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EC number: 275-602-1 | CAS number: 71550-21-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Principles of method if other than guideline:
- The study was performed for the assessment of the skin irritancy of the test item Bayscript Yell ow GGN with reconstructed human epidermis (RhE). The experiment was carried out in vitro using the commercially available test method epiCS®.
- GLP compliance:
- yes
Test material
- Reference substance name:
- m,m'-[carbonylbis[imino(3-methoxy-p-phenylene)azo]]bis(benzenesulphonic) acid, compound with 2,2'-iminodiethanol (1:2)
- EC Number:
- 275-602-1
- EC Name:
- m,m'-[carbonylbis[imino(3-methoxy-p-phenylene)azo]]bis(benzenesulphonic) acid, compound with 2,2'-iminodiethanol (1:2)
- Cas Number:
- 71550-21-5
- Molecular formula:
- C27H24N6O9S2.2C4H11NO2
- IUPAC Name:
- m,m'-[carbonylbis[imino(3-methoxy-p-phenylene)azo]]bis(benzenesulphonic) acid, compound with 2,2'-iminodiethanol (1:2)
- Details on test material:
- Test item: Bayscript Gelb GGN
Test item identity (including alternative names): Bayscript Gelb GGN Benzenesulfonic acid, 3,3’-(carbonylbis(imino(3-methoxy- 4,1-phenylene)-2,1-diazenediyl))bis-, compd. with 2,2’-iminobis(ethanol) (1:2)
CAS Number: 71550-21-5
Appearance: Russet colored crystaline solid
Constituent 1
- Specific details on test material used for the study:
- Test item: Bayscript Yellow GGN
Chemical name: Benzenesulfonic acid, 3,3' -( carbonylbis(imino(3-methoxy-4, 1-
phenylene)-2, 1-diazenediyl)bis-, compd. with 2,2'iminobis(ethanol) (1 :2)
CAS number: 71550-21-5
Molecular mass: 850,9 g/mol
pH-value, diluted 1:9 in water: 4.6
Content: 89.6%
Appearance: solid, crystalline, russet
In vitro test system
- Test system:
- human skin model
- Source species:
- other: artificial 3D-Skin model
- Cell type:
- other: artificial 3D-Skin model (reconstructed human epidermis)
- Cell source:
- other: reconstructed human epidermis model epiCS® (CellSystems, Troisdorf, Germany)
- Source strain:
- other: artificial 3D-Skin model
- Details on animal used as source of test system:
- not applicable: artificial 3D-Skin model
- Justification for test system used:
- The model used for this study has a functional stratum corneum with an underlying layer of living cells as recommended by the test guidelines (e.g. OECD Test guideline 439).
- Vehicle:
- other: Test item was used undiluted.
- Details on test system:
- Test System/ Study Design
The model used for this study has a functional stratum corneum with an underlying layer of living cells as recommended by the test guidelines. The barrier function of the stratum corneum is adequate, as has been shown by the supplier.
The viability of the living cells in the model must be sufficiently high to discriminate well between the positive and negative control substances. Cell viability is measured by the amount of MTT reduction, i.e. an OD value, following exposure to the negative control substance or the test item.
Methods and Parameters
Reconstructed tissues
The experiment was carried out on the reconstructed human epidermis model epiCS® (CellSystems, Troisdorf, Germany). The tissue equivalents were shipped in 24 well cell culture plates on agarose supplemented with maintenance medium (Kit contents epiCS® CellSystems, Cat.-No.CS-1001). Inserts were of 0.6 cm² size.
Adaptation to cell culture conditions
Inserts with epiCS® reconstructed human epidermis (0.6 cm2) were packed under sterile conditions and were shipped refrigerated on supplemented agarose. Upon arrival, 6 well culture plates were pre-filled with 1 ml of fresh and cool maintenance medium. The reconstructed tissues were placed into the prepared cell culture plates (1 insert/well) and were adapted to the recommended tissue culture conditions (5% C02, 37°C, max humidity) afterwards for at least 6 hours before use.
4.4.3 Environmental conditions
The environmental conditions in the incubator were standardized as follows:
Incubator temperature 37 +/- 2°C
CO2 gas concentration 5%
Humidity maximum
Occasional deviations from these conditions occurred e.g. as a result of opening the incubators door. However, these deviations had no effect on the course or outcome of the study. All Incubation steps were performed in a CO2 atmosphere incubator.
Test item formulation
Test item was used undiluted.
