2,6-dibromo-4-cyanophenyl octanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

18 Jun - 15 Jul 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 401 (Acute Oral Toxicity)

Version / remarks:

adopted 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

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 nulliparous and non-pregnant: not specified
- Age at study initiation:
approximately 6 weeks
- Weight at study initiation:
199 ± 12 g (males) and 165 ± 18 g (females)
- Fasting period before study:
overnight, approximately 18 h before dosing
- Housing:
5 per cage of the same sex in polycarbonate suspended cages containing sawdust bedding
- 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: 18 Jun To: 15 Jul 1999

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Amount of vehicle: 10 mL/kg bw
- batch no.: 107H1649 (Sigma, Saint-Quentin-Fallavier, France)

DOSAGE PREPARATION
On the day of treatment, the test substance was ground to a fine powder using a mortar and
pestle and the chosen concentrations in the vehicle were prepared. All preparations were made freshly on the morning of administration.

Doses:

50 (females), 100 (females) and 200 mg/kg bw (males and females)

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: Animals were observed frequently during the hours following administration and daily thereafter.
- Frequency of weighing: Animals were weighted before administration of the test substance on Day 1 and then on Days 8 and 15.
- Necropsy of survivors performed: yes, animals were killed by carbon dioxide asphyxiation

Statistics:

The LD50 value was calculated according to Probit-Analysis (Weber, 1972 and Bliss, 1938). The 70 to 95% confidence interval limits were calculated statistically according to Fieller's method (1944).

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

141 mg/kg bw

Based on:

test mat.

Remarks on result:

other: The toxicity was considered to be comparable in males based on the mortality at 200 mg/kg bw

Mortality:

50 and 100 mg/kg bw: no death occurred (only females were dosed)
200 mg/kg bw: 5/5 females and 3/5 males died on Day 2 following dosing
For details, please refer to attachment 1.

Clinical signs:

other: 50 and 100 mg/kg bw: no clinical signs were observed (only females were dosed) 200 mg/kg bw: No clinical signs were recorded in females before death. Hypoactivity was observed in all males on Day 1 and persisted on Day 2 in the surviving animals. For det

Gross pathology:

No apparent abnormalities were noted at necropsy in animals that survived to termination or died.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The study was performed in accordance with OECD TG 401 under GLP conditions and is considered reliable. Under the conditions chosen, the acute oral LD50 value was determined to be 141 mg/kg bw for female rats. As the male rats were only treated with the highest dose, the exact LD50 value was not determined. However, the toxicity for male rats was considered to be comparable to females based on the mortality at 200 mg/kg bw. According to criteria of the CLP Regulation (EU) No. 1272/2008, classification of the test substance for acute oral toxicity category 3 is warranted.