Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test method according to 96/54/EG, B.1 tris (Acute toxic class method). GLP study.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 96/54/EG, B.1tris (Akute-toxische-Klassen-Methode)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
440-240-7
EC Name:
-
Molecular formula:
C19H20N4.H2O
IUPAC Name:
1,7'-dimethyl-2'-propyl-1H,1'H-2,5'-bibenzimidazole hydrate
Details on test material:
- Name of test material: BIMBIM

Test animals

Species:
rat
Strain:
other: Wistar Crl:(WI)BR
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1% aqueous carboxymethycellulose.
Details on oral exposure:
VEHICLE: 1% aqueous carboxymethyl cellulose.
Doses:
2000 mg/kg
No. of animals per sex per dose:
3 animals per sexe per dose
Control animals:
not specified
Details on study design:
- Other examinations performed: clinical signs, gross pathology.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
2 - 4 h after application of the substance all females showed a hunched posture. No other toxicologic effects were observed.
Gross pathology:
No effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No mortalities, significant clinical signs or gross pathology changes were observed after the exposure of male and female rats to 2000 mg/kg test substance in 1% aqueous carboxymethyl cellulose.
Executive summary:

An oral acute study was performed in male and female rats under GLP conditions according the the guideline 96/54/EG, B.1tris (Acute toxic class method). 3 rats per sexe were exposed to a single administration of the test substance at concentration of 2000 mg/kg in 1% aqueous carboxymethyl cellulose. There were no mortalities, the only clinical sign was that 2 - 4 hours after the application of the substance all females showed a hunched posture. No effects in gross pathology were observed.