Application of the test item and incubation
The epiCS® inserts were exposed to 30 mg of the test item (plus 30 J.tl 0.9% NaCl to moisten and ensure good contact with the epidermis surface) for 20 min. (RT, three inserts). 0.9% NaCl and 5% SDS (each 30 J.tl) treated epidermal models were used as negative and positive controls, respectively (determination in triplicates). A piece of mesh was used as a spreading aid for the test item.
Determination of cell viability (MTT assay)
After the exposure to the test item the inserts were washed carefully in PBS. After a post - treatment incubation period of 42 h of the rinsed tissue in the incubator a MTT assay was performed. For viability testing the inserts were placed in new 24 well plates containing 300 µl ofMTT solution (37°C, 1 mg/ml in MTT-assay medium, delivered by Cell Systems®). The tissues were incubated for about 3 hours under cell culture conditions (5% CO2, 37°C, max humidity). The extraction of blue formazan was performed in isopropanol (24 well plates, 2 ml per insert) on a vertical shaker (2 hours). The concentration of formazan was measured by determining the OD of the isopropanol-extracts in duplicates at 570 nm in an automatic reader.
The MTT reduction assay is the most frequently used assay for the determination of cell viability. The assay depends on the intracellular capacity ofliving cells to chemically reduce the yellow 3- [4,5-Dimethythiazol-2-yl]-2,5-diphenyl tetrazolium bromide (MTT) to blue formazan crystals. The test has shown to give accurate and reproducible results in various laboratories and has practically been modified for accurate analysis of cell viability in three dimensional skin models. - Control samples:
- other: Negative control: NaCl 0.9%, Positive control: 5% SDS solution
- Amount/concentration applied:
- The epiCS® inserts were exposed to 30 mg of the test item (plus 30 µl 0.9% NaCl to moisten and ensure good contact with the epidermis surface) for 20 min. (RT, three inserts).
- Duration of treatment / exposure:
- The epiCS® inserts were exposed to 30 mg of the test item (plus 30 µl 0.9% NaCl to moisten and ensure good contact with the epidermis surface) for 20 min. (RT, three inserts).
- Duration of post-treatment incubation (if applicable):
- After the exposure to the test item the inserts were washed carefully in PBS. After a post - treatment incubation period of 42 h of the rinsed tissue in the incubator a MTT assay was performed. For viability testing the inserts were placed in new 24 well plates containing 300 µl ofMTT solution (37°C, 1 mg/ml in MTT-assay medium, delivered by Cell Systems®). The tissues were incubated for about 3 hours under cell culture conditions (5% CO2, 37°C, max humidity).
- Number of replicates:
- 3 replicates.
Test animals
- Species:
- other: not applicable: artificial 3D-Skin model
- Strain:
- other: not applicable: artificial 3D-Skin model
Test system
- Type of coverage:
- other: not applicable: artificial 3D-Skin model
- Preparation of test site:
- other: not applicable: artificial 3D-Skin model
- Vehicle:
- other: not applicable: artificial 3D-Skin model
- Amount / concentration applied:
- not applicable: artificial 3D-Skin model
- Duration of treatment / exposure:
- not applicable: artificial 3D-Skin model
- Observation period:
- not applicable: artificial 3D-Skin model
- Number of animals:
- not applicable: artificial 3D-Skin model
- Details on study design:
- not applicable: artificial 3D-Skin model
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Bayscript Yellow GGN
- Value:
- 97.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- All acceptance criteria were met.
The test item Bayscript Yellow GGN did not show a significant impact on cell viability and is thus identified as non-irritant substance in this test model.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item Bayscript Yellow GGN did not show a significant impact on cell viability and is thus identified as non-irritant substance in this test model.
- Executive summary:
The skin irritancy of the test item Bayscript Yellow GGN was assessed with reconstructed human epidermis (RhE). The experiment was carried out in vitro using the commercially available test method epiCS®.
The study was conducted in accordance with OECD TG 439 and EU Test Method B.46. The test item was applied undiluted topically to the RhE tissue construct in triplicates and incubated for 20 minutes, followed by a 42 hours post-treatment incubation period.
Cell viability was measured in a photometer by the amount ofMTT (methylthiazole tetrazolium) reduction. The optical density value obtained for the test item was used to calculate the percentage of viability relative to the negative control, which is set at 100%
The results of the concurrent negative control (NC, 0.9% NaCl) and positive control (PC, 5% SDS) demonstrated the viability (NC) and sensitivity (PC) of the test model.
The following value of cell viability was recorded for the test item: 97 % (rounded).
In conclusion the results of the assay used show no skin irritant properties of the test item Bayscript Yell ow GGN and thus, the test item requires no classification according to UN GHS (Category 2 or Category 1).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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