Ethylcyclohexane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-01-21 - 1992-03-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Ethylcyclohexane

EC Number:

216-835-0

EC Name:

Ethylcyclohexane

Cas Number:

1678-91-7

Molecular formula:

C8H16

IUPAC Name:

ethylcyclohexane

Test material form:

liquid: volatile

Specific details on test material used for the study:

SRID or Lot I.D. Number: 7482-9A
Physical State and Appearance: Colorless liquid

Test animals / tissue source

Species:

rabbit

Strain:

other: Hra:(NZW)SPF

Details on test animals or tissues and environmental conditions:

Source: Hazleton Research Animals, Denver, PA, USA
No. of Animals: 6; 3 Washed/3 Unwashed
Sex: Not Determined
Body Weight Range at Dosing: Not Determined
Age: Young Adults (At least three months old)
Housing:
All animals were individually housed in suspended, stainless-steel, mesh cages.
Environmental Conditions:
A photoperiod of 12 hours light from 6 am. to 6 p.m. Room temperature was maintained at
70-74°F. Relative humidity was maintained at 48-51%
Diet and Water: ad libitum

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0. 1 mL/eye

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

Both eyes of each rabbit selected for the study were tested with fluorescein dye and examined within 24 hours of administering the test material. Animals showing eye irritation, ocular defects, or pre-existing corneal injury were not used.
A single dose of the material was placed into the conjunctival sac of one eye of each animal. Three of the eyes were immediately washed with running distilled water; the other three eyes were not irrigated.
Clinical Observations:
Eyes were observed immediately after instillation of the test material and 1, 24, 48, and 72 hours thereafter. Observations included indications of immediate sensory irritation and estimations of edema and erythema of the cornea and adnexal structures. Also evaluated were effects on the iris, the presence of corneal opacity and/or discharge from the eye. Eyes were treated with a 2% ophthalmic solution of fluorescein at 24 hours and observed for staining.
Body Weight Determinations:
Animals were not weighed as weights are not critical to this study.
Necropsy:
No necropsies were conducted at the conclusion of the test.

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

Reversibility:

not specified

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

not specified

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

not specified

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Any other information on results incl. tables

Description of Other Serious Ocular Lesions. Including Fluorescein Staining No other serious ocular lesion was noted during the study. Corneal and adnexal staining were not evident when unwashed and washed eyes were tested with fluorescein dye 24 hours after administration of the test material. Description of Non-Ocular Effects

No non-ocular effects were observed.

ANIMAL NUMBER	IRRIGATED	EFFECTS (Corneal Opacity,Iris Effects,Erythema,Chemosis)
		1Hour	24Hours	48Hours	72Hours
803	No	0,0,1,0	0,0,0,0	0,0,0,0	0,0,0,0
804	No	0,0,1,0	0,0,0,0	0,0,0,0	0,0,0,0
805	No	0,0,0,0	0,0,0,0	0,0,0,0	0,0,0,0
806	Yes	0,0,1,0	0,0,0,0	0,0,0,0	0,0,0,0
807	Yes	0,0,1,0	0,0,0,0	0,0,0,0	0,0,0,0
808	Yes	0,0,1,0	0,0,0,0	0,0,0,0	0,0,0,0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the minimal irritant responses observed in unwashed and washed eyes, the material was classified as "not irritating to eyes"

Executive summary:

After administration of a single dose of 0.1 mL of the test material into the conjunctival sac of one eye of each animal, three of the six eyes were washed with distilled water. The remaining three eyes were not irrigated. Signs of irritation in unwashed eyes and washed eyes were limited to slight erythema. of the conjunctivae and nictitating membranes one hour after administration of the test material. At the time of examinations on the day following dosing, all eyes in both groups (unwashed and

washed) appeared clinically normal. When unwashed and washed eyes were tested with fluorescein dye 24 hours after administration of the test material, corneal and adnexal staining were not evident. No other signs of irritation were noted during the 72-hour observation period. Immediate irrigation of the eyes had no effect on the minimal irritation responses

observed. No non-ocular effects were noted for unwashed or washed eyes during the observation period.

Based on the minimal irritant responses observed in unwashed and washed eyes, the material was classified as "not irritating to eyes"