1,4-dioxacyclohexadecane-5,16-dione

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1991-12-10 to 1991-12-20

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The information is used for read across to Zenolide.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: (E)-oxacyclohexadec-12-en-2-one; (E)-oxacyclohexadec-13-en-2-one; a) (Z)-oxacyclohexadec-(12)-en-2-one and b) (Z)-oxacyclohexadec-(13)-en-2-one

EC Number:

422-320-3

EC Name:

A mixture of: (E)-oxacyclohexadec-12-en-2-one; (E)-oxacyclohexadec-13-en-2-one; a) (Z)-oxacyclohexadec-(12)-en-2-one and b) (Z)-oxacyclohexadec-(13)-en-2-one

Molecular formula:

C15H26O2

IUPAC Name:

(12E)-1-oxacyclohexadec-12-en-2-one; (12Z)-1-oxacyclohexadec-12-en-2-one; (13E)-1-oxacyclohexadec-13-en-2-one; (13Z)-1-oxacyclohexadec-13-en-2-one

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex - England
- Weight at study initiation: 2.7, 3.4, 2.8 & 3.2 kg
- Housing: individually housed in grid bottomed metal cages.
- Diet: Free access to antibiotic-free pelleted diet, SQC Stanrab (Special Diets Services, Witham, Essex). (Quality checked)
- Water: Free access via an automatic watering system were freely available. (Quality checked)
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 22 (On 3 occasions the temperature fell below the protocol specified range, the temperature of 15°C being recorded on only one of these occasions. These deviations were considered not to have affected the outcome of the study)
- Humidity (%): 37 to 59
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 10 Dec 1991 2004 To: 20 Dec 1991

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Observation period (in vivo):

Approximately 1 hour and 24, 48 and 72 hours following treatment. An assessment of the initial pain reaction was made immediately after administration of the test material.

Number of animals or in vitro replicates:

4

Details on study design:

A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for a few second immediately after treatment, to prevent loss of the test material, and then released. One rabbit was dosed initially to assess the severity of irritation or pain. As the response to treatment was considered acceptable the remaining three animals were then dosed.

TOOL USED TO ASSESS SCORE: animals were examined under a standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the Assessment of Colour).

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

One hour after dosing, conjunctival discharge and hyperaemia was apparent in the treated eye of all 4 animals. In addition, conjunctival chemosis was noted in one rabbit. Twenty four hours after dosing, these signs of irritation were no longer apparent and the eyes of all 4 rabbits appeared normal at the 48 and 72 hour observation periods.

Applicant's summary and conclusion

Interpretation of results:

other: Not an eye irritant

Remarks:

according to EU CLP (EC 1272/2008 and its amendments)

Conclusions:

In an OECD guideline 405 study conducted in compliance with GLP, the test substance is considered to be not irritating to the eye.

Executive summary:

In an eye irritation study performed according to GLP and OECD guideline 405, 0.1 ml of the test substance was instilled into one eye of each of four rabbits. The animals were then observed for seven days. One hour after dosing, conjunctival discharge and hyperaemia were apparent in the treated eye of all 4 animals. In addition, conjunctival chemosis was noted in one rabbit. Twenty four hours after dosing, these signs of irritation were no longer apparent and the eyes of all 4 rabbits appeared normal at the 48 and 72 hour observation periods. As such, the substance does not need to be classified for eye irritation.