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EC number: 900-501-2 | 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 30 Oct 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-Guideline study, tested with the source substance isomaltulose (Cas# 13718-94-0). According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
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:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- 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
- Details on test material:
- - Name of test material (as cited in study report): Isomaltulose
- Analytical purity: ≥ 98%
- Physical state: fine white powder
- Lot/batch No.: L121291500
- Expiration date of the lot/batch: 8 April 2014
- Storage condition of test material: at room temperature
Constituent 1
Test animals / tissue source
- Species:
- other: 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
PREPARATION OF THE EYES (BEFORE EXPOSURE)
- 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
- Quality check of the equilibrated corneas: initial opacity measurement; corneas with an initial opacity above 7 in the opacitometer were discarded.
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
Test system
- Vehicle:
- physiological saline
- Controls:
- other: 3 corneas each for the negative (physiological saline, 0.9% NaCl) and the positive control (20% imidazole)
- 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
- Observation period (in vivo):
- not applicable
- Number of animals or in vitro replicates:
- 3 corneas for the test item
- Details on study design:
- TEST CONDITIONS
- Short description of the method used: closed-chamber method.
The test substance or control substances were introduced into the anterior chamber.
POST-EXPOSURE TREATMENT
- Removal of the test substance: The test substance was removed after 4 h incubation and the epithelium washed at least three times with MEM.
- Medium for washing the corneas: MEM containing phenol red
- Medium for final rinsing: RPMI 1640 without phenol red
DETERMINATION OF THE FINAL OPACITY
- Method: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer.
- Time of determination: After refilling the anterior chamber with fresh RPMI 1640, the final opacity was measured.
- Specification of the device: MC2, Clermont, France
DETERMINATION OF THE CORNEAL PERMEABILITY:
- Method: Sodium fluorescein solution was added to the anterior chamber of the cornea holder while the posterior chamber was filled with fresh medium. The amount of sodium fluorescein that crosses into the posterior chamber was quantitatively measured via UV/VIS spectrophotometry at 490 nm recorded as optical density (OD490).
- Amount and concentration of the dye: 1 mL sodium fluorescein solution (5 mg/mL)
- Incubation time: 90 min at 32 ± 1 °C
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
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: opacity
- Basis:
- other: mean (out of all 3 eyes)
- Time point:
- other: 4 h
- Score:
- 1
- Reversibility:
- other: not applicable
- Remarks on result:
- other: negative control (0.9% NaCl)
- Irritation parameter:
- other: opacity
- Basis:
- other: mean (out of all 3 eyes)
- Time point:
- other: 4 h
- Score:
- 166.67
- Reversibility:
- other: not applicable
- Remarks on result:
- other: positive control (20% imidazole)
- Irritation parameter:
- other: opacity
- Basis:
- other: mean (out of all 3 eyes)
- Time point:
- other: 4 h
- Score:
- 1.33
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test item (20% isomaltulose)
- Irritation parameter:
- other: permeability
- Basis:
- other: mean (out of all 3 eyes)
- Time point:
- other: 5 h 30 min
- Score:
- 0.017
- Reversibility:
- other: not applicable
- Remarks on result:
- other: negative control (0.9% NaCl)
- Irritation parameter:
- other: permeability
- Basis:
- other: mean (out of all 3 eyes)
- Time point:
- other: 5 h 30 min
- Score:
- 1.846
- Reversibility:
- other: not applicable
- Remarks on result:
- other: positive control (20% imidazole)
- Irritation parameter:
- other: permeability
- Basis:
- other: mean (out of all 3 eyes)
- Time point:
- other: 5 h 30 min
- Score:
- 0.028
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test item (20% isomaltulose)
- Irritation parameter:
- other: IVIS
- Basis:
- other: mean (out of all 3 eyes)
- Score:
- 1.26
- Reversibility:
- other: not applicable
- Remarks on result:
- other: negative control (0.9% NaCl)
- Irritation parameter:
- other: IVIS
- Basis:
- other: mean (out of all 3 eyes)
- Score:
- 193.35
- Reversibility:
- other: not applicable
- Remarks on result:
- other: positive control (20% imidazole)
- Irritation parameter:
- other: IVIS
- Basis:
- other: mean (out of all 3 eyes)
- Score:
- 0.75
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test item (20% isomaltulose)
- Irritant / corrosive response data:
- 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 as severe 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: not corrosive/severe irritant
- Conclusions:
- There is regulatory acceptance in the EU that a substance can be considered a severe eye irritant (Serious eye damage Category 1/R41) based on a positive result in the Bovine Corneal Opacity and Permeability (BCOP) test. Negative in vitro corrosivity responses are not conclusive with respect to non-classification or classification as irritant (Category 2/R36) and shall therefore be subject to further evaluation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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