Bis(2-methoxyethyl) ether

Acute Toxicity: oral

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

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

Test material information

Constituent 1

Reference substance name:

Diethylenglykol-dimethylether

IUPAC Name:

Diethylenglykol-dimethylether

Constituent 2

Reference substance name:

Bis(2-methoxyethyl) ether

EC Number:

203-924-4

EC Name:

Bis(2-methoxyethyl) ether

Cas Number:

111-96-6

Molecular formula:

C6H14O3

IUPAC Name:

1-methoxy-2-(2-methoxyethoxy)ethane

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 or test system 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, 2500, 4000, 4500, 5600, 6300 mg/kg bw

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

Key result

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:

other: 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 symptom

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:

GHS criteria not met

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.