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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity Studies of Lactitol (NS-4)
- Author:
- Iwakura K, Tamura H, Watanabe M, and Sumi N
- Year:
- 1 994
- Bibliographic source:
- J Tox Sci, 19(Suppl. III):487–497
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Principles of method if other than guideline:
- Lactitol was examined for mutagenicity in the reverse mutation test in bacteria (S. typhimurium TA1535, TA100, TA1537, TA98 and E. coli WP2wvrA).
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
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:
- - NS-4
- Lot No. 12
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- - S-9 mix was constituted on 100 µL of S-9 fraction, MgCl2 8 µmoles, KCl 33 µmoles, glucose-6-phosphate 5 µmoles, NADPH 4 µmoles, NADH 4 µmoles, and Na-phosphate buffer (pH 7.4) 100 µmoles in 1 mL, and was prepared at time of use.
-S-9 fraction was liver homogenate 9000 X g supernatant fraction obtained by combined administration of phenobarbital and 5,6-benzoflavone as drug metabolizing enzyme inducers to male SD rats purchased from Oriental Yeast Co., Ltd., stored at –80°C, and used in testing after its activity was checked. - Test concentrations with justification for top dose:
- Preliminary test: 1000, 500, 100, 50, and 10 µg/plate, with a maximum concentration of 5000 μg/plate
Main test: 500, 2500, 1250, 625, 313 and 156 µg/plate - Vehicle / solvent:
- distilled water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoanthracene (all strains with S9) and 2-(2-furyl)-3-(5-nitr-2-furyl)-acryl-amide (TA100, TA98, and WP2urvA without S9)
- Details on test system and experimental conditions:
- 0.1 mL of the test substance solution, 0.5 mL of S9 mix or 0.1 M Na-phosphate buffer (pH 7.4), and 0.1 mL of the preculture of the test strain were added to sterile test tubes, mixed, and then subjected to pre-incubation while shaking for 20 minutes at 37°C. Next, after adding and mixing 2 mL of top agar maintained at a temperature about 45°C, the resultant mixture was layered atop minimum glucose agar plate medium, and cultured at 37°C for 48 hours. After culturing was finished, the number of reverse-mutated colonies produced were counted, and a microscope was used to observe antimicrobial effects of the test substance, sediment formation, etc. Additionally, after adding and mixing 2 mL top agar to 0.1 mL test substance solution, and S9 mix or 0.1 M Na-phosphate buffer, the resultant mixtures were layered atop nutrient agar culture medium and cultured for 48 hours at 37°C, it was confirmed that no contamination was present in the test system. During testing, 2 plates were used for each concentration.
- Evaluation criteria:
- Results of the plates were determined to be positive when their average values were more than twice that of the negative control and dose-dependent.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test substance at any concentration did not increase the number of revertant colonies for all testing bacteria stocks relative to the negative control irrespective of whether metabolic activation was present, nor was any dose-dependency observed between processing concentrations and revertant colonies. Also, no precipitate formation was observed on the agar plates up to the maximum concentration, nor was any antibiotic action. On the other hand, all positive control substances caused a marked increase in the number of revertant colonies.
Applicant's summary and conclusion
- Conclusions:
- The test substance was negative with and without activation when tested in the reverse mutation assay using strains S. typhimurium TA1535, TA1537, TA98, TA100, and E. coli WP2 uvrA at concentrations up to 5000 µg/plate.
- Executive summary:
Lactitol (NS-4) was examined for mutagenicity in the reverse mutation test in bacteria. In the reverse mutation test using Salmonella typhimurium (TA1535, TA100, TA1537, and TA98) and Escherichia coli (WP2wvrA), the drug did not significantly increase revertant colonies in any of the test strains with or without metabolic activation system (S-9 mix).
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