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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.