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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dipropylentriamin
- Analytical purity: 99%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Firma WIGA (Sulzfeld)
- Weight at study initiation: 185 ± 15 gram
- Diet: Tieren Herilan MRH (Firma H . EGGERSMANN KG, Rinteln/Weser), ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
other: ethanol
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: a constant quantity was ensured by a continuous infusion pump (UNITA I, B. BROWN, Melsungen) and by means of compressed air in a two-material nozzle which produces aerosols.
- Source and rate of air: 1000 L/h

TEST ATMOSPHERE
- Brief description of analytical method used: Gaschromatograph HP 5040 A with a 2 m glass colum (2 mm i.d.), with a Carbowax 20 M separation phase and Supelcoport 80/100 mesh carrier. The oventemperature is 200 °C, the detector (FID) and injector temperature are 280 °C, the corriergas flow is 20.4 ml/in, the hydrogen flow rate is 30 ml/min and the air flow is 255 ml/min. The retetion time of the internal standard (C17KW) is 2.66 min and the retetion time of the sample is 5.06.
- Samples taken from breathing zone: yes

CLASS METHOD
- Rationale for the selection of the starting concentration: First orientating dose was: 2.5 mg/L (analytical determined)
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Nominal concentrations: 0.015, 0.037, 0.063, 0.47, 0.931, 4.66 and 8.37 mg/L
Measured concentrations: 0.014, 0.027, 0.055, 0.235, 0.606, 1.3 and 2.0 mg/L
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 weighing: before dosing, after 7 days and after 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.
Statistics:
Probability analyses from D.J. Finney ( D.J. Finney; Probitanalysis 1971, Seite 1-150). The LC50 was calculated with 95% probability.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
ca. 0.03 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Sex:
male
Dose descriptor:
LC50
Effect level:
0.04 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
0.03 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
0.014 mg/L: none of the animals died after 14 days
0.027 mg/L: 3/10 males and 6/10 females after 14 days
0.055 mg/L: 8/10 males and 9/10 females after 14 days
0.235 mg/L and up: all animals died after 14 days
Clinical signs:
Red eye and nasal secretion, dyspnoea, imbalanced and insecure walk, crouched position, apathy, bad general condition, ragged and clotty fur, 2/10 females suffered hair loss, shaking, delayed pain reaction, cyanosis.
Body weight:
0.014 mg/L: normal body weight gain
0.027 mg/L: reduced body weight gain
0.055 mg/L: body weight loss
Gross pathology:
Diseased animals:
Acute dilatation of the heart, acute congested hyperemia, notable wet fleshy, edematous and diffuse redness of the lungs(bloody, lung hemorrhages), peripheral lobular pattern in the liver.

Euthanized animals:
0.014 mg/L: no abnormal findings
0.027 mg/L: carnification of the lungs
0.055 mg/L: strong weight loss, areas of carnification in the lungs

Applicant's summary and conclusion

Executive summary:

In an inhalation toxicity study, comparable to OECD 403, Sprague-Dawley rats (10/sex/dose) were exposed (nose/head only) for 4 hours to 0.014 to 2.0 mg dipropylenetriamine aerosols/L air followed by an 14 day observation period. The LC50 was ca. 0.03 mg/L air.