Registration Dossier
Registration Dossier
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EC number: 203-921-8 | CAS number: 111-92-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data only given as summary tables but acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 954
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Single oral dose toxicity is estimated by the gastric intubation of groups of five non-fasted, male rats four to five weeks of age and 90 to 120 grams. The dosages are arranged in a logarithmic series differing by a factor of two. The most probable LD50 value and its fiducial range are estimated by the method of Thompson.
- GLP compliance:
- no
- Remarks:
- predating GLP
- Limit test:
- no
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
- Details on test material:
- Di-n-butylamine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Carworth-Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: own breeding
- Age at study initiation: 4 - 5 w
- Weight at study initiation: 90 - 120 g
- Fasting period before study: unfasted
- Diet: Rockland rat diet
Administration / exposure
- Route of administration:
- oral: gavage
- Doses:
- No data; dosages were in a logartitmic series
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- moving average method according to Thompson (1947) and Weil (1952)
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 550 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no data
- Clinical signs:
- no data
- Body weight:
- no data
- Gross pathology:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of the test substance after single oral administration was found to be 550 mg/kg bw in male rats.
- Executive summary:
The test article was administered to a group of 5 non-fasted male Carworth-Wistar rats by intubation of dosages in a logartithmic series. After 14 days of observation the LD50 was calculated to be 550 mg/kg bw.
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