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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication.
Justification for type of information:
Read across is based on the category approach. Please refer to attached category document.

Data source

Reference
Reference Type:
publication
Title:
Pharmacokinetics and biotransformation of diethylene glycol and ethylene glycol in the rat.
Author:
Lenk W, Löhr D, Sonnenbichler J
Year:
1989
Bibliographic source:
Xenobiotica 19: 961-979

Materials and methods

Principles of method if other than guideline:
The authors report results on the pharmacokinetics and metabolism of DEG and EG in rat, obtained with 14C-labelled DEG and non-labelled EG, using high-resolution NMR spectroscopy as a highly specific and rapid technique.
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): Diethylene glycol
- Analytical purity: > 99%
- Other: purchased from Fluka AG, Switzerland

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 250 - 300 g
- Housing: in stainless-steel metabolic cages
- Diet: Alma standard diet for rats and mice (H 1003, Kempten, Germany), ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
physiological saline
Details on oral exposure:
Diethylene glycol (DEG) was administered to rats by gavage as 50% solution in 0.9% saline (v/v), at doses of 1 (i.e., 1.12 g), 5, 10, 12.5, 15 and 17. 5 mL DEG/kg bw.
Doses:
1 (i.e., 1.12 g), 5, 10, 12.5, 15 and 17. 5 mL DEG/kg bw.
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
Observation period: 7 days

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
19 600 mg/kg bw
Clinical signs:
The following effects have developped consecutively: narcotic phase, diuretic phase and thirst, drop of the pH of the urine and blood, either recovery or hydrotropic degeneration of the renal tubules and anuria, accumulation of urea and uric acid in the blood and finally death after 2-7 days from non-compensated metabolic acidosis and uraemia.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met