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EC number: 309-363-2 | CAS number: 100231-63-8
- 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:
- 09 - 14 Nov 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 23 July 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM, Medicines & Healthcare products Regulatory Agency
Test material
- Reference substance name:
- Pentyl D-glucoside
- EC Number:
- 309-363-2
- EC Name:
- Pentyl D-glucoside
- Cas Number:
- 100231-63-8
- Molecular formula:
- (C6H10O5)nC5H12O, n - number of D-glucopyranose units
- IUPAC Name:
- (2R,3S,4S,5R,6R)-2-(hydroxymethyl)-6-{[(2R,3S,4S,5R,6R)-3,4,5-trihydroxy-6-(pentyloxy)oxan-2-yl]methoxy}oxane-3,4,5-triol; (2S,3R,4R,5S,6S)-2-(hydroxymethyl)-6-(pentyloxy)oxane-3,4,5-triol
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: SkinEthic Laboratories, Lyon, France
- Source strain:
- other: EPISKIN™; reconstructed three-dimensional human epidermis
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEST METHOD:
The purpose of this test was to evaluate the skin irritation potential of the test item using the EPISKIN reconstructed human epidermis model after a treatment period of 15 min followed by a post-exposure incubation period of 42 h. 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 coated with type IV collagen. A highly differentiated and stratified epidermis model is obtained comprising of the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
The principle of the assay is based on the measurement of cytotoxicity in reconstructed human epidermal cultures following topical exposure to the test item by means of the colorimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt to a blue formazan salt within the mitochondria of viable cells in the test item treated tissues relative to the negative controls.
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE:
- Model used: EPISKIN™ Reconstructed Human Epidermis Model
- Tissue batch number: 16-EKIN-045
- Delivery date: 08 November 2016
- Maintenance Medium lot number: 16-MAIN3-075
- Assay Medium lot number: 16-ESSC-048
ADAPTATION TO CELL CULTURE CONDITIONS (PRE-INCUBATION):
2 mL of maintenance medium, warmed to approximately 37 °C, was pipetted into the first column of 3 wells of a pre-labelled 12-well plate. Each epidermis unit was transferred into the maintenance medium filled wells (3 units per plate). A different 12-well plate was used for the test item and each control item (positive and negative). The tissues were incubated at 37 °C, 5% CO2 in air overnight.
TREATMENT AND RINSING:
2 mL of maintenance medium, warmed to approximately 37 °C, was pipetted into the second column of 3 wells of the 12-well plate. Triplicate tissues were treated with 10 µL of the test item. The test item was applied topically to the corresponding tissues ensuring uniform covering. Triplicate tissues treated with 10 μL of Dulbecco’s Phosphate Buffered Saline (DPBS) served as the negative controls and triplicate tissues treated with 10 μL of Sodium Dodecyl Sulphate (SDS) 5% w/v served as the positive controls. To ensure satisfactory contact with the positive control item, the SDS solution was spread over the entire surface of the epidermis using a pipette tip (taking particular care to cover the centre). The plates were kept at room temperature for 15 min.
At the end of the exposure period, each tissue was removed from the well using forceps and rinsed using a wash bottle containing DPBS with Ca++ and Mg++. Rinsing was achieved by means of a constant soft stream of DPBS to gently remove any residual test item. The rinsed tissues were transferred to the second column of 3 wells containing 2 mL of maintenance medium in each well. The rinsed tissues were incubated at 37 °C, 5% CO2 in air for 42 h.
MTT LOADING, FORMAZAN EXTRACTION AND OPTICAL DENSITY MEASUREMENT.
Following the 42 h post-exposure incubation period each 12-well plate was placed onto a plate shaker for 15 min to homogenize the released mediators in the maintenance medium. 1.6 mL of the maintenance medium from beneath each tissue was transferred to pre-labeled micro tubes and stored in a freezer at -14 to -30 ºC for possible inflammatory mediator determination.
2 mL of a 0.3 mg/mL MTT solution, freshly prepared in assay medium, was pipetted into the third column of 3 wells of the 12-well plates. The tissues were transferred to the MTT filled wells, being careful to remove any excess maintenance medium from the bottom of the tissue insert by blotting on absorbent paper. The tissues were incubated for 3 h at 37 °C, 5% CO2 in air. At the end of the 3 h incubation period each tissue was placed onto absorbent paper to dry. A total biopsy of the epidermis was made. The epidermis was carefully separated from the collagen matrix using forceps and both parts (epidermis and collagen matrix) placed into labelled 1.5 mL micro tubes containing 500 μL of acidified isopropanol, ensuring that both the epidermis and collagen matrix were fully immersed. Each tube was plugged to prevent evaporation and mixed thoroughly on a vortex mixer. The tubes were refrigerated at 1 to 10 °C for 72 h, allowing the extraction of formazan crystals out of the MTT-loaded tissues.
At the end of the formazan extraction period each tube was mixed thoroughly on a vortex mixer to produce a homogenous coloured solution. For each tissue, duplicate 200 μL samples were transferred to the appropriate wells of a pre-labelled 96-well plate. 200 μL of acidified isopropanol alone was added to the two wells designated as ‘blanks’. The optical density was measured (quantitative viability analysis) at 562 nm (without a reference filter) using the Anthos 2001 microplate reader.
NUMBER OF REPLICATE TISSUES: triplicates
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL:
- The test substance is considered to be irritating to skin if the viability is less than or equal to 50% after a 15 min exposure period followed by a 42 h post-exposure incubation period
- The test substance is considered to be not irritating to skin if the viability is greater than 50% after a 15 min exposure period followed by a 42 h post-exposure incubation period - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µL (26.3 μL/cm2)
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 10 µL
- Concentration (if solution): 5% (w/v) - Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- The test was performed in triplicates for each test or control group.
Test animals
- Species:
- other: in vitro system
Test system
- Type of coverage:
- other: in vitro system
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean of all 3 test item tissues
- Value:
- 90.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no, as assessed in a suitable pre-experiment
- Colour interference with MTT: no, as assessed in a suitable pre-experiment
- IL-1alpha analysis: considered unnecessary as the results of the MTT test were unequivocal
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, OD of negative control 0.836 (criterion: OD ≥ 0.8 and ≤ 2.8)
- Acceptance criteria met for positive control: yes, tissue viability 11.8% (criterion: tissue viability ≤ 20%)
- Acceptance criteria met for variability between replicate measurements: yes, SD 1.3% (negative control), 4.2% (positive control), 8.3% (test item) (criterion: ≤ 18%)
Any other information on results incl. tables
Table 1: Mean OD562Values and Viabilities for the Negative Control Item, Positive Control Item and Test Item
Item |
OD562 of tissues |
Mean OD562 of triplicate tissues |
± SD of OD562 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative control item |
0.839 |
0.836 |
0.011 |
100.4 |
100* |
1.3 |
0.846 |
101.2 |
|||||
0.824 |
98.6 |
|||||
Positive control item |
0.138 |
0.099 |
0.035 |
16.5 |
11.8 |
4.2 |
0.089 |
10.6 |
|||||
0.070 |
8.4 |
|||||
Test item |
0.752 |
0.756 |
0.070 |
90.0 |
90.4 |
8.3 |
0.827 |
98.9 |
|||||
0.688 |
82.3 |
OD = Optical Density
SD = Standard deviation
∗= The mean viability of the negative control tissues is set at 100%
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- There is regulatory acceptance in the EU that a substance can be considered to be not irritating to skin based on an appropriate result in the human epidermis model test (OECD 439).
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