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EC number: 941-151-0 | CAS number: 1690331-63-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 28 November 2012 to 30 November 2012
- 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 439), 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
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 439 (In-vitro skin irritation)
- Qualifier:
- according to guideline
- Guideline:
- other: EU method B.46 (In vitro skin irritation)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [bis(phenylamino)methylidene]azanium 3-[(1E)-2-[4-(phenylamino)phenyl]diazen-1-yl]benzene-1-sulfonate
- EC Number:
- 941-151-0
- Cas Number:
- 1690331-63-5
- Molecular formula:
- C31H28N6SO3
- IUPAC Name:
- [bis(phenylamino)methylidene]azanium 3-[(1E)-2-[4-(phenylamino)phenyl]diazen-1-yl]benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):Sepisol Fast Yellow MG-DPG
- Substance type: Organic salt
- Physical state: Powder
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: reconstructed epidermis of normal human keratinocytes.
- Details on test animals or test system and environmental conditions:
- TEST SYSTEM
- Source: episkin snc - 4 rue Alexander Fleming - 69366 Lyon CEDEX 07.
- Cell system used: reconstructed epidermis of normal human keratinocytes. Cells are grown on inert polycarbonate filter on chemically defined medium, arilifted for 17 days.
- RhE model : SkinEthic RHE/S/17
- Lot/Batch No.: 12 022A 1103
Test system
- Type of coverage:
- open
- Preparation of test site:
- other:
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable
- Amount / concentration applied:
- 16 mg applied as such to the epidermal surface
- Duration of treatment / exposure:
- not applicable
- Observation period:
- not applicable
- Number of animals:
- not applicable
- Details on study design:
- I- TEST SYSTEM
Units of 0.50 cm² reconstituted epidermis (SkinEthic) were received on the day before the experiment. The insert (filter + epidermis) was gently removed from the agarose while avoiding leaving agarose on the polycarbonate filter.
II- CHECK OF THE COMPATIBILITY OF THE TEST ITEM (direct MTT reduction, coloring potential, ability to stain tissues) WITH MTT SOLUTION
Prior to experiment, 16 mg of the test item was put in contact with 300 µL of MTT solution (1 mg/mL). After a 3 hrs incubation period at 37°C, 5% CO2, no blue or purple coloration was noted.
Therefore, there is no direct interaction between the test item and MTT.
III- APPLICATION OF THE TEST AND CONTROL CHEMICALS
* For all steps of the protocol, one 24 wells plate (3 columns of 4 wells) was used for each item (the test item, the negative control and the positive control).
* The insert were placed in a 24 wells culture plated which has been previously filled with 300 µL of maintenance medium (Batch No. 12 011J-M 037).
* 3 units of reconstructed human epidermis were used for the test item, the negative and positive controls.
* For the test item: 16 mg was applied as such to the epidermal surface of the models. For the positive control: XXX µL of 5% SDS (CAS N° 151-21-3, Sigma Batch N° BCBF8969V) were applied to uniformly cover the epidermis surface. For the negative control: XXXX µL of PBS (Pan Biotech GmbH – Batch N° 2020312) were applied to uniformly cover the epidermis surface.
* At the end of an exposure period of 42 min at room temperature, the human epidermis was washed with25 x 1 mL of PSB (PAN BIOTECH GmbH, Batch n° 2020312) except for the three epidermises treated with the test item wich were rinces with 35 x 1 mL of PBS. Even after this rinse, there was remaining test item on the surface of the three epidermises.
* Rinsed epidermis were incubated in fresh medium for a 42 hours 10 min post-treatment incubation period at 37°C, 5% CO2.
* Then, the epidermis were put in contact with the MTT solution.
