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Diss Factsheets
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EC number: 931-687-3 | 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation for a read-across substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Metabolism and caloric utilization of orally administered maltitol-14C in rat, dog, and man.
- Author:
- HH Rennhard & JR Bianchine
- Year:
- 1 976
- Bibliographic source:
- J. Agric. Food Chem., Vol. 24, No. 2, 287-291
Materials and methods
- Objective of study:
- excretion
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Version / remarks:
- -reliability scoring based on 1984 guideline
- Deviations:
- yes
- Remarks:
- -purity and physico-chemical properties of test article, and housing and feeding conditions were not reported; only 1 dose tested; observation period should be 7 days or up until 95% of the absorbed dose for excretion studies, whichever comes first
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
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
- IUPAC Name:
- 4-O-alpha-D-glucopyranosyl-D-glucitol
- Details on test material:
- - Name of test material (as cited in study report): Maltitol
- Physical state: Liquid (solution)
- Analytical purity: Not reported
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported
- Radiochemical purity (if radiolabelling): Not reported
- Specific activity (if radiolabelling): Not reported
- Locations of the label (if radiolabelling): Maltitol-U-14-C
- Expiration date of radiochemical substance (if radiolabelling): Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- maltitol-U-14C
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: Not reported
- Weight at study initiation: 95 to 200 g
- Fasting period before study: Not reported
- Housing: Not reported
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
-Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: "solution" not specified
- Details on exposure:
- Details on exposure were not provided.
- Duration and frequency of treatment / exposure:
- Single administration
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1 mL of the radioactive maltitol solution (125 to 260 mg/kg bw, 49.7 μCi).
- No. of animals per sex per dose / concentration:
- 3 males and 2 females
- Control animals:
- no
- Positive control reference chemical:
- None used.
- Details on study design:
- Details on study design were not provided.
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (excretion)
- Tissues and body fluids sampled: urine and faeces obtained from all rats; breath was sampled in one rat
- Time and frequency of sampling: Sampled from 0 to 14 hours, 14 to 24 hours, 24 to 48 hours, and 48 to 72 hours.
- Other: Caloric utilization was measured.
Results and discussion
- Preliminary studies:
- None used.
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- See Table 1 under remarks on results section.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- Approximately 13% of total faecal radioactivity was due to volatile fatty acids.
Any other information on results incl. tables
Table 1: Recovery of Radioactivity following Oral Administration of Maltitol-U-14C to Rats
Rat no. |
Interval (hr) |
Percent of administered radioactivity recovered |
||
14CO2 |
Urine |
Faeces |
||
1 |
0 to 72 |
45.5 |
9.40 |
13.22 |
2 |
0 to 72 |
- |
4.03 |
11.55 |
3 |
0 to 72 |
- |
3.94 |
4.38 |
4 |
0 to 48 |
- |
4.34 |
4.96 |
5 |
0 to 48 |
- |
3.90 |
4.29 |
Caloric utilization in rat no.1 was reported to be 76% (based on recovery of 14CO2of rat no.1 and catabolic transformation factor of 0.6 for readily absorbed compounds such as acetate and glucose). The total 14C recovery was calculated to be approximately 98% (based on caloric utilization and urine and faeces of rat no.1).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
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