Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
specific investigations: other studies
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment. Vapour generation and analysis not well documented.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Principles of method if other than guideline:
Respiratory tract irritancy determined by measuring the degree of sensory irritation.
GLP compliance:
yes
Type of method:
in vivo
Endpoint addressed:
respiratory irritation

Test material

Constituent 1
Chemical structure
Reference substance name:
Octane
EC Number:
203-892-1
EC Name:
Octane
Cas Number:
111-65-9
Molecular formula:
C8H18
IUPAC Name:
octane
Details on test material:
- Name of test material (as cited in study report): n-octane
- Analytical purity: 100% pure commercial product

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River

Administration / exposure

Route of administration:
inhalation: vapour
Vehicle:
unchanged (no vehicle)
Details on exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: head only exposure chamber
- Source and rate of air: room air
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
2 treatments of 1 minute with 10 minute non-treatment period between each treatment.
Frequency of treatment:
once
Post exposure period:
none
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
100 mg/L (re-calculated; corresponding to 22050 ppm)
Basis:
analytical conc.
Remarks:
Doses / Concentrations:
24.88 mg/L
Basis:
nominal conc.
No. of animals per sex per dose:
4 males
Control animals:
other: each animal established control breathing pattern prior to treatment by exposure to room air

Results and discussion

Details on results:
No graphic patterns indicative of respiratory pauses were evident throughout the exposures.

Applicant's summary and conclusion

Conclusions:
Based on these results, exposure to N-Octane at a nominal and analytical concentration of 24.88 and 100 mg/L of air via inhalation, respectively, failed to produce upper airway irritancy in mice.
Executive summary:

Based on these results, exposure to N-Octane at a nominal and analytical concentration of 24.88 and 100 mg/L of air via inhalation, respectively, failed to produce upper airway irritancy in mice.