[2-(cyclohexyloxy)ethyl]benzene

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 - 24 March 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The present in vivo study can be used because it was performed before the current REACH requirements on in vitro testing (October, 2016)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1981)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

[2-(cyclohexyloxy)ethyl]benzene

EC Number:

279-576-2

EC Name:

[2-(cyclohexyloxy)ethyl]benzene

Cas Number:

80858-47-5

Molecular formula:

C14H20O

IUPAC Name:

[2-(cyclohexyloxy)ethyl]benzene

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Remarks:

albino strain

Details on test animals or tissues and environmental conditions:

- Source: Perfection Breeders, Inc., Douglassville, Pennsylvania
- Age at study initiation: No information provided
- Weight at study initiation: Body weights were in range of 2-3 kg
- Housing: Individually
- Diet: Wayne Rabbit Ration, ad libitum, checked daily and added or replaced as needed, checked for contaminants.
- Water: Fresh tap water, available ad libitum, checked for contaminants.
- Acclimation period: Five days

ENVIRONMENTAL CONDITIONS: The light cycle was: 12 hours light, 12 hours dark. The temperature was attempted to be maintained at the level of 20 ± 3°C and the humidity in the range of 30-70%. The waste material was removed daily. Cages and feeders were sanitized every two weeks.

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 (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

Single instillation on Day 1

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 males and 3 females

Details on study design:

STUDY DESIGN
The test material was applied at 100% in 6 animals (3 males and 3 females).

TREATMENT
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 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 (mean)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: #1, 2, 3, 4, 5 and 6 (mean)

Time point:

7 d

Score:

0

Max. score:

0

Results 3

Irritation parameter:

iris score

Basis:

animal: #1, 2, 3, 4, 5 and 6 (mean)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #1, 3, 4, 5 and 6 (mean)

Remarks:

(mean)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean)

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 6

Irritation parameter:

chemosis score

Basis:

animal: #1, 2, 3, 4, 5 and 6 (mean)

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 7

Irritation parameter:

iris score

Basis:

animal: #1, 2, 3, 4, 5 and 6 (mean)

Time point:

7 d

Score:

0

Max. score:

0

Results 8

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #1, 2, 3, 4, 5 and 6 (mean)

Time point:

7 d

Score:

0

Max. score:

0

Results 9

Irritation parameter:

chemosis score

Basis:

animal: #1, 2, 3, 4, 5 and 6 (mean)

Time point:

7 d

Score:

0

Max. score:

0

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal: #1, 2, 3, 4, 5 and 6 (mean)

Time point:

other: 1 hr

Score:

0

Max. score:

0

Results 11

Irritation parameter:

iris score

Basis:

animal: #1, 2, 3, 4, 5 and 6 (mean)

Time point:

other: 1 hr

Score:

0

Max. score:

0

Results 12

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal: #1, 2, 3, 4, 5 and 6 (mean)

Time point:

other: 1 hr

Score:

0.83

Max. score:

1

Reversibility:

fully reversible within: 48 hr

Results 13

Irritation parameter:

chemosis score

Basis:

animal: #1, 2, 3, 4, 5 and 6 (mean)

Time point:

other: 1 hr

Score:

0.17

Max. score:

1

Reversibility:

fully reversible within: 24 hr

Any other information on results incl. tables

Rabbit no.	Observations	1 hr	24 hr	48 hr	72 hr	7 days
1301	Cornea	0,0=0	0,0=0	0,0=0	0,0=0	0,0=0
	Iris	0=0	0=0	0=0	0=0	0=0
	Conjunctiva	1,0,0=2	0,0,0=0	0,0,0=0	0,0,0=0	0,0,0=0
1302	Cornea	0,0=0	0,0=0	0,0=0	0,0=0	0,0=0
	Iris	0=0	0=0	0=0	0=0	0=0
	Conjunctiva	1,0,0=2	1,0,0=2	0,0,0=0	0,0,0=0	0,0,0=0
1303	Cornea	0,0=0	0,0=0	0,0=0	0,0=0	0,0=0
	Iris	0=0	0=0	0=0	0=0	0=0
	Conjunctiva	0,0,0=0	0,0,0=0	0,0,0=0	0,0,0=0	0,0,0=0
1304	Cornea	0,0=0	0,0=0	0,0=0	0,0=0	0,0=0
	Iris	0=0	0=0	0=0	0=0	0=0
	Conjunctiva	1,0,0=2	0,0,0=0	0,0,0=0	0,0,0=0	0,0,0=0
1305	Cornea	0,0=0	0,0=0	0,0=0	0,0=0	0,0=0
	Iris	0=0	0=0	0=0	0=0	0=0
	Conjunctiva	1,0,0=2	0,0,0=0	0,0,0=0	0,0,0=0	0,0,0=0
1306	Cornea	0,0=0	0,0=0	0,0=0	0,0=0	0,0=0
	Iris	0=0	0=0	0=0	0=0	0=0
	Conjunctiva	1,1,0=4	0,0,0=0	0,0,0=0	0,0,0=0	0,0,0=0

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 according to OECD 405 (1981), no irritation was observed. Based on the results of this study, the substance is not considered an eye irritant.

Executive summary:

The substance was tested in an eye irritation test in rabbits according to OECD 405 (1981). Six New Zealand albino rabbits were used (3 males and 3 females). The volume applied was 0.1 ml. Ocular effects included only a slight redness of conjunctiva in 5 out of 6 animals (score 1) at 1 hr, which were fully reversible within 24 hours in 4 animals and within 48 hours in 1 animal. A slight chemosis was observed in 1 animal (score 1) that was fully resolved within 24 hours. No other effects were seen, resulting in absence of eye irritation.