4-(isopropyl)cyclohexyl propionate

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

Test performed before current guidelines

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was conducted in March 1977.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

Reliability 2 is assigned because although the study was conducted similar to the OECD TG 405, the guideline is not referenced and there is no documentation on experimental conditions. The study is also non-GLP. However, this did not influence the reliability of the results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

no

GLP compliance:

no

Test material

Test material information

1

Reference substance name:

4-(isopropyl)cyclohexyl propionate

EC Number:

264-165-2

EC Name:

4-(isopropyl)cyclohexyl propionate

Cas Number:

63449-95-6

Molecular formula:

C12H22O2

IUPAC Name:

4-(isopropyl)cyclohexyl propionate

Test material form:

other: liquid

Details on test material:

- Storage condition of test material: Store in cool dark place at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

albino strain

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. Undiluted

Duration of treatment / exposure:

Single instillation on Day 1, exposure for 24 hours

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6 animals

Details on study design:

STUDY DESIGN
The test material was applied at 100% in 6 animals.

TREATMENT
Similar and in accordance with OECD 405 (1981). 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.

REMOVAL OF TEST SUBSTANCE
-Washing: No

OBSERVATIONS
- Irritation:
The eyes of each animal were examined at 1, 24, 48 and 72 hours and 5 and 7 days after instillation of the test substance.
The irritation scores and a description of all other (local) effects were recorded. The irritation was assessed according to OECD 405 (1981).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, 2, 3, 4, 5 and 6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, 2, 3, 4, 5 and 6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1 and 3

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 24 h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: #2, 4, 5 and 6

Time point:

24/48/72 h

Score:

0

Max. score:

0

Any other information on results incl. tables

Results:

Rabbit no.	Observations	1 hr	24 hr	48 hr	72 hr	5 days	7 days
1	Cornea	0	0	0	0	0	0
	Iris	0	0	0	0	0	0
	Conjunctiva	6	4	0	0	0	0
2	Cornea	0	0	0	0	0	0
	Iris	0	0	0	0	0	0
	Conjunctiva	6	0	0	0	0	0
3	Cornea	0	0	0	0	0	0
	Iris	0	0	0	0	0	0
	Conjunctiva	6	4	0	0	0	0
4	Cornea	0	0	0	0	0	0
	Iris	0	0	0	0	0	0
	Conjunctiva	6	0	0	0	0	0
5	Cornea	0	0	0	0	0	0
	Iris	0	0	0	0	0	0
	Conjunctiva	6	0	0	0	0	0
6	Cornea	0	0	0	0	0	0
	Iris	0	0	0	0	0	0
	Conjunctiva	6	0	0	0	0	0

4 - Slight erythema, slight discharge (Draize score = 1)

6 - Slight erythema, moderate discharge (Draize score = 1)

The scores in the table above are from F.H.S.A (a US test guideline) and are different from Draize scores. The wording is therefore used qualitatively to convert the F.H.S.A scores into Draize scores. Slight erythema is considered to be Draize 1.

Applicant's summary and conclusion

Interpretation of results:

other: Not an eye irritant

Remarks:

According to EU CLP 1272/2008 and its amendments.

Conclusions:

In an eye irritation study with rabbits, performed similar to OECD 405 (1981), essentially no irritation was observed. Based on the results of this study, test substance is not an eye irritant.

Executive summary:

The substance was tested in an eye irritation test in rabbits similar to OECD 405 (1981). Six New Zealand albino rabbits were used. The volume applied was 0.1 ml and the material was applied undiluted. The scores in the test are from F.H.S.A (a US test guideline) and they are different from Draize scores. The wording is therefore used qualitatively to convert the F.H.S.A scores into Draize. Slight erythema and moderate discharge were seen in all animals at 1 hour, slight erythema and slight discharge were seen in 2/6 animals at 24 hours and none was seen after 48 hours. Discharge is not an endpoint for classification and labelling. Slight erythema is considered to be Draize 1. The mean conjunctiva score in the two affected animals was 0.3, based on the time points of 24, 48 and 72 hours, which is smaller than 2. Based on the results of this study, test substance is not an eye irritant.