2,2'-(ethylenedioxy)diethanol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

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:

secondary source

Title:

Toxicology Update: Triethylene glycol.

Author:

Ballantyne, B., Snellings, W.M.

Year:

2007

Bibliographic source:

J. Appl. Toxicol. 27, 291 - 299

Materials and methods

Principles of method if other than guideline:

Six New Zealand White rabbits were dosed with 0.1 mL of test material. The dose was instilled into the lower conjunctival sac of one eye. The eyes were scored according to Draize.

GLP compliance:

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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6

Details on study design:

Male and female rabbits are dosed with 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 according to Draize for 1 h, 4 h, 24 h, 48 h, 72 h and 7 days after dosing. Fluorescin (1%) staining is used to determine corneal injury before dosing and readings after 1 day.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

No corneal injury in any of 6 eyes, iritis in 6, minor (transient) conjunctival irritation in 6 (with moderate to substantial discharge in 5) with 0.1 mL; all healed at 24 hours.

Summary of eye scores:

		Observation times	1 h	4 h	24 h	48 h	72 h	7 days
		Animal No.	1	2	3	4	5	6
Cornea	Opacity	Range	All 0	All 0	All 0	All 0	All 0	All 0
		Mean	0.0	0.0	0.0	0.0	0.0	0.0
	Area	Range	All 0	All 0	All 0	All 0	All 0	All 0
		Mean	0.0	0.0	0.0	0.0	0.0	0.0
Iris	Injury	Range	All 1	0 - 1	All 0	All 0	All 0	All 0
		Mean	1.0	0.2	0.0	0.0	0.0	0.0
Conjunctivae	Redness	Range	All 1	All 1	All 0	All 0	All 0	All 0
		Mean	1.0	1.0	0.0	0.0	0.0	0.0
	Chemosis	Range	0 - 1	All 1	All 0	All 0	All 0	All 0
		Mean	0.8	1.0	0.0	0.0	0.0	0.0
	Discharge	Range	1 - 3	All 1	All 0	All 0	All 0	All 0
		Mean	2.2	1.0	0.0	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met