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EC number: 211-720-1 | CAS number: 691-37-2
- 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 / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-05-31 to 2011-06-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431 (In vitro skin corrosion: human skin model test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection 2010-07-20; Date of signature 2010-10-29
Test material
- Reference substance name:
- 4-methylpent-1-ene
- EC Number:
- 211-720-1
- EC Name:
- 4-methylpent-1-ene
- Cas Number:
- 691-37-2
- Molecular formula:
- C6H12
- IUPAC Name:
- 4-methylpent-1-ene
- Details on test material:
- - Name of test material (as cited in study report): 4-methylpent-1-ene
- Physical state: clear colourless liquid
- Analytical purity: ≥ 97 %
- Lot/batch No.: H1130311
- Date received: 2011-04-11
- Expiration date of the lot/batch: 2011-10-11
- Storage condition of test material: approximately 4 degrees Centigrade in the dark
Constituent 1
Test animals
- Species:
- other: not applicable
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- The Episkin model is a three-dimensional reconstructed human epidermis model consisting of adult human-derived epidermal keratinocytes seeded on a dermal substitute consisting of a collagen type I matrix loaded with type IV 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.
Test system
- Type of coverage:
- other: not applicable
- Preparation of test site:
- other: not applicable
- Vehicle:
- other: not applicable
- Controls:
- other: not applicable
- Amount / concentration applied:
- 50 μL
- Duration of treatment / exposure:
- 3, 60 and 240 minutes
- Observation period:
- Not applicable
- Number of animals:
- Not applicable
- Details on study design:
- METHOD
- The test is based on the experience that corrosive chemicals are 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 item treated relative to the negative control.
- The test material was applied topically to the stratum corneum, at the air interface, so that undiluted and/or end use dilutions could be tested directly.
ASSESSMENT OF DIRECT TEST ITEM REDUCTION OF MTT
- The MTT assay is a colourmetric method of determining cell viability based on reduction of the yellow tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan dye by mitochondrial succinate dehydrogenase in viable cells.
- A known limitation of the assay is that test materials may interfere with the MTT endpoint if they are directly reduce MTT and, at the same time, are present on or in the tissues when the MTT viability test is performed. To identify any possible interference, the test item was checked for the ability to reduce MTT.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: relative viability of test material treated tissue
- Basis:
- mean
- Time point:
- other: 3 minutes
- Score:
- 131.2
- Remarks on result:
- other: Percent
- Irritation parameter:
- other: relative viability of test material treated tissue
- Basis:
- mean
- Time point:
- other: 60 minutes
- Score:
- 141.5
- Remarks on result:
- other: Percent
- Irritation parameter:
- other: relative viability of test material treated tissue
- Basis:
- mean
- Time point:
- other: 240 minutes
- Score:
- 107.3
- Remarks on result:
- other: Percent
- Irritant / corrosive response data:
- The corrosivity potential of the test material was predicted from the relative mean tissue viabilities obtained after 3, 60 and 240 minute treatments, compared to the mean of the neagative control tissues (n = 2) treated with 0.9 % sodium chloride solution. The relative mean viabilities were calculated as shown below:
Relative mean viability (%) = (Mean OD540 of test material / Mean OD540 of negative control) * 100
Any other information on results incl. tables
DIRECT MTT REDUCTION
- The MTT solution containing the test material did not turn blue. This was taken to indicate that the test item did not reduce MTT.
TEST MATERIAL, POSITIVE CONTROL AND NEGATIVE CONTROL
- Mean OD540 values and viabilities are provided in Table 1 (attached) for the negative control, positive control and test material.
QUALITY CRITERIA
- The relative mean tissue viability for the positive control treated tissues was 2.4 % relative to the negative control treated tissues after 240 minutes. The positive control acceptance criterion was therefore satisfied.
- The mean OD540 for the negative control treated tissues was 0.205. The negative control acceptance criterion was therefore satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The test material was considered to be non-corrosive to skin.
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