Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
ethyl 3-{1-[2-(chloromethyl)-1-methyl-1H-1,3-benzodiazol-5-yl]-N-(pyridin-2-yl)formamido}propanoate
EC Number:
936-788-6
Cas Number:
1307233-94-8
Molecular formula:
C20 H21 Cl N4 O3
IUPAC Name:
ethyl 3-{1-[2-(chloromethyl)-1-methyl-1H-1,3-benzodiazol-5-yl]-N-(pyridin-2-yl)formamido}propanoate

Test animals

Species:
rat
Strain:
other: Crl:WI(Han)
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Hydroxyl Ethyl Cellulose (Natrosol 250) 0.5%
Doses:
300 and 2000mmg/kg
No. of animals per sex per dose:
6
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - <= 2 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The acute median lethal oral dose (LD50) to rats of BIBR 1048 CBI (Chlorbenzimidazole PD 768) was demonstrated to be between 300 and
2000 mg/kg bodyweight.
BIBR 1048 CBI (Chlorbenzimidazole PD 768) is included in Category 4, according to the Globally Harmonised System (GHS),