2-ethylhexane-1,3-diol

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:

other: Data published in a peer reviewed journal.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Unnamed

Year:

1985

Reference 2

Reference Type:

publication

Title:

Toxicology Update 2-Ethyl-1,3-hexanediol

Author:

Ballantyne

Year:

2005

Bibliographic source:

J. Appl. Toxicol 25: 248-259

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Six rabbits had 0.1 ml of undiluted EHD instilled into the inferior conjunctival sac, and further groups of six rabbits had 0.01 or 0.005 ml of EHD applied directly to the cornea

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexane-1,3-diol

EC Number:

202-377-9

EC Name:

2-ethylhexane-1,3-diol

Cas Number:

94-96-2

Molecular formula:

C8H18O2

IUPAC Name:

2-ethylhexane-1,3-diol

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report):2-EthylHexan-1,3-Diol
- Substance type: Aliphatic Alcohol
- Physical state: Liquid; slightly viscous
- Analytical purity: 98.5

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Body weights: 2.0 to 3.0 kg.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Six rabbits had 0.1 ml of undiluted EHD applied to the conjunctival sac.
Six rabbits had 0.01 or 0.005 ml of EHD applied directly to the cornea of the eye.

Duration of treatment / exposure:

14 days

Observation period (in vivo):

Eyes were inspected periodically: 1 and 24 h, and 2, 3 and 7 to 14 days after dosing, for signs of ocular and periocular inflammation and injury up to 14 days post-dosing.

Number of animals or in vitro replicates:

12 Animals. 6 had EHD instilled into the inferior conjunctival sac and six rabbits had EHD applied directly to the cornea

Details on study design:

The Draize scale was used for evaluation (Draize J.H., Woodard G., Calvery H.O. (1944). Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J. Pharmacol. And Exp. Therapeutics 82: 377–390.)

Results and discussion

In vivo

Results

Irritation parameter:

other:

Basis:

mean

Time point:

other: 1 h

Score:

>= 80

Max. score:

110

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

Following 0.1 ml of EHD there was a rapid development of mild to severe conjunctivitis (moderate to marked injection, mild to severe chemosis, mild to marked discharge), which took up to 7 days to resolve. A moderate iritis was seen that persisted for 24–48 h. A just detectable to moderate corneal injury was seen in five out of six rabbits, which persisted for 3–7 days. With the smaller volume of EHD applied to the cornea there was a moderate to severe conjunctivitis for 24 h post-instillation but the effects required 2–7 days to resolve. Scores for irritation were not provided. These were estimated based on the conclusions of the study.

Other effects:

In one animal the conjuntivitis resolved rapidly, and the eye appeared normal by 24 hr post instillation. However,
in the remaining 5 animals the conjunctival infection persisted from 3-7 days.

Any other information on results incl. tables

Summary of Scores for Eye Lesion Observed After the Instillation of Various Volumes of EHD into the Eyes of Rabbits

		Effect as Average (and range)
Volume	Observation	Cornea		Iris	Conjunctivae
(ml)		Opacity	Area		Redness	Chemosis	Discharge
0.1	1 h	0.7 (0-1)	2.7 (0-4)	0.8 (0-1)	2.8 (2-3)	2.8 (1-4)	2.7 (1-3)
	4 h	0.8 (0-1)	2.8 (0-4)	0.8 (0-1)	2.5 (1-3)	2.5 (1-3)	2.5 (1-3)
	1 day	1.0 (0-2)	2.7 (0-4)	0.8 (0-1)	2.0 (0-3)	1.2 (0-2)	1.5 (0-3)
	2 days	1.0 (0-2)	2.3 (0-4)	0.0	1.8 (0-3)	0.8 (0-1)	0.3 (0-2)
	3 days	0.8 (0-2)	2.3 (0-4)	0.2 (0-1)	1.3 (0-2)	0.5 (0-1)	0.3 (0-2)
	7 days	0.2 (0-1)	0.3 (0-2)	0.0	0.0	0.2 (0-1)	0
	14 days	0.0	0.0	0.0	0.0	0.0	0.0
0.01	1 h	0.3 (0-1)	0.8 (0-3)	1.0 (1-1)	2.8 (2-3)	2.7 (2-3)	2.7 (2-3)
	4 h	1.3 (0-2)	2.0 (0-4)	1.0 (1-1)	2.8 (2-3)	2.8 (1-4)	2.7 (1-3)
	1 day	1.5 (0-2)	1.0 (1-2)	0.8 (0-1)	2.7 (2-3)	1.3 (0-2)	1.8 (0-3)
	2 days	1.5 (0-2)	0.8 (0-1)	0.5 (0-1)	1.8 (0-3)	1.2 (0-2)	1.0 (0-2)
	3 days	0.7 (0-2)	0.5 (0-1)	0.5 (0-1)	1.2 (0-2)	1.2 (0-2)	0.3 (0-1)
	7 days	0.0	0.0	0.0	0.0	0.0	0.0
0.005	1 h	0.7 (0-1)	0.7 (0-1)	0.5 (0-1)	3.0 (3-3)	2.3 (2-3)	3.0 (3-3)
	4 h	0.3 (0-1)	0.3 (0-1)	1.0 (0-1)	3.0 (3-3)	3.2 (2-4)	3.0 (3-3)
	1 day	0.8 (0-1)	0.8 (0-1)	0.3 (0-1)	2.5 (2-3)	2.0 (2-2)	1.3 (2-3)
	2 days	0.8 (0 -1)	1.0 (0-2)	0.0	1.5 (1-2)	1.5 (1-2)	0.7 (1-2)
	3 days	0.5 (0-2)	0.3 (0-1)	0.2 (0-1)	0.8 (0-2)	0.8 (1.2)	0.7 (0-2)
	7 days	0.0	0.0	0.0	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

Category I

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

EHD causes severe eye damage when administered undiluted into the eyes of rabbits, which resolved within 7 days.