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Toxicological information

Acute Toxicity: oral

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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:
1954

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

Constituent 1
Chemical structure
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

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.