2,6-dibromo-4-cyanophenyl octanoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 - 29 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

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA Credo, L'Arbresle, France
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation:
approximately 8 weeks
- Weight at study initiation:
244 ± 10 g for males and 227 ± 10 g for females
- Housing:
During the acclimatization period, one to seven animals of the same sex were housed in polycarbonate cages (48 cm x 27 cm x 20 cm). During the treatment period, the animals were housed individually in polycarbonate cages (35.5 cm x 23.5 cm x 19.3 cm).
- Diet: A04C pelleted diet (UAR, Villemoisson-sur-Orge, France), ad libitum
- Water: drinking water filtered by a FG Millipore membrane (0.22 micron), ad libitum
- Acclimation period:
at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
21 ± 2
- Humidity (%):
30 - 70
- Air changes (per hr):
12
- Photoperiod (hrs dark / hrs light):
12/12

IN-LIFE DATES: From: 15 Jun 1999 To: 29 Jun 1999

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area
- % coverage: 10%
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage

REMOVAL OF TEST SUBSTANCE
- Washing: no; no residual test substance was observed at removal of the dressing
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: dose applied to each animal was adjusted according to body weight
- For solids, paste formed: test substance ground to a fine powder was placed on a hydrophilic gauze pad pre-moistened with 2 mL of water

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

On the day before treatment, the dorsal area (6 cm x 8 cm) of each animal was clipped using electric clippers. 5 male and 5 female rats with intact skin were treated with 2000 mg/kg bw of the test material.

- Duration of observation period following administration: 14 days
- Frequency of observations: at least once daily
- Frequency of weighing:
on day of treatment and weekly thereafter
- Necropsy of survivors performed: no (macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed)

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred during the study.

Clinical signs:

other: No clinical signs and no cutaneous reactions were observed during the study.

Gross pathology:

Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 12 72/2008

Conclusions:

The study was performed in accordance to OECD 402 under GLP conditions and is considered reliable. Under the conditions chosen, the acute dermal LD50 was determined to be > 2000 mg/kg bw/day for male and female rats. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for acute dermal toxicity is required.