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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
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:
Safety assessment of inhaled xylitol in mice and healthy volunteers
Author:
Lakshmi Durairaj, Janice Launspach, Janet L Watt, Thomas R Businga, Joel N Kline, Peter S Thorne and Joseph Zabner
Year:
2004
Bibliographic source:
Respiratory Research 2004, 5 :13 doi:10.1186/1465-9921-5-1
Report Date:
2004

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Test of the safety and tolerability of aerosolized iso-osmotic xylitol in mice and human volunteers
GLP compliance:
not specified
Test type:
other: in vivo and clinical study by inhalation
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
purity not specified, 5% solution in water and NaCl

Test animals

Species:
mouse
Strain:
C57BL
Sex:
not specified
Details on test animals and environmental conditions:
Clinical study as well: ten subjects who underwent graded exposure to aerosolized xylitol as a part of the pilot study. Mean age was 29.1 yrs, and equal numbers of males and females were studied

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: water saline salution
Mass median aerodynamic diameter (MMAD):
ca. 0.82 µm
Geometric standard deviation (GSD):
ca. 1.46
Details on inhalation exposure:
150 minutes
Duration of exposure:
ca. 150 min
Concentrations:
5% in saline solution
No. of animals per sex per dose:
6
Control animals:
yes

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
other: NOEC
Effect level:
ca. 5 other: %
Based on:
test mat. (dissolved fraction)
Exp. duration:
150 min
Mortality:
no
Clinical signs:
no

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Aerosolized xylitol was well tolerated by naïve and hypersensitive in mice with no significant effects on the airway physiology or composition of airway inflammatory cells. Results were further confirmed in healthy human volunteers.
Executive summary:

Aerosolized xylitol was well tolerated by naïve and hypersensitive  in mice   with   no   significant   effects   on   the   airway physiology or composition of airway inflammatory cells. Results were further confirmed in healthy human volunteers.