Registration Dossier
Registration Dossier
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EC number: 203-406-8 | CAS number: 106-52-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not performed in GLP laboratory No indication of Guideline in report, but found to be similar to OECD Guideline 401 (Acute Oral Toxicity)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-methylpiperidin-4-ol
- EC Number:
- 203-406-8
- EC Name:
- 1-methylpiperidin-4-ol
- Cas Number:
- 106-52-5
- Molecular formula:
- C6H13NO
- IUPAC Name:
- 1-methylpiperidin-4-ol
- Test material form:
- solid: bulk
- Details on test material:
- Op 114 - Inter II - B3
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA/CREDO (Saint-Germain sur l'Arbresle - France)
- Age at study initiation: about 6 weeks
- Weight at study initiation: around 150 g
- Fasting period before study: 15 to 20 hours
- Housing: dust free sawdust (Litalabo)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 to 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 5% gommi arabicum
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 1 ml for 100 g of body weight
MAXIMUM DOSE VOLUME APPLIED: 3750 mg/kg - Doses:
- 2750 mg/kg - 3500 mg/kg - 3750 mg/kg
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 0, 3, 7, 10 and 14
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight - Statistics:
- Calculation accordingly to Bliss model
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 257.22 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 3 159.83 - <= 3 357.6
- Mortality:
- 2750 mg/kg: 20 %
3500 mg/kg: 60 %
3750 mg/kg: 80 % - Clinical signs:
- At high doses, animals suffer from epileptiform crisis, followed by death.
For survivors, the substance has a sedative effect. They recover normal activity after 2 days without weight variation.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- LD50 (orl, rat) is > 2.000 mg/kg: intermediate substance is not classified with regards to Acute toxicity via oral route according to CLP criteria.
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