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EC number: 279-914-9 | CAS number: 82199-12-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 31 MAY 2006 to 23 Jun 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (EU method B.1 tris; OECD TG 423)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(2-methoxyphenyl)azo]-3-oxobutyramide
- EC Number:
- 279-914-9
- EC Name:
- N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(2-methoxyphenyl)azo]-3-oxobutyramide
- Cas Number:
- 82199-12-0
- Molecular formula:
- C18H17N5O4
- IUPAC Name:
- 2-[(1E)-2-(2-methoxyphenyl)diazen-1-yl]-3-oxo-N-(2-oxo-2,3-dihydro-1H-1,3-benzodiazol-5-yl)butanamide
- Test material form:
- solid: bulk
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanRCC: WIST (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Füllinsdorf, Switzerland
- Age at study initiation: 12 weeks
- Fasting period before study: 18 to 19 h
- Housing: Macrolon cages (type 4) in groups of three
- Diet: peletted standard Provimi Kliba 3433 rat/mouse maintenance diet (batch no. 001/06, Provimi Kliba AG, Kaiseraugst, Switzerland); ad libitum
- Water: community tap water; ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): between 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2 groups of 3 animals
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: at least daily
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no animals died within the 14 day observation period
- Mortality:
- - no deaths occurred
- Clinical signs:
- other: - all animals expressed mild clinical signs of toxicity following the treatment - slight ruffeled fur was noted in 3 animals from 30 minutes reading until day 2 and in 1 animal from the 1hour reading until day 3 - hunched posture was seen, respectively, i
- Gross pathology:
- - animals killed at the end of the observation period showed no macroscopically visible changes
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Single application of the limit dose of 2000 mg test substance per kg bw did not cause lethality in female HanRCC: Wist rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.
- Executive summary:
Female rats were subjected to test acute oral toxicity according to the acute class method (OECD TG 423, Limit test). The test substance was administered by gavage at the limit dose of 2000 mg/kg bw to two groups of 3 animals. All treated animals expressed mild clinical signs of toxicity following the treatment. A slightly ruffled fur was observed in some animals which lasted until day 3, at the most. Moreover all animals showed a hunched posture for a few hours after the treatment.
No animal died within the observation period, resulting in a LD50 > 2000mg/kg bw.
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