1-cyclohexylethyl butyrate

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: The study is considered to be a reliability 2 study since it predates GLP but is similar to OECD TG 405.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-cyclohexylethyl butyrate

EC Number:

264-158-4

EC Name:

1-cyclohexylethyl butyrate

Cas Number:

63449-88-7

Molecular formula:

C12H22O2

IUPAC Name:

1-cyclohexylethyl butanoate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: One eye of each animal remained untreated and served as the reference control.

Amount / concentration applied:

Amount applied: 0.1 mL

Duration of treatment / exposure:

Single instillation on Day 1

Observation period (in vivo):

at least 7 days

Number of animals or in vitro replicates:

6

Details on study design:

STUDY DESIGN
The test material was applied undiluted in 6 animals.

TREATMENT
Similar to OECD 405. The test substance is placed in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids are then gently held together for about one second. The other eye serves at control.

OBSERVATIONS
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 7 days after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
Eye irritation was scored according to Draize at al., 1944.
Cornea score: Opacity (max score 4) x Area of cornea involved (max score 4) x 5 = maximum score of 80
Iris score: iris lesion (max score 2) x 5 = maximum score of 10
Conjunctiva score: (Redness (max score 3) + Chemosis (max score 4) + Discharge (max score 3) x 2 = maximum score of 20

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: mean 24, 48 and 72 hrs

Score:

0

Max. score:

80

Remarks on result:

other: Score according to Draize et al., 1944

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: mean 24, 48 and 72 hrs

Score:

0

Max. score:

10

Remarks on result:

other: Score according to Draize et al., 1944

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness, chemosis and discharge

Basis:

mean

Time point:

other: mean 24, 48 and 72 hrs

Score:

1.3

Max. score:

20

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: Score according to Draize et al., 1944

Irritant / corrosive response data:

Immediately after application: Discomfort was slight
10 minutes: Slight erythema, moderate to copious discharge
1 hour: Slight to moderate erythema, copious discharge
24 hours: Slight erythema, slight discharge
48 hours: all scored zero

Any other information on results incl. tables

Ocular Irritant response data (for the undiluted test substance)

	Time after administration
	1 hour						24 hours						48 hours						72 hours
Animal	1	2	3	4	5	6	1	2	3	4	5	6	1	2	3	4	5	6	1	2	3	4	5	6
Cornea score	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Iris score	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctivae score (redness, chemosis and discharge	10	8	10	8	8	8	4	4	4	4	4	4	0	0	0	0	0	0	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Remarks:

according to the CLP Regulation EC 1272/2008

Conclusions:

In an eye irritation study with rabbits, performed similar to OECD 405, limited irritation was observed. Based on the results of this study, the substance is not considered to be an eye irritant.

Executive summary:

The substance was tested in an eye irritation test similar to OECD 405. 0.1 mL undiluted test substance was placed in the conjuctival sac of 6 new Zealand white rabbits. The effects were scored 1, 24, 48, 72, 120, and 168 hours after application according to Draize et al., 1944. No effects on the cornea and iris were observed. The conjunctivae score after 24 hours was 4 out of 20 and was fully reversible within 48 hours. The mean irritation score (24, 48, and 72 hrs) was determined to be 1.3. Under the conditions of the test, the substance is not eye irritating.