1,2-bis(2-methoxyethoxy)ethane

Acute Toxicity: oral

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 for cross-reference:

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

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

Test material information

Constituent 1

Reference substance name:

1,2-bis(2-methoxyethoxy)ethane

EC Number:

203-977-3

EC Name:

1,2-bis(2-methoxyethoxy)ethane

Cas Number:

112-49-2

Molecular formula:

C8H18O4

IUPAC Name:

2,5,8,11-tetraoxadodecane

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 or test system 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:

other: 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, piloerrecti

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:

GHS criteria not met

Conclusions:

The median lethal dose of Triethyleneglycol dimethylether (LD50) was 5390 mg per kg body weight.

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.