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EC number: 200-453-6 | CAS number: 60-09-3
- 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 / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted in compliance with GLP regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF AG, Department of Experimental Toxicology and Ecology
Test material
- Reference substance name:
- 4-aminoazobenzene
- EC Number:
- 200-453-6
- EC Name:
- 4-aminoazobenzene
- Cas Number:
- 60-09-3
- Molecular formula:
- C12H11N3
- IUPAC Name:
- 4-[(E)-2-phenyldiazen-1-yl]aniline
- Details on test material:
- - Name of test material (as cited in study report): 4-Aminoazobenzol
- Analytical purity: 97% (analytical report No.: 07L00179)
- Test-substance No.: 07/0429-1
Constituent 1
Test animals
- Species:
- other: EpiDerm™
- Strain:
- other: in vitro: Human Skin Model Test
- Details on test animals or test system and environmental conditions:
- - Tissue model: Epi-200
- Source: MatTek Corporation, Ashland MA, USA
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: On day of receipt EpiDerm tissues were kept in the refrigerator. At least 1 hour but not more than 1.5 hours before test-substance application, tissues were transferred to 6-well plates with 0.9 mL assay medium and preconditioned in the incubator at 37°C.
- Vehicle:
- other: doubly distilled water
- Controls:
- other: Control tissues were concurrently applied with 50 μL of doubly distilled water (negative control, NC) and with 50 μL of 8 n potassium hydroxide (positive control, PC) respectively.
- Amount / concentration applied:
- 25 μL (about 18 mg)
- Duration of treatment / exposure:
- 3 minutes at room temperature and 1 hour in the incubator
- Observation period:
- after 3 minutes and after 1 hour
- Number of animals:
- two pieces of tissue
- Details on study design:
- HUMAN EPIDERMIS MODEL:
The EpiDerm model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multi layered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm Ø).
EXPERIMENTAL PROCEDURE:
On day of receipt EpiDerm tissues were kept in the refrigerator. At least 1 hour but not more than 1.5 hours before test-substance application, tissues were transferred to 6-well plates with 0.9 mL assay medium and preconditioned in the incubator at 37°C. The preincubation medium was replaced with fresh medium immediately before application.
Two tissues per exposure time (3 minutes at room temperature and 1 hour in the incubator) and test group (test material, negative control and positive control) were used.
A bulk volume of 25 μL of the test material was applied with a sharp spoon. Thereafter 25 μL doubly distilled water were added and homogeneously distributed together with the test substance.
Control tissues were concurrently applied with 50 μL of doubly distilled water (negative control, NC) and with 50 μL of 8 n potassium hydroxide (positive control, PC) respectively.
The tissues were washed with PBS to remove residual test material 3 minutes and 1 hour, respectively, after start of treatment. Rinsed tissues were kept in 24-well plates (holding plates) at room temperature on assay medium until all tissues per application time are dosed and rinsed. The assay medium was then replaced by MTT solution and tissues were incubated for 3 hours. After incubation, tissues were washed again with PBS and the formazan produced by the tissues was extracted with Isopropanol over night at room temperature. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 3 microtiter wells filled with Isopropanol for each microtiter plate.
EVALUATINON OF RESULTS:
Corrosivity potential of the test materials is predicted from the mean relative tissue viabilities obtained after 3 min treatment compared to the negative control tissues concurrently treated with doubly distilled water. A chemical is considered as "corrosive", if the mean relative tissue viability after 3 min treatment with a test material is decreased below 50%. In addition, those materials with a viability of ≥ 50% after 3 min treatment are considered as "corrosive" if the mean relative tissue viability after 1 hour treatment with a test material is decreased below 15%.
Results and discussion
Any other information on results incl. tables
Exposure time |
Test article |
Optical density at 570nm (mean) |
Viability [% of negative control] |
3 minutes |
Negative control |
1.671 |
100 |
4-Aminoazobenzol |
1.764 |
106 |
|
Positive control |
0.233 |
14 |
|
1 hour |
Negative control |
1.662 |
100 |
4-Aminoazobenzol |
1.818 |
109 |
|
Positive control |
0.258 |
15 |
Based on the observed results and applying the evaluation criteria it was concluded, that 4-Aminoazobenzol, CAS 60-09-3 does not show a corrosive potential in the EpiDerm skin corrosivity test under the test conditions chosen.
Applicant's summary and conclusion
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