Registration Dossier
Registration Dossier
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EC number: 610-764-2 | CAS number: 51997-51-4
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:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4-[(oxiran-2-yl)methoxy]-9H-carbazole
- EC Number:
- 610-764-2
- Cas Number:
- 51997-51-4
- Molecular formula:
- C15H13NO2
- IUPAC Name:
- 4-[(oxiran-2-yl)methoxy]-9H-carbazole
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Intermediate No. 4 of Carvediol (OMECOL = Oxyranylmathoxy carbazol)
- Physical state: chamois powder
- Purity test date: 07. 10. 1998.
- Lot/batch No.: 98 / 02
- Expiration date of the lot/batch: : no measured time was available, it might be about one year, based on manufacturing experience (EGIS Active Substance Technology Department, 623/278/02.11.98.)
- Storage condition of test material: below 4 °C, protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CHARLES RIVER HUNGARY Ltd. Budapest
- Age at study initiation: 7 weeks
- Weight at study initiation: males: 259.9-287.0 g females: 187.2-207.0 g
- Fasting period before study: ~18 hours (after the test item administration food was withheld for 3 hours)
- Housing: 5 animals / sex / cage in MAKROLON II type plastic cages. (37x22x19 cm)
Cages with bedding were steam-sterilized at 121 °C for 20 minutes.
- Diet (e.g. ad libitum): ad libitum, CRLT / N standard pellets for rodents by Farmer Prompt Ltd. (Hungary)
- Water (e.g. ad libitum): tap water, ad libitum, offered daily in 500-ml, MAKROLON type drinking bottles (sterilized before use)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8 °C
- Humidity (%): 32.8-48.2 %
- Air changes (per hr): 10-15 / h
- Photoperiod (hrs dark / hrs light): 12 h dark / 12 h artificial light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% Methylcellulose mucilage
- Details on oral exposure:
- VEHICLE 1% metylcellulose mucilage
- Concentration in vehicle: 2000 mg / 20 ml suspension
- Amount of vehicle (if gavage): 20 ml / kg bw.
MAXIMUM DOSE VOLUME APPLIED: 2000 mg / kg bodyweight = 20 ml test item in vehicle suspension / kg bw - Doses:
- 2000 mg / kg
740 mg / kg
270 mg / kg
100 mg / kg
control - No. of animals per sex per dose:
- 5 (total: 50)
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: all animals were weighed on the day of randomisation, on the treatment day and on the second, third, eighth, fourteenth days and on the day of necropsy
- Necropsy of survivors performed: yes ( macroscopic)
- Other examinations performed: state of dkin, fur, eyes and mucous membranes; function of respiratory, circulatory, autonomic and central nervous system; somatomotor activity, behaviour, tremor, cramps, salivation, diarrhoea, urination, lethargy, sleep and coma
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality.
- Clinical signs:
- other: No clinical symptoms were observed after the treatment or during the observation period.
- Gross pathology:
- No alterations were detected at the scheduled necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 values of INTERMEDIATE NO. 4 OF CARVEDILOL in rats are over 2000 mg/kg, therefore, it is not classified.
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