Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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:
- 26 Sep - 01 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:
- 2 012
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- 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.
- 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
- Species:
- human
- Strain:
- other: EPISKIN-SM (TM): 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 system:
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.
- Adaptation to cell culture conditions: Upon receipt, tissues were transferred into 12-well plates containing 2 mL prewarmed maintenance medium per well and preincubated in a humidified incubator for at least 24 h (37 ± 1 °C, 5% CO2) before use.
ENVIRONMENTAL CONDITIONS (Incubator)
- Temperature (°C): 37 ± 1
- CO2 gas concentration (%): 5
- Humidity: maximum
Test system
- Type of coverage:
- open
- Preparation of test site:
- other: intact reconstructed human epidermis
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: concurrent control tissues treated with phosphate buffered saline served as negative controls, positive controls were exposed to 5% SDS.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 10 mg (26.3 mg/cm²)
POSITIVE CONTROL SUBSTANCE
- SDS, 5% (v/v) in aqua dest. - Duration of treatment / exposure:
- 15 ± 0.5 min
- Observation period:
- Not applicable. Post-treatment incubation period: 42 ± 1 h
- Number of animals:
- Not applicable.The test was performed in triplicates for each treatment and control group.
- Details on study design:
- TEST SITE
- Area of exposure: 0.38 cm²
REMOVAL OF TEST SUBSTANCE
- Washing: The test item was washed from the epidermal surface with phosphate buffered saline (PBS). Excess PBS was removed by blotting bottom with blotting paper.
- Time after start of exposure: 15 ± 0.5 min
- Post-treatment incubation period: 42 ± 1 h
CELL VIABILITY MEASUREMENTS
For determining alterations in cell viability, MTT reduction assays were performed 42 ± 1 h after the incubation period. Therefore, tissues were incubated in 2 mL prewarmed MTT solution for 3 h ± 5 min at 37 ± 1 °C and 5% CO2. Afterwards, tissues were dried on blotting paper and a total biopsy of the epidermis was performed. After separation of the epidermis and the collagen matrix, extraction of the formazan product from both parts was carried out in 500 µL acidic isopropanol. At the end of the extraction, extracts from the epidermis and collagen part were mixed and the optical density of 2 x 200 µL aliquots per sample was measured at 550 nm wave length in a plate spectrophotometer (Tecan Infinite 200, Tecan Austria).
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: other: cell viability (%)
- Value:
- 100
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of negative controls (PBS). Time point: 15 min. Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 7
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of positive controls (5% SDS). Time point: 15 min. Reversibility: other: not applicable. (migrated information)
- Irritation / corrosion parameter:
- other: other: cell viability (% of negative control)
- Value:
- 95
- Remarks on result:
- other:
- Remarks:
- Basis: other: mean value of the test item. Time point: 15 min. Reversibility: other: not applicable. (migrated information)
In vivo
- Irritant / corrosive response data:
- Topical application of Isomaltulose did not result in a decreased cell viability in the EPISKIN-SM model compared to the negative control tissues treated with PBS. In contrast, exposure to 5% SDS decreased the cell viability to 7% of the negative control tissues.
Any other information on results incl. tables
Table 1: 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:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.