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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 irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 5, 2008 to February 5, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Principles of method if other than guideline:
- The study procedures were based on the following documents:
- L'Oreal Standard Operating Procedure, ECVAM Skin Irritation Validation Study, Validation of the Episkin Skin Irritation Test (42 hours) assay for the prediction of acute skin irritation of chemicals, January 2005.
- The ESAC statement (ECVAM Scientific Advisory Committee) on the validity of in vitro tests for skin irritation, April 2007 - GLP compliance:
- yes (incl. QA statement)
Test material
- Details on test material:
- - Physical state: White powder
- Analytical purity: 99%
- Lot/batch No.: 08-018
- Expiration date of the lot/batch: 30 April 2009
- Stability under test conditions: Stable
- Storage condition of test material: At room temperature protected from light
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- water
- Details on test system:
- TEST SYSTEM:
Name: EPISKIN Standard model (EPISKIN-SM(TM), 0.38 cm2, human three dimensional epidermal model)
Lot No.: 09-EKIN-001
Source: SkinEthic Laboratories, Nice, France
Rationale: Recommended test system by the Institute for Health & Consumer Protection, European Centre for the Validation of Alternative Methods (ECVAM).
TREATMENT:
The test was performed on a total of 3 tissues per test substance together with negative and positive controls. 10mg of the test substance with 10 μL of Milli-Q water was applied directly on top of the skin tissue. After the exposure period of 15 minutes at room temperature, the tissues were washed with phosphate saline to remove residual test substance. The skin tissues were kept in new well plates on 2 mL pre-warmed maintenance medium until all tissues were dosed and rinsed.
After a 42 hour (at 37C) incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with the test substance compared to the negative control tissue was calculated
NEGATIVE CONTROL
- Name: Phosphate buffered saline (PBS, Invitrogen Corporation, Breda, The Netherlands)
- Amount(s) applied (volume or weight with unit): 10 μL
POSITIVE CONTROL
- Name: Sodium dodecyl sulphate (SDS, Sigma Aldrich, Zwijndrecht, The Netherlands)
- Amount(s) applied (volume or weight with unit): 10 μL
- Concentration: 5% (aqueous solution)
SCORING SYSTEM:
Cell viability measurement: reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT. The amount of extracted formazan was determined spectrophotometrically at 570 nm induplicate with Multiskan Spetrum (Thermo Labsystems).
ACCEPTABILITY OF THE ASSAY:
The in vitro skin irritation test is considered acceptable if it meets the following criteria:
a) The absolute mean OD570 of the three tissues of the negative control should be >=0.6 and the Standard Deviation value (SD) of the % viability should be <=18.
b) The mean relative tissue viability of the positive control should be <=40% relative to the negative control and the Standard Deviation value (SD) of the % vailbility shoukd be <=18.
c) The SD calculated from individual percentual tissues viabilities of the three identically treated replicates should be <=18.
DATA EVALUATION:
A test substance is considered irritant if:
The relative mean tissue viability of three individual tissues after 15 min of exposure to the test substance and 42 hours of post incubation is <=50% of the mean viability of the negative controls.
A test substance is considered non-irritant if:
The relative mean tissue viability of three individual tissues after 15 min of exposure to the test substance and 42 hours of post incubation is >50% of the mean viability of the negative controls. - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg
- Concentration (if solution):
VEHICLE
- Name: water (Milli-Q water)
- Amount(s) applied for moistening (volume or weight with unit): 10 μL - Duration of treatment / exposure:
- 15 minutes
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 101
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1 Mean absorption in the in vitro skin irritation with the test substance
Performance of study from 6 January 2009 to 12 January 2009
|
A (OD570) |
B (OD570) |
C (OD570) |
Mean SD (OD570) |
Negative control |
0.695 |
0.737 |
0.693 |
0.708 + 0.025 |
Test substance |
0.703 |
0.713 |
0.727 |
0.714 + 0.012 |
Positive control |
0.038 |
0.051 |
0.046 |
0.045 + 0.006 |
OD = optical density
SD = Standard deviation
Triplicate exposure are indicated by A, B and C.
In this table with the values are corrected for background absorption. Isopropanol was used to mesure the background absorption.
Table 2 Mean tissue viability in the in vitro skin irritation test with the test substance
|
Mean tissue viability (percentage of control) |
Negative control |
100 |
Test substance |
101 |
Positive control |
6 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- It is concluded that this test is valid and that the test substance is non-irritant in the in vitro skin irritation test under the experimental conditions described in the report.
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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