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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

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

Constituent 1
Chemical structure
Reference substance name:
2,2'-oxydiethanol
EC Number:
203-872-2
EC Name:
2,2'-oxydiethanol
Cas Number:
111-46-6
Molecular formula:
C4H10O3
IUPAC Name:
2-(2-hydroxyethoxy)ethan-1-ol
Specific details on test material used for the study:
- 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 or test system 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
Based on:
test mat.
Clinical signs:
other: The following effects have developed 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 bl

Applicant's summary and conclusion