3,6,9-trioxaundecane-1,11-diol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not specified but between 9 Dec 1985 and 6 April 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The report does not specify about GLP/Guideline but sufficient data is available for interpretation of results

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,6,9-trioxaundecane-1,11-diol

EC Number:

203-989-9

EC Name:

3,6,9-trioxaundecane-1,11-diol

Cas Number:

112-60-7

Molecular formula:

C8H18O5

IUPAC Name:

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

Test material form:

liquid: viscous

Details on test material:

Tetraethylene glycol (Sample No.; 48-349), obtained from UCC plant in Texas City, TX, was used.

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

New Zealand White rabbits, weighing between 2.0 and 3.0 kg, were used. The animals are maintained on appropriate commercial diet and municipal water.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Rabbits were subjected to 24 hours of contact with the test material 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.

Duration of exposure:

24 hours

Doses:

16 ml/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not specified

Details on study design:

After the contact period, excess fluid is removed to diminish ingestion. Observations for skin reaction are made at one hour, 7 days and 14 days after the contact period. Five male and 5 females are included on each level used for the LD50 calculation. Animal 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:

LD50's and the estimated LD50 slopes are calculated by the moving average method (Thompson, 1947; Weil, 1983) and are based on a 14-day observation period.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Based on:

test mat.

Mortality:

There was no mortality noted in male or female rabbits exposed dermally to 16 ml/kg tetraethylene glycol for 24 hours.

Clinical signs:

other: In male rabbits ,sample residue and edema were observed at day 1. In females rabbits, sample residue, edema and erythema where observed on day 1.

Gross pathology:

There were no treatment related gross pathologic observations in male or female rabbits.

Other findings:

No additional information available.

Any other information on results incl. tables

Table 1 Male and female rabbit body weights following a 24 hour dermal exposure to tetraethylene glycol.

	Day 0	Day 7	Day 14
Males	2679 + 270	2743 + 342	2846 + 344
Females	2775 + 174	2820 + 204	3011 + 224

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Tetraethylene Glycol had an extremely low order of toxicity following single dermal application. LD50 was greater than 16ml/kg (>18000mg/kg).

Executive summary:

The acute dermal toxicity of tetraethylene glycol was examined using New Zealand White rabbits. Tetraethylene Glycol had an extremely low order of toxicity following single dermal application. LD50 was greater than 16ml/kg (>18000mg/kg).