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tetrakis[({bis[4-(dimethylamino)phenyl] and 4-(methylamino)phenyl} or {4-(dimethylamino)phenyl and bis[4-(methylamino)phenyl]} or {tris[4-(dimethylamino)phenyl]}methylium)]C12-(branched and/or linear)-alkyl-(4-sulfonatophenoxy)benzenesulfonate and oxybis[C12-(branched and/or linear)-alkyl-benzenesulfonate].
EC number: 700-759-4 | 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 2008/03/18 to 2008/04/03
- 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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- bis(bis[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylium) bis(tris[4-(dimethylamino)phenyl]methylium) 3-(dodecan-3-yl)-4-(2-dodecyl-4-sulfonatophenoxy)benzene-1-sulfonate 3-dodecyl-4-(4-sulfonatophenoxy)benzene-1-sulfonate
- EC Number:
- 700-759-4
- Molecular formula:
- not applicable
- IUPAC Name:
- bis(bis[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylium) bis(tris[4-(dimethylamino)phenyl]methylium) 3-(dodecan-3-yl)-4-(2-dodecyl-4-sulfonatophenoxy)benzene-1-sulfonate 3-dodecyl-4-(4-sulfonatophenoxy)benzene-1-sulfonate
- Details on test material:
- - Name of test material : Sepisol Fast Violet 881239
- Substance type: Organic salt - UVCB
- Physical state/ appearance: violet powder
- Lot/batch No.: 601204
- Storage condition of test material: ambient temperature, in the dark
Constituent 1
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): 223.9 gram +/- 6.3
- Fasting period before study: deprived of food overnight prior administration.
- Housing:Housed in polypropylene cage (31 cm x 46 cm x 19 cm) with a stainless steel lid. 3 animals per cage. Sterilized and dust free sawdust litter.
- Diet : ad libitumexcept the night prior administration and 3-4 hours following administration (sterilized granules A04-10).
- Water: ad libitum. Distributed by a polypropylene 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 dark/12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg of test item in corn oil. Administration volume of 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. : Cooper - lot 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 just before administration, D4, D8, D15
- Necropsy of survivors performed: yes
- Other examinations performed:
* Body weight
* Clinical signs (spontaneous activity, Preyer's reflex, respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, mydriasis, salivation, lachrymation, righting reflex, piloerection, grip strength, diarrhea, lethargy, coma, skin, fur and eyes changes, mortality)
* Autopsy
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 for both groups.
- Clinical signs:
- other: At the 2000 mg/kg dose, symptoms occured: important piloerection and reduced motor activity which persisted maximum 24 hrs after administration of the test item. Colored feces on D1 for all 6 animals until D3 for 3/6 animals. No organic lesion or tissue
- Gross pathology:
- Nothing to report
Any other information on results incl. tables
Dose = 2000 mg/kg
Clinical observations
Time of observation |
Comments |
D1 (following administration) |
Important piloerection for all animals. |
D1 T30' |
Important piloerection and reduced motor activity for all animals. Violet feces for 3/6 animals |
D1 T1h |
Important piloerection, reduced motor activity and violet feces for all animals |
D1 T2h |
Important piloerection, reduced motor activity and violet feces for all animals |
D1 T3h |
Important piloerection, reduced motor activity and violet feces for all animals |
D1 T4h |
Important piloerection, reduced motor activity and violet feces for all animals |
D2 |
Animals 5644 to 5646: important piloerection, reduced motor activity and violet feces. Animals 5647 to 5649: Blue feces. |
D3 |
Animals 5644 to 5646: blue feces. Animals 5647 to 5649: Nothing to report. |
D4 |
Nothing to report |
D5 to D15 |
Nothing to report |
Autopsy
Animals N° |
Mortalilty |
Comments |
||
Day |
Cause |
|||
1stStep |
5644 |
D15 |
Euthanasia |
Nothing to report |
5645 |
D15 |
Euthanasia |
Nothing to report |
|
5646 |
D15 |
Euthanasia |
Nothing to report |
|
2dStep |
5647 |
D15 |
Euthanasia |
Nothing to report |
5648 |
D15 |
Euthanasia |
Nothing to report |
|
5649 |
D15 |
Euthanasia |
Nothing to report |
Body Weight evolution
Animals N° |
Weight (g) |
|||||
D1 |
D4 |
D8 |
D15 |
D15-D1 |
||
1stStep |
5644 |
219.4 |
245.6 |
258.4 |
278.7 |
59.3 |
5645 |
217.2 |
246.7 |
274.1 |
304.3 |
87.1 |
|
5646 |
230.5 |
242.9 |
274.7 |
290.4 |
59.9 |
|
2dStep |
5647 |
218.1 |
247.0 |
279.3 |
323.8 |
105.7 |
5648 |
228.2 |
253.3 |
261.3 |
278.8 |
50.6 |
|
5649 |
230.1 |
249.2 |
265.3 |
283.1 |
53.0 |
|
Mean (standard deviation) |
223.9 6.3 |
247.5 3.5 |
268.9 8.4 |
293.2 17.8 |
69.3 22.1 |
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 Violet 881239 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 a test element named SEPISOL FAST VIOLET 881239 suspended in corn oil, in 6 females rats, using a stepwise procedure. The experimental protocol was established according to the official method as defined in the OECD guideline No. 423 dated December 17th, 2001.
The animals were daily observed for at least 14 days after administration. Clinical signs and signs of toxicity were noted.
The first step of the assay was performed with a 2000 mg/kg dose after which no animals dies. So, the second step of the assay was also performed with a 2000 mg/kg dose, after which no animals dies.
Important piloerection, reduced motor activity which persisted 24 hrs after administration were observed
No organic lesion or tissue injury has been observed at the autopsy.
In conclusion, the LD50 of the test item Sepisol Fast Violet 881239 is higher than 2000 mg/kg body weight by oral route in rats.
In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in rats.
According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the EEC directive 67/548, 2001/59 and 99/45, the test item Sepisol Fast Violet 881239 must not be classified. No symbol or risk phrase is required.
In accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures, the test item must not be classsified. No signal word or hazard statement is required.
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