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
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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
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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
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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
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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
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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
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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
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3.8 Additional Remarks –
4. Ecotoxicity Substance ID: 21829–25–4
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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
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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 –
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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
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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 –
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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
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(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
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7.1 Risk Assessment –
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