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EC number: 700-761-5 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The reliability is rated 2 because this is the result of a read-across from an analogue of the same category of substance, namely the organic dyes synthetized from a cationic and an anionic dyes. The reliability of the crossed-reference substance’s results is rated 1 because the study is equivalent of the standard guideline OECD 437. The results were reviewed and assessed as valid, and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 437
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sepisol Fast Violet 3B
- IUPAC Name:
- Sepisol Fast Violet 3B
- 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
- 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
- Reference substance name:
- 700-615-0
- EC Number:
- 700-615-0
- IUPAC Name:
- 700-615-0
- Details on test material:
- - Name of test material (as cited in study report): Sepisol Fast Violet 3B
- Substance type: Organocopper
- Physical state: Dark violet Powder
- Lot/batch No.: 028942
- Stability under test conditions: Stable
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Constituent 3
Test animals / tissue source
- Species:
- other: isolated corneas from the eyes of freshly slaughtered cattle
- Details on test animals or tissues and environmental conditions:
- TEST EYES
- Source: Slaughterhouses Sobeval Boulazac 24759 - France
- Age of the donors animals: less than 8 month
- Transport of eyes: Balanced salt solution
- Time between collection and use of corneas:The corneas were transported to the laboratory straight after removal on animals and used in a maximum delay of 24 hours after reception at the laboratory.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 750 mg+/-75 mg
- Duration of treatment / exposure:
- 30 min and 10 min.
- Number of animals or in vitro replicates:
- 3 eyes for the negative control corneas and 3 eyes for the treatment group for each contact times (30 et 10 minutes).
- Details on study design:
- Selection of corneas free of defects.
They were dissected with a 2 to 3 mm rim of sclera to assist in subsequent handling, with care taken to avoid damage to the corneal epithelium and endothelium. Isolated corneas were mounted on a corneal holder which was composed of an anterior and a posterior compartment which interfaced with the epithelial and endothelial sides of the cornea, respectively.
Both compartments were filled with a nutritious medium.
After a preincubation period (at 32 +/-1°C for at least one hour in a water bath), the baseline opacity of each cornea was determined.
Then the posterior compartment was filled with the nutrious medium. In the anterior compartment, 750 mg +/- 75 mg of the substance test was applied by direct application onto the corneal surface, in order to cover the entire corneal surface. For the negative control, the anterior compartment was filled with 750 µL of the nutrious medium.
Corneal holders were incubated in a water bath (32°C) for 30 (first assay) or 10 min (second assay).
After exposure period, the test substance is removed from the anterior chamber (a cotton bud was necessary to remove the test item in excess) and epithelium was washed at least three times. The anterior compartment was refilled with the nutrient medium and corneas were incubated for an additional two hours at 32 +/-1°C in a wash bath.
The opacity and permeability of each cornea were recorded:
- The opacitometer was calibrated before each readings: one before the application of the test item and a second one two hours after the end of exposure.
- The permeability was determined after the second reading of opacity by optical density (VISIONLite 2.2 v software). 1 ml of fluorescein solution was added to the anterior compartment and the holder was then incubated in a horizontal position for 90 +/-5 min at 32 +/-1°C.
At the end of the study, each cornea was visually checked and observations were recorded.
The in vitro irritancy score (IVIS) for each treatment group was calculated as follows:
IVIS= mean corrected opacity value + (15 x mean corrected permeability optical density)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: In vitro Irritancy Score (IVIS)
- Basis:
- mean
- Time point:
- other: 30 min contact time
- Score:
- 11.2
- Irritation parameter:
- other: In vitro Irritancy Score (IVIS)
- Basis:
- mean
- Time point:
- other: 10 min contact time
- Score:
- 0.9
- Irritant / corrosive response data:
- According to the rating scale, Sepisol Fast Violet 3B tested as such by direct application was found to be moderately irritant.
Nonetheless, corneas from the treatment group were colored in blue after 30 min of contact. Since opacity can be due to the corneal blue coloration and not due to a real corneal opacity, the result in uncertain. - Other effects:
- After a contact of 30 min with the test item, the cornea was colored in blue with an epithelial detachment.
