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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Full study report available. Well documented. Not to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
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 mono methyl ether
- Physical state: liquid
- Analytical purity: >99.5%
- Other: EK Acc #:907229. TEX#:79-1. PM#:1798. HS&HFL La#:79-431

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories
- Weight at study initiation: 15-17g
- Fasting period before study: Two studies conducted, with and without fasting. Studies conducted 2 months apart. When fasting used 16-20hrs.
- Housing: individual in suspended wire bottomed cages.
- Diet (e.g. ad libitum): ad libitum prior to fasting
- Water (e.g. ad libitum): ad libitum
- Acclimation period:Yes


ENVIRONMENTAL CONDITIONS
- no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
Not specified but within the range 2.6-168mM/kg and increasing by a factor of 2 between doses.
No. of animals per sex per dose:
5
Control animals:
other: no, but 8 other compounds tested in same study which acted as reference controls
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: General appearance and activity, pharmacologic and toxicologic signs and mortality checked daily except weekends. Appearance of stools/urine also noted. Weighings done before dosing and at end of observation period.
- Necropsy of dead animals performed: yes, gross pathology.
- Necropsy of survivors performed: yes
Statistics:
LD50 calculated with its 95% confidence interval using the method of Thompson and Weil (Biometrics 8, p51-4 (1952)

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
7 128 mg/kg bw
95% CL:
> 5 400 - < 9 408
Remarks on result:
other: Results for fasted animals
Sex:
male
Dose descriptor:
LD50
Effect level:
8 188 mg/kg bw
95% CL:
> 5 288 - < 12 696
Remarks on result:
other: Results for fed animals
Mortality:
Deaths occured within 1-10 days but most within 1-3 days
Clinical signs:
Clinical signs of toxicity for both fed and fasted animals were inactivity, labored breathing, rapid respiration, anorexia, slight to moderate weakness, tremors, prostration and death. Animals that died exhibited bloody urine, and/or blood in the stomach and intestines (fed animals).
These conditions were not noted in survivors autopsied at termination.
Body weight:
no effects reported.
Gross pathology:
no effects reported.
Other findings:
no further effects reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance has very low acute toxicity by the oral route.
Executive summary:

In a single dose acute oral toxicity study, male CD-1 mice were exposed to 2 -(2 -methoxyethoxy)ethanol. The experiment was repeated in duplicate, once with fasted animals and once with fed animals. The LD50 values are shown below. Sub-lethal effects included labored breathing, rapid respiration, anorexia, slight to moderate weakness, tremors and prostration. Based on the results of this study, this substance would not be classified for acute toxicity in accordance with the current EU guidelines.

Results synopsis

LD50 (fasted animals): 7128mg/kg

LD50 (fed animals); 8188mg/kg