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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:
- 25 June 2008 and 01 July 2008.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPISKINTM reconstituted human epidermis model
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The work described was performed in compliance with UK GLP standards (Schedule 1, Good Laboratory Practice Regulations 1999 (SI 1999/3106 as amended by SI 2004/0994)).
Test material
Constituent 1
Test animals
- Species:
- other: The EPISKIN model is a three-dimensional reconstituted human epidermis model
- Strain:
- other: The EPISKIN model is a three-dimensional reconstituted human epidermis model consisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. A highly differentiat
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS: Not applicable
TEST ANIMALS: Not applicable
- Tissue: The EPISKIN model is a three-dimensional reconstituted human epidermis model consisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. A highly differentiated and stratified epidermis model is obtained after 13 day culture period comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): warmed to approximately 37ºC
- Humidity (%): Not applicable
- Air changes (per hr): Not applicable
- Photoperiod (hrs dark / hrs light): Not applicable
IN-LIFE DATES: Not applicable
Test system
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):10 ± 2 mg of the test material was applied to the epidermis surface.
- Concentration (if solution): Not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit):Not applicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable - Duration of treatment / exposure:
- Triplicate tissues were treated with the test material for an exposure period of 15 minutes.
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- TEST SITE
- Area of exposure:Not applicable
- % coverage: Not applicable
- Type of wrap if used: Not applicable
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, each tissue was removed from the well using forceps and rinsed with 25 ml of PBS. Rinsing was achieved by filling and emptying each tissue insert with PBS using a pipette. The rinsed tissues were transferred to the second column of 3 wells containing 2 ml of maintenance medium in each well. The rinsed tissues were incubated at 37ºC, 5% CO2 in air for approximately 42 hours.
- Time after start of exposure: 15 minutes
SCORING SYSTEM: For each test material the relative mean tissue viabilities obtained after the 15 minute treatment followed by the 42 hour post-exposure incubation period were compared to the mean of the negative control treated tissues (n=3).
Criteria for in vitro interpretation
Mean tissue viability is ≤50% Irritant (I) R38
Mean tissue viability is >50% Non-Irritant (NI)
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: % Viabiltiy
- Value:
- 102.3
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 15 minutes. Max. score: 110.0. Reversibility: no data. Remarks: The relative mean viability of the test material treated tissues was 102.3% after a 15 minute exposure.. (migrated information)
In vivo
- Irritant / corrosive response data:
- According to the protocol the test material was considered to be Non-Irritant.
- Other effects:
- Following the 15-minute exposure the test material treated tissues appeared blue which was considered indicative of viable tissue.
Any other information on results incl. tables
Direct MTT Reduction
The MTT solution containing the test material did not turn blue/purple which indicated that the test material did not directly reduce MTT.
Test Material, Positive Control Material and Negative Control Material
The individual and mean OD540values, standard deviations and tissue viabilities for the negative control, test material and positive control are given in Table 1. The mean viabilities and standard deviations of the test material and positive control, relative to the negative control are also given in Table 1.
The relative mean viability of the test material treated tissues was 102.3% after a 15‑minute exposure.
The qualitative evaluation of tissue viability is given in Table 2.
Following the 15-minute exposure the test material treated tissues appeared blue which was considered indicative of viable tissue.
Quality Criteria
The relative mean tissue viability for the positive control treated tissueswas≤40% relative to the negative control treated tissues and the Standard Deviation (SD) value of the % viability was ≤20%. The positive control acceptance criterion was therefore satisfied.
The mean OD540for the negative control treated tissueswas≥0.6 and the SD value of the % viability was ≤20%. The negative control acceptance criterion was therefore satisfied.
Table 1-Mean OD540Values and % Viabilities for the Negative Control Material, Positive Control Material and Test Material
Material |
OD540of tissues |
Mean OD540of triplicate tissues |
± SD of OD540 |
Relative individual tissue viability |
Relative mean % viability |
± SD of % viability |
Negative Control MaterialÅ |
0.753 |
0.791 |
0.090 |
95.2 |
100* |
11.4 |
0.894 |
113.0 |
|||||
0.727 |
91.9 |
|||||
Positive Control MaterialÅ |
0.131 |
0.110 |
0.019 |
16.6 |
13.9 |
2.4 |
0.100 |
12.6 |
|||||
0.098 |
12.4 |
|||||
Test Material |
0.826 |
0.809 |
0.070 |
104.4 |
102.3 |
8.9 |
0.870 |
110.0 |
|||||
0.732 |
92.5 |
Table 2-Qualitative Evaluation of Tissue Viability (MTT uptake visual evaluation)
Material |
Tissue 1 |
Tissue 2 |
Tissue 3 |
Negative Control MaterialÅ |
- |
- |
- |
Positive Control MaterialÅ |
++ |
++ |
++ |
Test Material |
- |
- |
- |
MTT
visual scoring scheme
- = blue
tissue (viable)
+ = blue/white
tissue (semi-viable)
++ = tissue
is completely white (dead)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be Non-Irritant.
- Executive summary:
Introduction. The purpose of this test was to evaluate the skin irritation potential of the test material using the EPISKINTMreconstituted human epidermis model after a treatment period of 15 minutes followed by a post-exposure incubation period of 42 hours. The principle of the assay was based on the measurement of cytotoxicity in reconstituted human epidermal cultures following topical exposure to the test material by means of the colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt (3‑[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test material treated tissues relative to the negative controls. The concentration of the inflammatory mediator IL-1α in the culture medium retained following the 42 hour post-exposure incubation period is also determined for test materials which are found to be non-irritant based upon the MTT reduction endpoint. This complimentary end‑point will be used to either confirm a non-irritant result or will be used to override the non‑irritant result.
Methods. Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period each tissue was rinsed before incubating for approximately 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. The maintenance medium from beneath each tissue was transferred to pre‑labelled micro tubes and store in a freezer for possible inflammatory mediator determination. 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.
Data are presented in the form of % viability (MTT reduction in the test material treated tissues relative to negative control tissues).
Results. The relative mean viability of the test material treated tissues was 102.3% after a 15‑minute exposure.
Quality criteria. The quality criteria required for acceptance of results in the test were satisfied.
Conclusion. The test material was considered to be non-irritant.
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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