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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Relevant methodological deficiencies

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Principles of method if other than guideline:
According to the method described by Smyth H.F. et al.: Am. Ind. Hyg. Ass. J. 23, 95-107, (1962).

This test (also called inhalation hazard test) was performed in principle as described in OECD Guideline 403.

Several groups of 3 rats per sex were exposed sequentially to the vapours, generated by bubbling 200 L/h air through a substance
column of about 5 cm above a fritted glass disc in a glass cylinder for 8 hours. The temperature chosen for volatile compound generation was
usually 20 °C and the exposure time not causing lethality was determined.
No analytical determination of the atmosphere concentrations was performed. The nominal concentration usually can be calculated as quotient of
the amount of test substance weight loss during the exposure, which is given in the raw data, and the amount of air used during the exposure.
Group-wise documentation of clinical signs was performed over the 7-day study period. The clinical signs and findings were reported in
summarized form.
GLP compliance:
no
Test type:
other: Inhalation Hazard Test (IHT)
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-bis(3-aminopropyl)ethylenediamine
EC Number:
234-147-9
EC Name:
N,N'-bis(3-aminopropyl)ethylenediamine
Cas Number:
10563-26-5
Molecular formula:
C8H22N4
IUPAC Name:
(3-aminopropyl)({2-[(3-aminopropyl)amino]ethyl})amine
Details on test material:
- Name of test material (as cited in study report): N4-Amin
- Analytical purity: > 97 %

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males 230 - 307 g; females 183 - 192 g


Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
The test substance vapours were generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass
cylinder for 8 hours.

- Brief description of analytical method used:
No analytical determination of the atmosphere concentrations was performed. The nominal concentration usually was calculated as quotient of
the amount of test substance weight loss during the exposure, which is given in the raw data, and the amount of air used during the exposure.
Duration of exposure:
8 h
Concentrations:
The nominal concentration calculated as quotient of the amount of the test substance weight loss during exposure was 0 mg/kg bw. The vapor saturation concentration of the test substance calculated based on the vapour pressure (0.0009 hPa) at 25 °C and the molecular weight (174.3 g/mol) is equal to 0.01 mg/l.
No. of animals per sex per dose:
3
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Results and discussion

Mortality:
No mortality was observed after 8 hours exposure.
Clinical signs:
other: Respiratory tract irritation.
Body weight:
Body weight gain was observed in course of the study.
Gross pathology:
No abnormalities were noted.

Any other information on results incl. tables

No mortality was observed after 8 hours exposure to a saturated atmosphere.

Applicant's summary and conclusion