3,3'-[butane-1,4-diylbis(oxy)]bispropanamine

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-[butane-1,4-diylbis(oxy)]bispropanamine

EC Number:

230-745-9

EC Name:

3,3'-[butane-1,4-diylbis(oxy)]bispropanamine

Cas Number:

7300-34-7

Molecular formula:

C10H24N2O2

IUPAC Name:

3-[4-(3-aminopropoxy)butoxy]propan-1-amine

Specific details on test material used for the study:

- Analytical purity: approximately 99%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: MUS RATTUS, Brunnthal
- Weight at study initiation: 185 + 15 g
- Diet: Herilan MRH
- Water: ad libitum

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

air

Details on inhalation exposure:

The test substance was applied in a constant quantity with the help of an infusion pump to a 2-step blast pipe. Synthetic air (2.6 bar) was used to generate an aerosol, which was infused into the system.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

22.9, 10.01, 2.19 and 0.41 [mg/L] (nominal concentration)
3.72, 1.76, 0.81, 0.17 [mg/L] (analytic concentration)

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

according to D.J. Finney (D..J*. Finney; Probitanalysis 1971, Seite 1 - 150). Published by the Syndics of the Cambridge University Press, Bentley House, 200 Euston Road, London N.W. 1

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

1.5 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

see table below; the animals died within 1-5 days after test item application

Clinical signs:

other: 3.72, 1.76 [mg/L] (analytic concentration): reddish head, dyspnea, scrubby, shaggy fur, tremor 0.81 [mg/L] (analytic concentration): accelerated respiration 0.17 [mg/L] (analytic concentration): nothing abnormal detected Surviving animals did either not

Body weight:

The only male animal surviving exposure to 3.75 mg/l showed a significantly reduced body weight; furthermore, males at 1.76 mg/l showed some reduction on body weight, whereas all other animals exhibited body weights similar to control animals 14 days subsequent to exposure. (see table below)

Gross pathology:

heart: acute dilatation
lung: strong hyperemia
kidney: some animals showed tubule necrosis

Any other information on results incl. tables

Analytic concentration	Nominal concentration	Mortality males	Mortality females
3,72	22,9	9/10	10/10
1,76	10,01	6/10	6/10
0,81	2,19	0/10	3/10
0,17	0,41	0/10	0/10

Analytic concentration	Mean body weight d0		Mean body weight d7		Mean body weight d14
	males	females	males	females	males	females
3,72	186 (10)	183 (10)	124 (1)	all dead	151 (1)	all dead
1,76	179 (10)	180 (10)	211 (4)	181 (4)	238 (4)	214 (4)
0,81	179 (10)	179 (10)	213 (10)	186 (7)	266 (10)	207 (7)
0,17	182 (10)	180 (10)	225 (10)	201 (10)	269 (10)	214 (10)
Control	182 (10)	182 (10)	218 (10)	199 (10)	264 (10)	213 (10)

The number in brackets indicates the number of animals alive at the respective time point.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria