2,6-dibromo-4-cyanophenyl octanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 Jun - 22 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 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1992

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 2015

Deviations:

yes

Remarks:

housing temperature slightly different, age of animals 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, Prouzel, France
- Age at study initiation: not specified
- Weight at study initiation: 2.5 ± 0.1 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: 15 Jun To: 22 Jun 1999

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g
A single dose of 0.5 g test item was grounded to a fine powder, which was applied to a moistened gauze pad. This was held in place on the clipped skin site of the right flank by means of an adhesive hypoallergenic aerated semi-occlusive dressing and restraining bandage.

VEHICLE
No vehicle was used.

NEGATIVE CONTROL
The untreated skin on the left flank served as a control.

POSITIVE CONTROL
No positive control was used.

Duration of treatment / exposure:

4 h

Observation period:

6 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure:
clipped skin on the right flank
- Type of wrap if used:
adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage

REMOVAL OF TEST SUBSTANCE
- Washing:
After removal of the dressing, any residual test substance was wiped off by means of a dry gauze pad.
- Time after start of exposure:
4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 h and on Day 5 and 6

SCORING SYSTEM:
- Method of calculation: Draize scoring system

OTHER:
As possible irritant effects were anticipated, the test substance was evaluated on a single animal in the first instance. The duration of exposure was 3 min on one flank and 4 h on the other flank. Since the test substance was not irritant on this first animal, it was then applied for 4 h to two other animals.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

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:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible

Remarks:

on Day 6

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Remarks:

on Day 5

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

3 min-exposure (one animal)
No cutaneous reactions were observed.

4 h-exposure (three animals)
No cutaneous reactions were observed in one animal at any time point. In the other two animals, very slight or well-defined erythema (grade 1 or 2) were noted from Day 1 up to Day 5 at the latest. No oedema were observed. The mean scores over 24, 48 and 72 h for each animal were 0.0, 2.0 and 1.0 for erythema and 0, 0 and 0 for oedema. For details, please refer to the 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 404, was conducted under GLP and is considered valid and reliable. Under the conditions chosen the test substance caused slight reversible irritation when applied topically to rabbits. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for skin irritation is required.