2,2'-(ethylenedioxy)diethanol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Reference 2

Reference Type:

publication

Title:

Toxicology Update: Triethylene glycol.

Author:

Ballantyne B. and Snellings, W.M.

Year:

2007

Bibliographic source:

J. Appl. Toxicol. 27, 291-299

Materials and methods

Principles of method if other than guideline:

Five Sprague-Dawley rats per sex per dose were exposed to the test substance via oral gavage at a dose level of 16 mL/kg bw (equivalent to 18080 mg/kg bw). After an observation period of 14 days animals were necropsied.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-(ethylenedioxy)diethanol

EC Number:

203-953-2

EC Name:

2,2'-(ethylenedioxy)diethanol

Cas Number:

112-27-6

Molecular formula:

C6H14O4

IUPAC Name:

2-[2-(2-hydroxyethoxy)ethoxy]ethan-1-ol

Test material form:

liquid

Specific details on test material used for the study:

- Batch no.: TS-3200424
- Appearance: Colorless, transparent viscous liquid
- Purity: 99.82%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 200-300 g
- Fasting period before study: The rats are fasted overnight before dosing.
- Diet: commerical diet (ad libitum)
- Water: municipal water (ad libitum)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

The animals receive the test material by stomach intubation with a ball-end stainless steel needle. The sample is injected trough the needle by means of a syringe and doses are varied by adjusting the volume of the test material or its dilution.

Doses:

16 mL/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

5 males and 5 females are included on each level used for the LD50 calculation. LD50 and the estimated LD50 slopes are calculated by the moving average method and are based on a 14-day observation period. Animals weights are recorded at 0 days (before dose), 7 days and 14 days (just prior to sacrifice). At death or sacrifice, each animal is subjected to gross pathologic evaluation.

Statistics:

no data

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Based on:

test mat.

Remarks on result:

other: Equivalent to 18080 mg/kg bw

Mortality:

none

Clinical signs:

other: sluggishness, unsteady gait

Gross pathology:

no remarkable gross lesions

Any other information on results incl. tables

Signs of toxicity included sluggishness and an unsteady gait. Recovery occurred at 3 hours to 1 day. There were no remarkable gross lesions evident at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met