2,6-dibromo-4-cyanophenyl heptanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 Jul - 17 Aug 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

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 1987

Deviations:

yes

Remarks:

No details regarding environmental conditions.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

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 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:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc., Houston, Texas
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young adults
- Weight at study initiation: 234 - 309 g (males), 175 - 198 g (females)
- Fasting period before study: for at least 16 hours prior to treatment
- Housing: 1 - 3 per cage (separated by sex) suspended, wire bottom, stainless steel cages
- Diet: Purina Formulab Chow #5008, 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: 19 Jul To: 17 Aug 1989

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The dose was administered by gavage using an appropriately sized syringe and stainless steel ball-tipped intubation needle. The animals were returned to their cages immediately after treatment.

Doses:

249, 500 and 750 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: three times on the day of treatment and at least once daily thereafter
- Frequency of weighing: just prior to treatment and on Days 7 and 14, or at the time of discovery after death
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes

Statistics:

None

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

362.4 mg/kg bw

Based on:

test mat.

95% CL:

193.2 - 679.8

Remarks on result:

other: Mortality occurred starting from the lowest tested dose level of 249 mg/kg bw.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

291.9 mg/kg bw

Based on:

test mat.

95% CL:

157.1 - 542.1

Remarks on result:

other: Mortality occurred starting from the lowest tested dose level of 249 mg/kg bw.

Effect levels 3

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

322.4 mg/kg bw

Based on:

test mat.

95% CL:

219.5 - 473.3

Remarks on result:

other: both sexes combined

Mortality:

- 249 mg/kg bw: 2/5 males and 2/5 females died (males: both on Day 1, females: 1 in the first 6 h after treatment, 1 on Day 2)
- 500 mg/kg bw/day: 2/5 males and 4/5 females died (all deaths occurred during the first 6 h after treatment, except 1 male which died on Day 1)
- 750 mg/kg bw: 5/5 males and 5/5 females died (all males died within 3 h after treatment, all females on Day 1)

Clinical signs:

other: - 249 mg/kg bw: signs of salivation, lacrimation and nasal discharge, piloerection (reversible within 4 days), activity decrease (reversible within 1 day) - 500 mg/kg bw: signs of lacrimation, nasal discharge and salivation, signs of nasal discharge, pilo

Gross pathology:

A gross pathological examination was conducted on each animal which died during the study and on each animal which survived through termination of the study. Of the gross pathological findings noticed, those described as signs of lacrimation, nasal discharge, polyuria, and salivation; discoloration of the contents of the gastrointestinal tract, discoloration of the lungs, gastrointestinal tract distended with gas, large intestine empty, and variations thereof were considered possibly related to the treatment.

Summarized results can be found in Attachment 1.

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The study was conducted under GLP conditions, according to U.S. EPA guideline No. 81-1, which in principle is similar to the OECD test guideline 401. The resulting LD50 for male and female rats was 362 and 292 mg/kg bw, respectively; the combined LD50 was 322.4 mg/kg bw. Taking into account the most sensitive LD50 value of 292 mg/kg bw which refers to female rats, the substance is to be classified in Cat 3 according to the criteria of the the CLP Regulation (EU) No. 1272/2008.