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Diss Factsheets
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EC number: 939-039-1 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October 2009 --- 9 November 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:
- 2010
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name of test material (as cited in study report): 20231250
- Physical state: white powder
- Storage condition of test material: room temperature (ca. 20°C) in the dark
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: EpiskinTM Model Kit (0.38 cm2 tissues)
- Cell source:
- other: SkinEthic Laboratories, Lyon, France
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: several
- Observable damage in the tissue due to washing: no
- Modifications to validated SOP: no
DYE BINDING METHOD
- Dye used in the dye-binding assay: MTT
- Spectrophotometer: no data
- Wavelength: 540 nm
- Filter: no data
- Filter bandwidth: no data
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
SCORING SYSTEM:
- Optical density (OD) was measured at 540 nm:
Relative mean viability (%) = 100 x mean cOD(test item) / mean cOD(negative control)
where:
- mean cOD Negative Control = mean ODNC – mean ODblank
- mean cOD Test Item = mean ODTI – mean ODblank
- mean cOD Positive Control = mean ODPC - mean ODblank
DECISION CRITERIA
Mean relative viability is = or < 50%: category 2 (H315)
Mean relative viability is > 50% : no category - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Amount/concentration applied
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 +/- 2 mg
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10µL
- Concentration (if solution):
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10µL
- Concentration (if solution): 5% in distilled water - Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- MTT-loading after a 42h-incubation period following rinsing. Observation of MTT-> formazan transformation by viable cells
- Number of replicates:
- 3
Test animals
- Species:
- other: in vitro test
- Details on test animals or test system and environmental conditions:
- The test was conducted in accordance with the Standard Operating Procedure " In Vitro Skin Irritation Test: Human Epidermis Model (L’Oreal 2009)" supplied by L’Oreal (leading laboratory in the validation of the test for ECVAM) and the
OECD Guideline For The Testing of Chemicals Draft proposal for a new guideline In Vitro Skin Irritation (OECD 2008).
The test involves the application of the test substance for 15 minutes to the EPISKIN threedimensional human skin model. The model consists of normal, human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type 1 matrix coated with type IV collagen. After 13 days in culture a multilayered, highly differentiated model of the human epidermis with a functional multi-layered stratum corneum has formed. The epidermis surface area supplied is 0.38cm2. The EPISKIN kits include assay medium, maintenance medium, 12 well plates and the tissues which are shipped on nutritive agar.
The principle of the assay is that irritant substances are sufficiently cytotoxic to cause cell death in the cell layers. The cell viability is determined by mitochondrial dehydrogenase activity, assessed by the reduction of MTT to a soluble, coloured, formazan product. The prediction model uses the percentage viability values (compared to negative control viability) to identify irritant and non-irritant substances. The test includes acceptance criteria for both negative and positive controls.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Time point: 15 min exposure + 42h expression
- Value:
- 117
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 9.6%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes
- Range of historical values if different from the ones specified in the test guideline: no
Any other information on results incl. tables
Assay validity:
The mean absorbance of the triplicate negative control values was 0.7 which was above the minimum acceptance value of 0.6. The standard deviation (SD) of the % viability was 12.0 which was below the maximum acceptance value of 18.
The mean % viability of the positive control was 9.60 ± 4.10 of the negative control. These were below the maximum acceptance values of 30% viability and SD of 18.
Table 7.3.1/1 : Episkin results
Sample |
Tissue viability as percentage of mean OD negative control |
Prediction |
|||
Replicate tissues |
Mean +/- SD |
||||
a |
b |
c |
|||
Negative control |
86.3 |
109 |
105 |
100 +/- 12.0 |
Not applicable |
Positive control |
8.00 |
6.50 |
14.3 |
9.60 +/-4.10 |
Irritant |
Test Substance |
115 |
113 |
123 |
117 +/- 5.40 |
Non irritant |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is considered to be non-irritant to skin.
- Executive summary:
The purpose of this test was to evaluate the skin irritation potential of the test substance using the EPISKINTMreconstructed human epidermis model (in vitro assay). The test procedure was equivalent to the one described in the OECD guideline 439 and the study was performed in compliance with Good Laboratory Practice..
Preliminary tests were performed to detect the ability of the test substance to directly reduce MTT as well as its colouring potential. following these preliminary tests, triplicate tissues (Episkin epidermis surface area of 0.38 cm²) were treated with 10 mg of the test item as a powder for an exposure period of 15 minutes. The tissues were wetted with 5 µL of distilled water prior to application of the test substance. At the end of the exposure period each tissue was rinsed to remove residual test substance before incubating for 42 hours at 37°C in a humidified atmosphere of 5% CO2 in air. At the end of the post-exposure incubation period each tissue was taken for MTT-loading (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide). After MTT loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues. At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µl samples were transferred to the appropriate wells of a pre-labelled 96-well plate. The optical density was measured at 540 nm with acidified isopropanol solution as a blank.
Negative (sterile Dulbecco's Phosphate Buffered Saline (DPBS) with magnesium and calcium) and positive controls (5% sodium dodecyl sulphate (SDS) in distilled water) were used in the study. The mean absorbance of the triplicate negative control values was 0.7 which was above the minimum acceptance value of 0.6. The standard deviation (SD) of the % viability was 12.0 which was below the maximum acceptance value of 18. The mean % viability of the positive control was 9.60 +/- 4.10 of the negative control. This was below the maximum acceptance values of 30% viability and SD of 18. Therefore the study was considered as valid.
The relative mean viability of the test item treated tissues was 117 +/- 5.40 % after the 15-minute exposure period. As the mean viability was above 50% after MMTT reduction, the result met the criteria for a non-irritant response.
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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