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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- publication
- Title:
- Single Dose Toxicity Studies of Lactitol (NS-4) in Mice and Rats
- Author:
- Okazaki S, Suwa K, Hamasu Y, and Sumi N
- Year:
- 1 994
- Bibliographic source:
- J Toxicol. Sci., 19(Suppl. 3):295-299
Materials and methods
- Principles of method if other than guideline:
- The single dose toxicity study of lactitol were performed in SD rats of both sexes by administering the substance via gavage followed by a 14-day observation period.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
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:
- Lot No. 6 used in study
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan SLAC
- Age at study initiation: 6 weeks
- Weight at study initiation: 150~174 g for males; 127~150 g for females
- Fasting period before study: yes (overnight for a total of ~16 hours)
- Housing: Plastic enclosure containing floor coverings
- Diet (e.g. ad libitum):fixed-shaped food ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: ~1-2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2°C
- Humidity (%): 55±10%
- Air changes (per hr): 11-13
- Photoperiod (hrs dark / hrs light): 12 hr light/day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Test substance was prepared by dissolving it in distilled water for injection at time of use.
- Doses:
- 11, 14, 18, 23, 30 g/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On the day of administration, the general condition and mortality status of the animals were checked at 5, 15, and 30 minutes and 1, 2, 4, and 6 hours after administration, and then once per day thereafter. Body weights were recorded immediately prior to administration and on days 1, 2, 3, 7, 10, and 14 after administration.
- Necropsy of survivors performed: yes - Statistics:
- Not reported
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 30 other: g/kg
- Based on:
- test mat.
- Mortality:
- 1 of 5 males and 2 of 5 females died at 30 g/kg. Death was observed in 1 male and 1 female at 4 and 6 hours, respectively after administration and in 1 female on the 3rd day after administration.
- Clinical signs:
- other: Decreased spontaneous locomotor activity and diarrhoea were observed after 30 minutes in animals that died at 30 g/kg. Prone position was observed prior to death. In surviving animals, diarrhoea was observed in a few males and females beginning at 15 minu
- Gross pathology:
- No gross changes were observed in either animals that died or survived to scheduled termination.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (rats): >30 g/kg
- Executive summary:
The single dose toxicity study of lactitol was performed in SD rats of both sexes by administering the test material orally. The test material was administered as a single dose followed by a 14-day observation. Oral LD50 value of the test material was >30 g/kg in male and female rats. The signs of toxicity observed in rats following the administration of the test material included decreased spontaneous movement, diarrhoea, oligopnea, or prone position, and transient decreased body weight. There were no treatment-related changes in gross examination.
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