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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 473-690-8 | CAS number: 738602-93-2
- 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
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
Predictions of the reproductive effects of the identified constituents have been performed using OECD QSAR Toolbox.
The majority of source substances were tested to different top doses without showing effects. Therefore the derived regression presents a worst-case assumption, as data with qualifiers (">") was used.
In addition, the carbohydrate monomers of the substance, Glucose and Glucitol are listed in Annex IV of REACH.
Although Maltotriose and Maltrotetraose are typically hydrogenated in
the manufacturing process of MG-60 and only small amounts can be present in MG-60,
these oligosaccharides are included in the prediction approach to cover also
representatives of the starting materials of MG-60.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- May 2021
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Prediction from OECD QSAR Toolbox
- Justification for type of information:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
[Please provide information for all of the points below addressing endpoint-specific elements that were not already covered by the overall category approach justification made available at the category level. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]
1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
The OECD QSAR Toolbox is designed to create categories of substances based on defined similarity criterions. The category consists of similar substances and experimental data for category members is available. Therefore a prediction for the target chemical is possible based on the experimental data of the source substances. For details, please refer to attached documentation.
2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
[Summarise here based on available experimental data how these results verify that the read-across is justified]
The OECD QSAR Toolbox is designed to create categories of substances based on defined similarity criterions. Data is gathered from internationally recognised inventories and databases. For details, please refer to attached documentation.
1. SOFTWARE
OECD QSAR Toolbox
2. MODEL (incl. version number)
4.4.1
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
OC[C@H](O)[C@@H](O)[C@H](O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O)[C@H](O)CO
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
[[Explain how the model fulfils the OECD principles for (Q)SAR model validation. Consider attaching the QMRF and/or QPRF or providing a link]
- Defined endpoint: for this prediction, any studies on reproductive effects were considered. Therefore the defined endpoint is "reproductive toxicity"
- Unambiguous algorithm: the prediction is done based on categorising similar chemicals with known experimental data
- Defined domain of applicability: the category is build up around the target substance. Therefore the substance is within the domain of applicability
- Appropriate measures of goodness-of-fit and robustness and predictivity: given in reports
- Mechanistic interpretation: when effects are predicted, an analysis of the category members contributing to the prediction will be done and a mechanistic interpretation will be performed.
5. APPLICABILITY DOMAIN
[Explain how the substance falls within the applicability domain of the model]
The category build up with QSAR toolbox considers the structural, empirical and/or mechanistical (including metabolism) properties of the substance. Therefore the category which is used for predicition is unique to the substance and it can be concluded that the substance falls within the applicability domain.
6. ADEQUACY OF THE RESULT
[Explain how the prediction fits the purpose of classification and labelling and/or risk assessment]
No adverse effects for the substance are predicted. Therefore information are available to conclude on classification. - Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Prediction using OECD QSAR Toolbox.
- GLP compliance:
- no
- Limit test:
- no
- Specific details on test material used for the study:
- not applicable for in silico
- Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- experimental data from various studies using mainly rats is considered.
- Sex:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 3 130 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- reproductive performance
- Remarks on result:
- other: predicted value
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 3 130 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: any toxicological effects
- Key result
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 3 130 mg/kg bw/day (nominal)
- Treatment related:
- no
- Conclusions:
- A NOAEL of 3130 mg/kg bw/day for Reproductive effects is predicted using OECD QSAR Toolbox.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The carbohydrate monomers, which build up the constituents of the substance are Glucose and Glucitol, both substances which are listed in Annex IV of REACH. These two substance are exempted from Registration as sufficient information is available that they are considered to cause minimum risk because of their intrinsic properties. The constituents of the substance will be readily metabolised by specialised enzymes in the gastro-intestinal tract (enzymatic cleavage of glycosidal 1,4-bond) to yield Glucose and Glucitol.
Effects on developmental toxicity
Description of key information
Predictions of the reproductive effects of the identified constituents have been performed using OECD QSAR Toolbox.
The majority of source substances were tested to different top doses without showing effects. Therefore the derived regression presents a worst-case assumption, as data with qualifiers (">") was used.
In addition, the carbohydrate monomers of the substance, Glucose and Glucitol are listed in Annex IV of REACH.
Under REACH Annex VII or VIII, no specific information on developmental toxicity is requested. However, the available predictions give hints to the absence of developmental effects.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
The carbohydrate monomers, which build up the constituents of the substance are Glucose and Glucitol, both substances which are listed in Annex IV of REACH. These two substance are exempted from Registration as sufficient information is available that they are considered to cause minimum risk because of their intrinsic properties. The constituents of the substance will be readily metabolised by specialised enzymes in the gastro-intestinal tract (enzymatic cleavage of glycosidal 1,4-bond) to yield Glucose and Glucitol.
Therefore no Mode of Action can be identified as the substance enters the general carbohydrate metabolism and will be ultimately metabolised to Carbondioxide and water.
Justification for classification or non-classification
The available information is conclusive but not sufficient for classification.
Additional information
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.