demonstrating adequate performance of the assay.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 0.5%: 1.55 1.0%: 1.10 2.5%: 0.77
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean DPM/animal ± Standard Deviation: Vehicle: 217 ± 60.1 0.5%: 338 ± 149.8 1.0%: 238 ± 133.1 2.5%: 168 ± 42.1 Positive control: 2084 ± 745.9
Any other information on results incl. tables
Conclusion:
The Local Lymph Node Assay demonstrated that No.408 Yellow does not have the potential to cause skin sensitisation.
The test article did not meet the criteria for classification as a sensitiser according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.
Applicant's summary and conclusion
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