Registration Dossier
Registration Dossier
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EC number: 203-919-7 | CAS number: 111-90-0
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- 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:
- Safety assessment of the pharmacological excipient, diethylene glycol monoethyl ether (DEGEE), using in vitro and in vivo systems
- Author:
- Srivastava S, Mishra S, Dewangan J, Divakar A, Gupta N, Kalleti N, Mugale MN, Kumar S, Sharma S, Rath SK.
- Year:
- 2 019
- Bibliographic source:
- DARU Journal of Pharmaceutical Sciences (2019) 27:219–231
Materials and methods
Test material
- Reference substance name:
- 2-(2-ethoxyethoxy)ethanol
- EC Number:
- 203-919-7
- EC Name:
- 2-(2-ethoxyethoxy)ethanol
- Cas Number:
- 111-90-0
- Molecular formula:
- C6H14O3
- IUPAC Name:
- 2-(2-ethoxyethoxy)ethan-1-ol
- Test material form:
- liquid
- Details on test material:
- Source: Sigma Aldrich (St. Louis, MO, USA).
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Remarks:
- albimo
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory Animal Division of Central Drug Research Institute, India
- Weight at study initiation: 20-25g
- Diet ad libitum
- Water ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): 51% ± 10%)
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Remarks:
- sterile
- Doses:
- 1000, 3000, 5000mg/kgbw
- No. of animals per sex per dose:
- 3
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Observations on days 1, 7, 14
- Clinical signs including body weight, food and water intake: yes
- Other examinations performed:At the end of the experiment, animals were sacrificed by cervical dislocation, and their organs collected for histological analysis.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Remarks on result:
- not determinable because of methodological limitations
- Mortality:
- Survival of animals significantly declined at higher doses. All animals treated with 3000 mg/kg died by day 9. 33% mortality was observed within 24 h in the group treated with 5000 mg/kg and mortality rate reached hundred percent by day 6, post treatment.
- Clinical signs:
- Not reported
- Body weight:
- No effects seen
- Gross pathology:
- No effects seen
- Other findings:
- - Histopathology: No effects seen
- Other observations: No effects on water or food consumption
Applicant's summary and conclusion
- Executive summary:
An acute toxicity study using male and female Swiss albino mice found that whilst a 1000mg/kgbw dose by the ip route caused no adverse effects, a dose of 3000mg/kgbw was fatal for all animals by post dose observation day 10. The data does not allow an LC50 to be calculated. The study is therefore not suitable to determine classification and it is also not by a route normall used for classification purposes
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