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Diss Factsheets

Toxicological information

Acute Toxicity: other routes

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Administrative data

acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference Type:
Embolic Pneumopathy Induced by Oleic Acid
Derks, C., Jacobovitz-Derks, D.
Bibliographic source:
American Journal of Pathology 87: 143-151

Materials and methods

Test guideline
no guideline followed
GLP compliance:
not specified
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Oleic acid
EC Number:
EC Name:
Oleic acid
Cas Number:
Molecular formula:
octadec-9-enoic acid
Test material form:
other: liquid

Test animals

not specified
not specified
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 6-8 kg

Administration / exposure

Route of administration:
unchanged (no vehicle)
0.045 g/kg bw and 0.09 g/kg bw
No. of animals per sex per dose:
8 animals for the low dose, 11 animals received the high dose
Control animals:
Details on study design:
- Duration of observation period following administration: animals were sacrificed 1,2,3, 4,6, 12, 24 and 48 hours or 1,2 and 4 weeks after injection
- Necropsy of survivors performed: yes
- Other examinations performed: histopathology (lung)

Results and discussion

Effect levels
not specified
Dose descriptor:
Effect level:
90 mg/kg bw
Based on:
test mat.
Clinical signs:
No clinical signs (and no signs of respiratoy distress) were observed before sacrificing.
Body weight:
not examined
Gross pathology:
Only the lungs were examined. Lesions were found in the lungs of all animals, but more distinct in the higher dose group.

Any other information on results incl. tables

Mostly ventral and subpleural hemorrhagic lesions of the lungs were observed in the early stage. Later yellow-tan patches were seen over the pleura. Lesions occurred mostly on the ventral sides of the lower lobes. Light microscopic examination revealed normal lung areas and damaged areas, these were more distinct in the higher dose group of the single injection-group. Large microcysts were seen in the peripheral portions of the lobe. After 1 week acute lesions had disappeared except for moderate edema. Fibrotic areas scattered over the lungs were found as well as thickened alveolar walls containing macrophages. These Macrophages were less numerous after 2 weeks and 1 month, but the extent of fibrosis increased. Electron microscopy examinations revealed obstruction of capillaries by recent thrombi (out of fibrin, platelets and cell debris) 1 hour after the injection, but not lasting longer than 4 hours. Necrotic endothelial and Type I cells were observed. Endophagocytosis and polymorphonuclear leukocytes were seen in the vessels after 2 hours. Cytoplasmic modifications were observed at the fourth hour. After 1 week an increase in Type 2 cells of irregular shape (irregular limits and connections between the cells, containing abnormal lipid inclusions) was recorded. Large cells containing osmiophilic inclusions and phagocytized material were found in the alveolar spaces. After 2 and 4 weeks, Type 2 cells could still be seen and the alveolar septa were found to be thickened. Inflammatory cells had not been recorded.

Applicant's summary and conclusion