IV-CELL VIABILITY MEASUREMENTS
* After the 42h10min incubation period, the cell viability was quantified by measurement of the cell succinate dehydrogenase activity. The skin sample was placed in 300 µL of a MTT solution of 1 mg/mL concentration for 3 hours at 37°C, 5% CO2. The precipitated blue formazan product is then extracted using isopropanol during 2 hours under agitation in the dark, and the concentration of formazan was measured by determining the Optical Density (OD) at 570 nm, just after dilution of the extractions in isopropanol (1:2).
The absorbance was measured in triplicate of MTT extract.
The optical density was performed usgin the ELx800 absorbance microplate reader and the validated software Gen5ELISA V1.05.11
V- INTERPRETATION OF RESULTS
* The results were expressed as a viability percentage compared with the negative control :
Viability %= [OD (test item)/OD (negative control)] ×100
The optical density (OD) values obtained for each test sample were used to calculate a percentage of viability relative to the negative control, which was arbitrarily set at 100%.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: cell viability percentage
- Value:
- ca. 86.3
- Remarks on result:
- other:
- Remarks:
- Basis: mean. (migrated information)
Any other information on results incl. tables
|
Skin |
OD |
Mean OD/disc (Mean of the 3 OD measurements) |
Mean OD/ product |
Viability % |
Mean Viability % |
SD |
Conclusion |
Negative Control |
1 |
1.041 1.100 1.138 |
1.093 |
1.031* |
106.0 |
100.0 |
5.9 |
|
2 |
0.961 1.039 1.092 |
1.030 |
99.9 |
|||||
3 |
0.908 0.976 1.029 |
0.971 |
94.1 |
|||||
Positive Control |
4 |
0.012 0.014 0.013 |
0.013 |
0.013 |
1.3 |
1.2 |
0.1 |
Irritant |
5 |
0.011 0.013 0.012 |
0.012 |
1.2 |
|||||
6 |
0.013 0.012 0.014 |
0.013 |
1.3 |
|||||
Test Item |
7 |
0.216 0.243 0.250 |
0.236 – Aberrant values |
|
|
|
|
|
8 |
0.763 0.761 0826 |
0.783 |
0.890 |
76.0 |
86.3* |
14.6* |
Non irritant |
|
9 |
0.918 1.030 1.040 |
0.996 |
96.6 |
* The result is based on two tissues replicates (n° 8 and 9) instead of three as initially scheduled in the study plan. The rinsing of the epidermises in view to eliminate the test item after treatment was difficult and required more rinsing with PBS than usually. The first treated epidermis was compromised during this rinsing step and was not taken into account for the classification of the test item.
Negative control and positive control are in the expected range
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results obtained under these experimental conditions, enable to conclude that the test item must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is required.
In accordance with the Regulation EC No. 1272/2008, the test item must not be classified. No signal word or hazard statement is required. - Executive summary:
The aim of the study was to evaluate the possible irritating effects of SEPISOL FAST YELLOW MG-DPG after topical administration on in vitro human reconstructed epidermis (RHE® model). The test item SEPISOL FAST YELLOW MG-DPG was applied, as supplied, at the dose of 16 mg, to 3 Reconstructed Human epidermis small during 42 minutes, followed by a 42 hours postincubation period at 37°C, 5% C02.
The elimination of the test item on the epidermis after treatment was difficult. Even after a rinse with 35 mL of PBS, there was remaining test item. The first epidermis was compromised during rinsing and was not taken into account for the classification of the test item.
The experimental protocol was established in accordance with OECD guideline No. 439 adopted 22 July 2010 and the Test method B.46 of Council regulation No. 761/2009 dated 23 July 2009 (EU Journal L220)-ATP Council regulation No. 4401/2008 of 30 May 2008 (E. U. Journal L142).
The mean viability ofthe epidermis skins was 86.3%, versus 1.2% in the positive control (5% Sodium Dodecyl Sulfate ).
The results obtained, under these experimental conditions, enable to conclude that the test item SEPISOL FAST YELLOW MG-DPG must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol or risk phrase is required.
In accordance with the Regulation EC No. 1272/2008, the test item must not be classified. No signal word or hazard statement is required.
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