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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
Toxicity to reproduction
Administrative data
- Endpoint:
- multi-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Multigeneration reproduction study of lactitol in rats
- Author:
- Sinkeldam EJ, Hollanders VM, Woutersen RA, Koëter HBWM, and Bär A
- Year:
- 1 992
- Bibliographic source:
- J. Am. Coll. Toxicol., 11(2): 233-248
- 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
- Principles of method if other than guideline:
- In a multigeneration reproduction study, lactitol was fed to rats of both sexes throughout 3 successive generations at dietary concentrations of 0, 2, 5, and 10%.
- 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:
- - Source of test material: D.V. Chemie Combinatie Amsterdam (CCS), Gorinchem, The Netherlands
- Purity: The test material contained 9.67% water and had a purity of >98% on a dry matter basis
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- - Diets containing 0, 2, 5 or 10% of the test substance over three successive generations.
- Because of the tendency of lactitol to induce diarrhea, animals of the F0 generation were adapted to the ingestion of the sugar. - Duration of treatment / exposure:
- 3 successive generations
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 other: %
- Dose / conc.:
- 5 other: %
- Dose / conc.:
- 10 other: %
- No. of animals per sex per dose:
- - Initially each group of parent rats consisted of 20 males and 40 females.
- Number of parent rats per group was then reduced to 10 males and 20 females for the second mating of the F1 generation and the same numbers were maintained in successive generations. - Control animals:
- yes, plain diet
- other: 20% lactose during F0 generation
- Details on study design:
- A multigeneration study in Wistar rats was conducted by feeding diets containing 0, 2, 5 or 10% of the test substance over three successive generations. Because of the tendency of lactitol to induce diarrhea, the animals of the F0 generation were adapted to the ingestion of this sugar. Initially each group of parent rats consisted of 20 males and 40 females. Weanling rats of the F1a litters were used to constitute the groups for a chronic toxicity/carcinogenicity study and for a teratogenicity study. The number of parent rats per group was then reduced to 10 males and 20 females for the second mating of the F1 generation and the same numbers were maintained in successive generations. One group of rats, fed a diet with 20% lactose, served as an additional control during the F0 generation.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
Overall reproductive toxicity
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 10 other: % (no reproductive effects at highest dose tested)
Any other information on results incl. tables
Body weights of the F1 male parents were somewhat decreased at the 5% and 10% lactitol levels. No unfavourable effects were observed in fertility, gestation period, gestation index, resorption quotient and litter size. Viability (day 4) and lactation indices were reduced at the 5% and 10% levels in most generations. F3b rats fed 5% or 10% lactitol for four weeks after weaning showed caecum enlargement, which is commonly seen in rodents fed polyols or slowly digestible carbohydrates and was attributed to poor digestibility of lactitol. Growth rate during and after lactation was decreased in pups of groups fed 10% lactitol, which was also attributed to poor digestibility. Treatment-related changes were observed in the livers of F3b males of all treated groups, characterized by a uniform and homogeneous cytoplasm of the liver cells. There was no dose-response relationship and was not accompanied by any other hepatic changes in the lactitol groups. Since this phenomenon was not seen in older rats or after chronic administration of lactitol, it was considered to be a transient manifestation of an altered metabolism in young rats. It is concluded that lactitol administered in the diet to three successive generations of rats at levels up to 10%, has no adverse effects on reproductive performance in either sex. The slight developmental delay which occurred in some generations, has been observed earlier with other polyols and may be attributed to the poor digestibility of these compounds.
Applicant's summary and conclusion
- Conclusions:
- The reproductive NOEL > 10% of the test substance with no adverse effects on reproductive performance.
- Executive summary:
A multigeneration study in Wistar rats was conducted by feeding diets containing 0, 2, 5 or 10% of lactitol over three successive generations. Because of the tendency of lactitol to induce diarrhea, the animals of the F0 generation were adapted to the ingestion of this sugar. Initially each group of parent rats consisted of 20 males and 40 females. Weanling rats of the F1a litters were used to constitute the groups for a chronic toxicity/carcinogenicity study and for a teratogenicity study. The number of parent rats per group was then reduced to 10 males and 20 females for the second mating of the F1 generation and the same numbers were maintained in successive generations. One group of rats, fed a diet with 20% lactose, served as an additional control during the F0 generation. In each generation, two litters were reared until they were at least 3 weeks old.
Body weights of the F1 male parents were somewhat decreased at the 5% and 10% lactitol levels. No unfavourable effects were observed in fertility, gestation period, gestation index, resorption quotient and litter size. Viability (day 4) and lactation indices were reduced at the 5% and 10% levels in most generations. F3b rats fed 5% or 10% lactitol for four weeks after weaning showed caecum enlargement, which is commonly seen in rodents fed polyols or slowly digestible carbohydrates and was attributed to poor digestibility of lactitol. Growth rate during and after lactation was decreased in pups of groups fed 10% lactitol, which was also attributed to poor digestibility. Treatment-related changes were observed in the livers of F3b males of all treated groups, characterized by a uniform and homogeneous cytoplasm of the liver cells. There was no dose-response relationship and was not accompanied by any other hepatic changes in the lactitol groups. Since this phenomenon was not seen in older rats or after chronic administration of lactitol, it was considered to be a transient manifestation of an altered metabolism in young rats. It is concluded that lactitol administered in the diet to three successive generations of rats at levels up to 10%, has no adverse effects on reproductive performance in either sex. The slight developmental delay which occurred in some generations, has been observed earlier with other polyols and may be attributed to the poor digestibility of these compounds.
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