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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
Endpoint summary
Administrative data
Description of key information
skin sensitisation (OECD 429, mouse): not sensitising
Read-across from isomaltulose (CAS 13718 -94 -0)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- refer to analogue approach justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- test substance at 6.25%
- Remarks on result:
- other: Source: CAS 13718-94-0, Luetkenhaus, 2013, LLNA
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- test substance at 12.5%
- Remarks on result:
- other: Source: CAS 13718-94-0, Luetkenhaus, 2013, LLNA
- Key result
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- test substance at 25%
- Remarks on result:
- other: Source: CAS 13718-94-0, Luetkenhaus, 2013, LLNA
- Parameter:
- SI
- Value:
- 13.7
- Test group / Remarks:
- positve control
- Interpretation of results:
- other: not sensitising according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Justification for read-across
Data on the sensitisation potential of Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol are not available. The assessment of its sensitistaion potential was therefore based on studies conducted with a surrogate substance, isomaltulose (CAS 13718 -94 -0) as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Common functional groups and structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
Skin sensitisation
The sensitisation potential of isomaltulose (CAS 13718-94-0) was assessed in a GLP-conducted local lymph node assay according to OECD 429 in female CBA/CaOlaHsD mice (Lütkenhaus, 2013). Given the results of a preliminary test, test animals were exposed to 6.25, 12.5 and 25% (w/v) test item solutions suspended in DMSO. According to OECD 429, the test substance was applied topically to the entire surface of each ear of each mouse once daily for three consecutive days. The proliferative response of lymphocytes in the draining auricular lymph nodes was determined via 3H-methyl thymidine incorporation and the stimulation indices relative to the sham treated controls were calculated. No mortality, clinical signs of toxicity, alterations in body weight or local effects at the application site were observed until the end of the study. Furthermore, no dose-related lymphoproliferative response exceeding the threshold level (SI ≥ 3) was noted for the test substance at the tested concentrations. In detail, the observed stimulation index values were 1.0, 1.0 and 0.9 at test item concentrations of 6.25, 12.5 and 25%, respectively. Thus, isomaltulose did not induce skin sensitisation in the conducted study.
Based on the available data on the sensitising potential of isomaltulose, Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol is not considered to exhibit sensitising properties.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on read-across, the available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.
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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