2,6-dibromo-4-cyanophenyl octanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23 Jun - 26 Jun 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 1987

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 2021

Deviations:

yes

Remarks:

housing temperature slightly different, no anesthetics and analgesics used, age of rabbits not provided

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,6-dibromo-4-cyanophenyl octanoate

EC Number:

216-885-3

EC Name:

2,6-dibromo-4-cyanophenyl octanoate

Cas Number:

1689-99-2

Molecular formula:

C15H17Br2NO2

IUPAC Name:

2,6-dibromo-4-cyanophenyl octanoate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, Prouzel, France
- Age at study initiation: not specified
- Weight at study initiation: 2.6 ± 0.2 kg
- Housing: individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm)
- Diet: 112 C pelleted diet (UAR, Villemoissonsur-Orge, France), ad libitum
- Water: drinking water filtered by a FG Millipore membrane (0.22 micron), ad libitum
No contaminants were known to have been present in the diet or drinking water at levels, which may be expected to have interfered with or prejudiced the outcome of the study.
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23 Jun To: 26 Jun 1999

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 100 mg
A single dose of 100 mg of the test substance, first ground to a fine powder, was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test substance.

VEHICLE
No vehicle was used.

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

Observation period: 21 days
Reading time points: 1, 24, 48 and 72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: DRAIZE criteria as stated in OECD TG 405

TOOL USED TO ASSESS SCORE: Where required one or two drops of 0.5% sodium fluorescein solution were instilled into the eye to determine the presence or absence of corneal opacity and to evaluate the affected area.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of two animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

of two animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Very slight conjunctival reactions were observed in all animals 1 h after treatment. This included a very slight chemosis (grade 1, 2/3 animals), a very slight redness of the conjunctiva (grade 1, 2/3 animals) and/or clear discharge (3/3 animals). A slight iritis (grade 1) was recorded in two animals at the 1 h reading time point only. The signs of minimal eye irritation had completely resolved latest by 48 h after ocular instillation of the test substance. No other ocular reactions were observed during the study. Mean scores calculated for each animal over 24, 48 and 72 h were 0.0, 0.0 and 0.3 for chemosis, 0.0, 0.0 and 0.3 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity. For details, please refer to attachment 1.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

The study is in accordance with OECD TG 405, was conducted under GLP and is considered valid and reliable. Under the conditions chosen the test substance caused minimal ocular irritation in 1/3 rabbits. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for eye irritation is required.