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

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

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 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

not specified

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) was obtained from Union Carbide Corporation, Texas City, Texas.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

No additional information available.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Yes, other eye

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

Since fluorescein is used 24 hours after dosing, the eye is washed at that time. Thus duration is for 24 hours

Observation period (in vivo):

Up to 7 days.

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

Male or female New Zealand White rabbits are dosed with volumes of 0.1 ml. The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Fluorescein (2%) staining is used to determine corneal injury before dosing and at readings after one day.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1 hr

Score:

0

Max. score:

0

Remarks on result:

other: Following application of 0.1 ml test material into the eye of rabbits, minor, transient irritation which did not involve the cornea was observed..

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1 hr

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 4 hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hour

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Score represents mean discharge value. See Table 1 for other conjunctival endpoints examined.

Irritant / corrosive response data:

In 6 rabbit eyes, 0.1 ml of sample produced no corneal injury. Iritis developed in all 2 eyes by one hour but did not persist at 4 hours. Minor conjunctival irritation was observed in all 6 eyes. After 24 hours, there was no ocular irritation evident in any rabbit.

Other effects:

No additional information available.

Any other information on results incl. tables

Table 1 Primary Eve Irritation-Rabbit

	Observation Times, Mean (Range)
	1 hr	4 hr	24 hr	48 hr	72 hr	7 days
Cornea - Opacity	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)
- Area	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)
Iris - Injury	0.3 (0 to 1)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)
Conjunctivae - Redness	1.0 (All 1)	1.0 (All 1)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)
- Chemosis	0.7 (0 to 2)	0.3 (0 to 1)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)
- Discharge	1.7 (1 to 3)	1.0 (All 1)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)	0.0 (All 0)

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Instillation of 0.1 ml of sample into rabbit eyes produced minor, transient irritation which did not involve the cornea.

Executive summary:

The eye irritation potential of tetraethylene glycol was examined in rabbits. Instillation of 0.1 ml of sample into rabbit eyes produced minor, transient irritation which did not involve the cornea.