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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:
1979
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:
1979
Report Date:
1979

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): Diethylenglykol-dimethylether
- 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: 180-200 g (female); (mean = 191,0 g; s = ± 6,95; n = 60)
- 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, wood shavings

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- concentration in vehicle: 25 % (w/v)
Doses:
1600 mg/kg bodyweight
2500 mg/kg bodyweight
4000 mg/kg bodyweight
4500 mg/kg bodyweight
5600 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 showed higher sensitiveness for females. Therefore only females were used for the main study.
Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
4 760 mg/kg bw
95% CL:
> 4 450 - < 5 160
Mortality:
Sex: female, Dose: 1600 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 2500 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 4000 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 4500 mg/kg bw, Mortality rate: 4 / 10
Sex: female, Dose: 5600 mg/kg bw, Mortality rate: 9 / 10
Sex: female, Dose: 6300 mg/kg bw, Mortality rate: 10 / 10
Clinical signs:
Mortally poisened animals died within 1-4 days after application.
Following symptoms were observed: agitation, disturbance of equilibrium, prone position, slow breathing, noisy respiration.
Animals of the dose groups 1600 - 4000 mg/kg bw showed no symptoms after 24 hours.
Animals of the higher dose groups showed disturbance of equilibrium, prone position, discharge of reddish secretion from eye-holes.
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: grey-red coloured, partially dark-red speckled lungs, slight liver lobule markings in some animals.


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 Diethyleneglycol-dimethylether (LD50) was 4760 mg per kg body weight. Based on the result of this study Diethyleneglycol-dimethylether is not subject for labelling and classification requirements according to regulatory requirements.
Executive summary:

The median lethal dose of Diethyleneglycol-dimethylether (LD50) was 4760 mg per kg body weight. Based on the result of this study Diethyleneglycol-dimethylether is not subject for labelling and classification requirements according to regulatory requirements.