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EC number: 209-566-5 | CAS number: 585-86-4
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Remarks:
- Article is in Japanese; abstract only in English.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Reproductive and developmental toxicity studies of lactitol (NS-4) (3) — Teratogenicity study in rabbits by oral administration
- Author:
- Tesh JM, Ross FW, Wightman TJ, Wilby OK, Weith A, Watanabe M, Sumi N.
- Year:
- 1 994
- Bibliographic source:
- J. Tox. Sci., 19(Suppl 3):463-470
- Reference Type:
- publication
- Title:
- Reproductive and developmental toxicity studies of lactitol (NS-4) (3) - Teratogenicity study in rabbits by oral administration
- Author:
- Tesh JM , Ross FW, Wightman TJ, Wilby OK, Weith A, Watanabe M, and Sumi N
- Year:
- 1 995
- Bibliographic source:
- J. Tox. Sci., 20(2):172
Materials and methods
- Principles of method if other than guideline:
- The test substance was administered by oral gavage to pregnant New Zealand white rabbits during organogenesis from day 6 to day 18 of gestation inclusive, at dosages of 0, 0.25, 0.75, or 4.5 g/kg/day. On day 29 of gestation, females were killed to allow examination of their uterine contents.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-O-β-D-galactopyranosyl-D-glucitol
- EC Number:
- 209-566-5
- EC Name:
- 4-O-β-D-galactopyranosyl-D-glucitol
- Cas Number:
- 585-86-4
- Molecular formula:
- C12H24O11
- IUPAC Name:
- 4-O-beta-D-galactopyranosyl-D-glucitol
Constituent 1
- Specific details on test material used for the study:
- Test material:
NS-4
CAS 585-86-4
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- Days 6 to 18 of gestation
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.25 other: g/kg/day
- Dose / conc.:
- 0.75 other: g/kg/day
- Dose / conc.:
- 4.5 other: g/kg/day
- Control animals:
- yes
- Details on study design:
- On day 29 of gestation, females were killed to allow examination of their uterine contents.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- There was a slight reduction in food intake and faecal output among females receiving 4.5 g/kg. One female receiving 4.5 g/kg aborted following a prolonged period of weight loss.
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Effect level:
- >= 0.75 other: g/kg
- Basis for effect level:
- clinical signs
- food consumption and compound intake
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- No adverse effects on litter parameters were recorded that could be attributed to treatment. Foetal morphogenesis was unaffected by treatment with the test substance.
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- >= 4.5 other: g/kg
- Basis for effect level:
- other: highest dose tested
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The no-effect level of the test substance is 0.75 g/kg in mother rabbits for general toxicity and for reproductive functions, and 4.5 g/kg for their foetuses.
- Executive summary:
Lactitol was administered by oral gavage to pregnant New Zealand white rabbits during organogenesis from day 6 to day 18 of gestation inclusive, at dosages of 0, 0.25, 0.75, or 4.5 g/kg/day. On day 29 of gestation, females were killed to allow examination of their uterine contents. There was a slight reduction in food intake and foetal output among females receiving 4.5 g/kg. One female receiving 4.5 g/kg aborted following a prolonged period of weight loss. No adverse effects on litter parameters were recorded that could be attributed to treatment. Foetal morphogenesis was unaffected by treatment with lactitol. The results show that no-effect dose levels of lactitol are 0.75 g/kg in mother rabbits for general toxicity and for reproductive functions, and 4.5 g/kg for their fetuses.
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