Registration Dossier
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EC number: 204-445-3 | CAS number: 121-03-9
- 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
- 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:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report Date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to
- Guideline:
- other: OECD 431
- Principles of method if other than guideline:
- EpiDerm-Test
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): 4-Nitrotoluene-2-sulphonic acid
- Analytical purity: 84.2 %
- Lot/batch No.: 090330
Test animals
- Species:
- other: in vitro test
- Strain:
- other: in vitro test
Test system
- Type of coverage:
- other: in vitro test
- Preparation of test site:
- other: in vitro test
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):25 µl of the solid test substance - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Details on study design:
- The EpiDermTM 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 EpiDermTM tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm Ø) and commercially available as kits (EpiDerm™ 200), containing 24 tissues on shipping agarose.
TEST PROCEDURE
- For the corrosion test two tissue samples were uses for 3 minutes and 1 hour, the irritaion test was perfomed with tree tissue sampels, which were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period.
- After 3 minutes (room temperature) or after 1 hour (incubator) tissue contact with the test material, the tissues were washed with buffer to remove residual test material. Rinsed tissues were kept in 24-well plates (holding plates) at room temperature on assay medium until all tissues per application time were dosed and rinsed. The assay medium was then replaced by MTT solution and tissues were incubated for 3 hours. After incubation tissues were washed with buffer and formazan was extracted with Isopropanol over night at room temperature. The optical density at a wavelength of 570 nm (OD570) of extracted formazan was determined spectrophotometrically and cell viability was calculated for each tissue as % of the mean of the negative control tissues. Skin corrosivity potential of the test material was classified according to remaining cell viability obtained after test material treatment with either of the 2 exposure times.
CONTROLS
- Negative control (NC): Doubly distilled water
- Positive control (PC): 8 N potassium hydroxyde (Sigma-Aldrich, Munich, Germany)
ASSAY ACCEPTANCE CRITERIA:
- Negative control (NC ): mean OD570 of the NC per exposure time 2.5
- Positive control (PC ): mean relative tissue viability of the 3 min positive control is <= 30 %
- Tissue variability: The inter tissue variability is considered to be acceptable if the difference of the OD570 values of the two tissues is <= 0.3
Results and discussion
In vivo
- Irritant / corrosive response data:
- See result tables. Based on the observed results and applying the evaluation criteria cited, it was concluded, that 4-Nitrotoluene-2-sulphonic acid shows a skin irritation potential in the EpiDerm TM skin corrosion/irritation test under the test conditions chosen.
Any other information on results incl. tables
Corrosion test
|
| Exposure: 3 min | Exposure: 1 hour | ||||
Test Substance |
| Tissue 1 | Tissue 2 | Mean | Tissue 1 | Tissue 2 | mean |
NC | Mean OD570 | 1.6233 | 1.8758 | 1.7496 | 1.5827 | 1.8112 | 1.6969 |
| Viability [% of NC] | 92.8 | 107.2 | 100 | 93.3 | 106.7 | 100 |
09/0641-1 | Mean OD570 | 1.9028 | 1.6308 | 1.7668 | 0.2857 | 0.2772 | 0.2814 |
| Viability [% of NC] | 108.8 | 93.2 | 101 | 16.8 | 16.3 | 17 |
PC | Mean OD570 | 0.3493 | 0.3223 | 0.3358 | 0.1902 | 0.1907 | 0.1904 |
| Viability [% of NC] | 20.0 | 18.4 | 19 | 11.2 | 11.2 | 11 |
Irritation Test
Test Substance |
| Tissue 1 | Tissue 2 | Tissue 3 | Mean | SD |
NC | Mean OD570 | 1.8535 | 2.3000 | * | 2.0768 |
|
| Viability [% of NC] | 89.3 | 110.7 | * | 100 | 15.20 |
09/0641-1 | Mean OD570 | 0.1445 | 0.1385 | 0.1635 | 0.1488 |
|
| Viability [% of NC] | 7.0 | 6.7 | 7.9 | 7 | 0.63 |
PC | Mean OD570 | 0.1005 | 0.1140 | 0.1000 | 0.1048 |
|
| Viability [% of NC] | 4.8 | 5.5 | 4.8 | 5 | 0.38 |
* For the NC two tissues were valid for evaluation, only (details are available with the raw data)
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information
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