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EC number: 700-579-6 | CAS number: -
- 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
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- tetrakis(4-{[4-(diethylamino)phenyl][4-(ethylamino)naphthalen-1-yl]methylidene}-N,N-diethylcyclohexa-2,5-dien-1-iminium) 2-(dodecan-5-yl)-4-(4-sulfonatophenoxy)benzene-1-sulfonate 2-(dodecan-5-yl)-4-[3-(dodecan-5-yl)-4-sulfonatophenoxy]benzene-1-sulfonate
- EC Number:
- 700-579-6
- Molecular formula:
- C90H114O7S2N6 (MW = 1454) and C102H138O7S2N6 (MW = 1622)
- IUPAC Name:
- tetrakis(4-{[4-(diethylamino)phenyl][4-(ethylamino)naphthalen-1-yl]methylidene}-N,N-diethylcyclohexa-2,5-dien-1-iminium) 2-(dodecan-5-yl)-4-(4-sulfonatophenoxy)benzene-1-sulfonate 2-(dodecan-5-yl)-4-[3-(dodecan-5-yl)-4-sulfonatophenoxy]benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Batch N° 310551
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: élevage Janvier, Le Genest-St-Isle, France
- Age at study initiation: approximately 7 weeks
- Weight at study initiation:
At d1, mean for the 2000 mg/kg group: 221.1 gram +/- 8.8
At d1, mean for the 300 mg/kg group: 223.3 gram +/-8.6
- Fasting period before study: deprived of water overnight prior to dosing
- Housing: polypropylen cage. Maximum 3 animals per cage
- Diet : ad libitum except the 4 hours following administration. granules A04-10
- Water: ad libitum
- Acclimation period: 5 days at least before administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs/12hrs
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: adapted for each animal
- Amount of vehicle : 5 mL/kg for both doses
- Justification for choice of vehicle: corn oil was chosen among various vehicules because it does not induce pain. Following several preliminary
assays, the aqueous-based vehicles (pure water, HCMC) were disregarded and the non-polar vehicle (corn oil commonly used for oral toxicity assay ) has been chosen since it allowed to prepare a homogenous mixture usable for oral adiministration.
- Lot/batch no. : 07030169/C - Doses:
- 2000 mg/kg
300 mg/kg - No. of animals per sex per dose:
- 6 rats for the 2000 mg/kg dose
6 rats for the 300 mg/kg dose - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: regularly following administration (30 min, 1h, 2h, 3h and 4 h) and at least once a day during the 14 days
- Frequency of weighing: d-1, d1 T0, d4, d8, d15
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- first dose of 2000 mg/kg with 3 animals
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At the 300mg/kg dose tested, no deaths were observed.
At the 2000 mg/Kg dose: deaths occurred for all animals between day 2 and day 6. - Clinical signs:
- other: At the 2000 mg/kg dose, significant symptoms occured: important piloerection, reduced motor activity with diarrhoea and hypotonia among one female. At the 300 mg/kg dose, the test materai has caused piloerection associated with a reduced motor activity d
- Gross pathology:
- At the 2000 mg/kg dose: the test material (colorant) has been found to be present all along the digestive tract and also in the main organs
(kidneys, liver, spleen, blader, pancreas) for the 6 females.
At the 300 mg/kg dose: no tissue neither organic abnormalities have been found for all 6 females.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- According to the Global Harmonised System (GHS), the test material Sepisol Fast Blue 85219 has been classified as acute toxicity category 4 with a LD 50 determined between 2000 and 300 mg/kg in rat.
- Executive summary:
The aim of this study was to assess qualitatively and quantitatively the toxic effects and the delay of the appearance after single oral administration of pre-defined doses of 2000 mg/kg and 300 mg/kg of body weight, of test element named SEPISOL FAST BLUE 85219 suspended in corn oil, in 6 females rats for each dose level, using a stepwise procedure. The study has been performed by using the OECD guideline 423.
The animals were daily observed for at least 14 days after administration and the clinical signs and signs of toxicity were noted.
A preliminary test was performed with a 2000 mg/kg dose after which all animals died.
The results of the assay showed that 6 animals died with the 2000 mg/kg dose level (100 % of mortality) and that no animals died with the 300 mg/kg dose level (0% of mortality).
At the 2000 mg/kg dose, significant symptoms occured: important piloerection, reduced motor activity with diarrhoea and hypotonia among one female. At the 300 mg/kg dose, the test materai has caused piloerection associated with a reduced motor activity during the first 4 hours but no deaths occured. At the 2000 mg/kg dose: the test material (colorant) has been found to be present all along the digestive tract and also in the main organs (kidneys, liver, spleen, blader, pancreas) for the 6 females. At the 300 mg/kg dose: no tissue neither organic abnormalities have been found for all 6 females.
This test provided results allowing the test element to be classified according to the Classification and Labeling of Products regulation (CLP EC 1272/2008) , which cause acute toxicity.
The test element was classified in the hazard category 4 with a LD50 ranging between 2000 mg/kg and 300 mg/kg
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