Benzimidazole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer- reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Acute oral toxicity study of test chemical was performed in rats.

Author:

Schafer et. al.

Year:

2004

Bibliographic source:

United States Department of Agriculture, Animal and Plant Health Inspection Service, Wildlife Services, National Wildlife Research Center

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Acute oral toxicity study of 1H-benzimidazole in mice

GLP compliance:

not specified

Test type:

other: No data

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzimidazole

EC Number:

200-081-4

EC Name:

Benzimidazole

Cas Number:

51-17-2

Molecular formula:

C7H6N2

IUPAC Name:

1H-1,3-benzodiazole

Details on test material:

- Name of test material (IUPAC name): 1H-1,3-benzodiazole
- Common name: benzimidazole
- Molecular formula: C7H6N2
- Molecular weight: g/mol
- Smiles notation: c12c(nc[nH]1)cccc2
- InChl: 1S/C7H6N2/c1-2-4-7-6(3-1)8-5-9-7/h1-5H,(H,8,9)
- Substance type: Organic

Specific details on test material used for the study:

- Name of test material: Benzimidazole
- IUPAC name: 1H-benzimidazole
- Molecular formula: C7H6N2
- Molecular weight: 118.1384 g/mole
- Substance type: Organic
- Physical state: Solid

Test animals

Species:

mouse

Strain:

other: Deer

Remarks:

Peromyscus maniculatus

Sex:

not specified

Details on test animals or test system and environmental conditions:

Source: Wild-trapped house and deer mice or domestically bred house mice were used
-Age at study initiation: No data
Weight at study initiation: 20 g
Fasting period before study: No data
Housing: No data
Diet (e.g. ad libitum): Wheat seeds, ad libitum
Water (e.g. ad libitum): water, ad libitum
Acclimation period: No data

ENVIRONMENTAL CONDITIONS
Temperature (°C): No data
Humidity (%): No data
Air changes (per hr): No data
Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: To: No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: water, corn oil, or 1.0% carbopol

Details on oral exposure:

No data

Doses:

470 mg/kg bw

No. of animals per sex per dose:

2 to 4 animals were used per geometrically spaced dosage level.

Control animals:

not specified

Details on study design:

Duration of observation period following administration: 3 days
Frequency of observations: 3 days observation for mortality

Statistics:

The statistical method used to estimate the acute oral LD50 is Thompson (1948) and Thompson and Weil

Results and discussion

Preliminary study:

No data

Effect levels

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 470 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No 50 % mortality observed

Mortality:

when treated with 470 mg/kg bw, no 50 % mortality were observed in treated mice.

Clinical signs:

other: No data

Gross pathology:

No data

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 value was considered to be > 470 mg/kg bw when Deer Mice (Peromyscus maniculatus) were treated with 1H-benzimidazole orally by gavage.

Executive summary:

In a acute oral toxicity study, Deer Mice (Peromyscus maniculatus) were treated with 1H-benzimidazole administered by gavage using water, corn oil, or 1.0% carbopol as carriers and observed for 3 days. No 50 % mortality were observed in treated mice at 470 mg/kg bw. Therefore, LD50 was considered to be > 470 mg/kg bw when Deer Mice (Peromyscus maniculatus) were treated with 1H-benzimidazole orally by gavage.