Registration Dossier
Registration Dossier
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EC number: 614-478-9 | CAS number: 684269-94-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from March 1, 2004 to March 24, 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study has been made on structural analogue. Study performed on mice.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- (S)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate hydrogen sulfate
- EC Number:
- 601-679-1
- Cas Number:
- 120202-66-6
- Molecular formula:
- C16 H16 Cl N O2 S . H2 O4 S
- IUPAC Name:
- (S)-methyl 2-(2-chlorophenyl)-2-(6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl)acetate hydrogen sulfate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name of test material (as cited in study report): Clopidogrel hydrogen sulphate
- Molecular formula (if other than submission substance): C16H16ClNO2S.H2SO4
- Molecular weight (if other than submission substance): 419.90
- Smiles notation (if other than submission substance): O=C(OC)[C@H](C1=CC=CC=C1Cl)N2CCC3=C(C=CS3)C2.O=S(O)(O)=O
- InChl (if other than submission substance): InChI=1S/C16H16ClNO2S.H2O4S/c1-20-16(19)15(12-4-2-3-5-13(12)17)18-8-6-14-11(10-18)7-9-21-14;1-5(2,3)4/h2-5,7,9,15H,6,8,10H2,1H3;(H2,1,2,3,4)/t15-;/m0./s1
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: drug
- Physical state: powder
- Analytical purity: 98%
- Impurities (identity and concentrations): unknown, up to 0.7% individual
- Composition of test material, percentage of components: n/a
- Isomers composition: less than 0.5% of (-)-isomer
- Purity test date: 17.12.2003
- Lot/batch No.: T2A-K87/35
- Expiration date of the lot/batch: 17.12.2006
- Radiochemical purity (if radiolabelling): n/a
- Specific activity (if radiolabelling): n/a
- Locations of the label (if radiolabelling): n/a
- Expiration date of radiochemical substance (if radiolabelling): n/a
- Stability under test conditions:
- Storage condition of test material: 15 to 25 °C, protected from light and moisture
- Other:
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: maize starch
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 8 males/8 females
- Control animals:
- yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Any other information on results incl. tables
In general, animals were in good condition and no clinical signs of toxicity were registered after administration of test item, although sedation, decreased locomotor activity and dyspnoea were seen for few hours after dosing. Pathomorphological evaluation of sacrificed animals at the end of observation period revealed no pathological effects that could be attributed to test item.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 values were over 2 g/kg, indicationg low toxicity of material.
- Executive summary:
LD50 values were over 2 g/kg, indicationg low toxicity of material.
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