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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 209-567-0 | CAS number: 585-88-6
- 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:
- From 14 August 2018 to 05 November 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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: EpiSkin™ SOP, Version 1.8 (February 2009), ECVAM Skin Irritation Validation Study: Validation of the EpiSkin™ test method 15 min - 42 hours for the prediction of acute skin irritation of chemicals.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-O-α-D-glucopyranosyl-D-glucitol
- EC Number:
- 209-567-0
- EC Name:
- 4-O-α-D-glucopyranosyl-D-glucitol
- Cas Number:
- 585-88-6
- Molecular formula:
- C12H24O11
- IUPAC Name:
- 4-O-α-D-glucopyranosyl-D-glucitol
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: supplied by the sponsor; Batch/Lot number: ELEL7
- Expiration date of the lot/batch: 07 October 2022
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity: not applicable
- Specific activity: not applicable
- Locations of the label: not applicable
- Expiration date of radiochemical substance: not applicable
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: controlled room temperature
- Stability under test conditions: not applicable
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none
- Preliminary purification step (if any): none
- Final dilution of a dissolved solid, stock liquid or gel: none
- Final preparation of a solid: none
FORM AS APPLIED IN THE TEST (if different from that of starting material) : tested as supplied
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable) : not applicable
OTHER SPECIFICS: none
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: three-dimensional human epidermis model (EPISKINTM (SM))
- Cell source:
- other: adult donors
- Source strain:
- other: not applicable
- Details on animal used as source of test system:
- Not applicable (EPISKINTM (SM) kits).
- Justification for test system used:
- The EPISKINTM (SM) model has been validated for irritation testing in an international validation study and its use is recommended by the relevant OECD guideline for irritation testing (OECD No. 439); therefore, it was considered to be suitable for this study.
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- prior to test item application, distilled water was applied to the epidermal surface in order to improve further contact between test item and epidermis.
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN TM (SM) model
- Tissue batch number(s): 18-EKIN-036
- Production date: 04 September 2018
- Shipping date: not specified
- Delivery date: not specified
- Date of initiation of testing: 05 September 2018
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: at room temperature (23.4-25.3°C)
- Temperature of post-treatment incubation (if applicable): 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: volume not specified, once (After the 15 minutes incubation time, the EPISKINTM (SM) units were removed and rinsed thoroughly with PBS to remove any remaining material from the epidermal surface as much as possible. The rest of the PBS was removed from the epidermal surface with a pipette (without touching the epidermis).
- Observable damage in the tissue due to washing: not specified
- Modifications to validated SOP: none specified
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL (MTT working solution)
- Incubation time: 3 hours at 37°C
- Spectrophotometer: not specified
- Wavelength: 570 nm
- Filter: not specified
- Filter bandwidth: not specified
- Linear OD range of spectrophotometer: not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
After receipt, the two indicators of the delivered kit were checked. Based on the observed colours, the epidermis units were in proper conditions.
EPISKINTM (SM) kits are manufactured according to defined quality assurance procedures (certified ISO 9001). All biological components of the epidermis and the kit culture medium have been tested for the presence of viruses, bacteria and mycoplasma.
The quality of the final product is assessed by undertaking a MTT cell viability test and a cytotoxicity test with sodium dodecyl sulphate (SDS). These quality control experiments were conducted at SkinEthic laboratories (supplier of the EPISKINTM (SM) test kits used in the present study) and were documented in an appendix to the study report.
NUMBER OF REPLICATE TISSUES: three replicates were used for the test item
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE : not applicable (the test material did not interact with MTT).
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
-The test item may be considered to be non-irritant to skin in accordance with UN GHS (No Category), if the mean relative viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours post incubation is more than (˃) to 50% of the mean viability of the negative controls.
-The test chemical is identified as requiring classification and labelling according to UN GHS (Category 2 or Category 1) if the mean relative viability of three individual tissues after 15 minutes of exposure to the test item and 42 hours post incubation is less or equal (≤) to 50% of the mean viability of the negative controls.
-In case the test chemical is found to be non-corrosive, and shows tissue viability after exposure and post-treatment incubation is less than or equal (≤) to 50%, the test chemical is considered to be irritant to skin in accordance with UN GHS Category 2.
- Justification for the selection of the cut-off point(s) if different than recommended in TG 431 and 439: not applicable (not different from TG 439 recommendations). - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg
- Concentration (if solution): not applicable
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
- Concentration (if solution): not applicable
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 μL
- Concentration (if solution): 5% (w/v) - Duration of treatment / exposure:
- 15 minutes (± 0.5 min) at room temperature (23.4-25.3°C).
- Duration of post-treatment incubation (if applicable):
- 42 hours + 3 hours (MTT test)
- Number of replicates:
- 3 replicates were used for the test item.
