1H-Benzimidazole-7-carboxylic acid, 2-ethoxy-1-[[2'-(2H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

other information

Study period:

2003-2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant study. Adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

CAN6

IUPAC Name:

CAN6

Test material form:

solid: crystalline

Details on test material:

Appearance: white crystals.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Females are to be nulliparous and non-gravid.
Age: 8-12 weeks at the time of administration.
Number: 3 animals per step.
Weight: within ± 20% of the mean weight of any previously dosed animals.
Food was available ad libitum.
Water was available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Sterile water was chosen on the basis of the physical-chemical characteristics of the test substance as vehicle.

Doses:

The dose volume was 10 mL/kg.
The substance was administered to animals deprived of food since the previous day. It was administered to the animals as a single dose, by gavage, using a cannula of appropriate size.

Control animals:

not specified

Statistics:

All data were recorded as and when obtained using forms identified by the study number. Data were presented tabulated by dose level and time, nature, severity and durati an of effects. Results of the body weight were given as means ± SEM (Standard Errar of the Mean).

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study.

Clinical signs:

other: No clinical signs were observed during the generai clinica! examination of the study. During the full clinical examination on D7, reduced or increased spontaneous locomotor activity or vocalisation were noted in two animals of the first step.

Gross pathology:

Necroscopy: no organ or tissue gross findings were seen at necropsy of animals except far two animals of the first step which presented a whitening of the glandular zone of the stomach or black points on the glandular zone of the stomach.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions adopted, oral administration of the test sabstance at a dose of 2000 mg/kg caused no mortality and did not reqnire enthanasia during 14-day periods, in the female Sprague-Dawley Rat.