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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: Study according to OECD401; no individual data reported

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:
yes
Remarks:
only one sex tested, limitations in study reporting
Principles of method if other than guideline:
acute oral toxicity after single application
GLP compliance:
no
Remarks:
performed before GLP guidelines
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Monoethylenglykoldimethylether
- Analytical purity: not stated
- physical state: clear colourless liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Hoe WISKf(SPF71)
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 170-198 g (female); (mean = 181,8 g; s = ± 8,14; n = 30)
- Age at study initiation: no data
- Fasting period before study: 16 hours before and 2 hours after application
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water: Tap water ad libitum
- Acclimatization period: no data

ENVIRONMENTAL CONDITIONS
- Housing: in groups, in plastic cages, softwood pellets

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- concentration in vehicle: 25 % (w/v)
Doses:
4000 mg/kg bodyweight
5000 mg/kg bodyweight
6300 mg/kg bodyweight
No. of animals per sex per dose:
10 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations after application / Weighing once weekly
- Necropsy of survivors performed: yes
Statistics:
Probit analysis (method by Linder and Weber);
Confidence limits according to Fieller

Results and discussion

Preliminary study:
Preliminary experiments did not show differences related to gender. Therefore only females used for main study.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
5 370 mg/kg bw
95% CL:
> 4 890 - < 5 920
Mortality:
Sex: female, Dose: 4000 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 5000 mg/kg bw, Mortality rate: 3 / 10
Sex: female, Dose: 6300 mg/kg bw, Mortality rate: 9 / 10
Clinical signs:
Mortally poisened animals died within 1-4 days after application.
Following symptoms were observed: Passivity, torpidness, disturbance of equilibrium, ataxia, crouch, creeping and ducked position, prone position, lateral position, tremor, abdomen adducted, flank retracted, piloerrection, narrowed palpebral fissure, miosis, increased lacrimation, blood-red lacrimation, diarrhoea, yellowish-coloured urine, intermittant breathing, gasping and noisy breathing.
Body weight:
- normal body weight gain in all surviving animals.
Gross pathology:
Dissection of rats killed at the end of the observation period revealed no macroscopic findings.
Necropsy of the deceased animals revealed following macroscopic findings: Stomach tight filled with feed, adrenal dicoloured dark-red, blood-vessels injected, small intestine filled with red brown serous liquid, small intestine strongly reddened, pin-head sized ulcerations in stomach wall.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of Monoethyleneglycol dimethylether (LD50) was 5370 mg per kg body weight. Based on the result of this study Monoethyleneglycol dimethylether is not subject for labelling and classification requirements according to regulatory requirements.
Executive summary:

The median lethal dose of Monoethyleneglycol dimethylether (LD50) was 5370 mg per kg body weight. Based on the result of this study Monoethyleneglycol dimethylether is not subject for labelling and classification requirements according to regulatory requirements.