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Toxicological information

Acute Toxicity: oral

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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:
2004
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

Constituent 1
Chemical structure
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:

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.