Registration Dossier
Registration Dossier
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EC number: 609-095-9 | CAS number: 352232-17-8
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:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 10-[4-(2-chloroethyl)piperazin-1-yl]-2-thia-9-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,9,12,14-heptaene
- EC Number:
- 609-095-9
- Cas Number:
- 352232-17-8
- Molecular formula:
- C19H20ClN3S
- IUPAC Name:
- 10-[4-(2-chloroethyl)piperazin-1-yl]-2-thia-9-azatricyclo[9.4.0.0^{3,8}]pentadeca-1(11),3(8),4,6,9,12,14-heptaene
- Details on test material:
- - Name of test material (as cited in study report): chloro-ethyl thiazepine (Quetiapin 3rd intermediate)
- Physical state: cream-coloured crystalline powder
- Lot/batch No.: 2000/1
- Expiration date of the lot/batch: : April 2001
- Storage condition of test material: at room temperature
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 (EUROPE) LABORATORIES INC.
- Age at study initiation: young adult
- Fasting period before study: the day before treatment (after the test item administration food was withheld for 3 hours)
- Housing: 3 animals / cage in III type polypropylene/polycarbonate cages.
- Bedding: laboratory bedding
- Diet (e.g. ad libitum): ad libitum, ssniff R/M-Z+H extruded complete diet for rats and mice by ssniff Spezialdiäten GmbH.
- Water (e.g. ad libitum): potable water, ad libitum, from 500-ml bottles
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- 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:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE CMC 1% aqueous
- Concentration in vehicle: 200 mg / ml suspension
- Amount of vehicle (if gavage): 10 ml / kg bw.
MAXIMUM DOSE VOLUME APPLIED: 2000 mg / kg bodyweight - Doses:
- 2000 mg / kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations : continuously for 30 minutes, 1, 2, and 5 hours after the treatment and then once a day
and weighing before treatment, on the 7th and 14th day (accuracy: 1 g)
- Necropsy of survivors performed: yes (gross, macroscopic)
- Other examinations performed: clinical signs of toxicity, status of skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- Slight-moderate activity decrease, squatting position and piloerection were found in the course of the clinical observation. The first symptoms appeared 10 minutes (male animals) and 60 minutes (female rats) after the treatment. All animals became symptom-free on the first day.
- Body weight:
- The body weight gain of male animals was transiently less than normally (untreated animals with the same age and strain) on the first week.
- Gross pathology:
- Macroscopic alterations referring to the test item effect were not seen at the 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 value of the test item was established as exceeding 2000 mg/kg body weight.
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