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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
Reference substance name:
Benzimidazole
EC Number:
200-081-4
EC Name:
Benzimidazole
Cas Number:
51-17-2
Molecular formula:
C7H6N2
IUPAC Name:
benzimidazole
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:
No data
Body weight:
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.