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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 Oct 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- adopted in 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- adopted in 2013
- Deviations:
- no
- 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
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- IDENTIFICATION OF THE SOURCE OF THE EYES, STORAGE AND TRANSPORT CONDITIONS
- Source: Attenberger Fleisch GmbH & Co. KG, Munich, Germany
- Date of eye collection: 30 Oct 2012
- Transport medium and temperature conditions: Hanks´ Balanced Salt Solution (HBSS) containing 5% penicillin/streptomycin on ice
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied in the test: 750 µL
- Concentration (if solution): 20%
VEHICLE
- Amount(s) applied in the test: 750 µL
- Lot/batch no. (if required): 111214
POSITIVE SUBSTANCE
- Substance: imidazole
- Concentration: 20%
- Solvent: physiol. saline
- Amount(s) applied in the test: 750 µL
- Lot/batch no.: 109K5306V - Duration of treatment / exposure:
- 4 h ± 5 min at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- 90 min at 32 ± 1°C
- Number of animals or in vitro replicates:
- 3 corneas each for the test item, negative and positive controls
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
- Eyes free of defects (scratches, neovascularisation): yes
- Dissection of the eyes and treatment: corneas were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in cornea holders.
- Type of cornea holder used: MC2, Clermont, France
- Description of the cornea holder: the cornea holders consist of an anterior and a posterior compartment, which interface with the epithelial and endothelial side of the cornea.
- Test medium and temperature conditions used in the cornea holder: RPMI 1640 without phenol red supplemented with 1% [v/v] fetal bovine serum and 2 mM L-glutamine
- Equilibration time: 1 h at 32 ± 1 °C in a water bath
DETERMINATION OF THE INITIAL OPACITY
- Method: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer.
- Specification of the device: MC2, Clermont, France
QUALITY CHECK OF THE ISOLATED CORNEAS
Corneas were visually checked for defects and any defective corneas were discarded. Corneas with an initial opacity reading above 7 units were discarded.
NUMBER OF REPLICATES
3
NEGATIVE CONTROL USED
0.9% NaCl
POSITIVE CONTROL USED
Imidazole (20% in 0.9 NaCl)
APPLICATION DOSE AND EXPOSURE TIME
Corneas were exposed to 750 µL of test substance and control substances for 4 h ± 5 min.
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: yes, 90 min at 32 ± 1°C
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: The test substance was removed and the epithelium washed at least three times with MEM containing phenol red. Once the medium was macroscopically free of test substance, the cornea was finally rinsed with complete RPMI 1640 phenol red.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer (MC2, Clermont, France).
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (OD490)
- Others (e.g, pertinent visual observations, histopathology): (please specify)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: Test substance with an IVIS ≥ 55.1 was regarded as severe irritant/corrosive and labelled Category 1 according to the decision criteria given in OECD 437.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 0.75
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Isomaltulose at a concenration of 20% (v/v) reached an in vitro irritation score of 0.75. According to the evaluation criteria, the test substance is not considerd an eye irritant.
The in vitro irritation score obtained with the positve control fell within the two standard deviations of the current historical mean and therefore the assay is considered to be valid.
Any other information on results incl. tables
Table 1: Opacity values
Parameter |
Initial opacity |
Final opacity |
Opacity change |
Mean opacity change of NC |
Corrected opacity change |
Mean opacity value |
Negative control (0.9% NaCl) |
2 |
4 |
2 |
1 |
- |
- |
3 |
3 |
0 |
||||
3 |
4 |
1 |
||||
Positive control |
4 |
155 |
151 |
- |
150 |
165.67 |
4 |
183 |
179 |
178 |
|||
4 |
174 |
170 |
169 |
|||
Test substance |
4 |
5 |
1 |
- |
0 |
0.33 |
2 |
3 |
1 |
0 |
|||
1 |
3 |
2 |
1 |
Table 2: Permeability values (optical density (OD) at 490 nm)
Parameter |
OD490 change |
Mean OD490 change of NC |
Corrected OD490 change |
Mean OD490 value |
Negative control (0.9% NaCl) |
0.015 |
0.017 |
|
|
0.012 |
||||
0.024 |
||||
Positive control |
1.812 |
|
1.795 |
1.846 |
1.906 |
1.889 |
|||
1.870 |
1.853 |
|||
Test substance |
0.014 |
|
-0.003 |
0.028 |
0.035 |
0.018 |
|||
0.086 |
0.069 |
Table 3: Historical Data
|
IVIS (positive control)
|
Mean value (MV)
|
203.04 |
Standard Deviation (SD)
|
27.63 |
MV – 2x SD
|
147.79 |
MV + 2x SD
|
258.29 |
Applicant's summary and conclusion
- Interpretation of results:
- other: non-irritant to the eye according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Under the conditions of the Bovine Corneal Opacity and Permeability (BCOP) Test the test item does not possess eye iritant properties.
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