2,6-dibromo-4-cyanophenyl heptanoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 Jul - 27 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 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

Version / remarks:

adopted 2017

Deviations:

yes

Remarks:

No details regarding environmental conditions.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

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 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

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton. Texas
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young adults
- Weight at study initiation: 2.725 - 3.300 kg (males), 2.400 - 3.425 (females)
- Fasting period before study: no
- Housing: individually in suspended, wire bottom, stainless steel cages
- Diet: Purina Rabbit Chow; ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

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: 12 Jul To: 27 Jul 1989

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: at least 10
- Type of wrap if used: Surgical gauze (10 x 10 cm and two layers thick) was applied to the trunk of the animal and held in place with non-irritating adhesive tape. Then, the trunk was wrapped with a semi-occlusive dressing held in place non-irritating adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: with room temperature tap water and a clean wet cloth
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 1.32 mL/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: no but heated to 45 °C in a water bath to liquefy the test substance

Duration of exposure:

24 h

Doses:

2020 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1/2, 3 and 6 h after treatment and at least once daily thereafter
- Frequency of weighing: on Days 0, 7 and 14 or at the time of discovery after death
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 020 mg/kg bw

Based on:

test mat.

Remarks on result:

other: except for one female, no mortality occurred.

Mortality:

1 female died on Day 2. The gross necropsy examination conducted on this animal and on each animal which survived through termination of the study revealed no obvious abnormalities.

For details, please refer to Attachment 1.

Clinical signs:

other: - decreased defecation (1 female, Day 2 - 4, 3 males on Day 2 and 3, 1 male on Day 4) - diarrhea (1 female, Day 13) For details, please refer to Attachment 2.

Gross pathology:

At necropsy, the gross pathological examination conducted on the animal that died on Day 2 and on each animal which survived through termination of the study revealed no obvious abnormalities.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The study was conducted under GLP conditions, according to U.S. EPA guideline No. 81-2, which in principle is similar to the OECD test guideline 402. The resulting LD50 was > 2020 mg/kg bw for both, male and female rabbits. According to criteria of the CLP Regulation (EU) No. 1272/2008, no classification of the test item for acute dermal toxicity is warranted.