Registration Dossier
Registration Dossier
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EC number: 618-944-2 | CAS number: 93413-69-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April to May 1984
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- This study used rat (male/female), and the dosage was 3, 10, 50, 200, 400 and 600 mg/kg bw.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexan-1-ol
- EC Number:
- 618-944-2
- Cas Number:
- 93413-69-5
- Molecular formula:
- C17H27NO2
- IUPAC Name:
- 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexan-1-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CRL:CD (SD) BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River Breeding Laboratories, Inc., Wilmington, MA 01887
- Age at study initiation:6 to 7 weeks
- Weight at study initiation:110 to 209 grams
- Fasting period before study:Rats were deprived of food overnight prior to, and 1 hour following administration.
- Housing:Metal and wire mesh suspended cages
- Diet (e.g. ad libitum):Purina Rodent Laboratory Chow No. 5001 (Checkers). Food is freely offered at all other times.
- Water (e.g. ad libitum):Tap water in individual bottles. Water is offered ad libitum throughout the study.
- Acclimation period:7 to 8 days
Administration / exposure
- Route of administration:
- other: oral gastric intubation
- Vehicle:
- other: sterile water
- Doses:
- Dose range testing:
Male: 100, 200, 400, 600, 800, 1000, 1740, 2950 mg/kg
Female: 100, 200, 280, 400, 600 mg/kg
No effect testing: 3, 10 and 50 mg/kg
Dose volume: 5 ml/kg - No. of animals per sex per dose:
- 3 females and 3 males per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing:during the first day amd at least daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs,gross visceral abnormalities
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- >= 200 - < 400 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- >= 200 - < 280 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- approximate LD50
- Effect level:
- 672.7 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 327.8 - <= 1 058.8
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- 336.4 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 179.6 - <= 789.2
- Mortality:
- All deaths occurred from 8 minutes to approximately 4 hours after dosing. Immediate antemortem observations included tonic convulsions, a loss of righting reflex and dyspnea with subsequent respiratory arrest.
- Clinical signs:
- other: Mydriasis, salivation and evidence of a combination of central nervous system depression, motor incoordination (decreased motor activity, bradypnea, ataxia, tremors), and CNS excitation (tonic convulsions, straub tail). Effects began within 1 minute after
- Gross pathology:
- From gross visceral examinations, rats that died after doses of 280, 400, 600, 800, 1000, 1740 and 2950 mg/kg: heart activity was present and there were no remarkable abnormalities found.
Rats that were sacrificed 7 days after doses of 3, 10, 50, 100, 200, 280, 400, 600, 800 and 1000 mg/kg: There were no remarkable abnormalities
found.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information
- Conclusions:
- No-Effect dose: 50 mg/kg (male and female)
Lowest dose administered at which death occurred: Male-400 mg/kg; Female-280 mg/kg.
Highest dose administered which was non-lethal: 200 mg/kg (male and female)
Approximate Median Lenthal Doses (95% confidence limits):
Male: 672.7 (327.8-1058.8) mg/kg; Female: 336.4 (179.6-789.2) mg/kg
These results suggest a possible sex-related difference in the lethality of WY-45,030 HCl, with females having greater sensitivity than males. - Executive summary:
An acute oral toxicity study of WY-45,030 HCl showed approx.LD50 to be 672.7 and 336.4 mg/kg for males and females, respectively. And females had greater sensitivity than males.
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