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Diss Factsheets
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EC number: 201-788-0 | CAS number: 87-99-0
- 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
Health surveillance data
Administrative data
- Endpoint:
- health surveillance data
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- The safety and tolerability of aerosolized iso-osmotic test substance was tested in mice
- GLP compliance:
- no
- Test type:
- other: The safety and tolerability of aerosolized iso-osmotic test substance was tested in mice
- Limit test:
- no
- Species:
- mouse
- Strain:
- other: C57Bl/6
- Sex:
- not specified
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- water
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 150 min
- Concentrations:
- 5% solution in water
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Sex:
- not specified
- Dose descriptor:
- other: NOEC
- Effect level:
- 5 other: %
- Based on:
- test mat.
- Exp. duration:
- 150 min
- Remarks on result:
- other:
- Remarks:
- No significant increase in enhanced respiratory pause and no change in airway cellular response. Inhalation of aerosolized iso-osmotic test substance was well-tolerated by naïve and atopic mice.
- Conclusions:
- Inhalation of aerosolized iso-osmotic test substance was well-tolerated by naïve and atopic mice
- Executive summary:
This was a prospective cohort study of C57B1/6 mice in an animal laboratory at the clinical research center of a university hospital. Mice underwent a baseline methacholine challenge, exposure to either aerosolized saline (control) or the test substance (5% solution) for 150 minutes and then a follow-up methacholine challenge. The saline and test substance exposures were repeated after eosinophilic airway inflammation was induced by sensitization and inhalational challenge to ovalbumin. Mice were evaluated for bronchial hyperreactivity to inhaled methacholine (using the Buxco whole body plethysmography system) before and after the exposures; other mice were monitored periodically during exposure by whole body plethysmography. All mice underwent whole lung lavage the next day for cell count and differential.
In naïve mice, methacholine responsiveness was unchanged after exposures to the test substance compared to inhaled saline (p = 0.49). There was no significant increase in enhanced respiratory pause in antigen-challenged mice after test substance exposure (p = 0.38). There was no change in airway cellular response after test substance exposure in naïve and antigen-challenged mice.
Inhalation of aerosolized iso-osmotic test substance was well-tolerated by naïve and atopic mice
In naïve mice, methacholine responsiveness was unchanged after exposures to the test substance compared to inhaled saline (p = 0.49). There was no significant increase in enhanced respiratory pause in antigen-challenged mice after test substance exposure (p = 0.38). There was no change in airway cellular response after test substance exposure in naïve and antigen-challenged mice.
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety assessment of inhaled xylitol in mice and healthy volunteers
- Author:
- Durairaj L, Launspach J, Watt JL, Businga TR, Kline JN, Thorne PS and Zabner J
- Year:
- 2 004
- Bibliographic source:
- Respiratory Research, 5:13
Materials and methods
- Study type:
- other: The safety and tolerability of aerosolized iso-osmotic test substance was tested in humans
- Principles of method if other than guideline:
- The safety and tolerability of aerosolized iso-osmotic test substance was tested in humans.
- GLP compliance:
- no
Test material
- Reference substance name:
- Xylitol
- EC Number:
- 201-788-0
- EC Name:
- Xylitol
- Cas Number:
- 87-99-0
- Molecular formula:
- C5H12O5
- IUPAC Name:
- (2R,3r,4S)-pentane-1,2,3,4,5-pentol
- Test material form:
- aerosol dispenser: not specified
- Remarks:
- migrated information: aerosol
- Details on test material:
- - Purity: not reported
Constituent 1
Method
- Details on study design:
- - Subjects: Human (male/female)
- Aerosol nose only
- Vehicle: water
- Analytical verification of test atmosphere concentrations performed
- Duration of exposure: 49 minutes
- Volume: 1,5, and 10 mL of 5% solution in water
- 10 subjects received 1-10 mL sequentially; 11 subjects received only 10 mL
Results and discussion
- Results:
- LOEC (male/female) = 10 mL based on test material (49-minute exp. duration)
Any other information on results incl. tables
In normal volunteers, there was no change in Forced Expiratory Volume in 1 second (FEV1) after test substance exposures compared with baseline as well as normal saline exposure (p = 0.19). Safety laboratory values were also unchanged. The only adverse effect reported was stuffy nose by half of the subjects during the 10 mL test substance exposure, which promptly resolved after exposure completion. Bronchoalveolar lavage (BAL) cytokine levels were below the detection limits after xylitol exposure in normal volunteers.
Applicant's summary and conclusion
- Conclusions:
- Inhalation of aerosolized iso-osmotic test substance was well-tolerated by healthy human volunteers.
- Executive summary:
This was a prospective cohort study of healthy human volunteers at the clinical research center of a university hospital. Normal human volunteers underwent exposures to aerosolized saline (10 mL) and the test substance, with spirometry performed at baseline and after inhalation of 1, 5, and 10 mL. Serum osmolality and electrolytes were measured at baseline and after the last exposure. A respiratory symptom questionnaire was administered at baseline, after the last exposure, and five days after exposure. In another group of normal volunteers, bronchoalveolar lavage (BAL) was done 20 minutes and 3 hours after aerosolized test substance exposure for levels of inflammatory markers.
In normal volunteers, there was no change in Forced Expiratory Volume in 1 second (FEV1) after test substance exposures compared with baseline as well as normal saline exposure (p = 0.19). Safety laboratory values were also unchanged. The only adverse effect reported was stuffy nose by half of the subjects during the 10 mL test substance exposure, which promptly resolved after exposure completion. Bronchoalveolar lavage (BAL) cytokine levels were below the detection limits after xylitol exposure in normal volunteers. Inhalation of aerosolized iso-osmotic the test substance was well-tolerated by healthy human volunteers.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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