Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979
Reference Type:
publication
Title:
Comparative acute toxicity and primary irritancy of various classes of amines
Author:
Myers R.C., Ballantyne B.
Year:
1997
Bibliographic source:
Toxic Substance Mechanisms, 16:151-193

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
The substance was administered by stomach intubation to Wistar-derived male rats, 90-120 grams in weight and 3 to 4 weeks of age .
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethylamine
EC Number:
203-716-3
EC Name:
Diethylamine
Cas Number:
109-89-7
Molecular formula:
C4H11N
IUPAC Name:
diethylamine

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 3-4 weeks
- Weight at study initiation: 90-120 g
- Fasting period before study: No
- Diet (e.g. ad libitum): Wayne diets ad libitum
- Water (e.g. ad libitum): ad libitum







Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
undiluted and 10% dilution in distilled water
Details on oral exposure:
- Lower concentrations of the undiluted substance could not be investigated due to the small volumes of sample required
VEHICLE (experiments with dilution)
- Concentration in vehicle: 10%
Doses:
undiluted: 0.25, 0.5 and 1ml/kg bw = 178, 355 and 710 mg/kg bw (conversion is based on the density d: 0.71 g/cm3)
diluted: 0.5, 1 and 2 ml/kg bw = 35.5, 71 and 142 mg/kg bw (conversion is based on the dilution factor 1:10 and the substance density d: 0.71 g/cm3)
No. of animals per sex per dose:
5 (males only)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At least once daily; weighing on the day of dosing and after 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
1.41 mL/kg bw
Based on:
test mat.
Remarks:
10% solution
Remarks on result:
other:
Remarks:
equals 100 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
< 178 mg/kg bw
Remarks on result:
other: conversion in mg/kg is based on the density d: 0.71 g/cm3
Sex:
male
Dose descriptor:
LD50
Effect level:
> 71 - < 142 mg/kg bw
Remarks on result:
other: 10% dilution of the test substance; conversion in mg/kg is based on the density d:0.71 g/cm3
Mortality:
Undiluted:
710 mg/kg bw: 5/5, days to death: 2, 3, 3, 3, 3
355 mg/kg bw: 5/5, days to death: 2, 3, 3, 5, 5
178 mg/kg bw: 4/5, days to death: 2, 3, 3, 3

Diluted sample:
142 mg/kg bw: 5/5, days to death: 0, 0, 1, 1, 1
71 mg/kg bw: 0/5,
35.5 mg/kg bw: 0/5
Clinical signs:
Sluggish and gasping
Body weight:
The surviving animals gained weight
Gross pathology:
Animals that died:
Lungs with petichiae;
Stomachs distended, liquid filled, red, walls thickened, ulcerated and adhered to surrounding tissue;
Intestines yellow or red, gas filled;
Kidneys slightly enlarged;
Adrenale enlarged;
Livers, spleens and kidneys mottled

In survivors: Livers mottled, stomach walls thickened.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Conclusions:
The reported LD50 is 1.41 mL/kg.
Whereas 1 mL = 0.10 mL sample diluted in distilled water; and density = 0.71 g/cm³.
This results in a LD50 value of 100 mg/kg bw.
Executive summary:

A single dose of the test substance (diluted and undiluted) was given peroral to non-fasted male Wistar rats at 3 different concentrations. The undiluted sample testing provoked death for all tested concentration groups. Exposure to the lowest applied concentration of 178 mg/kg bw killed 4/5 rats. Higher concentrations killed all animals. A second test with a 10% solution of the test substance revealed 100% mortality for the highest tested concentration (142 mg/kg bw), whereas no detahs occured in the lower concentration groups. Clinical signs observed after treatment were sluggishness and gasping. Dead animals showed effects of the lungs, stomachs, intestines, kidneys, adrenal gland and livers. Surviving rats had mottled livers and thickened stomach walls.