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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
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 Handbook

Data source

Reference
Reference Type:
review article or handbook
Title:
Developmental Toxicity of test chemical in rat
Author:
Thomas H, Shepard M.D
Year:
2011
Bibliographic source:
Catalog of teratogenic agents,2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Developmental toxicity study of test chemical in rats
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material : Benzimidazole
Molecular formula : C7H6N2
Molecular weight :118.1384 g/mol
Smiles notation : c12c(nc[nH]1)cccc2
InChl : 1S/C7H6N2/c12476(31)8597/h15H,(H,8,9)
Substance Type: Organic
Physical State: Solid

Test animals

Species:
rat
Strain:
not specified
Details on test animals and environmental conditions:
Sex: Female

Administration / exposure

Route of administration:
oral: unspecified
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Details on exposure:
No data
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data
Details on mating procedure:
pregnant female rat were used
Duration of treatment / exposure:
5 days
Frequency of treatment:
Daily
Duration of test:
day 8 through day 12
Doses / concentrations
Dose / conc.:
53 mg/kg bw/day
Remarks:
upto
No. of animals per sex per dose:
No data
Control animals:
not specified

Examinations

Maternal examinations:
No data
Ovaries and uterine content:
No data
Fetal examinations:
Fetal weight and gross pathology were examined.
Statistics:
No data
Indices:
No data
Historical control data:
No data

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Maternal developmental toxicity

Number of abortions:
not specified
Pre- and post-implantation loss:
not specified
Total litter losses by resorption:
not specified
Early or late resorptions:
not specified
Dead fetuses:
not specified
Changes in pregnancy duration:
not specified
Changes in number of pregnant:
not specified
Other effects:
no effects observed
Details on maternal toxic effects:
No effect on fetal growth were observed in trearted rats

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
53 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: No effect on No effect on fetal growth
Remarks on result:
other: No toxic effect were observed

Maternal abnormalities

Abnormalities:
not specified

Results (fetuses)

Fetal body weight changes:
no effects observed
Reduction in number of live offspring:
not specified
Changes in sex ratio:
not specified
Changes in litter size and weights:
not specified
Changes in postnatal survival:
not specified
External malformations:
no effects observed
Skeletal malformations:
not specified
Visceral malformations:
not specified
Other effects:
not specified

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
53 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
fetal/pup body weight changes
external malformations
Remarks on result:
other: No toxic effect were observed

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified
Treatment related:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL was considered to be 53 mg/kg bw for F1 generation when pregnant female rat were treated with test chemical orally.
Executive summary:

In a developmental toxicity study, pregnant female rat were treated with test chemical orally upto 53 mg/kg bw on day 8 through 12. No effect on fetal growth nor malformation were observed in treated female rats. Therefore, NOAEL was considered to be 53 mg/kg bw for F1 generation when pregnant female rat were treated with test chemical orally.