INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
VETERINARY DRUG RESIDUES IN FOOD
WHO FOOD ADDITIVES SERIES 31
Prepared by:
The fortieth meeting of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA)
World Health Organization, Geneva 1993
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
Anthelminthic agents
Flubendazole
Ivermectin
Tiabendazole (Thiabendazole)
Triclabendazole
Antimicrobial agents
Furazolidone
Nitrofural (Nitrofurazone)
Production aids
Bovine somatotropins
Ractopamine
Trypanocide
Isometamidium
Annexes
Annex 1 Reports and other documents
resulting from previous meetings
of the Joint FAO/WHO Expert
Committee on Food Additives
Annex 2 Abbreviations used in the
Monographs
Annex 3 Joint FAO/WHO Expert Committee
on Food Additives, Geneva,
9-18 June 1992
Annex 4 Recommendations on compounds
on the agenda
PREFACE
The monographs contained in this volume were prepared by the
fortieth Joint FAO/WHO Expert Committee on Food Additives (JECFA),
which met in Geneva, Switzerland, 9-18 June 1992. 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 fortieth report of JECFA will be published by the World
Health Organization as WHO Technical Report Series No. 832. 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.
Residue monographs on the veterinary drugs that were evaluated
at the fortieth meeting of JECFA will be issued separately by FAO as
FAO Food and Nutrition Paper No. 41/5. 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.
JECFA 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, naturally occurring toxicants, and contaminants in food.
Committees accomplish this task by preparing reports of their
meetings and publishing specifications or residues monographs 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 at the beginning of each monograph
to those who prepared these working papers.
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 JECFA
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. WHO Food Additives Series
No. 20 which was prepared by the twenty-ninth Committee in 1985,
through WHO Food Additives Series No. 24, which was prepared by the
thirty-third Committee in 1988, were published by the Cambridge
University Press. Beginning with WHO Food Additives Series No. 25,
which was prepared by the thirty-fourth Committee, 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 Organisation, 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. All monographs may not, however, require the use of
each heading.
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 toxicity 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
5. REFERENCES
See Also:
Toxicological Abbreviations