Any other information on results incl. tables
Opacitometer calibration
|
30 min contact time |
10 min contact time |
|||
Opacity before Treatment (OPT 0) |
Calibrator 1 |
-75 |
75 |
-75 |
75 |
Calibrator 2 |
-153 |
150 |
-153 |
151 |
|
Calibrator 3 |
-230 |
225 |
-230 |
227 |
|
Opacity 2h after Rinsing (OPT 2) |
Calibrator 1 |
-74 |
75 |
-76 |
75 |
Calibrator 2 |
-152 |
152 |
-153 |
152 |
|
Calibrator 3 |
-229 |
227 |
-235 |
229 |
OPT 0: Opacity 0 before treatment
OPT 2: Opacity 2h after rinsing
cOPT: corrected Opacity
cOD: corrected Optical Density
In vitroIrritancy Score (IVIS)
|
|
30 min contact time |
|
|||||
|
|
OPACITY |
PERMEABILITY |
|
||||
Holder N° |
Treatment |
OPT 0 |
OPT 2 |
OPT 0-OPT 2 |
cOPT |
OD |
cOD |
IVSI |
15 |
Negative control |
0 |
0 |
0 |
0.019 |
0.019 |
0.3 |
|
2 |
2 |
2 |
0 |
0.029 |
0.029 |
0.4 |
||
12 |
1 |
0 |
-1 |
0.029 |
0.029 |
0.4 |
||
MOYENNE (écart-type) |
-0.3 (0.6) |
0.026 (0.006) |
0.4 (0.1) |
|||||
13 |
Sepisol Fast Violet 3B |
5 |
12 |
7 |
7.3 |
0.168 |
0.142 |
9.5 |
8 |
0 |
11 |
11 |
11.3 |
0.081 |
0.055 |
12.2 |
|
56 |
1 |
10 |
9 |
9.3 |
0.201 |
0.175 |
12.0 |
|
MOYENNE (écart-type) |
9.3 (2.0) |
0.124 (0.062) |
11.2 (1.5) |
Control OD (fluorescein solution at 5 µg/ml) = 0.863
|
|
10 min contact time |
|
|||||
|
|
OPACITY |
PERMEABILITY |
|
||||
Holder N° |
Treatment |
OPT 0 |
OPT 2 |
OPT 0-OPT 2 |
cOPT |
OD |
cOD |
IVSI |
3 |
Negative control |
0 |
2 |
2 |
0.022 |
0.022 |
0.3 |
|
14 |
0 |
0 |
0 |
0.019 |
0.019 |
0.3 |
||
44 |
-1 |
1 |
2 |
0.013 |
0.013 |
0.2 |
||
MOYENNE (écart-type) |
1.3 (1.2) |
0.018 (0.005) |
0.3 (0.1) |
|||||
48 |
Sepisol Fast Violet 3B |
2 |
2 |
0 |
-1.3 |
0.080 |
0.062 |
-0.4 |
1 |
0 |
3 |
3 |
1.7 |
0.109 |
0.091 |
3.0 |
|
2 |
0 |
1 |
1 |
-0.3 |
0.049 |
0.031 |
0.1 |
|
MOYENNE (écart-type) |
0.0 (1.5) |
0.061 (0.030) |
0.9 (1.8) |
Control OD (fluorescein solution at 5 µg/ml) = 0.871
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Gautheron0 P. et al - Fundam. Appl. Toxicol., 1992, 18, 442-449.
- Conclusions:
- The test item is considered moderately irritating with uncertainty.
- Executive summary:
The aim of the study was to assess quantitatively the irritant potential of Sepisol Fast Violet 3B after the application to the isolated calf cornea. The assessment was based on the measurement of two parameters: the opacity and permeability of the cornea whose deteriorations reflected the damage of the tissue. The test element was let in contact with the isolated cornea for 30 minutes (first assay) and 10 minutes (second assay).
On the basis of the results obtained for each time of contact, a corneal score was calculated and the test element classified moderately irritant. However, corneas from the treatment group were colored in blue after 30 min of contact. Since opacity can be due to the corneal blue coloration and not due to a real corneal opacity, the result is uncertain. Furthermore, the laboratory doesn't have any recoil on this category of substances (i.e. organic dye) and no comparison with an appropriate database was performed. So the accuracy of BCOP and its applicability domain for this category of substance cannot be assessed and the results are uncertain.
Those identified limitations for the BCOP assay (i.e. coloration of the test material and uncertainty of the applicability) can be extrapolated to the other in vitro tests method (validated or not), since (1) their current validation database did not allow an adequate evaluation of organic dyes class and (2) the coloring property of the dye is most likely to interfere with the implementation of the test protocols and/or the interpretation of the results. Therefore, the realization of an in vitro assay, to test the eye irritancy potency of the Sepisol Fast Red SN is not technically feasible.
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