Registration Dossier
Registration Dossier
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EC number: 440-240-7 | CAS number: 1282554-35-1
Acute Toxicity: oral
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:
- 1 998
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
- Reference substance name:
- -
- EC Number:
- 440-240-7
- EC Name:
- -
- Cas Number:
- 1282554-35-1
- Molecular formula:
- C19 H20 N4
- IUPAC Name:
- 2-Propyl-4-methyl-6-(1-methylbenzimidazol-2-yl)benzimidazole
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Mortality:
- No mortality occurred.
Applicant's summary and conclusion
- Conclusions:
- Assessment of acute oral toxicity with BIBR 2271BIMBIM in the rat (Acute Toxic Class Method).The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.l tris "Acute Toxicity-Oral, Acute Toxic Class Method" and OECD No.423, "Acute Oral Toxicity - Acute Toxic Class Method".BIBR 227lBIMBIM was administered by oral gavage to three Wistar rats of each Sex at 2000 mglkg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).No mortality occurred.Hunched posture was noted in all females, 2 and 4 hours after dosing.Body weight gain shown by the animals over the study period was considered to be normal.No abnormalities were found in the animals at macroscopic post mortem examination.The oral LD50 value of BIBR 2271BIMBIM in Wistar rats was established as exceeding 2000 mglkg body weight.Based on these results and according to the EEC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC, 27th April 1993), BIBR 2271BIMBIM does not have to be classified and has no obligatory labelling requirement for oral toxicity.
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