Registration Dossier
Registration Dossier
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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.
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EC number: 906-936-4 | CAS number: -
Acute Toxicity: oral
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:
- 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 NMR spectroscopy as a highly specific and rapid technique.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- 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:
- - Name of test material (as cited in study report): Diethylene glycol
- Analytical purity: > 99%
- Other: purchased from Fluka AG, Switzerland
Constituent 1
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
- Clinical signs:
- other: 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
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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