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EC number: 208-857-4 | CAS number: 544-01-4
- 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: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to the OECD guideline No.439 (July 2010) and in compliance with the GLP guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Diisopentyl ether
- EC Number:
- 208-857-4
- EC Name:
- Diisopentyl ether
- Cas Number:
- 544-01-4
- Molecular formula:
- C10H22O
- IUPAC Name:
- 3-methyl-1-(3-methylbutoxy)butane
- Details on test material:
- - Name of test material (as cited in study report): Diisopentyl ether
- Analytical purity: 99.2%
- Lot/batch No.: TAP 625
- Storage condition of test material: 2-8 °C
Constituent 1
Test animals
- Species:
- other: In vitro human skin model
- Strain:
- other: EpiDerm model
- Details on test animals or test system and environmental conditions:
- TEST MATERIAL
- Test material: commercially available Epi-200-SIT-Kit
- Source: MatTek Corporation Ashland USA (first experiment), MatTek In Vitro Life Science Laboratories, Bratislava (Second experiment)
- Acclimation period: On the day of receipt the tissues were transferred to 12-well plates and preincubated with prewarmed Maintenance Medium for 24 hours at 37°C.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37.1 – 37.4°C
- Humidity (%): 88 – 89% containing 5 +/- 0.5% CO2 in air
- Photoperiod (hrs dark / hrs light): dark
Test system
- Type of coverage:
- other: In vitro human skin model
- Preparation of test site:
- other: In vitro human skin model
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other: Negative control: Phosphate buffered saline; positive control: 5% Sodium dodecyl sulphate in deionised H2O.
- Amount / concentration applied:
- Three tissues of the human skin model EpiDerm were treated with 30 µl diisopentyl ether.
- Duration of treatment / exposure:
- The skin tissues were exposed to diisopentyl ether for 60 minutes at 37°C.
- Observation period:
- Not applicable
- Number of animals:
- Not applicable (in vitro study)
- Details on study design:
- The purpose of this study was to determine skin irritation potential of diisopentyl ether using the in-vitro human epidermal model (EpiDerm). The test consists of a topical exposure of the neat test item to a human reconstructed epidermis model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT (3-[4,5-dimethyl thiazole 2-yl]2,5-diphenyl-tetrazoliumbromide), present in cell mitochondria, into a blue formazan salt that is quantitatively meaured after extraction from tissues. The percent reduction of cell viability in comparison of untreated negative controls is used to predict skin irritation potential .
Protocol:
1- Pre-Tests: first, it was tested whether the test item is compatible with the EpiDerm test system. No reaction with reagens or materials was observed and therefore this protocol was considered suitable for the determination of the skin irritation potential of diisopentyl ether.
2- Pre-incubation: Skin tissues were pre-incubated to test their viability.
3- Treatment: Pre-incubated tissues were treated with buffer (negative control), SDS solution (positive control) or diisopentyl ether. Hereafter the tissues were incubated for 60 minutes. After the incubation period, the tissues were rinsed, dried and then transferred into a new plate with fresh asay medium. After a total post-incubation period of 42 hours, the cytotoxic effect was measured by determination of the relative formazan production (photometric absorption at 570 nm). The photometric absorption of the negative controls is considered as 100%. The mean of the three replicates of test item and positive control, formazan production is calculated as % photometric absorption compared with the negative control. If the formazan production is < 50% in comparison to the control, the test item is considered as irritant. If >50%, the test item is considered as non-irritant.
Two independant experiments were performed.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: EpiDerm Model
- Remarks:
- Mean of three tissues
- Run / experiment:
- 1
- Value:
- ca. 1.517
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- other: Epiderm Model / Mean of three tissues
- Run / experiment:
- 2
- Value:
- ca. 2.237
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- After treatment, the absorbance values in the negative controls were within the required acceptability criterion. The positive control showed clear irritating effects. Variation within tissues was acceptable (<18%) for negative control, positive control and test item. In the first experiment the relative aabsorbance values were increased to 148.2% after the treatment with diisopentyl ether. In the second experiment, the relative absorbance values were increased to 151.8% after the treatment with the test item. Both values are well above the threshold for irritation potential (50%) but lie far above the value of the negative control, indicating an increased viability effect of the test item on the skin. It is clear that this effect is not caused by a direct interaction from the test substance with MTT since in the pre-test it was concluded that no interaction takes place.
Any other information on results incl. tables
Mean absorption values, Exp. 1
|
Negative control |
Diisopentyl ether |
Positive control |
Tissue 1 |
1.017 |
1.531 |
0.115 |
Tissue 2 |
1.024 |
1.518 |
0.111 |
Tissue 3 |
1.031 |
1.503 |
0.117 |
Mean of three tissues |
1.024 |
1.517 |
0.114 |
Relative SD of the three tissues |
0.7% |
0.9% |
2.7% |
Mean absorption values, Exp. 2
|
Negative control |
Diisopentyl ether |
Positive control |
Tissue 1 |
1.493 |
2.226 |
0.079 |
Tissue 2 |
1.466 |
2.241 |
0.079 |
Tissue 3 |
1.463 |
2.245 |
0.095 |
Mean of three tissues |
1.474 |
2.237 |
0.084 |
Relative SD of the three tissues |
1.1% |
0.4% |
11.0% |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Diisopentyl ether is considered as not irritant in the Human Skin Model Test.
- Executive summary:
A GLP compliant in-vitro study was performed according to OECD Guideline 439 in order to evaluate the potential of diisopentyl ether to evoke skin irritation in a human skin model. Two valid, independant experiments were performed. Three tissues of the human skin model EpiDerm were treated with diisopentyl ether for 60 minutes. After a post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. DPBS-buffer was used as negative control, 5% SDS-solution was used as postive control.
After treatment, the absorbance values in the negative controls were within the acceptability criterion. The positive control showed clear irritating effects. In the first experiment the relative absorbance values were increased to 148.2% after the treatment with diisopentyl ether. In the second experiment, the relative absorbance values were increased to 151.8% after the treatment with the test item. Both values are well above the threshold for irritation potential (50%) and therefore it can be concluded that diisopentyl ether is not a skin irritant in the Human Skin Model Test.
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