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Existing Chemical Substance ID: 21829–25–4
CAS No. 21829–25–4
EINECS Name nifedipine
EINECS No. 244–598–3
Molecular Weight 346.32
Structural Formula O=C(OC)C2(C(C1(=C(N(=O)(=O))C=CC=C1))C(C(OC)=O)=C(C)NC=2C
Molecular Formula C17H18N2O6
Dataset created by: EUROPEAN COMMISSION – European Chemicals Bureau
This dossier is a compilation based on data reported by the European
Chemicals Industry following ’Council Regulation (EEC) No. 793/93
on the Evaluation and Control of the Risks of Existing Substances’.
All (non–confidential) information from the single datasets, submitted
in the IUCLID/HEDSET format by individual companies, was integrated
to create this document.
The data have not undergone any evaluation by the European Commission.
Creation date: 18–FEB–2000
Number of Pages: 14
Chapters: all
Edition: Year 2000 CD–ROM edition
Flags: non–confidential
(C) 2000 EUROPEAN COMMISSION
European Chemicals Bureau
1. General Information Substance ID: 21829–25–4 ______________________________________________________________________________ 1.0.1 OECD and Company Information
Name: Arzneimittelwerk Dresden GmbH
Street: Meißner Straße 35
Town: 01445 Radebeul
Country: Germany
Phone: 0351/8341389
Telefax: 0351/8341703
Name: Bayer AG
Town: 51368 Leverkusen
Country: Germany
1.0.2 Location of Production Site

1.0.3 Identity of Recipients

1.1 General Substance Information
Substance type: organic
Physical status: solid
1.1.1 Spectra

1.2 Synonyms
Source: Arzneimittelwerk Dresden GmbH Radebeul
b: 3,5–Pyridinedicarboxylic acid, 1,4–dihydro–2,6–dimethyl–4–(2–nitrophenyl)–, Source: Arzneimittelwerk Dresden GmbH Radebeul
c: 3,5–Pyridinecarboxylic acid, 1,4–dihydro–2,6–dimethyl–4–(o–nitrophenyl)–, Source: Arzneimittelwerk Dresden GmbH Radebeul
d: 2,6–Dimethyl–3,5–dicarbomethoxy–4–(2–nitrophenyl)–1,4–dihydropyridine Source: Arzneimittelwerk Dresden GmbH Radebeul
Source: Arzneimittelwerk Dresden GmbH Radebeul
Source: Arzneimittelwerk Dresden GmbH Radebeul
1. General Information Substance ID: 21829–25–4 ______________________________________________________________________________ Source: Arzneimittelwerk Dresden GmbH Radebeul
Source: Arzneimittelwerk Dresden GmbH Radebeul
Source: Arzneimittelwerk Dresden GmbH Radebeul
Source: Arzneimittelwerk Dresden GmbH Radebeul
Source: Arzneimittelwerk Dresden GmbH Radebeul
Source: Bayer AG Leverkusen
1.3 Impurities

1.4 Additives

1.5 Quantity

1.6.1 Labelling

1.6.2 Classification

1.7 Use Pattern

1.7.1 Technology Production/Use

1.8 Occupational Exposure Limit Values
Type of limit: other
Limit value: 1 mg/m3
Source: Arzneimittelwerk Dresden GmbH Radebeul
1. General Information Substance ID: 21829–25–4 ______________________________________________________________________________ 1.9 Source of Exposure

1.10.1 Recommendations/Precautionary Measures

1.10.2 Emergency Measures

1.11 Packaging

1.12 Possib. of Rendering Subst. Harmless

1.13 Statements Concerning Waste

1.14.1 Water Pollution

1.14.2 Major Accident Hazards

1.14.3 Air Pollution

1.15 Additional Remarks

1.16 Last Literature Search

1.17 Reviews

1.18 Listings e.g. Chemical Inventories

2. Physico–chemical Data Substance ID: 21829–25–4 ______________________________________________________________________________ 2.1 Melting Point
Value: 171 – 175 degree C
Decomposition: ambiguous
Sublimation: ambiguous
Method: other
GLP: no data
Source: Arzneimittelwerk Dresden GmbH Radebeul
2.2 Boiling Point

2.3 Density
Type: bulk density
Value: ca. 500 – 600 kg/m3
Method: other
GLP: no data
Remark: Firmeninterne Angabe ohne Methodennachweis.
Source: Arzneimittelwerk Dresden GmbH Radebeul
2.3.1 Granulometry

