Registration Dossier
Registration Dossier
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EC number: 280-322-8 | CAS number: 83249-52-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 5-[(3,4-dichlorophenyl)azo]-1,2-dihydro-6-hydroxy-1,4-dimethyl-2-oxonicotinonitrile
- EC Number:
- 280-322-8
- EC Name:
- 5-[(3,4-dichlorophenyl)azo]-1,2-dihydro-6-hydroxy-1,4-dimethyl-2-oxonicotinonitrile
- Cas Number:
- 83249-52-9
- Molecular formula:
- C14H10Cl2N4O2
- IUPAC Name:
- 5-[(3,4-dichlorophenyl)azo]-1,2-dihydro-6-hydroxy-1,4-dimethyl-2-oxonicotinonitrile
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant:yes
- Age at study initiation: males 9 wks, females 14 wks
- Weight at study initiation: males: 158 - 166 g, females: 155 - 161 g
- Fasting period before study: 4 - 16 h prior to study initiation
- Housing: Makrolon Type III cages with dustfree softwood granulate
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 23.5°C
- Humidity (%): 55 - 65% r.h.
- Photoperiod (hrs dark / hrs light): 12/12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 20 mL/kg bw
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 5000 mg/kg bw as cut-off criterion for classification - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: beginning and end of experimental phase
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occured
- Clinical signs:
- other: No clinical signs observed
- Gross pathology:
- No remarkable finding in necropsy analysis observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item has a LD50 (oral, gavage) of >5000 mg/kg bw in male/female rats. The substance is not classifiable according to the CLP Regulation.
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