Registration Dossier
Registration Dossier
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EC number: 604-045-2 | CAS number: 137862-53-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02.02.1993 - 04.03.1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-Pentanoyl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-L-valine
- EC Number:
- 604-045-2
- Cas Number:
- 137862-53-4
- Molecular formula:
- C24 H29 N5 O3
- IUPAC Name:
- N-Pentanoyl-N-{[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl}-L-valine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague Dawley Tif:RAlf
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Switzerland
- Age at study initiation: 46 - 71 d
- Weight at study initiation: 165 - 325 g (males), 162 - 223 g (females)
- Fasting period before study: 18 h
- Diet: SDS PCD 3/8 irradiated diet, ad libitum
- Water: purified by filtration, ad libitum
- Acclimation period: 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% carboxymethylcellulose and 0.5% Tween 80 in purified water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
- Doses:
- 1000 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- No signs related to treatment were observed.
- Body weight:
- No effects on body weight were observed.
- Gross pathology:
- No abnormalities were seen at terminal necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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