Registration Dossier
Registration Dossier
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EC number: 203-895-8 | CAS number: 111-68-2
Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication which meets basic scientifical principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Structure-activity relationships of airway irritating aliphatic amines. Receptor activation mechanisms and predicted industrial exposure limits
- Author:
- Nielsen GD and Yamagiwa M
- Year:
- 1 989
- Bibliographic source:
- Chem. Biol. Inter., 71:223-244
Materials and methods
- Principles of method if other than guideline:
- Determination of sensory irritation potency by oronasal exposure, key parameter: RD50 (the exposure concentration resulting in a 50-% decrease in the respiratory rate).
- Type of method:
- in vivo
- Endpoint addressed:
- respiratory irritation
Test material
- Reference substance name:
- Dibutylamine
- EC Number:
- 203-921-8
- EC Name:
- Dibutylamine
- Cas Number:
- 111-92-2
- Molecular formula:
- C8H19N
- IUPAC Name:
- N-butylbutan-1-amine
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Scc:CF-1
Administration / exposure
- Route of administration:
- other: nose-only inhalation of vapors & tracheal cannulation
- Vehicle:
- air
- Duration of treatment / exposure:
- 30 min (upper airway irritation)
30 min (pulmonary irritation)
Results and discussion
- Details on results:
- Upper airway irritation (RD50), 30-min exposure: 81 (54-121) ppm
Pulmonary toxicity (RD50TC), 30-min exposure: 101 (86-119) ppm
Applicant's summary and conclusion
- Executive summary:
Four male Ssc:CF-1 mice per group were exposed to dibutylamine for 30 minutes and the concentration which reduces the respiratory rate by 50 % was determined (RD50). To determine the sensory irritation of the upper respiratory tract (RD50) and irritation of the lungs (tRD50) the animals inhaled the substance via the head and nose, and a tracheal cannula, respectively.
The tRD50 was determined to be 101 ml/m3 (86–119 ml/m3). The RD50 was determined to be 81 ml/m3 (54–121 ml/m3.
The authors suggested that the 2-minute reduction in the respiratory rate observed in the beginning after head and nose exposure, the subsequent normalization and then renewed reduction in the respiratory rate were not induced by irritation of the upper respiratory tract but by irritation of the lungs (Nielsen and Yamagiwa 1989).
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