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EC number: 278-388-8 | CAS number: 76199-85-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 12th May 1981
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide
- EC Number:
- 278-388-8
- EC Name:
- 2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide
- Cas Number:
- 76199-85-4
- Molecular formula:
- C16H11N5O4
- IUPAC Name:
- 2-cyano-N-methyl-2-[3-(2,4,6-trioxotetrahydropyrimidin-5(2H)-ylidene)-2,3-dihydro-1H-isoindol-1-ylidene]acetamide
- Test material form:
- solid
- Details on test material:
- - Physical state: solid, yellow
- Analytical purity: 88 %
- Stability: At least 2 years under normal conditions
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Biberach, Germany
- Age at study initiation: 12 weeks
- Mean weight at study initiation: 170 g (males), 180 g (females)
- Fasting period before study: 16 hours before administration, but water is available ad libitum.
- Housing: 5 per cage, Stainless steel wire meeh cages, type DK-III
- Diet (e.g. ad libitum): Ssniff R; FA. SSNIFF, Soest, Germany
- Water: Demineralized water each workday, tap water on holidays; ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 45-75
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25 % in 0.5% aqueous carboxymethyl cellulose
MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg - Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing: day of application, then days 3, 7 and 13; cageside observations: < 15', 15', 30', 1 h, 2 h, 4 h and 5 h after administration of the test substance and then once each workday. Check for moribund and dead animale twice each workday and once on holidays.
- Necropsy of survivors performed: yes, withdrawal of food 16 houre before sacrifice; necropsy with grose-pathological examination.
- Other examinations performed: body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality, no toxicity observed.
- Mortality:
- No mortality observed (0/10 animals).
- Clinical signs:
- other: No clinical signs observed.
- Gross pathology:
- No abnormalities detected.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 5000 mg/kg body weight for male and female rats.
- Executive summary:
A study was performed to assess the acute toxicity following oral administration of the test substance in rats according to OECD guideline 401. To a group of five animals per sex and per dose a single oral dose of the test material preparation (dose volume: 20 ml/kg bw) in an aqueous solution of carboxymethyl cellulose at a dose of 5000 mg/kg bw was given.
The animals were examined for clinical signs and dead animals twice each workday and once on holidays. The observation period was 14 days following administration. Surviving animals were necropsied at the end of the study.
No clinical signs were observed during the study. All animals survived until the end of the study period. At necropsy no abnormalities were observed.
Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 5000 mg/kg body weight for male and female rats.
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