Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key 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:
1982
Report Date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
- limit test concentration: 5 mg/L
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.1300 (Acute inhalation toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isooctane
- Analytical purity: 100% pure commercial product

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Duration of exposure:
4 h
Concentrations:
33.52 mg/L nominal concentration
21561.5 ± 776.32 ppm mean analytical concentration
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 2, 3, and 4 mentioned, not further specified
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not reported

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 33.52 mg/L air (nominal)
Exp. duration:
4 h
Mortality:
No mortality occurred during the 14-day observattion period.
Clinical signs:
Exposure-related observations noted in all animals during the exposure period included lying prostrate in the cage and rapid respiration. All animals appeared normal throughout the post exposure period.
Body weight:
Sightly decreased body weights were noted in the males on day 2 post exposure and in the females on days 2, 3 and 4 post exposure.
Gross pathology:
No abnormal gross pathology observations were noted in any animals upon necropsy.

Any other information on results incl. tables

Inhalation LC50 > 33.52 mg/L air (nominal) for 4 hours in male and female rats.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: GHS, EU, 2007
Conclusions:
Based on the study design the test substance, Isooctane, needs not to be classified.
Executive summary:

Based on the study design the test substance, Isooctane needs not to be classified.