Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Principles of method if other than guideline:
Single intratracheal injection of the test material in six rats.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triethylene glycol diacetate
- Analytical purity: no data
- Physical state: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A&E Farms, Altamont, USA
- Diet: Purina Laboratory Chow, either ground or pelleted

Administration / exposure

Route of administration:
other: intratracheal
Vehicle:
unchanged (no vehicle)
Details on exposure:
The animals were placed under deep ether anaesthesia and the hair of the ventral notch region was closely clipped and the skin washed with alcohol. A small incision was made through the skin and the underlying musculature was separated with muscle probes exposing the trachea. A bent needle was inserted into the trachea and the test material was injected. The skin incision was closed with adhesive (Eastman 910). After closure, the animals were held, head up, for a moment to facilitate flow into the lungs.
Doses:
0.1 mL
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of all animals performed: yes
- Other examinations performed: histopathology of lungs and trachea

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
other: tracheal and pulmonary lesions
Effect level:
0.1 other: mL
Based on:
test mat.
Mortality:
1/6 animals died 11 days after the surgery (animal #590)
Clinical signs:
2/6 animals were weak, had rough coats, laboured respiration, avoided food and developed diarrhoea (animal #586 and #590).
Body weight:
4/6 animals had normal weight gain. One animal lost weight (animal #586), one animal died at Day 11 (animal #590)
Gross pathology:
1/6 animals had mottled lung (animal #590)
Other findings:
- Histopathology: The tracheas of two animals had massive aspiration pneumonia (animal #590 and 596). Of the four rats that survived, one had no inflammatory pulmonary lesions, two had mild to moderate chronic murine pneumonitis and one had patchy pulmonary edema and localized interstitial suppurative pneumonitis.

Any other information on results incl. tables

The tracheal lesions were those that occur routinely in rats and are not treatment related. The pulmonary lesions could be related to the introduction of foreign material into the airway and did not represent specific toxicologic effects.

Applicant's summary and conclusion