2.4 Vapour Pressure

2.5 Partition Coefficient

2.6.1 Water Solubility
Value: = .01 g/l at 20 degree C
Method: other
GLP: no data
Remark: Firmeninterne Angabe ohne Methodennachweis.
Source: Arzneimittelwerk Dresden GmbH Radebeul
Result: praktisch unlöslich in Wasser
Source: Arzneimittelwerk Dresden GmbH Radebeul
2.6.2 Surface Tension

2.7 Flash Point

2. Physico–chemical Data Substance ID: 21829–25–4 ______________________________________________________________________________ 2.8 Auto Flammability

2.9 Flammability

2.10 Explosive Properties

2.11 Oxidizing Properties

2.12 Additional Remarks

3. Environmental Fate and Pathways Substance ID: 21829–25–4 ______________________________________________________________________________ 3.1.1 Photodegradation

3.1.2 Stability in Water

3.1.3 Stability in Soil

3.2 Monitoring Data (Environment)

3.3.1 Transport between Environmental Compartments

3.3.2 Distribution

3.4 Mode of Degradation in Actual Use

3.5 Biodegradation
Type: aerobic
Inoculum: aerobic microorganisms
Concentration: 100 mg/l related to Test substance
Degradation: 3 % after 28 day
Result: other
Method: other
Year: GLP: yes
Test substance: as prescribed by 1.1 – 1.4
Method: Bioabbau –Manometrischer Respirations– test
Verfahren nach Richtlinie 79/831 EWG, Anhang V, Teil C (aktualisierte Fassung vom Juli 1990), Methode C.4–D: Manometrischer Respirationstest (SOP 3.003, 3.008) Remark: Prüfeinrichtung, Bayer AG, Institut für Umweltanalyse und
Result: Not Readily Biodegradable
Source: Arzneimittelwerk Dresden GmbH Radebeul
3.6 BOD5, COD or BOD5/COD Ratio

3.7 Bioaccumulation

3. Environmental Fate and Pathways Substance ID: 21829–25–4 ______________________________________________________________________________ 3.8 Additional Remarks

4. Ecotoxicity Substance ID: 21829–25–4 ______________________________________________________________________________ AQUATIC ORGANISMS
4.1 Acute/Prolonged Toxicity to Fish
Type: static
Species: Brachydanio rerio (Fish, fresh water)
Exposure period: 96 hour(s)
Unit: mg/l Analytical monitoring: no data
LC0: >= 5.77
Method: other
Year: 1992 GLP: yes
Test substance: as prescribed by 1.1 – 1.4
Method: SOP 4.002
Prüfrichtlinie "Akute Toxizität für Fische" (C.1) Abweichend von der SOP 4.002 erfolgt die Testdurchführung Remark: Prüfeinrichtung Bayer AG, Institut für Umweltanalyse und
Source: Arzneimittelwerk Dresden GmbH Radebeul
4.2 Acute Toxicity to Aquatic Invertebrates
Species: Daphnia magna (Crustacea)
Exposure period: 48 hour(s)
Unit: mg/l Analytical monitoring: no data
EC0: >= 3.88
Method: other
Year: 1992 GLP: yes
Test substance: as prescribed by 1.1 – 1.4
Method: SOP 4.004
Prüfrichtlinie "Akute Toxizität für Daphnien" (C.2) Abweichend von der SOP 4.004 erfolgt die Testdurchführung Remark: Prüfeinrichtung Bayer AG, Institut für Umweltanalyse und
Source: Arzneimittelwerk Dresden GmbH Radebeul
4.3 Toxicity to Aquatic Plants e.g. Algae

4. Ecotoxicity Substance ID: 21829–25–4 ______________________________________________________________________________ 4.4 Toxicity to Microorganisms e.g. Bacteria
Type: aquatic
Species: activated sludge of a predominantly domestic sewage
Exposure period: 30 minute(s)
Unit: mg/l Analytical monitoring: no data
EC50: > 10000
Method: ISO 8192 "Test for inhibition of oxygen consumption by
Year: GLP: yes
Test substance: as prescribed by 1.1 – 1.4
Method: ISO 8192 und Amtsblatt der EG L133 Teil C:
Biologische Abbaubarkeit: Prüfung der Atmungshemmung (entspricht weitgehend der Testmethode OECD 209) SOP 3.005 Remark: Prüfeinrichtung Bayer AG, Institut für Umweltanalyse und
Source: Arzneimittelwerk Dresden GmbH Radebeul
4.5 Chronic Toxicity to Aquatic Organisms
4.5.1 Chronic Toxicity to Fish

