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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 irritation (OECD 439): not irritating
Eye irritation (OECD 437): not irritating
Read-acrross from isomaltulose (CAS 13718 -94 -0)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- 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
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 3 tissues
- Run / experiment:
- 15 min
- Value:
- 95
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Source: CAS 13718-94-0, Lehmeier, 2012, EpiSkin
- Interpretation of results:
- other: non-irritant according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
Under the conditions of the reconstructed human epidermis test the test item does not possess iritant properties. Applying the read-across approach, similar results are expected for the target substance.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 30 Oct 2012
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Number of animals or in vitro replicates:
- 3 corneas each for the test item, negative and positive controls
- Irritation parameter:
- in vitro irritation score
- Value:
- 0.75
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Source: CAS 13718-94-0, Luetkenhaus, 2013, BCOP
- 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. Applying the read-across approach, similar results are expected for the target substance.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for read-across
There are no experimental data available regarding skin and eye irritation/corrosion for Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol. Thus, read-across from an appropriate surrogate substance (isomaltulose, CAS 13718-94-0) is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5 in order to fulfil the standard information requirements defined in Regulation (EC) No 1907/2006, Annex VII and VIII, 8.1. Common functional groups and structural similarities 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 irritation in vitro
The skin irritation potential of isomaltulose (CAS 13718-94-0) was determined in a GLP-compliant in vitro skin irritation test according to OECD 439 on EpiSkinTM human skin equivalents (SkinEthic laboratories, Lyon, France) after moistening (Lehmeier, 2012). After exposure to 10 mg isomaltulose and a post-incubation period of 42 h, cytotoxicity measurements revealed a relative mean tissue viability of 95% compared to the respective controls. In contrast, application of the positive control substance SDS (5%) reduced the relative tissue cell viability to 7% of the control tissues thereby validating the study. In accordance with the classification criteria given in OECD guideline 439 and Regulation (EC) No 1272/2008, isomalutlose is considered as non-irritant.
Furthermore, no signs of skin irritation were noted in a Local Lymph Node Assay conducted with isomaltulose. Thus, together with the available data on in vitro skin irritation, there is sufficient weight of evidence available leading to the conclusion that isomaltulose and hence isomalt is not irritating to skin.
Based on the available data on the surrogate substance isomaltulose, Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol is not considered to exhibit irritating properties to the skin.
Eye irritation in vitro
The eye irritation/corrosion potential of isomaltulose (CAS 13718-94-0) was tested in a GLP-compliant in vitro bovine corneal opacity and permeability test according to OECD 437 (Lütkenhaus, 2013). 750 µL of the test item solution, 20% dissolved in 0.9% NaCl, were introduced into the anterior chamber of the corneal holders for 4 h. Subsequent measurements after rinsing revealed a mean opacity value of 1.33 and a mean permeability value of 0.028 resulting in an in vitro irritancy score (IVIS) of 0.75. According to the evaluation criteria given in OECD 437, the conducted in vitro test did not identify isomaltulose as an ocular irritant.
Based on the available data on the surrogate substance isomaltulose, Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol is not considered to exhibit irritating properties to the eye.
Justification for classification or non-classification
Based on read-across, the available data on skin or eye irritation are conclusive but not sufficient for classification
according to Regulation (EC) No. 1272/2008.
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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