2,6-dibromo-4-cyanophenyl heptanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10 - 17 Jul 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 2021

Deviations:

yes

Remarks:

Age and weight of animals not reported, environmental and general conditions of animals not reported, no data on untreated eye, no anesthetics and systemic analgesics were applied

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-4 (Acute Eye Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,6-dibromo-4-cyanophenyl heptanoate

EC Number:

260-300-4

EC Name:

2,6-dibromo-4-cyanophenyl heptanoate

Cas Number:

56634-95-8

Molecular formula:

C14H15Br2NO2

IUPAC Name:

2,6-dibromo-4-cyanophenyl heptanoate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas, USA
- Age at study initiation: young adults
- Weight at study initiation: not reported
- Housing: individually in suspended, wire bottom, stainless steel cages
- Diet: Purina Rabbit Chow, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

IN-LIFE DATES: From: 10 Jul 1989 To: 17 Jul 1989

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration: 100% actual test material as received
- The test item has been liquified by heating to 45 °C prior to treatment.

Duration of treatment / exposure:

30 seconds (wash group)
continuous treatment (non-wash group)

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

non-wash group: 3 per sex
wash group: 3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: either no washing was performed (non-wash group) or the treated eye was rinsed with deionized water for one minute (wash group)
- Time after start of exposure: 30 seconds (wash group only)

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: 0.2% fluorescein sodium ophthalmic solution

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of two animals scored (wash group)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: one male was found dead on Day 1

Results 2

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

male (non-wash group)

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

male (non-wash group)

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

male (non-wash group)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

chemosis score

Basis:

animal #4

Remarks:

female (non-wash group)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

chemosis score

Basis:

animal #5

Remarks:

female (non-wash group)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

chemosis score

Basis:

animal #6

Remarks:

female (non-wash group)

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 8

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of two animals scored (wash group)

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: one male was found dead on Day 1

Results 9

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of all six animals (non-wash group)

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 4 to 7 days

Results 10

Irritation parameter:

iris score

Basis:

mean

Remarks:

of two animals scored (wash group)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: one male was found dead on Day 1

Results 11

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all six animals (non-wash group)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Results 12

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of two animals scored (wash group)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: one male was found dead on Day 1

Results 13

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all six animals (non-wash group)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

No effects on iris and cornea opacity were noted in any animal (wash and non-wash group). The test item induced conjunctivae redness in all animals of the non-wash group at the 1 h reading time point (6/6 animals scored grade 1). Full reversibility was observed after 4 (3/6 animals) to 7 days (3/6 animals). Chemosis was also observed at the 1 h reading time point for the non-wash group; 6/6 animals were scored grade 1 for this endpoint. In one animal the effect was already reversed after 24 h, in 3/6 animals after 48 h and in the remaining 2 animals after 72 h. In the wash group, conjunctivae redness was observed in all animals at the 1 h reading time point (grade 1) and full reversibility was observed after 72 h. In the same group, chemosis of grade 1 was noted in all three animals 1 h after exposure lasting until the 48 h reading time point.

Other effects:

One male of the wash group was found dead on Day 1 of the study (24 h after exposure). Positive fluorescein staining did not occur in any of the non-washed or washed eyes.

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 EPA guideline no. 81-4 and was conducted under GLP conditions. Although the study possesses deviations from the current OECD guideline no. 405 (eye irritation), such as missing information on age and weight of animals, environmental and general conditions of anima, no anesthetics and systemic analgesics were applied; in some animals washing occured 30 sec after substance instillation, it is considered valid and reliable. Under the conditions chosen the test substance did not induce eye irritation to rabbits. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for eye irritation is required.