Registration Dossier
Registration Dossier
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EC number: 215-926-2 | CAS number: 1453-82-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not performed in GLP laboratory No indication of Guideline in report, but found to be similar to OECD Guideline 401 (Acute Oral Toxicity)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Isonicotinamide
- EC Number:
- 215-926-2
- EC Name:
- Isonicotinamide
- Cas Number:
- 1453-82-3
- Molecular formula:
- C6H6N2O
- IUPAC Name:
- pyridine-4-carboxamide
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA/CREDO (Saint-Germain sur l'Arbresle - France)
- Age at study initiation: about 6 weeks
- Weight at study initiation: around 150 g
- Fasting period before study: 15 to 20 hours
- Housing: dust free sawdust (Litalabo)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 to 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 5% gommi arabicum
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 1 ml for 100 g of body weight
MAXIMUM DOSE VOLUME APPLIED: 875 mg/kg - Doses:
- The highest dose that could be set in suspension in gommi arabicum was 875 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0, 3, 7, 10 and 14
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight - Statistics:
- Calculation accordingly to Bliss model
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 875 mg/kg bw
- Remarks on result:
- not determinable because of methodological limitations
- Mortality:
- None at 875 mg/kg
- Clinical signs:
- other: No comportemental behaviour at 875 mg/kg
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- LD50 (orl, rat) is > 875 mg/kg
As there was no death observed at this dose, we could assume that LD50 (orl, rat) is > 2.000 mg/kg and in consequence, the substance should not be classified with regards to Acute toxicity by ingestion.
Danish (Q)SAR Database predicts a LD50 (orl, rat) at 2600 mg/kg/d (reliability Index: 0.74)
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