3 negative controls and 3 positive controls were also run in the assay.
Furthermore, as the test item was coloured, 2 additional test item-treated living tissues were used for the non-specific OD evaluation.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- relative viability compared to the negative control
- Run / experiment:
- 1 (mean three samples)
- Value:
- 93.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: none specified.
- Direct-MTT reduction: no colour change (yellow colour) was observed after three hours of incubation of the test item in MTT working solution, the test material did not interact with MTT.
- Colour interference with MTT: The mean optical density (measured at 570 nm) of tissues was 0.011, Non Specific Colour % was calculated as 1.3%
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS: All thee parameters below met the acceptability criteria, therefore the study was considered to be valid.
- Acceptance criteria met for negative control: As no colour change (yellow colour) was observed after three hours of incubation of the test item in MTT working solution, the test material did not interact with MTT. Therefore, additional controls and data calculations were not necessary. The false estimation of viability can be excluded.
- Acceptance criteria met for positive control: As the test item was coloured (white), two additional test item-treated living tissues were used for the non-specific OD evaluation. The mean optical density (measured at 570 nm) of tissues was 0.011, Non Specific Colour % was calculated as 1.3%. This value was below 5%, therefore additional data calculation was not necessary (mean blank value was 0.048).
- Acceptance criteria met for variability between replicate measurements: The standard deviation of viability values of the three test item-treated tissue samples in the MTT assay was 3.1%.
- Range of historical values if different from the ones specified in the test guideline:
Negative control (PBS) (number of cases 251)
Mean optical density (OD): 0.788 ± 0.129 (SD) (Min. OD: 0.573 and Max. OD: 1.362)
Positive control (5% (w/v) SDS solution) (number of cases 246):
Mean optical density (OD): 0.065 ± 0.041 (SD) (Min. OD: 0.019 and Max. OD: 0.354)
Any other information on results incl. tables
Table 1 : Optical Density (OD) and the calculated relative viability % of the samples
Substance | Optical Density (OD) | Viability (% RV) | Standard Deviation | ||
Measured | Blank corrected | ||||
Negative control (Phosphate buffered saline) |
1 | 0.834 | 0.786 | 97.0 | 2.7 |
2 | 0.866 | 0.818 | 100.9 | ||
3 | 0.876 | 0.828 | 102.1 | ||
mean | - | 0.811 | 100.0 | ||
Positive Control (5% (w/v) SDS solution) |
1 | 0.072 | 0.025 | 3.0 | 1.0 |
2 | 0.076 | 0.029 | 3.5 | ||
3 | 0.088 | 0.040 | 4.9 | ||
mean | - | 0.031 | 3.8 | ||
Test item (Maltitol) | 1 | 0.807 | 0.760 | 93.7 | 3.1 |
2 | 0.833 | 0.786 | 96.9 | ||
3 | 0.783 | 0.736 | 90.7 | ||
mean | - | 0.760 | 93.8 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this in vitro skin irritation study, the test item Maltitol, is not irritant to skin. The test material is not classified as irritating to the skin according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.
- Executive summary:
This GLP compliant study was performed to assess the skin irritation potential of the test item Maltitol in vitro using the reconstructed human epidermis model EPISKINTM (SM). This test was performed according to the OECD Test Guideline No. 439.
Material and methods
Disks of EPISKINTM (SM) (three units) were treated with the test item and incubated for 15 minutes at room temperature. Exposure of the test item was terminated by rinsing with Phosphate Buffered Saline (PBS). The epidermis units were then incubated at 37°C for 42 hours in an incubator with 5% CO2, in a >95% humidified atmosphere. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in an incubator with 5% CO2, in a >95% humidified atmosphere, protected from light. The precipitated formazan crystals were then extracted using acidified isopropanol and quantified spectrophotometrically.
PBS and 5% (w/v) Sodium Dodecyl Sulphate (SDS) solution treated epidermis were used as negative and positive controls, respectively (three units / control). Two additional disks were used to provide an estimate of color contribution (NSCliving) from the test item. The test item did not react with MTT and therefore the use of additional controls was not necessary. For each treated tissue, the viability was expressed as a % relative to the negative control. If the mean relative viability after 15 minutes exposure and 42 hours post incubation is less or equal (≤) to 50% of the negative control, the test item is considered to be irritant to skin.
Results
Following exposure with Maltitol, the mean cell viability was 93.8% compared to the negative control. This is above the threshold of 50%, therefore the test item was considered as being non-irritant to skin. The experiment met the validity criteria, therefore the study was considered to be valid.
Conclusion
In conclusion, under the experimental conditions of this in vitro skin irritation study, the test item Maltitol, is not irritant to skin. The test material is not classified as irritating to the skin according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.
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.