Propylenediamine

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:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1966

Report date:

1966

Materials and methods

Principles of method if other than guideline:

BASF-Test. The test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of the test substance at the temperature chosen for vapour generation (20 °C). 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 glassdisc in a glass cylinder for 30 min,1 h, 2 h and 2.5 h. For a 8 h exposure a desiccator was used as exposure chamber.The documentation of clinical signs was performed over a period of 14 days.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propylenediamine

EC Number:

201-155-9

EC Name:

Propylenediamine

Cas Number:

78-90-0

Molecular formula:

C3H10N2

IUPAC Name:

propane-1,2-diamine

Details on test material:

- Name of test material (as cited in study report): 1 ,2-Propylendiamin
- Analytical purity: 99 %

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: 210 g (mean)

Administration / exposure

Route of administration:

inhalation: mixture of vapour and aerosol / mist

Type of inhalation exposure:

nose/head only

Remarks:

except 8h exposure, which was a whole body exposure

Vehicle:

air

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

> 0.5 - < 8 h

Remarks on duration:

several exposure times: 30min, 1 h, 2 h, 2.5 h and 8 h

Concentrations:

30 min exposure: 26 mg/L air
1 h exposure: 30 mg/L air
2 h exposure: 26 mg/L air
2.5 h exposure: 25,2 mg/L air
8 h exposure: 18 mg/L air, 49 mg/L air
Nominal concentrations based on the substance loss.

No. of animals per sex per dose:

30 min exposure: 3
1 h exposure: 3
2 h exposure: 6
2.5 h exposure: 3
8 h exposure: 6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of exposure and daily afterwards.
- Frequency of weighing: before the treatment and at the end of the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 49 mg/L air

Exp. duration:

8 h

Remarks on result:

other: theoretical saturated vapour concentration is 32.8mg/L. Higher value likely results from substance loss in the experimental setup describes as severe fogging.

Mortality:

30 min exposure: 0/6 (head/nose only)
1 h exposure: 0/6 (head/nose only)
2 h exposure: 2/12 (head/nose only)
2.5 h exposure: 2/6 (head/nose only)
8 h exposure: 0/12 (whole body, exsikkator)

Clinical signs:

other: At the beginning of the test: impetuous attempts to escape, bloody eye and nose discharge, severe irritation of mucous membranes. During the post exposure period: severe corrosion of the exposed tissues (face, eyes, fore limbs).

Body weight:

The surviving animals gained weight

Gross pathology:

2.5 h exposure: pulmonary emphysema in one animal

Any other information on results incl. tables

The inhalation of a highly saturated vapor-air-mixture caused mortality after 2 h of exposure. The substance caused severe corrosion at exposed tissues.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No mortality was observed after an 8-h exposure at the saturated vapour concentration.

Executive summary:

To evaluate the acute toxicity after inhalation an inhalation risk test was conducted. Male and female rats (strain not specified) were exposed to vapours of the test substance for various exposure durations (30 min, 1 h, 2 h, 2.5 h, 8 h). The vapours were generated by bubbling air through a column which contained the test substance. The vapour concentrations were calculated based on the substance loss.

At the beginning of the exposure the animals showed impetuous attempts to escape. Bloody eye and nose discharge and severe dyspnea and reduced breathing were observed during the exposure duration.

After the exposure period the animals developed severe corrosion of the exposed tissues (face, eyes, fore limbs). Two animals of the 2-h and the 2.5 -h exposure group died within 4 days after exposure (head/nose only, app. 25mg/L)

No mortality was observed after an 8-h exposure (whole body, 49mg/L).