4.5.2 Chronic Toxicity to Aquatic Invertebrates

TERRESTRIAL ORGANISMS
4.6.1 Toxicity to Soil Dwelling Organisms

4.6.2 Toxicity to Terrestrial Plants

4.6.3 Toxicity to other Non–Mamm. Terrestrial Species

4.7 Biological Effects Monitoring

4.8 Biotransformation and Kinetics

4.9 Additional Remarks

______________________________________________________________________________ 5.1 Acute Toxicity
5.1.1 Acute Oral Toxicity
Type: LD50
Species: rat
Number of
Animals:
Vehicle:
Value: = 1022 mg/kg bw
Method: other
Year: GLP: no data
Test substance: as prescribed by 1.1 – 1.4
Source: Arzneimittelwerk Dresden GmbH Radebeul
Type: LD50
Species: mouse
Number of
Animals:
Vehicle:
Value: = 310 mg/kg bw
Method: other
Year: GLP: no data
Test substance: as prescribed by 1.1 – 1.4
Source: Arzneimittelwerk Dresden GmbH Radebeul
Type: LD50
Species: rabbit
Number of
Animals:
Vehicle:
Value: = 504 mg/kg bw
Method: other
Year: GLP: no data
Test substance: as prescribed by 1.1 – 1.4
Source: Arzneimittelwerk Dresden GmbH Radebeul
Type: LD50
Species: cat
Number of
Animals:
Vehicle:
Value: = 100 mg/kg bw
Method: other
Year: GLP: no data
Test substance: as prescribed by 1.1 – 1.4
Source: Arzneimittelwerk Dresden GmbH Radebeul
______________________________________________________________________________ 5.1.2 Acute Inhalation Toxicity

5.1.3 Acute Dermal Toxicity

5.1.4 Acute Toxicity, other Routes
Species:
Number of
Animals:
Vehicle:
Route of admin.:
Year: GLP:
Test substance:
Source: Arzneimittelwerk Dresden GmbH Radebeul
5.2 Corrosiveness and Irritation
5.2.1 Skin Irritation

5.2.2 Eye Irritation

5.3 Sensitization

5.4 Repeated Dose Toxicity

5.5 Genetic Toxicity ’in Vitro’

5.6 Genetic Toxicity ’in Vivo’

5.7 Carcinogenicity

______________________________________________________________________________ 5.8 Toxicity to Reproduction
Type: other
Species: rat Sex: female
Strain: no data
Route of admin.:
Exposure Period:
Frequency of
treatment:
Duration of test:
Doses: TDLo 10 mg/kg 21D preg
Control Group:
Method: other
Year: GLP: no data
Test substance: as prescribed by 1.1 – 1.4
Source: Arzneimittelwerk Dresden GmbH Radebeul
Type: other
Species: human Sex: female
Strain: no data
Route of admin.: oral unspecified
Exposure Period:
Frequency of
treatment:
Duration of test:
Doses: TDLo 200 µg/kg 27W preg
Control Group:
Method: other
Year: GLP: no data
Test substance: as prescribed by 1.1 – 1.4
Source: Arzneimittelwerk Dresden GmbH Radebeul
5.9 Developmental Toxicity/Teratogenicity

5.10 Other Relevant Information

5.11 Experience with Human Exposure

6. References Substance ID: 21829–25–4 ______________________________________________________________________________ (1) Pharmainterner Richtwert (PIR) in der Arzneimittelwerk (2) Monographie Europäische Pharmakopoe 3 Arzneimittel–Forschung Drug Research. 22, 1, 72 Japanese Journal of Pharmacology, 40, 399, 86 Arzneimittel–Forschung Drug Research. 35, 915, 85 Gynecologic and Obstetric Investigation 24, 151, 87 7. Risk Assessment Substance ID: 21829–25–4 ______________________________________________________________________________ 7.1 Risk Assessment

Source: http://esis.jrc.ec.europa.eu/doc/IUCLID/data_sheets/21829254.pdf

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