Carcinogenicity and chronic toxicity of copovidone (Kollidon VA 64) in Wistar rats and Beagle dogs

Food and Chemical Toxicology

Volumn 42, Issue 10, 2004, Pages 1573-1587

  Mellert, W ^a   Deckardt, K ^a   Gembardt, C ^a   Hildebrand, B ^a   Schulte, S ^a  

^a BASF SE   (Germany)

Author keywords

Beagle dog; Carcinogenicity; Chronic toxicity; Copolymer; Copolyvidone; Copovidone; Rat; Vinylpyrrolidone

Indexed keywords

COPOLYMER; COPOVIDONE; POVIDONE DERIVATIVE; UNCLASSIFIED DRUG;

ANIMAL EXPERIMENT; ANIMAL MODEL; ANIMAL TISSUE; ARTICLE; BLOOD PRESSURE MEASUREMENT; BODY WEIGHT; CARCINOGENICITY; CHRONIC TOXICITY; CLINICAL CHEMISTRY; CONTROLLED STUDY; DOG; ELECTROCARDIOGRAM; FECES; FEMALE; FOOD INTAKE; HEARING TEST; HEMATOLOGY; HISTIOCYTOSIS; HISTOPATHOLOGY; INFLAMMATION; LYMPH NODE; MALE; NONHUMAN; OPHTHALMOSCOPY; RAT; RISK ASSESSMENT; STATISTICAL SIGNIFICANCE; TOXICITY TESTING; URINALYSIS;

ANIMALS; BLOOD CELL COUNT; BLOOD PRESSURE; BODY WEIGHT; CARCINOGENICITY TESTS; CARCINOGENS; DIET; DOGS; EATING; ELECTROCARDIOGRAPHY; EXCIPIENTS; EYE DISEASES; FEMALE; HEARING DISORDERS; MALE; ORGAN SIZE; POVIDONE; RATS; RATS, WISTAR;

CANIS FAMILIARIS; RATTUS NORVEGICUS;

EID: 4043153439     PISSN: 02786915     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.fct.2004.05.003     Document Type: Article

References (6)

1. European Community (EC) Commission, 1981. Directive 87/302/EEC of 18 November, 1987; Part B: Methods for the determination of toxicity; Carcinogenicity test. Official Journal of the European Communities No. L 133, 1988, pp. 32-36
2. OECD, 1981a. Guidelines for Testing of Chemicals; Method No. 451: Carcinogenicity Studies
3. OECD, 1981b. Guidelines for Testing of Chemicals; Method No. 452: Chronic Toxicity Studies
4. Official Journal of the European Communities, No. L 147 (75/318 EEC), June 9, 1975. Council Directive of 20 May, 1975 on the approximation of the laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect to the testing of proprietary medicinal products
5. Official Journal of the European Communities, No. L 332 (83/571 EEC), November 28, 1983. Council recommendation of 26 October, 1983 concerning tests relating to the placing on the market of proprietary medicinal products
6. US FDA (Food and Drug Administration), 1982. Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives used in Food; Carcinogenicity Study in the Rodents, Appendix II Guidelines for Toxicological Testing, pp. 53-65