INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY
WORLD HEALTH ORGANIZATION
TOXICOLOGICAL EVALUATION OF CERTAIN
VETERINARY DRUG RESIDUES IN FOOD
WHO FOOD ADDITIVES SERIES 29
Prepared by:
The thirty-eighth meeting of the Joint FAO/WHO Expert
Committee on Food Additives (JECFA)
World Health Organization, Geneva 1991
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
ß-adrenoceptor blocking agent
Carazolol
Anthelmintic agents
Febantel
Fenbendazole
Oxfendazole
Summary
Antimicrobial agents
Spiramycin
Tylosin
Tranquilizers
Azaperone
Chlorpromazine
Propionylpromazine
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,
22-31 January, 1991
Annex 4. Recommendations on compounds on the agenda
PREFACE
The monographs contained in this volume were prepared by the
thirty-eighth Joint FAO/WHO Expert Committee on Food Additives
(JECFA), which met in Geneva, Switzerland, 22-31 January 1991. 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-eighth report of JECFA has been published by the
World Health Oerganization as WHO Technical Report Series No. 815.
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 veterinary drugs that were evaluated at
the thirty-eighth meeting of JECFA will be issued separately by FAO
as FAO Food and Nutrition Paper No. 41/4. 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, 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.
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.
Volumes in the WHO Food Additives Series are available from WHO
except for Numbers 20-24 (prepared by the twenty-ninth through
thirty-third Committees), which were published by the Cambridge
University Press.
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 delimitlation 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 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