Dichlobenil

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 April 1999 to 23 June 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:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dichlobenil

EC Number:

214-787-5

EC Name:

Dichlobenil

Cas Number:

1194-65-6

Molecular formula:

C7H3Cl2N

IUPAC Name:

2,6-dichlorobenzonitrile

Test material form:

solid: particulate/powder

Details on test material:

- Physical state: solid
- Storage condition of test material: room temperature and humidity

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, PA, USA
- Weight at study initiation: 206-275 g (male); 200-237 g (female)
- Fasting period before study: 16-20 hours prior to dosing
- Housing: suspended wire cages
- Diet (e.g. ad libitum): Purina Rat Chow (Diet #5012) ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

DOSAGE PREPARATION
10 g of test material was added to 40 mL of corn oil

Doses:

2000 mg/kg

No. of animals per sex per dose:

Five

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2 and 4 hours postdose and once daily for 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: body weights were recorded immediately pretest, at death and at termination in the survivors

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:

Nine out of ten animals survived. One male was sacrificed on day 2 due to moribund condition.

Clinical signs:

other: Physical signs in the surviving animals included: lethargy, chromorhinorrhoea, ataxia, sagging eyelids, soiling of the anogenitial area, diarrhoea, red staining of the nose/mouth area, wetness of the anogenital area and localised alopecia. Similar symptom

Gross pathology:

Necroposy of the survivors was normal in 2/9 animals. Kidney abnormalities were noted in 7/9 survivors. Necropsy of the sacrificed animal revealed abnormalities of the intestines, as well as red staining of the nose/mouth area.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the test, the LD50 of the test material was >2000 mg/kg.

Executive summary:

In a GLP compliant acute oral toxicity study conducted in line with standardised guideline EPA OPPTS 870.1100, the acute oral toxicity of the test material was determined. Under the conditions of the test, the LD₅₀ of the test material in rats was determined to be >2000 mg/kg bw and so the substance is considered to be unclassified for this endpoint.