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EC number: 700-610-3 | 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:
- From 2008/03/17 to 2008/04/02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The reliability is rated 1 because the study followed the standard guideline of reference (OECD 423), which describes a procedure designed to evaluate this endpoint, the results were reviewed for reliability and assessed as valid, and the study was conducted under GLP condition.
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:
- yes
Test material
- Reference substance name:
- Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3- sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
- IUPAC Name:
- Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3- sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
- Reference substance name:
- Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3-sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
- EC Number:
- 700-610-3
- Molecular formula:
- UVCB substance - not applicable
- IUPAC Name:
- Bis{tris[4-(mono and dimethylamino)phenyl]methylium} 2-(bis{4-[ethyl(3-sulfonatobenzyl)amino]phenyl}methyliumyl)benzenesulfonate
- Details on test material:
- - Name of test material : Sepisol Fast Blue 2BR
- Physical state/ appearance: dark blue powder
- Lot/batch No.: 905536
- Storage condition of test material: ambient temperature and in the dark
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: élevage JANVIER (53940 Le Genest-St-Isle, France).
- Age at study initiation: approximately 8 weeks.
- Weight at study initiation: At D1, mean (for group 1 and 2): 225.8 gram +/- 7.8.
- Fasting period before study: deprived of food overnight prior administration.
- Housing:Housed in cage (1 cm x 46 cm x 19 cm) with a stainless steel lid. Maximum 3 animals per cage. Sterilized and dust free sawdust litter.
- Diet : ad libitumexcept the night prior administration and 3-4 hours following administration (granules A04-10).
- Water: ad libitum. Distributed a propylene biberon with a stainless steel teat.
- Acclimation period:at least 5 days before dosing.
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
- 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 for both groups.
- No. of animals per sex per dose:
- 3 rats for both groups (6 in total)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: regularly following administration (immediately, 30 min, 1h, 2h, 3h and 4 h) and at least once a day until the end of the study
- 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
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At the 2000 mg/Kg dose: no deaths were observed.
- Clinical signs:
- other: At the 2000 mg/kg dose, significant symptoms occured: important piloerection and reduced motor activity which persisted 2-3 days after administration of the test item. Colored feces on D1. No organic lesion or tissue injury observed at the autopsy.
Any other information on results incl. tables
Dose = 2000 mg/kg
Clinical observations
Time of observation |
Comments |
Time of observation |
Comments |
D1 (following administration) |
Important piloerection for all animals and reduced motor activity for 2 of them. |
D6 |
Nothing to report |
D1 T30' |
Important piloerection and reduced motor activity for all animals. |
D7 |
Nothing to report |
D1 T1h |
Similar to D1 T30' and blue feces. |
D8 |
Nothing to report |
D1 T2h |
Similar to D1 T30'. |
D9 |
Nothing to report |
D1 T3h |
Similar to D1 T30'. |
D10 |
Nothing to report |
D1 T4h |
Similar to D1 T30'. |
D11 |
Nothing to report |
D2 |
Similar to D1 T30'. |
D12 |
Nothing to report |
D3 |
For 3 animals: similar to D1 T30'. Slight piloerection and reduced motor activity for the other 3. |
D13 |
Nothing to report |
D4 |
Important piloerection and round back for 1 animal. Nothing to report for all other animals. |
D14 |
Nothing to report |
D5 |
Nothing to report |
D15 |
Nothing to report |
Autopsy
Animals N° |
Mortalilty |
Comments |
||
Day |
Cause |
|||
1st Step |
5632 |
D15 |
Euthanasia |
Death by sacrifice |
5633 |
D15 |
Euthanasia |
Death by sacrifice |
|
5634 |
D15 |
Euthanasia |
Death by sacrifice |
|
2d Step |
5635 |
D15 |
Euthanasia |
Death by sacrifice |
5636 |
D15 |
Euthanasia |
Death by sacrifice |
|
5637 |
D15 |
Euthanasia |
Death by sacrifice |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the CLP regulation, the test material Sepisol Fast Blue 2BR has not been classified as acute toxicity with a
LD 50 determined to be above the threshold of 2000 mg/kg bw. - 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 a pre-defined dose of 2000 mg/kg body weight, of test element named SEPISOL FAST BLUE 2BR suspended in corn oil, in 6 females rats, 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 no animals dies.
The results of the assay showed that 6 animals did not die with the 2000 mg/kg dose level.
Significant symptoms occured: important piloerection, reduced motor activity which persisted 2-3 days after administration.
No organic lesion or tissue injury has been observed at the autopsy.
This test provided results allowing the test element not to be classified according to the Classification and Labeling of Products regulation (CLP EC 1272/2008).
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