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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:
- From February 14th to 17th, 2017
- 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:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 - 45 °C
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on animal used as source of test system:
- SOURCE ANIMAL
- Source: Human adult donors - Justification for test system used:
- The EPISKIN Small ModeITM (EPISKIN-SMTM) is one of the biological systems of the validated alternative method for skin irritation (OECD TG 439).
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN Small ModeITM (EPISKIN-SMTM) supplied by EPISKIN Laboratoires, 4 Rue Alexander Fleming 69366 Lyon, France.
- Tissue batch number(s): N° 17-EKIN-007
- Delivery date: 14.02.2017
- Date of initiation of testing: 14.02.2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: washing were performed with saline solution.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- Incubation time: 42 hours
- Spectrophotometer: TECAN INFINITE M-200 spectrophotometer.
- Wavelength: 570 nm
- Linear OD range of spectrophotometer: 0-2 OD
NUMBER OF REPLICATE TISSUES: test item, positive and negative controls were evaluated in triplicate on viable episkin tissues.
INSTRUMENT USED FOR THE TEST:
Analytical bilance XS204 I
CO2 incubator
Microplate Autoreader INFINITE M200
Micropipettes
Refrigerator FRL 360
PREDICTION MODEL / DECISION CRITERIA
- If the mean relative tissue viability (%) of treated tissues exposed to the test substance is > 50 % the test substance is identified as not requiring classification and labeling(NO Category- Non-irritant to skin).
- If the mean relative viability is ≤ 50 % the test substance is identified as potentially requiring classification and labeling as Category 1 (risk phrase H314: causes severe skin burns and eye damage) or Category 2 (risk phrase H315: causes skin irritation).
In absence of information on skin corrosion the test method cannot resolve between UN GHS Categories 1 and 2.
ACCEPTANCE CRITERIA
- Acceptance criteria for negative control: negative control meets the acceptance if the mean OD negative control value of the three tissues is ≥ 0.6 and ≤ 1.5 and if the Standard Deviation value (SD) of the % viability is ≤ 18 %.
- Acceptance criteria for positive control: positive control satisfies acceptance criteria if mean cell viability expressed as percentage compared to Negative Control is ≤ 40 % and Standard Deviation value (SD) is ≤ 18 %.
- Acceptance criteria for test substance: test substance meets the acceptance criteria if the Standard Deviation value (SD) of the cell viability % (expressed as percentage compared to Negative Control) between the 3 tissue replicates is ≤ 18 %. - Control samples:
- other: Positive (Sodium Dodecyl Sulfate at 5%) and negative (NaCl 0.9%) controls
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg of test item were directly and uniformly applied topically on epidermal surface pre-treated with 10 µL of saline solution.
NEGATIVE CONTROL
- Concentration (if solution):10 µL of saline solution (NaCl 0.9%) were directly and uniformly applied topically on epidermal surface.
POSITIVE CONTROL
- Concentration (if solution):10 µL of Sodium Dodecyl Sulfate at 5% (SDS 5%) were directly and uniformly applied topically on epidermal surface. - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- Test item, positive and negative controls were evaluated in triplicate on viable episkin tissues.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- test item mean of three replicates
- Value:
- ca. 104.16
- Vehicle controls validity:
- not valid
- Remarks:
- no vehicle used
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Direct-MTT reduction: no direct MTT reduction observed for test item in the qualitative visual inspection.
- Colour interference with MTT: no colour intereference with MTT observed for test item in the qualitative visual inspection.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: negative control meets the acceptance if the mean OD negative control value of the three tissues is ≥ 0.6 and ≤ 1.5 and if the Standard Deviation value (SD) of the % viability is ≤ 18 %.The mean OD negative control value of the three tissues was 0.87 (inside the range of acceptability 0.6 - 1.5) and the Standard Deviation value (SD) of the % viability was 2.87 (≤ 18% as indicated in the accepability criteria).
- Acceptance criteria met for positive control: positive control satisfies acceptance criteria if mean cell viability expressed as percentage compared to negative control is ≤ 40 % and Standard Deviation value (SD) is ≤ 18 %.A cell viability ≤ 40% corresponding to the cut-off value for positive control acceptance criteria was quantified for SDS 5% (26.58%). Also the standard deviation for positive control was inside the range of acceptability 0.86 ≤ 18%.
- Acceptance criteria met for variability between replicate measurements: test substance meets the acceptance criteria if the Standard Deviation value (SD) of the cell viability % (expressed as percentage compared to Negative Control) between the 3 tissue replicates is ≤ 18 %. (i.e. 4.14 % ≤ 18 %).
STATISTICAL ANALYSIS
No specific statistical analysis has been carried out except the standard deviation calculation.
Any other information on results incl. tables
O.D |
||||||||
SAMPLE |
BIOLOGICAL REPLICATE 1 |
BIOLOGICAL REPLICATE 2 |
BIOLOGICAL REPLICATE 3 |
|||||
NC |
0.8164 |
0.8624 |
0.8875 |
0.8759 |
0.8787 |
0.8879 |
||
SDS 5% |
0.2226 |
0.2262 |
0.2266 |
0.2310 |
0.2419 |
0.2359 |
||
test item |
0.8450 |
0.8818 |
0.9427 |
0.9192 |
0.9096 |
0.9270 |
||
O.D MEAN |
||||||||
SAMPLE |
BIOLOGICAL REPLICATE 1 |
BIOLOGICAL REPLICATE 2 |
BIOLOGICAL REPLICATE 3 |
|||||
NC |
0.8394 |
0.8817 |
0.8833 |
|||||
SDS 5% |
0.2224 |
0.2288 |
0.2389 |
|||||
test item |
0.8634 |
0.9310 |
0.9183 |
|||||
|
VIABILITY |
VIABILITY% MEAN±SD |
||||||
|
BIOLOGICAL REPLICATE 1 |
BIOLOGICAL REPLICATE 2 |
BIOLOGICAL REPLICATE 3 |
|
||||
NC |
96.69 |
101.57 |
101.75 |
100.00± 2.87 |
||||
SDS 5% |
25.85 |
26.36 |
27.52 |
26.58±0.86 |
||||
test item |
99.46 |
107.25 |
105.78 |
104.16±4.14 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not skin irritant according to the CLP Regulation (EC n.1272/2008)
- Conclusions:
- Non-skin irritant.
- Executive summary:
The present study has been conducted in order to assess the skin irritation of the test item on the reconstructed human epidermis model EPISKIN-SMTMaccording to OECD TG 439 (July 2015).
Skin irritation was assessed at 15 min treatment followed by product washing and a post incubation period of 42h by using the MTT test method to quantify the residual cell viability.
Based on adopted prediction model and to MTT results (104.16 %) the test item was classified as not skin irritant according to UN GHS and according to the CLP Regulation (EC n.1272/2008).
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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