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: Acceptable, well documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Range-finding toxicity data: List VI
Author:
Smyth H.F. et al.
Year:
1962
Bibliographic source:
Am Ind Hyg Assoc J. 1962 Mar-Apr;23:95-107

Materials and methods

Principles of method if other than guideline:
Inhalation Risk Test, where animals were exposed to a flowing stream of saturated vapour for up to 8 hours. The inhalation period is defined by killing half of the animals within a 14 day recovery period.
GLP compliance:
no
Test type:
other: Inhalation Risk Test (IRT)
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Octanoic Acid (mixed isomers)

Test animals

Species:
rat
Strain:
other: Albino
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Source and rate of air: dried room air
- System of generating vapour: by passing 2.5 L/minute dried room air through a fritted glass disc immersed to a deep at least 1 inch in approx. 50 ml of test substance contained in a gas-washing bottle
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
0.1621 mg/l (Danish EPA QSAR database, 2004 )
No. of animals per sex per dose:
6 males or females
Control animals:
other: analogue tests with other substances were also reported
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 0.162 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: vapour

Applicant's summary and conclusion