Registration Dossier
Registration Dossier
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EC number: 276-851-9 | CAS number: 72797-41-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14th to 28th april 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Oral acute toxicity according to OECD 401
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
Test material
- Reference substance name:
- (±)-7-[(3-chloro-6,11-dihydro-6-methyldibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid S,S-dioxide
- EC Number:
- 276-851-9
- EC Name:
- (±)-7-[(3-chloro-6,11-dihydro-6-methyldibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid S,S-dioxide
- Cas Number:
- 72797-41-2
- Molecular formula:
- C21H25ClN2O4S
- IUPAC Name:
- (±)-7-[(3-chloro-6,11-dihydro-6-methyldibenzo[c,f][1,2]thiazepin-11-yl)amino]heptanoic acid S,S-dioxide
- Test material form:
- solid: crystalline
- Details on test material:
- White powder
Constituent 1
- Specific details on test material used for the study:
- 1574 acide crist batch 2/88 R SI
Test animals
- Species:
- rat
- Strain:
- other: ICO (OFA-SD - IOPS caw)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- During acclimatation period :
Temp = 22°C +/- 3°C
Hygrometry : 50 +/- 20%
12 hours day light / 12 hours dark
Non recycled filtered air
5 animals of the same sex per box
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- Substance administrated by suspension to animals
One administration by means of oesophagic pipe - Doses:
- DOse : 2000mg/kg in a volume of 10ml/kg.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- Observation once per day until the 14th day to notice clinical signs
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1 male after 1 hour - 1 female after 4 hours and on male and one female after 24 hours
- Clinical signs:
- Hypokinesy after 15min the sedation
lateral decubitus after 30 minutes and piloerection after 46 hours.
After 24h less symptoms and normal behaviour of all survivors at day 6 - Body weight:
- Weight evolution slow between days 1 and 5 then, normal growth from day 8 to day 15
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under experimental conditions LD50 (oral route- Rat) of the substance 1574 acide is > 2000mg/kg. At this dose mortality is 40%
- Executive summary:
Under experimental conditions LD50 (oral route- Rat) of the substance 1574 acide is > 2000mg/kg. At this dose mortality is 40%
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