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Diss Factsheets
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EC number: 200-879-2 | CAS number: 75-56-9
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 431 (In vitro skin corrosion: human skin model test)
- Principles of method if other than guideline:
- The test material is applied topically to the stratum corneum surface, at the air interface, so that undiluted and or end use dilutions can be tested directly. The test is based on the experience that corrosive chemicals are sufficiently cytotoxic after a short term exposure to the
EPISKIN model. Corrosive chemicals are able to penetrate the stratum corneum and are sufficiently cytotoxic to cause cell death in the underlying cell layers. Toxicity is determined by the metabolic conversion of the vital dye MTT to formazan by viable cells in the test material treated cultures relative to the negative control. - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Harlan Laboratories Ltd. Shardlow Business Park Shardlow Derbyshire DE72 2GD UK
Test material
- Reference substance name:
- Methyloxirane
- EC Number:
- 200-879-2
- EC Name:
- Methyloxirane
- Cas Number:
- 75-56-9
- Molecular formula:
- C3H6O
- IUPAC Name:
- 2-methyloxirane
- Details on test material:
- Sponsor's identification : Propylene oxide
Description : clear colourless liquid
Batch number : S-122009-310041
Date received : 14 December 2009
Expiry date: 14 June 2010
Storage conditions : room temperature in the dark
Purity:99.98 %
Constituent 1
Test animals
- Species:
- other: The EPISKIN model is a three-dimensional reconstituted human epidermis modelconsisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix coated with type lV collagen.
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- The EPISKINTM model is a three-dimensional reconstituted human epidermis modelconsisting of adult human-derived epidermal keratinocytes
seeded on a dermal substitute consisting of a collagen type I matrix coated with type lV collagen. A highly differentiated and stratified epidermis
model is obtained after a 13-day culture period comprising the main basal, supra basal, spinous and granular layers and a functional stratum
corneum.
EPISKN ModeI Kit
Supplier : SkinEthic Laboratories, Nice, France
Date received : 26 January 2010
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: use of the Episkin model kit
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- 50 microliter of the test material was applied topically to the corresponding tissues ensuring uniform coverage of the tissues.
Duplicate tissues, treated with 50 microliter of 0.9% w/v sodium chloride solution served as negative controls.
Duplicate tissues, treated with 50 microliter of glacial acetic acid served as positive controls. - Duration of treatment / exposure:
- 3, 60 and 240 minutes
- Observation period:
- not required
- Number of animals:
- not required
- Details on study design:
- The MTT assay, a colourimetrĂc method of determining cell viability, is based on reduction of the yellow tetrazolium salt (3-[4,5-dimethylthiazol2-yl]-2,5-diphenyltetrazolium bromide) to a purple formazan dye by mitochondrial succinate dehydrogenase in viable cells.
Duplicate tissues were treated with the test material for exposure periods of 3, 60 and 240 minutes. Duplicate tissues were treated with the positive and negative control materials for an exposure period of 240 rninutes. 50 microliter of the test material was applied topically to the corresponding tissues ensuring uniform coverage of the tissues. Duplicate tissues, treated with 50 microliter of 0.9% w/v sodium chloride solution served as negative controls. Duplicate tissues, treated with 50 microliter of glacial acetic acid served as positive controls. The treated tissues were kept in the biological safety cabinet at
room temperature for the appropriate exposure period.
At the end of each exposure period, each tissue was removed from the well using forceps and rinsed using a wash bottle containing Phosphate Buffered Saline Dulbeccos
(PBS) with Ca++ and Mg ++. Rinsing was achieved by filling and emptying each tissue insert for approximately 40 seconds using a constant soft
stream of PBS to gently remove any residual test material. Each rinsed tissue was placed into the third column of the 12-well plate until all tissues wererinsed.
2.2 ml of 0.3 mg/ml MTT solution, freshly prepared in assay medium, was pipetted into 2 wells of the fourth column of each 12 well plate.
The tissues were transferred into the MTT filled wells. The tissues were incubated for 3 hours +/- 5 minutes at room temperature in a biological
safety cabinet ensuring that the plates were protected from light. At the end of the 3-hour incubation period each tissue was placed onto absorbent
paper to dry. The tissues were examined and the degree of MTT staining evaluated (qualitative evaluation of cell viability).
Following qualitative evaluation of tissue viability a total biopsy of the epidermis was taken using the EPISKIN biopsy punch. The
epidermis was carefully separated from the collagen matrix using forceps and both parts (epidermis and collagen matrix) were placed into labelled
1.5 ml micro tubes containing 850 microliter of acidified isopropanol. Each tube was plugged, mixed thoroughly and stored
overnight at room temperature, protected from light, to extract formazan crystals out of the MTT-loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly on a vortex
mixer to produce a homogenous coloured solution.
For each tissue, duplicate 200 microliter samples were transferred to the appropriate wells of a pre-labelled 96-well plate. 200 microliter of acidified isopropanol alone was added to the two wells designated as 'blanks'. The optical density was measured (quantitative viability analysis) at 540 nm (without a reference fifter) using the Anthos 2001 microplate reader.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: relative mean tissue viability
- Value:
- 96.4
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 240 minutes. (migrated information)
- Irritation / corrosion parameter:
- other: other: relative mean tissue viability
- Value:
- 119.4
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 60 minutes. (migrated information)
- Irritation / corrosion parameter:
- other: other: relative mean tissue viability
- Value:
- 141.3
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 3 minutes. (migrated information)
- Irritation / corrosion parameter:
- other: other: relative mean tissue viabilty
- Value:
- 5.6
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 240 minutes. Remarks: positive control. (migrated information)
Any other information on results incl. tables
The test material was considered to be Non-Corrosive to the skin.
Applicant's summary and conclusion
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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