Registration Dossier
Registration Dossier
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EC number: 203-916-0 | CAS number: 111-86-4
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
- Principles of method if other than guideline:
- other: oronasal exposure
- GLP compliance:
- not specified
- Type of method:
- in vivo
- Endpoint addressed:
- respiratory irritation
Test material
- Reference substance name:
- Octylamine
- EC Number:
- 203-916-0
- EC Name:
- Octylamine
- Cas Number:
- 111-86-4
- Molecular formula:
- C8H19N
- IUPAC Name:
- octan-1-amine
- Details on test material:
1-Octanamine, not further specified, "high purity"
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: OF1
- Sex:
- male
Administration / exposure
- Route of administration:
- inhalation
- Vehicle:
- other: none
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Exposure period: 15 minute(s)
- Frequency of treatment:
- 1x
Doses / concentrations
- Remarks:
- Doses / Concentrations:
6, 8, 17, and 24 ml/m3 (32, 43, 90, and 129 mg/m3)
Basis:
analytical conc.
- No. of animals per sex per dose:
- 6
- Control animals:
- other: each animal served as its own control (pre-treatment breathing frequency)
- Details on study design:
- Observation period: 90 min
Results and discussion
Any other information on results incl. tables
N-Octylamine
depressed the breathing frequency rapidly within a minute in a
concentration-related manner:
RD50
= 17 ppm (91 mg/m³) [with 1 ppm = 5.37 mg/m³]. An initial decrease of
about 20% was observed already at 6 and 8 ppm (43 mg/m³). In any case,
the normal respiration rate restored completely within 30 min after
cessation of exposure.
The RD50TC was 35 ppm (188 mg/m³) in trachea-cannulated mice. The ratio RD50/RD50TC was 2.0, which indicates that n-octylamine is an upper respiratory tract irritant, rather than an irritant of the lower airways.
As an occupational exposure level derivation, the authors suggested to use 0.03 x RD50 for upper respiratory tract irritants, i.e. 0.51 ppm (2.74 mg/m³) Gagnaire, 1993).
Applicant's summary and conclusion
- Conclusions:
- The test item caused respiratory depression in mice after single exposure, RD50 = 17 ppm.
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