Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

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
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

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:
1H-benzimidazole
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 or test system 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.