Registration Dossier
Registration Dossier
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EC number: 264-497-8 | CAS number: 63817-45-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
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:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 1-ethyl-2-[1,2,3,4-tetrahydro-1-(2-hydroxyethyl)-2,2,4-trimethyl-6-quinolyl]benz[cd]indolium chloride
- EC Number:
- 264-497-8
- EC Name:
- 1-ethyl-2-[1,2,3,4-tetrahydro-1-(2-hydroxyethyl)-2,2,4-trimethyl-6-quinolyl]benz[cd]indolium chloride
- Cas Number:
- 63817-45-8
- Molecular formula:
- C27H31N2O.Cl
- IUPAC Name:
- 1-ethyl-2-[1-(2-hydroxyethyl)-2,2,4-trimethyl-1,2,3,4-tetrahydroquinolin-6-yl]benzo[cd]indolium chloride
- Test material form:
- solid
- Details on test material:
- Basic Blue 147 Cl
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 wks
- Weight at study initiation: 163 g (mean)
- Fasting period before study: 16 h
- Housing: Makrolon Type III cages (group of 5 animals)
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 23.5
- Humidity (%): 55 - 65
- Light/darkness (h): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Lutrol
- Details on oral exposure:
- 20 mL/kg bw application volume
- Doses:
- 100, 600, 1000, 3100, 5000 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: h 0 and d 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- Probit analysis
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 805 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- > 490 - < 1 232
- Mortality:
- 100: 0/10; 600: 2/10; 1000: 5/10; 3100: 8/10; 5000 mg/kg bw: 10/10 dead
Death occurred between 4 h and 14 d after application. - Clinical signs:
- 100: no symptoms; 600 - 5000: bad general condition; 1000 mg/kg bw: scrubby fur
Symptoms occurred between 5 min to 1 h after application. - Body weight:
- 600 mg/kg bw: weight loss
- Gross pathology:
- No findings
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 (oral, gavage) in male rats was determined to be 805 mg/kg bw (act. ingr.). The substance is classified as Category 4 according to CLP criteria.
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