Registration Dossier
Registration Dossier
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EC number: 906-265-7 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- acceptable, well-documented publication
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:
- 1 989
- 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 n.m.r. spectroscopy as a highly specific and rapid technique.
- GLP compliance:
- no
Test material
- 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'-oxydiethanol
- Details on test material:
- Diethylene glycol, purity > 99% was purchased from Fluka AG, CH-9470 Buchs
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Male Sprague-Dawley rats, 250-300g, housed in stainless-steel metabolic cages and fed Alma standard diet for rats and mice (H 1003), D-8960 Kempten, and water ad lib. were used.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- physiological saline
- Details on oral exposure:
- Diethylene glycol were administered to rats by gavage as a 50% solution in 0,9% saline (v/v), at doses of 1ml (1,12g), 5 ml, 10ml, 12,5ml, 15ml, and 17,5ml DEG/kg. Ten male rats (270-305g body weight) were used for each dose level. The animals were observed for 7 days after administration.
- Doses:
- 1 mI(1-12 g), 5 ml, 10 ml, 12.5 ml, 15 ml, and 17.5 ml DEG/kg and 3 ml (3.34 g) and 5 ml EG/kg, respectively.
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- Observation period: 7 days
- Statistics:
- no data
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 developed in order: 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
Applicant's summary and conclusion
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