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Diss Factsheets
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EC number: 908-700-6 | CAS number: 64519-82-0
- 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:
- 26 Sep - 01 Oct 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- adopted in 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- adopted in 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: L´Oréal Standard Operating Procedure: “EpiSkinTM SKIN IRRITATION TEST METHOD 15 min – 42 hours” – ECVAM Skin Irritation Validation Study – VALIDATION OF THE EpiSkinTM TEST METHOD 15 min – 42 hours FOR THE PREDICTION OF ACUTE SKIN IRRITATION OF CHEMICALS.
- Version / remarks:
- Version 1.8, adopted February 2009
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (BAYERISCHES LANDESAMT FÜR GESUNDHEIT UND LEBENSMITTELSICHERHEIT, LANDESINSTITUT FÜR ARBEITSSCHUTZ UND PRODUKTSICHERHEIT, München, Germany)
Test material
- Reference substance name:
- 6-O-α-D-glucopyranosyl-D-fructose
- EC Number:
- 237-282-1
- EC Name:
- 6-O-α-D-glucopyranosyl-D-fructose
- Cas Number:
- 13718-94-0
- Molecular formula:
- C12H22O11
- IUPAC Name:
- 6-O-alpha-D-glucopyranosyl-D-fructose
- Test material form:
- other: powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EPISKIN-SM (TM): reconstructed three-dimensional human epidermis model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: EpiDerm™ (EPI-200)
- Source strain:
- not specified
- Justification for test system used:
- The model represents a reconstructed three-dimensional skin model based on normal human-derived epidermal keratinocytes which have been cultured on a collagen matrix for 13 days in cell culture inserts to form a multilayered epidermis including basal, spinous and granular layers, and a multi-layered 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.
This system is recommended in international guidelines. - Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN-SM (TM): reconstructed three-dimensional human epidermis model (SkinEthic Laboratories, Lyon, France)
- Tissue batch number(s): 12-EKIN-035
- Date of initiation of testing: 26 Sep 2012
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation: 37 ± 1 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: the tissues were washed with PBS to remove any residual test item; excess PBS was removed by blotting bottom with blotting paper
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 h ± 5 min. at 37 ± 1 °C, 5.0% CO2
- Spectrophotometer: plate spectrophotometer (Tecan Infinite 200)
- Wavelength: 550 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: The quality of the EpiSkin tissue was assessed by undertaking an MTT cell viability test with SDS. The SDS concentration to inhibit tissue viability by 50% (IC 50) was determined to be 2.2 mg/mL (acceptance criteria: ≥ 1.5 mg/mL).
- Morphology: Histology scoring of HES stained vertical paraffin sections (n = 6) was used to assess morphology of the tissues. The tissues consisited of well-differentiated epidermis consissting of a basal layer, several spinous and granular layers and a thick stratum corneum with ascore of 21.8 ± 0.3, CV = 1.3% (acceptance criteria: ≥ 19.5)
- Contamination: The cells used to produce the EpSkin tissue were screened for the presence of bacteria, fungus and mycoplasma.
NUMBER OF REPLICATE TISSUES: 3 each, for the test substance, positive and negative control
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
not applicable
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: single experiment
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the tissue viability after 15 minutes exposure and 42 h post-incubation is less or equal to 50%.
- The test substance is considered to be non-irritant to skin if the viability after 15 minutes exposure and 42 h post-incubation is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent vehicle
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 10 mg ± 5 µL aqua dest. (26.3 mg/cm²)
VEHICLE
5 µL distilled water (aqua dest.) were applied by a pipette to the epidermal surface in order to improve further contact between the test subsbatnce and the epidermis. The water was gently spread with the pipette. Afterwards, the tes substance powder was applied to the epidermis surface.
NEGATIVE CONTROL
- Amount applied: 10 µL PBS
POSITIVE CONTROL
- Amount applied: 10 µL SDS
- Concentration: 5% - Duration of treatment / exposure:
- 15 ± 0.5 min
- Duration of post-treatment incubation (if applicable):
- 42 ± 1 h
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 3 tissues
- Run / experiment:
- 15 min
- Value:
- 95
- 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:
- Direct-MTT reduction: The mixture of 10 mg test item with 2 mL MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple.
- Colour interference with MTT: The mixture of 10 mg of the test item per with 90 µL aqua dest. showed no colouring detectable by unaided eye-assessment
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: mean OD550 nm of the three negative control tissues is ≥ 0.6 and ≤ 1.5
- Acceptance criteria met for positive control: mean relative tissue viability of the three positive control tissues is ≤ 40%
- Acceptance criteria met for variability between replicate measurements: the standard deviation (SD) of relative tissue viability obtained from each three concurrently tested tissues is < 18%
Any other information on results incl. tables
Table 2. MTT assay after 15 min exposure
|
Negative Control |
Positive Control |
Test Item |
Blank |
||||||
Tissue |
1 |
2 |
3 |
1 |
2 |
3 |
1 |
2 |
3 |
|
OD550 |
0.901 |
0.827 |
0.707 |
0.113 |
0.092 |
0.092 |
0.742 |
0.816 |
0.757 |
0.043 |
0.899 |
0.817 |
0.697 |
0.107 |
0.088 |
0.087 |
0.741 |
0.813 |
0.762 |
||
OD550(mean, blank corrected) |
0.857 |
0.779 |
0.659 |
0.067 |
0.047 |
0.047 |
0.698 |
0.771 |
0.717 |
|
SDOD550 |
0.089 |
0.011 |
0.034 |
|||||||
OD550(mean values of triplicates) |
0.765 |
0.053 |
0.729 |
|||||||
SD tissue viability (%) |
13.1 |
1.5 |
4.9 |
|||||||
Viability (%) |
100 |
7 |
95 |
According to the Test Acceptance Criteria, the validity criteria are fulfilled:
1. mean OD550 nm of the 3 negative control tissues is ≥ 0.6 and ≤ 1.5
2. OD550of the blank is < 0.1
3. mean relative tissue viability of the 3 positive control tissues is ≤ 40%
4. the standard deviation (SD) obtained from the three concurrently tested tissues is
< 18%.
Applicant's summary and conclusion
- Interpretation of results:
- other: non-irritant according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Under the conditions of the reconstructed human epidermis test the test item does not possess iritant properties.
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