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EC number: 203-380-8 | CAS number: 106-27-4
- 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:
- 2015-01-22 to 2015-02-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- yes
- Remarks:
- without any impact on the outcome of the study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- without any impact on the outcome of the study
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-methylbutyl butyrate
- EC Number:
- 203-380-8
- EC Name:
- 3-methylbutyl butyrate
- Cas Number:
- 106-27-4
- Molecular formula:
- C9H18O2
- IUPAC Name:
- 3-methylbutyl butanoate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm TM tissues (Epi-200-SIT Kit)
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEST SYSTEM
- Source: MatTek Corporation
- Cell culture: The EpiDerm™ tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm ).
- Pre-incubation period: pre-incubation phase of the EpiDerm™ tissues started on the day of receipt.
- Treatment: The test substance was added into the insert atop the corresponding EpiDerm™ triplicate tissues
- Amount/test concentration: 30 µL
- Duration of treatment: 60 minutes
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 35 minutes at 37 ± 1 °C in the remaining period at room temperature
- Temperature of post-treatment incubation: 37 ± 1 °C
CONTROL
- Negative Control: 30 µL DPBS (Gibco) was used as negative control per tissue;
- Positive Control: 30 µL of a 5 % SLS solution in deionised water (MatTek) was used a positive control per tissue, freshly prepared prior to the start of the experiment.
REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing: Tissues washed with DPBS at least 15 times in order to remove any residual test material. After the rinsing the inserts were submerged in DPBS at least three times
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 h
- Spectrophotometer: Versamax®Molecular Devices, Softmax Pro (version 4.7.1)
- Wavelength: 570 nm
- Filter: 570 ± 1 nm
- Viability:
Positive control: mean viability: 5.6 %; relative standard deviation: 2.4 %; range of viabilities: 2.9 - 11.3 %.
-Absorption:
Positive control: mean absorption: 0.098; relative standard deviation: 0.038 %; range of absorbance: 0.030 - 0.194
Negative control: mean absorption: 1.796; relative standard deviation: 0.281%, range of absorbance: 1.397 - 2.651
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
Yes. Evaluation of colour interference: 30 µL of the test item mixed with 300 µL deionised water was incubated for 60 minutes at 37 ± 1.5 °C. Since the colour of the test item mixture did not change during the incubation period, additional testing with viable tissues was not required.
Evaluation of direct reduction of MTT: 30 µL of the test item added to MTT (1 mg/mL). Incubated in the dark at room temperature for 60 minutes. Since the colour did not turn blue/purple, the test item was not considered to be a MTT reducer.
SCORING SYSTEM:
Viability measured using MTT assay
mean tissue viability < 50 %; irritant (I), H315 (category 2)
mean tissue viability > 50 %; non-irritant (NI)
Amount/concentration applied :undiluted
Duration of treatment / exposure: 60 minutes
Acceptability of the Assay
Criterion 1 (negative control): The absolute OD 570 nm of the negative control tissues in the MTT test is an indicator of tissue viability obtained after the shipping and storing procedure and under specific conditions of the assay. Tissue viability is meeting the acceptance criterion if the mean OD570 of the negative control tissues is > 0.8 and = 2.8.
Criterion 2 (positive control): An assay is meeting the acceptance criterion if mean relative tissue viability of the positive control is at or below 20 %.
Criterion 3 (standard deviation): The SD of 3 identical replicates should be < 18 %.
OD values should not be below historically established boundaries. - Control samples:
- yes, concurrent negative control
- yes, concurrent no treatment
- Amount/concentration applied:
- 30 µL
- Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 115.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: mean relative absorbance
- Other effects / acceptance of results:
- - Direct-MTT reduction: test item did not reduce MTT
- Colour interference with MTT: test item did not change colour in the colour interference test
- After treatment with the negative control the absorbance values were well in the required range of the acceptability criterion of mean OD = 0.8 and = 2.8 for the 60 minutes treatment interval, thus assuring the quality of the tissues.
- Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 60 minutes treatment interval, and thus assuring the validity of the test system; the mean relative absorbance value of the positive control was 3.8 % compared to the negative control.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions reported, the test substance is not irritating to skin.
- Executive summary:
The skin irritant potential of the test item was determined by means of the Human Skin Model Test (OECD 439). The relative absorbance value of the test item was 115.2% after exposure of the skin tissues to the test item. This value is above the threshold for irritancy of <= 50%. There, the test item is not considered to possess an irritant potential.
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