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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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study according to OECD401; no detailed clinical observations reported;
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

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:
-
GLP compliance:
no
Remarks:
performed before GLP guidelines
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): Triethylenglykoldimethylether-Hoechst
- 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: SPF-Wistar rats Hoe WISKf(SPF71)
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 190-217 g (female); (mean = 200.4 g, s = ± 6.84 g, n = 30)
- Age at study initiation: no data
- Fasting period before study: 16 hours before and 2 hours after application
- Diet: Altromin 1324 (Fa. Altromin GmbH, Lage/Lippe), ad libitum
- Water: Tap water ad libitum
- Acclimatization period: no data

ENVIRONMENTAL CONDITIONS
- Housing: in groups, in plastic cages, on 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:
5 390 mg/kg bw
95% CL:
> 4 860 - < 6 100
Mortality:
Sex: female, Dose: 4000 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 5000 mg/kg bw, Mortality rate: 4 / 10
Sex: female, Dose: 6300 mg/kg bw, Mortality rate: 8 / 10
Clinical signs:
Following symptoms were observed: Passivity, torpidness, deep anesthesia, disturbance of equilibrium, ataxia, crouch, creeping and ducked position, prone position, lateral position, convulsions, abdomen adducted, flank retracted, hyporeflexia, piloerrection, narrowed palpebral fissure, mydriasis, increased lacrimation, erythema, light red-coloured urine and noisy breathing.
Normal behaviour during observation period after application.
Body weight:
- normal body weight gain in all surviving animals.
Gross pathology:
Dissection of rats killed at the end of the observation period revealed punctual reddening on kidney surface.
Necropsy of the deceased animals revealed following macroscopic findings: lungs filled with blood, bladder tight filled with dark-red liquid, surface of liver light spotted, marking of liver lobules, adrenal dicoloured dark-red.
Other findings:
-

Any other information on results incl. tables

-

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 Triethyleneglycol dimethylether (LD50) was 5390 mg per kg body weight. Based on the result of this study Triethyleneglycol dimethylether is not subject for labelling and classification requirements according to regulatory requirements.
Executive summary:

The median lethal dose of Triethyleneglycol dimethylether (LD50) was 5390 mg per kg body weight. Based on the result of this study Triethyleneglycol dimethylether is not subject for labelling and classification requirements according to regulatory requirements.