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Diss Factsheets
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EC number: 939-389-5 | CAS number: -
- 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:
- other: in-vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines for Testing of Chemicals, Guideline No. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method (adopted 22 July 2010)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: European Community (EC). Commission regulation (EC) No. 440/2008, Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.46 “In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test "
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EpiSkin™ SOP, Version 1.8 (February 2009), ECVAM Skin Irritation Validation Study: Validation of the EpiSkin™ test method 15 min - 42 hours for the prediction of acute skin irritation of chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Food and Consumer Product Safety Authority (VWA), GG Utrecht, The Netherlands
Test material
- Reference substance name:
- D-Glucopyranose, oligomeric, butyl glycoside
- EC Number:
- 939-389-5
- Molecular formula:
- not applicable, UVCB substance
- IUPAC Name:
- D-Glucopyranose, oligomeric, butyl glycoside
- Details on test material:
- - Name of test material (as cited in study report): LIN11001-butylglucoside
- Physical state: beige chunks
- Analytical purity: > 98%
- Expiration date of the lot/batch: 2013-02-06
- Storage condition of test material: at room temperature in the dark
- Other: stability under storage conditions: stable
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: EPISKIN Small ModelTM (EPISKIN-SMTM), reconstructed three-dimensional human epidermis model
- Details on test animals or test system and environmental conditions:
- TEST SKIN MODEL
- Source: SkinEthic Laboratories, Lyon, France
TEST METHOD
This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum. Irritant materials are identified by their ability to penetrate the stratum corneum and to damage the underlaying cell layers which is determined through a decrease in cell viability as determined by MTT reduction assay.
ADAPTATION TO CELL CULTURE CONDITIONS
On the day of receipt, the tissues were transferred to 12-well plates and preincubated with prewarmed Maintenance Medium (SkinEthic Laboratories, Lyon, France) for 24 h at 37 °C.
INCUBATION CONDITIONS (INCUBATOR)
- Temperature (°C): 36.2-37.6
- CO2 gas concentration (%): 5.0 ± 0.5
- Humidity (%): 80-97
Test system
- Type of coverage:
- other: open (in vitro system)
- Preparation of test site:
- other: intact reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent control tissues treated with PBS served as negative controls, positive controls were exposed to 5% SDS
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 11.9-13.6 mg on the skin tissue moistened with 5 μL of Milli-Q water (Millipore Corp., Bedford, Mass., USA)
POSITIVE CONTROL SUBSTANCE:
- Positive control substance: SDS (Sigma Aldrich, Zwijndrecht, The Netherlands), 5% (v/v) in PBS - Duration of treatment / exposure:
- 15 min
- Observation period:
- Not applicable. Post-treatment incubation period: 44 h
- Number of animals:
- Not applicable. The test was performed in triplicates for each treatment and control group.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: the tissues were washed with PBS to remove residual test substance.
- Time after start of exposure: 15 min
- Post-treatment incubation period: 44 h
CELL VIABILITY MEASUREMENTS
For determining alterations in cell viability, MTT reduction assays were performed 44 h after the incubation period. Therefore, tissues were incubated in 2 mL prewarmed MTT solution (0.3 mg/mL) for approximately 3 h at 37 °C and 5% CO2. After aspiration of the MTT solution, tissues were placed on blotting paper for drying. Extraction of the formazan product was carried out in 0.5 mL isopropanol (Merck, Darmstadt, Germany). The optical density was measured at 570 nm wave length in a 96 wells plate using a plate spectrophotometer (TECAN Infinite® M200 Pro Plate Reader).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: cell viability (% of negative control)
- Basis:
- other: mean value of negative controls (sterile Milli-Q water)
- Time point:
- other: 15 min
- Score:
- 100
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- other: cell viability (% of negative control)
- Basis:
- other: mean value of positive controls (5% SDS)
- Time point:
- other: 15 min
- Score:
- 5
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- other: cell viability (% of negative control)
- Basis:
- other: mean value of the test item (100%)
- Time point:
- other: 15 min
- Score:
- 99
- Reversibility:
- other: reversibility: not applicable
- Other effects:
- No further effects were observed.
Any other information on results incl. tables
Table 3. Results of MTT assay after 15 min exposure
|
Negative control |
Positive control |
Test item |
||||||
Tissue sample |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
OD570 |
0.908 0.947 |
0.941 0.968 |
0.970 1.001 |
0.045 0.051 |
0.039 0.065 |
0.042 0.057 |
0.957 0.982 |
0.951 0.845 |
0.988 0.979 |
OD570 (mean) |
0.928 |
0.955 |
0.986 |
0.048 |
0.052 |
0.050 |
0.970 |
0.898 |
0.984 |
SD |
0.028 |
0.019 |
0.022 |
0.004 |
0.018 |
0.011 |
0.018 |
0.075 |
0.006 |
OD550 (mean values of replicates ± SD) |
0.956 ± 0.029 |
0.050 ± 0.002 |
0.950 ± 0.046 |
||||||
Viability (%) |
100 |
5 |
99 |
OD = optical density; SD = standard deviation
In this table, the values are corrected for background absorption (0.042). Isopropanol was used to measure the background absorption.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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