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EC number: 413-410-3 | CAS number: 88150-62-3 AMLODIPINE STEP 3; UK-52,416
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study according to international accepted guidelines and GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate
- EC Number:
- 413-410-3
- EC Name:
- 3-ethyl 5-methyl 4-(2-chlorophenyl)-1,4-dihydro-2-[2-(1,3-dihydro-1,3-dioxo-(2H)isoindol-2-yl)-ethoxymethyl]-6-methyl-3,5-pyridinedicarboxylate
- Cas Number:
- 88150-62-3
- Molecular formula:
- C28H27ClN2O7
- IUPAC Name:
- 3-ethyl 5-methyl 4-(2-chlorophenyl)-2-{[2-(1,3-dioxo-2,3-dihydro-1H-isoindol-2-yl)ethoxy]methyl}-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Phthaloyl Amlodipine
- Physical state: pale yellow crystalline powder
- Lot/batch No.: 130306
- Expiration date of the lot/batch: May 2007
- Purity test date: 09 05 2006
- Storage condition of test material: in brown powder-flask, at ambient temperature, dry
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CHARLES RIVER (EUROPE) LABORATORIES INC.
- Age at study initiation: 8-9 weeks old, healthy adult
- Weight at study initiation: 177 - 213 g
- Fasting period before study: overnight
- Housing: 3 animas/cage type II polypropylene/polycarbonate; laboratory bedding
- Diet (e.g. ad libitum): ad libitum ssniff SM R/M-Z+H
- Water (e.g. ad libitum): tap water from municipal supply from 500ml-bottle ad libitum
- Acclimation period: 6 days (at least)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 ºC
- Humidity (%): 30-70 %
- Air changes (per hr): 8-12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/l and 200 mg/l
- Amount of vehicle (if gavage): 10 ml/kg bw)
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw - Doses:
- 300 mg/kg bw and 2000 mg/kg bw
- No. of animals per sex per dose:
- 4 groups of female rats, 3 rats/group , 2 dose / group
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: 30 min., 1, 2, 3, 4, 6 hours after the treatment, and thereafter once a day
weighing: shortly after treatment, on the 7th day, on the 14th day (accuracy to the next 1 g)
- Necropsy of survivors performed: yes/no yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality
- Clinical signs:
- other: no signs
- Gross pathology:
- group 1: (300 mg/kg bw): 1 case of hydrometra
2: (300 mg/kg bw): 1 case of hydrometra
3: (2000 mg/kg bw): 1 case of pinprick-sized haemorrhages and 1 case of hydrometra
4: (2000 mg/kg bw): macroscopic alteration could not be found
Any other information on results incl. tables
Groups |
Treatment |
Lethality |
|
Test item |
Dose (mg/kg bw) |
Females |
|
1 |
“Amlodipine phthaloyl” |
300 |
0/3 |
2 |
“Amlodipine phthaloyl” |
300 |
0/3 |
3 | "Amlodipine phthaloyl"Step3 | 2000 | 0/3 |
4 | "Amlodipine phthaloyl"Step4 | 2000 | 0/3 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item can not be classified by Globally Harmonized Classification System (GHS).
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