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Diss Factsheets
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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Experiment start date - 12 November 2009; Experiment completion date - 13 November 2009; Study completion date - 01 December 2009.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2009
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)
Test material
- Details on test material:
- - Substance type: reactive dyestuff
- Physical state: orange powder
- Analytical purity: 69.9% of all colored components
- Lot/batch No.: TZ 5891 / BOP 02-09
- Expiration date of the lot/batch: 2014-07-31
- Storage condition of test material: At room temperature at about 20 °C
Constituent 1
- Specific details on test material used for the study:
- Identification: FAT 40851/A TE
Batch Number: TZ 5891 / BOP 02-09
Purity: 69.9% all coloured components
Appearance: Orange powder
Expiry Date: July 31, 2014
Storage Conditions: At room temperature at about 20 °C
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- water
- Remarks:
- Deionised water
- Details on test system:
- EST-1000 kits were purchased from CellSystems® Biotechnologievertrieb GmbH (53562 St. Katharinen; Germany). The EST-1000 tissue consisted of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consisted 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 EST-1000 tissues (surface 0.6 cm²) were cultured on specially prepared cell culture inserts (MILLICELLs®, 10 mm ∅).
EST-1000 kits were shipped at 4 °C on medium-supplemented agarose gels in a 24-well plate. On day of receipt (November 10, 2009) EST-1000 tissues were kept in the refrigerator at 2 - 8 °C until November 12, 2009 prior to use. At least one hour before starting the assay, tissues were transferred to 6-well plates with assay medium, which is immediately replaced before the test is started. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test material was not crushed or ground in a mortar and a pestle since this did not improve the consistency. About 25 mg of the test material were wetted with 50 μL deionised water. The test item was spread to cover the surface of the tissue. For the positive and negative controls, a volume of 50 μL was dosed per tissue.
- Duration of treatment / exposure:
- 3 minutes and 1 hour.
- Number of replicates:
- Two
Test animals
- Species:
- human
Test system
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period the tissues were removed from the 6-well plate and gently rinsed using a wash bottle containing PBS to remove any residual test material. Excess PBS was removed by gently shaking the tissue insert and blotting the lower surface with blotting paper.
- Time after start of exposure: after 3 min and 1h exposure
SCORING SYSTEM: MTT assay
After the exposure procedure, the cell culture inserts were incubated for 3 hours with MTT solution. Subsequently, the MTT solution was aspirated from the wells and the wells were rinsed three times with PBS. The inserts were transferred into new 24-well plates and extracted with isopropanol for 17 hours 35 minutes.
Aliquots of the blue formazan solution were transferred from each tissue into a 96-well flat bottom microtiter plate and optical density (OD) was read at 570 nm (OD570).
The mean values were calculated for each set of 3 wells per tissue insert.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean Experiment I & II - 3 min
- Value:
- 93.9
- Negative controls validity:
- valid
- Remarks:
- 100% tissue viability
- Positive controls validity:
- valid
- Remarks:
- 5.7% tissue viability
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean Experiment I & II - 1 hour
- Value:
- 88.8
- Negative controls validity:
- valid
- Remarks:
- 100% tissue viability
- Positive controls validity:
- valid
- Remarks:
- 4.6% tissue viability
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The optical evaluation of the MTT-reducing capacity of the test item after a 1 hour incubation with MTT-reagent did not show evidence of a blue colour and thereby was not considered to be an MTT reducer.
Any other information on results incl. tables
After exposure to the test item test substance the relative absorbance values were irrelevantly decreased to 93.9% after 3 minutes. After the 1 hour exposure relative absorbance values were reduced to 88.8%. Both values did not exceed the threshold for corrosivity of 50% for the 3 minutes exposure and 15% for the 1 hour exposure.
Therefore, the test item was not considered to be corrosive.
The optical evaluation of the MTT-reducing capacity of the test item after a 1 hour incubation with MTT-reagent did not show evidence of a blue colour and thereby was not considered to be an MTT reducer.
Table 1: Results after treatment with test substance
Dose group |
Exposure time |
OD570 |
Mean absorbance |
Rel. absorbence [% of negative control] |
|
Tissue 1 * |
Tissue 2 * |
||||
Negative control |
3 min |
1.869 |
1.484 |
1.676 |
100.0 |
Positive control |
3 min |
0.089 |
0.100 |
0.095 |
5.7 |
test substance |
3 min |
1.635 |
1.514 |
1.574 |
93.9 |
Negative control |
1 h |
1.696 |
1.939 |
1.817 |
100.0 |
Positive control |
1 h |
0.083 |
0.085 |
0.084 |
4.6 |
test substance |
1 h |
1.451 |
1.778 |
1.614 |
88.8 |
* Mean of three replicate wells after blank correction
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was non corrosive to skin.
- Executive summary:
This in vitro study was performed according to OECD Guideline 431 and to EU Method B.40 under GLP to assess the corrosive potential of test substance by means of the Human Skin Model Test.
Independent duplicate tissues of the human skin model EST-1000 were exposed to either the test item, the negative control or the positive control for 3 minutes and 1 hour, respectively. About 25 mg of the test item were applied to each tissue, wetted with 50 μL deionised water, and spread evenly over the surface of the tissue. A volume of 50 μL of either the negative control (deionised water) or the positive control (8.0 N KOH) was applied to each tissue. Viability of the cells were determined by MTT assay by measuring the absorbance at 570 nm (OD570) and expressed as relative absorbance in % of negative control.
After exposure to the negative control the absorbance values exceeded the required acceptability criterion of mean OD570 ≥0.8 for both treatment intervals thereby confirming the acceptable quality of the tissues. Exposure to the positive control induced a decrease in the relative absorbance as compared to the negative control, both for the 3 minutes exposure period and for the 1 hour exposure period thus confirming the validity of the test system.
After exposure to the test item, the relative absorbance values were decreased to 93.9% after 3 minutes. After the 1 hour exposure relative absorbance values were reduced to 88.8%. Both values did not exceed the threshold for corrosivity of 50% for the 3 minutes exposure and 15% for the 1 hour exposure. Therefore, the test item was not considered to be corrosive.
In conclusion, it can be stated that in this study and under the reported experimental conditions, the test item test substance was non corrosive to skin.
According to the referred classification (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008), test substance does not have to be classified with respect to skin corrosion.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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