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EC number: 700-615-0 | 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2011-12-06 to 2011-12-20
- 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 402), 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:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
Test material
- Reference substance name:
- Bis and tris and tetra (4-{bis[4-(dimethylamino)phenyl]methylene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium) [12,21-dihydro-29H,31H-phthalocyanine-bis and tris and tetrasulfonato-k4N29,N30,N31,N32]cuprate
- EC Number:
- 700-615-0
- Molecular formula:
- BIS: C82H74N14CuS2O6 TRIS: C107H103N17CuS3O9 TETRA: C132H132N20CuS4O12
- IUPAC Name:
- Bis and tris and tetra (4-{bis[4-(dimethylamino)phenyl]methylene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium) [12,21-dihydro-29H,31H-phthalocyanine-bis and tris and tetrasulfonato-k4N29,N30,N31,N32]cuprate
- Details on test material:
- - Name of test material (as cited in study report): Sepisol Fast Violet 3B
- Substance type: Organocopper salt - UVCB substance
- Physical state: Dark purple to black powder.
- Lot/batch No.:028942
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle - FRANCE)
- Age at study initiation: MALE: 8 weeks old. FEMALE: 9 weeks old
- Weight at study initiation: MALE : from 261 g to 290 g. FEMALE: from 220 g to 245 g
- Housing: During the treatment, the animals were kept in individual cages. On D1, the animals were put into their cage by 5, in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet (e.g. ad libitum): ad libitum (foodstuff: M20-SDS)
- Water (e.g. ad libitum): ad libitum (tap water from public distribution system)
- Acclimation period: of at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 25°C
- Humidity (%): 30% to 70%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 dark/12 light
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: dimethylsulfoxide
- Details on dermal exposure:
- TEST SITE
- Area of exposure:dorsal area of the trunk
- % coverage: at least 10% of the body surface cleared for the application of the test item
- Type of wrap if used: porous gauze dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing with dimethylsulfoxide
- Time after start of exposure: After 24 hours exposure period
TEST MATERIAL and VEHICULE:
- Concentration: 4g or 2g of the test item was weighed and dimethylsulfoxide was added in a 20 mL or 10 mL volumetric flask, respectively. The preparation was magnetically stirred to abtain a blue solution just before administration.
-Administration: The preparation was administered under a volume of 10 mL/kg body weight - Duration of exposure:
- Exposure period of 24 hours
- Doses:
- Group 1: 2000 mg/kg
Group 2: 2000 mg/kg - No. of animals per sex per dose:
- Group 1: 5 male rats
Group 2: 5 female rats - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily examination (spontaneous activity, preyer's reflex, respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance). Weighing on days D0 (before administration of th test item), D2, D7 and D14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Macroscopic examinations at the end of the study (after anaesthesia) with the examination of organs likely to be modified in cases of acute toxicity (oesophagus, stomach, the entire digestiv tract, spleen, liver, thymus, trachea, lungs, heart, kidneyx, urinary bladder, testicules, skin of the treatment area, adrenals, pancreas).
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured during the study
- Clinical signs:
- other: T0 + 1h, 3h and 5hours: Decreased of spontaneous activity in all treated animals in both groups. D1 to D14: Blue coloration of the treatment site in all treated animals in both groups. D3 to D7: Erythema and dryness at the treatment site in all treated
- Gross pathology:
- No gross pathology or changes was observed.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the test item Sepisol Fast Violet 3B is higher than 2000 mg/kg body weight by dermal route in the rat in both sex.
According to the criteria for the classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C directives 67/548, 2001/59 and 99/45, the test item Sepisol Fast Violet 3B must not be classified. No symbol or risk phrase is required.
In accordance with the Regulation EC n°1272/2008, the test item must not be classified. No signal word or hazard statement is required. - Executive summary:
The test item Sepisol Fast Violet 3B was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline n° 402 dated February 24th, 1987 and the test method B.3. of the Council regulation n°440/2008 of 30 May 2008.
No mortality occured during the study.
A decrease in spontaneous activity was noted in all treated animals (10/10) on day 0. From day 1, no systemic clinical sign related to the administration of the test item was observed. From day 1 to day 14, a blue coloration of the treatment site was noted in all treated animals. Erythema and dryness were noted in all animals from day 3 to day 7.
A decrease in body weight was noted in treated females at 48 hours post-dose, with a mean of -12 % compared to day 0. Then the body weight evolution was normal, comparable with the body weight evolution noted in the historical control group.
The body weight evolution of the males remained normal throughout the study.
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50 of the test item Sepisol Fast Violet 3B is higher than 2000 mg/kg body weight by dermal route in the rat in both sex.
According to the criteria for the classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C directives 67/548, 2001/59 and 99/45, the test item Sepisol Fast Violet 3B must not be classified. No symbol or risk phrase is required.
In accordance with the Regulation EC n°1272/2008, the test item must not be classified. No signal word or hazard statement is required.
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