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Acute Toxicity: inhalation

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

Data source

Reference Type:
study report
Report Date:

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:

Test material

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

Test animals

not specified
Details on test animals and environmental conditions:
- 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
except 8h exposure, which was a whole body exposure
Analytical verification of test atmosphere concentrations:
Duration of exposure:
> 0.5 - < 8 h
Remarks on duration:
several exposure times: 30min, 1 h, 2 h, 2.5 h and 8 h
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:
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
Dose descriptor:
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.
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
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).