Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
additional toxicological information
Type of information:
(Q)SAR
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Amlodipin FIA
- Molecular formula (if other than submission substance): C28H27ClN2O7
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state:
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other:
- Name of test material (as cited in study report):
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance): CCOC(=O)C3=C(COCCn2c(=O)c1ccccc1c2=O)NC(C)=C(C(=O)OC)C3c4ccccc4Cl
- Substance type:pharmaceutical intermediate

Results and discussion

Applicant's summary and conclusion

Conclusions:
No structural alert for mutagencity was detected for 3-ethyl 5-methyl 4-(2-chlorophenyl)-2-((2-(1,3-dioxoisoindolin-2-yl)ethoxy)methyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate.