INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
VETERINARY DRUG RESIDUES IN FOOD
WHO FOOD ADDITIVES SERIES 25
Prepared by:
The 34th meeting of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA)
World Health Organization, Geneva 1990
The International Programme on Chemical Safety (IPCS) is a
joint venture of the United Nations Environment Programme, the
International Labour Organisation, and the World Health Organization.
The main objective of the IPCS is to carry out and disseminate
evaluations of the effects of chemicals on human health and the
quality of the environment. Supporting activities include the
development of epidemiological, experimental laboratory, and risk-
assessment methods that could produce internationally comparable
results, and the development of manpower in the field of toxicology.
Other activities carried out by the IPCS include the development of
know-how for coping with chemical accidents, coordination of
laboratory testing and epidemiological studies, and promotion of
research on the mechanisms of the biological action of chemicals.
CONTENTS
Preface
Monograph Format
Antihelminthic
Albendazole
Antiprotozoal agents
Dimetridazole
Ipronidazole
Ronidazole
Antimicrobial sulfonamides
Sulfadimidine
Sulfathiazole
Growth promoter
Trenbolone acetate
Trypanosides
Diminazene
Isometamidium
Annexes
Annex 1 Reports and other documents resulting
from meetings of the Joint FAO/WHO
Expert Committee on Food Additives
Annex 2 Abbreviations used in the monographs
Annex 3 1989 JECFA participants
Annex 4 Accceptable daily intakes, other
toxicological recommendations and
information on specifications
Annex 5 Further toxicological studies and
other information required or desired
PREFACE
The monographs contained in this volume were prepared by the
thirty-fourth Joint FAO/WHO Expert Committee on Food Additives
(JEFCA), which met in Geneva, Switzerland, 30 January-8 February 1989.
These monographs summarize the safety data on selected veterinary drug
residues reviewed by the Committee. The data reviewed in these
monographs form the basis for acceptable daily intakes (ADIs)
established by the Committee.
The thirty-fourth report of JECFA has been published by the World
Health Organization as WHO Technical Report Series No. 788. The
participants in the meeting are listed in Annex 3 of the present
publication and a summary of the conclusions of the Committee is
included as Annex 4. Further information required or desired is listed
in Annex 5.
Residues monographs on the veterinary drugs that were evaluated
at the thirty-fourth meeting of JECFA will be issued separately by FAO
in the FAO Food and Nutrition Paper Series. These toxicological
monographs should be read in conjunction with the residues monographs
and the report.
Reports and other documents resulting from previous meetings of
the Joint FAO/WHO Expert Committee on Food Additives are listed in
Annex 1.
JEFCA serves as a scientific advisory body to FAO, WHO, their
Member States, and the Codex Alimentarius Commission, primarily
through the Codex Committee on Food Additives and Contaminants and the
Codex Committee on Residues of Veterinary Drugs in Foods, regarding
the safety of food additives, residues of veterinary drugs, and
contaminants in food. Committees accomplish this task by preparing
reports of their meetings and publishing specifications and
toxicological monographs, such as those contained in this volume, on
substances that they have considered.
The toxicological monographs contained in this volume are based
upon working papers that were prepared by temporary advisers. A
special acknowledgement is given to those who prepared these working
papers, Dr R. Benson, US Environmental Protection Agency, Denver,
Colorado, USA; Dr F.X.R. van Leeuwen, National Institute of Public
Health and Environmental Protection, Bilthoven, The Netherlands; Dr
J.C. McLean, Swinburne Institute of Technology, Hawthorn, Australia;
Dr E. Schlede, Max van Pettenkofer Institute of the Federal Office
of Public Health, Berlin, FRG; Dr K.N. Woodward, Division of
Toxicology and Environmental Protection, Department of Health, London,
England; and Dr M.S. Yong, Bureau of Veterinary Drugs, Ottawa,
Canada.
Many proprietary unpublished reports are referenced. These were
voluntarily submitted to the Committee by various producers of the
veterinary drugs under review and in many cases these reports
represent the only safety data available on these substances. The
temporary advisers based the working papers they developed on all the
data that were submitted, and all these studies were available to the
Committee when it made its evaluations.
From 1972 to 1975 the toxicology monographs prepared by Joint
FAO/WHO Expert Committees on Food Additives were published in the WHO
Food Additives Series; after 1975 this series was available in the
form of unpublished WHO documents provided upon request to the
Organization. Beginning with WHO Food Additives Series No, 20, which
was prepared by the twenty-ninth Committee in 1985 until WHO Food
Additives Series No. 24, which was prepared by the thirty-third
Committee in 1988, volumes in this series were published by the
Cambridge University Press. Beginning with this issue, WHO is
producing these volumes as priced documents.
The preparation and editing of the monographs included in this
volume have been made possible through the technical and financial
contributions of the Participating Institutions of the International
Programme on Chemical Safety (IPCS), which support the activities of
JECFA. IPCS is a joint venture of the United Nations Environment
Programme, the International Labour Organization, and the World Health
Organization, which is the executing agency. One of the main
objectives of the IPCS is to carry out and disseminate evaluations of
the effects of chemicals on human health and the quality of the
environment.
The designations employed and the presentation of the material in
this publication do not imply the expression of any opinion whatsoever
on the part of the organizations participating in the IPCS concerning
the legal status of any country, territory, city, or area or its
authorities, or concerning the delimitation of its frontiers or
boundaries. The mention of specific companies or of certain
manufacturers' products does not imply that they are endorsed or
recommended by those organizations in preference to others of a
similar nature that are not mentioned.
Any comments or new information on the biological or
toxicological data on the compounds reported in this document should
be addressed to: Joint WHO Secretary of the Joint FAO/WHO Expert
Committee on Food Additives, International Programme on Chemical
Safety, World Health Organization, Avenue Appia, 1211 Geneva 27,
Switzerland.
MONOGRAPH FORMAT
Note: Each monograph in this document follows the general
format presented below. Each heading may not, however, be applicable
to all monographs.
1. EXPLANATION
2. BIOLOGICAL DATA
2.1 Biochemical aspects
2.1.1 Absorption, distribution and excretion
2.1.2 Biotransformation
2.1.3 Effects on enzymes and other biochemical
parameters
2.2 Toxicological studies
2.2.1 Acute toxicity studies
2.2.2 Short-term studies
2.2.2.1-2.2.2.X Species tested
2.2.3 Long-term/carcinogenicity studies
2.2.4 Reproduction studies
2.2.5-2.2.X Special studies
2.3 Observations in humans
3. COMMENTS
4. EVALUATION
Level causing no toxicological effect
Estimate of acceptable daily intake
Further work or information
Required for substances given a temporary ADI
Desired
5. REFERENCES
See Also:
Toxicological Abbreviations