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Diss Factsheets
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EC number: 900-501-2 | 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study and basic data given
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Remarks:
- adopted 1983
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 64519-82-0
- Cas Number:
- 64519-82-0
- IUPAC Name:
- 64519-82-0
- Details on test material:
- - Name of test material (as cited in study report): isomalt (mixture of α-D-glucopyranosyl-1,6-D-sorbitol and α-D-glucopyranosyl-1,1-D-mannitol; SZ-i-rH 5093)
- Analytical purity: no data
- Impurities (identity and concentrations): minor saccharides and saccharide alcohols (main components: sorbitol, mannitol) (not further specified)
- Lot/batch No.: SZ-i-rH 5093
A special batch was produced for the conducted study in which the content of minor components occuring during the production process was greatly exagerated to the maximum feasible content.
Composition of the test material (batch SZ-i-rH 5093):
α-D-glucopyranosyl-1,1-D-mannitol (52.5%), α-D-glucopyranosyl-1,6-D-sorbitol (36%), α-D-glucopyranosyl-1,1-D-sorbitol (2.1%), sorbitol + mannitol (7.5%), (glucosyl)2-fructose (isomelezitose) (0.4%) and (glucosyl)2-sorbitol or (glucosyl)2-mannitol (0.5%) (as provided in TNO report V 95.660)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily, 7 days/week
- Post exposure period:
- no data
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
2.5, 5 and 10%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
1.25, 2.5 and 5 mg/kg bw/day
Basis:
nominal in diet
calculated based on the average daily food consumption of 5 g/100 g bw (WHO, 1987)
- No. of animals per sex per dose:
- 10
- Control animals:
- other: 10% starch ... (see attached file)
- Positive control(s):
- mitomycin C
- Justification for choice of positive control(s): due to the known properties of inducing micronuclei, mitomycin C was selected as the appropriate positive control
- Route of administration: intraperitoneal
- Doses / concentrations: 1.5 mg/kg bw
Examinations
- Tissues and cell types examined:
- Tissue: bone marrow
Cell type: bone marrow cells - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The highest dose group represented an overall intake of isomalt of more than 5 times the maximum limit dose that needs to be investigated in the micronucleus test according to the OECD Guideline 474 (1 mg/kg bw for treatments longer than 14 days).
METHOD OF ANALYSIS:
GENOTOXICITY: The incidence of micronucleated polychromatic erythrocytes per 1000 polychromatic erythrocytes was determined in test and control groups.
CYTOTOXICITY: The incidence of polychromatic erythrocytes per 1000 erythrocytes was compared in control and test groups.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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