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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study predates GLP and OECD guidelines, clear reporting of technical methods, data analysis (probit) and results, but no characterization of test species or test substance.

Data source

Reference
Reference Type:
publication
Title:
The toxicology of some glycols and derivatives
Author:
Laug EP, Calvery HO, Morris HJ, Woodard G
Year:
1939
Bibliographic source:
J. Ind. Hyg. Tox., 21, 173-201.

Materials and methods

Principles of method if other than guideline:
Groups of 9 or 10 rats were administered propylene glycol by gavage in two independent experiments at dose levels ranging from 15 to 25 ml/kg bw and the LD50 was determined.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: different sources
- Weight at study initiation: 250 ± 75 g
- Fasting period before study: ca. 18 hours (overnight)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
1st experiment (serie A): 15, 17.5, 20, 22.5 and 25 ml/kg bw
2nd experiment (serie B): 17.6, 18,6, 20.0, 21.4 and 22.6 ml/kg bw
No. of animals per sex per dose:
10/dose in experiment 1; 9/dose in experiment B
Control animals:
not specified
Details on study design:
All animals that died were necropsied and those showing evidence of mechanical injury were excluded from calculation of the LD50. The liver and kidneys were examined by light microscopy.
Statistics:
In brief, a straight line was fitted to a plot of the log dose versus the percentage mortality (expressed in probits) using a least-squares method. The log dose corresponding to a 50% mortality was then determined by inspection of these graphical data.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
22 000 mg/kg bw
Remarks on result:
other: This value corresponds to 21.0 ml/kg bw, with standard errors of 19.2-23.9 ml/kg bw.
Mortality:
Mortalities were observed at all dose levels.
Clinical signs:
General signs of toxicity included loss of equilibrium, marked depression, analgesia, coma and finally death after a prolonged moribund state shortly after administration of large doses of propylene glycol. 
Gross pathology:
Gross examination of the internal organs were essentially negative except for hemorrhagic areas in the small intestine. Microscopic changes in kidney were minimal, with nuclear pyknosis and vacuolar degeneration of the cytoplasm. A few cortical tubules contained protein debris or loose casts. The liver showed only slight congestion and hyperemia with no fatty changes.

Applicant's summary and conclusion