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Diss Factsheets
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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-08-30 to 2011-09-01
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- other: SkinEthic reconstructed human corneal epithelial model (10-minute exposure)
- Deviations:
- no
- Principles of method if other than guideline:
- The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently cytotoxic to cause cell death.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of Inspection: 2011-07-19 to 2011-07-21; Date of signature 2011-08-31
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 / tissue source
- Species:
- other: not applicable
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- The SkinEthic HCE model consists of transformed human corneal epithelial cells of the cell line HCE (LSU EYE Center, New Orleans, USA) that form a corneal epithelial tissue (mucosa), devoid of stratum corneum, resembling histologically the mucosa of the human eye. The model consists of an airlifted, living, corneal tissue construct, produced in polycarbonate inserts in serum-free and chemically defined medium.
Test system
- Vehicle:
- not specified
- Controls:
- other: not applicable
- Amount / concentration applied:
- 30 μL
- Duration of treatment / exposure:
- 10 minutes
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- Not applicable
- Details on study design:
- METHOD
- The test material was applied directly to the culture surface, at the air interface, so that undiluted and/or end use dilutions could be tested directly.
- Cytotoxicity was determined by the reduction of MTT to formazan by viable cells in the test item treated tissues (quantitative measurement of tissue viability) relative to the negative control.
- One tissue for each treatment group was retained for possible tissue histopathology.
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
Results
- Irritation parameter:
- other: relative viability of treated tissues
- Basis:
- mean
- Time point:
- other: 10 minutes
- Score:
- 86.4
- Remarks on result:
- other: Percent
- Irritant / corrosive response data:
- No data
Any other information on results incl. tables
DIRECT MTT REDUCTION
- The MTT solution containing the test item turned yellow, which indicated the test material did not directly reduce MTT.
ASSESSMENT OF EYE IRRITATION POTENTIAL
- Individual and mean OD540 values and mean viabilities for each treatment group are given in Table 1 (attached).
HISTOPATHOLOGY
- It was considered unnecessary to proceed with tissue histopathology.
VALIDITY CRITERIA
- The quality criterion required for acceptance of results was satisfied.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test material was considered to be non-irritating.
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