Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
01 August - 15 September 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study meets generally accepted scientific principles, acceptable for assessment.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
very limited documentation
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

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:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male (mean): 291 g, female (mean): 217.4 g

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
yes
Remarks:
THC
Duration of exposure:
4 h
Concentrations:
24.88 mg/L (nominal)
99.5 ± 7.49 mg/L (re-calculated from 21300 ± 1604.23 ppm (mean measured)
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 24.88 mg/L air (nominal)
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC0
Effect level:
>= 24.88 mg/L air (nominal)
Exp. duration:
4 h
Mortality:
none
Clinical signs:
other: After 15 min of exposure all animals displayed rapid breathing. At 30 min of exposure one male and all females showed tremors and hyperactivity. At one hour these animals became languid with tremors. All animals then were noted to be inactive with rapid r
Body weight:
mean body weight males: 302.2 g (Day 2 postexposure), 309.4 g (Day 3), 317.8 g (Day 4), 331.4 g (Day 7), 347 g (Day 14)
mean body weight females: 213.6 g (Day 2 postexposure), 215.6 g (Day 3), 221.4 g (Day 4), 227.4 g (Day 7), 232.8 g (Day 14)
Gross pathology:
All animals appeared normal at the terminal sacrifice with the exception of one male noted to have a small left testis and one male observed to have a dilated right renal pelvis filled with clear fluid.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: GHS, EU, 2007
Conclusions:
According to the study design N-octane can be considered to be non-toxic.
Executive summary:

According to the study design N-octane can be considered to be non-toxic.