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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
- Reference Type:
- other: Published secondary source
- Title:
- Lactitol
- Author:
- WHO/FAO
- Year:
- 1 983
- Bibliographic source:
- WHO/FAO: Expert Committee on Food Additives Summary of Toxicological Data of Certain Food Additives Series 18 (http://www.inchem.org/documents/jecfa/jecmono/v18je10.htm)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- only 2 rabbits/sex/dose; abraded and non-abraded skin
- GLP compliance:
- not specified
- Test type:
- standard acute method
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:
- di-saccharide alcohol lactitol (4-B-D-galactopyranosylD-sorbitol)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.34 to 2.86 kg
- Housing: individually caged
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 18°C
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- % coverage: 10%
- Type of wrap if used: The treated area was covered with a thin layer of cellulose sheet and wrapped in polyethylene foil.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test substance was removed from the skin with water and the animals were wiped dry with towels
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): All dose levels were applied in the same volume of 9 ml/kg body weight by appropriate dissolving in water
Part of the trunk of the animals was freed from hair the day before the start of the experiment using electric clippers. Half the number of animals received the material on the intact skin, the other half on the abraded skin. - Duration of exposure:
- 24 hours
- Doses:
- 0.0, 1.5, 3.0 and 4.5 g/kg body weight
- No. of animals per sex per dose:
- 2/sex/dose
- Control animals:
- yes
- Details on study design:
- Duration of observation period following administration: 2 weeks
- Frequency of observations and weighing: Body weights were recorded on day 0 and at the end of weeks 1 and 2. Food and water consumption was recorded weekly. Clinical signs and local skin reactions were recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: haematological endpoints (Hb, PCV, RBC, and WBC) and histopathological endpoints (liver, kidney, spleen, treated and untreated skin)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: highest dose tested
- Mortality:
- In the course of the subsequent observation period one female rabbit of the 3.0 g/kg group died on day 3. The animal that died at day 3 of the study showed signs of peritonitis and pericarditis, which probably caused the death of this animal.
- Clinical signs:
- other: None observed
- Gross pathology:
- At autopsy, no gross lesions were found that could be related to treatment. At microscopic examination, no treatment-related changes were seen
- Other findings:
- Dermal effects included slight scaliness at 1.5 and 3.0 g/kg. No dermal effects were observed at 4.5 g/kg.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test substance is > 4.5 g/kg.
- Executive summary:
Lactitol was examined for its acute dermal toxicity in an experiment with albino rabbits. Lactitol was applied at dose levels of 0.0 (control), 1.5, 3.0 and 4.5 g/kg body weight. All dose levels were applied in the same volume of 9 ml/kg body weight by appropriate dissolving in water. Half the number of animals received the material on the intact skin, the other half on the abraded skin. The treated area was covered with a thin layer of cellulose sheet and wrapped in polyethylene foil. After an exposure time of 24 hours the test substance was removed from the skin with water and the animals were wiped dry with towels. Subsequently they were caged individually in a room of constant temperature and provided ad libitum with the standard laboratory diet and tap water. The rabbits were observed for two weeks with regard to general appearance and behaviour, mortality, local skin reactions, growth, food and water intake. At the end of the two-week period, examinations were carried out for possible changes in blood composition and macroscopic appearance of several organs. Samples of the liver, kidneys, spleen, treated and untreated skin were collected for histological examination. Dermal application of lactitol caused slight skin reactions at 1.5 g/kg, and 3.0 g/kg and no skin reactions at 4.5 g/kg. Growth, food and water intake, and haematology were not affected by lactitol. Gross and microscopic examination conducted terminally did not reveal any treatment-related changes. The dermal LD50 of lactitol was found to be higher than 4.5 g/kg body weight.
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