Registration Dossier
Registration Dossier
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EC number: 249-220-0 | CAS number: 28783-41-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 1991
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: GLP study but not well detailed study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No further data available
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,5,6,7-tetrahydrothieno[3,2-c]pyridine hydrochloride
- IUPAC Name:
- 4,5,6,7-tetrahydrothieno[3,2-c]pyridine hydrochloride
- Reference substance name:
- 4,5,6,7-tetrahydrothieno[3,2-c]pyridinium chloride
- EC Number:
- 249-220-0
- EC Name:
- 4,5,6,7-tetrahydrothieno[3,2-c]pyridinium chloride
- Cas Number:
- 28783-41-7
- Molecular formula:
- C7H9NS.ClH
- IUPAC Name:
- 4,5,6,7-tetrahydrothieno[3,2-c]pyridin-5-ium chloride
- Details on test material:
- Test compound: PCR 0665 (Batch 191-160-1)
Constituent 1
Constituent 2
Test animals
- Species:
- other: Rat and Mouse
- Strain:
- other: Rat, Sprague Dawley, CD(SD)BR / Mouse, Swiss, OF1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- tap water
- Doses:
- 0; 321.5; 625; 1250 mg/kg (expressed as salified compound)
- No. of animals per sex per dose:
- 10 (male or female)
- Details on study design:
- Observation period 14 days (day of treatment = Day 1)
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 625 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Rat
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 625 - 1 250 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Rat
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 625 - 1 250 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Mouse
- Clinical signs:
- other: Rats: Tremors, laboured breathing, ptyalism with blood, convulsions (Day 1) Mice: Laboured breathing, tremors, convulsions (Day 1), piloerection (Day 1 and 2)
- Gross pathology:
- Animals found dead:
- Rats: Gastric hemorrhage, lungs not collapsed
- Mice: No abnormality detected
Sacrifice on Day 15.
No abnormality detected
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 is between 625 and 1250 mg/kg. No major differences between species and sexes were detected.
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