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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Nousan 8147 2-1-2
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute 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:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Ltd, Bicester
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: males 148 - 278 g; females 186 - 221 g
- Fasting period before study: not necessary
- Housing: individually from day -1 to 3, 5/sex/group from day 3 until end of study
- Diet (e.g. ad libitum): SQC(E) Rat and Mouse Diet No. 1, Special Diets Services Ltd, Witham, UK, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 to 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsum
- % coverage: at least 10% of the total body
- Type of wrap if used: A dense gauze patch was placed over the treated skin and retained in place by an elasticated, open-weave, adhesive compression bandage. This was wrapped securely around the torso of the animal. The dressing was considered to be semi-occlusive.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dermal test site of each rat was lightly brushed clean of any solid residues and swabbed with water-moistened cotton wool.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Individual dose weights (mg) were calculated from the body weight of the rats on the morning of dosing
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 (including 1 each of preliminary test)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Clinical signs were recorded immediately post-dose, at approximately 15 and 30 minutes post-dose, hourly between 1 and 4 hours post-dose (inclusive), twice daily on days 2, 3 and 4 and once daily from day 5 to 15; weighing was performed on day -1 (day before dosing) and on days 1, 4, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- not necessary
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- No clinical signs observed.
- Body weight:
- All rats gained weight during the first and second week.
- Gross pathology:
- Pale, red or dark foci on the lungs and pale kidneys.
- Other findings:
- - Other observations: Dermal reactions noted were very slight to well-defined erythema noted in four males and one female on Day 2 with very slight erythema noted in one male and one female on Day 3.
Any other information on results incl. tables
Conclusion:
The acute median lethal dermal dose of No. 408 Yellow to rats was found to exceed 5000 mg/kg.
The test material was considered to have no significant acute toxic risk in respect of its acute dermal toxicity and did not meet the criteria for classification according to Commission Directive 2001/59/EC. No symbol and risk phrase are required.
Applicant's summary and conclusion
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