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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Nousan 8147 2-1-1
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
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.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 162 - 196 g
- Fasting period before study: overnight until 3 hours after dosing
- Housing: 3/group
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Maintenance Diet No.1, Special Diets Services Ltd, Witham, UK; ad libitum except fasting period
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 to 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous methyl cellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 and 500 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: test article did not dissolve or suspend in purified water
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Since there were no data to indicate that deaths my occur at dose levels of less than 2000 mg/kg, the first dose level was 2000 mg/kg. - Doses:
- 2000 and 5000 mg/kg
- No. of animals per sex per dose:
- 2000 mg/kg: 6 females
5000 mg/kg: 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: clinical signs immediately post-dose, at 15 and 30 minutes post-dose, hourly betwen 1 to 4 hours post-dose (inclusive), twice daily on days 2, 3 and 4 and once daily from day 5 to 15; weighing on day -1 (before dosing) and on days 1, 4, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Not required by guideline.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality occurred
- Clinical signs:
- 2000 mg/kg bw: piloerection in 3/6 on the day of dosing
5000 mg/kg bw: piloerection in 3/3 from 1 h after dosing and lasting up to day 8, hunched posture in 1/3 from day 2 to 4, orange coloured faeces in 2/3 from day 4 to 7 - Body weight:
- All rats gained weight during the first and second week of the observaion period, except for one animal at 2000 mg/kg which showed a slight body weight loss during the second week.
- Gross pathology:
- 2000 mg/kg bw: dark or pale foci on the lungs of 2/6 rats, 1/6 had a red and distended bladder with a prominent vascular structure.
5000 mg/kg: no abnormalities observed.
Any other information on results incl. tables
Conclusion:
The acute median lethal oral dose level of the test article, No. 408 Yellow, was found to exceed 5000 mg/kg.
The test article did not need to be classified according to the Globally Harmonised System for the classification of chemicals which cause acute toxicity.
The test material was considered to have no significant acute toxic risk if swallowed and did not meet the criteria for classification according to Commission Directive 2001/59/EC.
Applicant's summary and conclusion
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