Registration Dossier
Registration Dossier
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EC number: 604-137-2 | CAS number: 139481-44-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 27 May to 10 June 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Methyl 1-[(2’-cyanobiphenyl-4-yl)methyl]-2-ethoxy-1H-benzimidazole-7-carboxylate
- EC Number:
- 604-137-2
- Cas Number:
- 139481-44-0
- Molecular formula:
- C25H21N3O3
- IUPAC Name:
- Methyl 1-[(2’-cyanobiphenyl-4-yl)methyl]-2-ethoxy-1H-benzimidazole-7-carboxylate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Remarks:
- absorbent gauze was moistened with sterile water
- Details on dermal exposure:
- to the back of the animal on a previously shaved area
- Duration of exposure:
- 24 hours
- Doses:
- Each dose is expressed in mg/kg of CAN 4 (the maximum limit dose of 2000 mg/kg body weight) administered and adjusted to individual body weight as determined immediately before administration
- No. of animals per sex per dose:
- 10 animals (5 males and 5 females)
- Control animals:
- yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occurred during the study
- Clinical signs:
- no clinical signs were observed during the course of the study
- Body weight:
- the individual results of body weight gain in treated animals was normal when compared with values usually found in the "Centre de Recherches"
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions adopted, dermal application of the test substance at dose of 2000 mg/kg caused no mortalityand no dermal reactions during a 14 -day period.Under the experimental conditions adopted, the LD50 of the test substance administrated by the dermal route was higher then 2000 mg/kg body weight in Sprague-Dawley rats.
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