2,2'-(ethylenedioxy)diethanol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 New Zealand White rabbits per sex per dose were received a dermal application of 16.0 mL/kg bw. This was held into place for 24 hours under occlusive dressing. After the contact period, excess fluid is removed to diminish ingestion. After an observation period of 14 days animals the LD50 was determined.

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.0-3.0 kg
- Diet: commerical diet (ad libitum)
- Water: municipal water (ad libitum)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

Animals are subjected to 24 hours of contact with the test substance which is retained under impervious sheeting on the clipped, intact skin of the trunk. As necessary for larger doses, gauze is wrapped around the trunk over the sample to prevent leakage. Vetrap Bandaging Tape is wrapped over the impervious sheeting and the animal is returned to its cage for the contact period. Doses are varied by adjusting the volume or weight of the test material. Solids are dosed as powders and are moistened with a sufficient amount of water or other suitable vehicle to form a paste. After the contact period, excess fluid is removed to diminish ingestion.

Duration of exposure:

24 hours

Doses:

16.0 mL/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

Observations for skin reaction are made at one hour, 7 days and 14 days after the contact period. 5 males and 5 females are included on each level used for the LD50 calculation.

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: Effect value equivalent to 18080 mg/kg bw

Mortality:

- males: 0/5
- females:1/5

Clinical signs:

other: There were no cutaneous effects observed on any animal during the observation period. The only abnormal signs noted were emaciation (in one female) and abdominal distention (in 2 females)

Gross pathology:

Necropsy of the animal that died revealed gas-filled intestines.

Any other information on results incl. tables

None of 5 male rabbits died from 16.0 mL/kg. One of 5 females died from this dose. There were no cutaneous effects observed on any animal during the observation period. The only abnormal signs noted were emaciation (in one female) and abdominal distention (in 2 females). One female rabbit died at 6 days. Necropsy of the animal that died revealed gas-filled intestines. The afore-mentioned signs, the one death and the necropsy findings could be attributable to a spontaneous intestinal disorder often observed in this species rather than to chemical toxicity. Gross pathologic evaluation of survivors revealed tan lungs (of one female), liquid-filled stomach and intestines (one female) and slight vascularization of the treated skin (one male).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met