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    FAO Nutrition Meetings 
    Report Series No. 48A 
    WHO/FOOD ADD/70.39




    TOXICOLOGICAL EVALUATION OF SOME
    EXTRACTION SOLVENTS AND CERTAIN 
    OTHER SUBSTANCES




    The content of this document is the 
    result of the deliberations of the Joint 
    FAO/WHO Expert Committee on Food Additives 
    which met in Geneva, 24 June  -2 July 19701




    Food and Agriculture Organization of the United Nations
    World Health Organization


                   

    1 Fourteenth report of the Joint FAO/WHO Expert Committee on Food
    Additives, FAO Nutrition Meetings Report Series in press; Wld Hlth
    Org. techn. Rep. Ser., in press.

    CONTENTS

    INTRODUCTION

    ALLOCATION OF ACCEPTABLE DAILY INTAKES

    TOXICOLOGICAL EVALUATIONS: MISCELLANEOUS FOOD ADDITIVES AND
    CONTAMINANTS

    TOXICOLOGICAL EVALUATIONS: FILTRATION AIDS AND RELATED SUBSTANCES

    TOXICOLOGICAL EVALUATIONS: EXTRACTION SOLVENTS

    THE MONOGRAPHS

    MISCELLANEOUS FOOD ADDITIVES AND CONTAMINANTS

    Brominated Vegetable Oils
    Calcium Cyclamate and Sodium Cyclamate (including Cyclohexylamine)
    Cyclohexylamine
    Saccharin
    Copper and Cupric Sulphate
    Ethyl Maltol
    Food-Grade Mineral Oil
    Monosodium Glutamate
    Oleoresins of Paprika
    Phosphoric Acid, Phosphates and Polyphosphates
    Tin and Stannous Chloride

    FILTRATION AIDS AND RELATED SUBSTANCES

    Activated Vegetable Carbon (Food Grade)
    Tannin (Food Grade)

    EXTRACTION SOLVENTS

    Acetone
    1,2-Dichloroethane
    Dichloromethane
    Ethanol
    Methanol
    Petroleum Hydrocarbon Fractions (Hexane and Heptane) 
    Propan-2-OL
    Trichlorethylene

    ANNEX 1
    

    INTRODUCTION

         The monographs contained in this paper are the result of the
    deliberations of the Joint FAO/WHO Expert Committee on Food Additives
    which met in Geneva from 24 June to 2 July 1970. Since the report 1
    of this meeting also contains comments on groups of as well as
    individual substances considered, these monographs should be read in
    conjunction with the report.

         Any new information and comments relating to the biological data
    and their evaluation should be addressed to: Food Additives Unit,
    World Health Organization Avenue Appia, Geneva, Switzerland.

         Specifications on the food additives considered have been
    prepared, and these will be issued in a separate document entitled
    "Specifications for the Identity and Purity of Some Extraction
    Solvents and Certain Other Substances".2   Comments relating to
    specifications should be addressed to: Food Policy and Feed Science
    Service, Nutrition Division, FAO, Rome, Italy.


                   

    1 14th Report of the Joint FAO/WHO Expert Committee on Food
    Additives: FAO Nutrition Meetings Report Series, in press.; Wld
    Hlth Org. techn. Rep. Ser., in press.

    2 FAO Nutrition Meetings Report Series, 49B
    WHO/Food Add./71.40 (in preparation)

    ALLOCATION OF ACCEPTABLE DAILY INTAKES

         It is generally recognized that all chemicals are toxic to
    animals and man if large enough amounts are administered. Even those
    so called innocuous substances, when given in excessive doses, may
    induce untoward effects as a result  various non-specific actions,
    e.g. physical obstruction of the G.I. tract, alteration of osmotic
    pressure and nutritional imbalance. A limit on the daily intake of a
    substance is therefore essential for the protection of the health of
    the consumer. The Committee therefore followed previous practice where
    appropriate in allocating acceptable daily intakes to the food
    additives considered.

         An unconditional ADI was allocated only to those substances for
    which the biological data available included either the results of
    adequate short-term and long-term toxicological investigations or
    information on the biochemistry and metabolic fate of the compound or
    both.

         A conditional ADI was allocated for specific purposes arising
    from special dietary requirements.

         A temporary ADI was allocated when the available data were not
    fully adequate to establish the safety of the substance and it was
    considered necessary that the additional evidence be provided within a
    stated period of time. If the further data requested do not become
    available within the stated period, it is possible that the temporary
    ADI will be withdrawn by a future Committee.

         Whereas all the ADIs are subject to periodic review, especially
    when additional data are available, reconsideration of temporary ADIs
    is obligatory after the date specified. The decision arrived at will
    depend on the information available at the time of review. It is
    certainly not intended that the temporary status of the ADI for a food
    additive will continue to be maintained indefinitely.

          For those additives for which the available information was
    grossly inadequate to establish safety, no ADI was allocated.

         On the other hand, the Committee took cognizance of the fact that
    the level of use of certain food additives is limited by good
    manufacturing practice and that they possess a very low toxicity. For
    these additives the Committee established no limit except as based on
    good manufacturing practice.

    TOXICOLOGICAL EVALUATIONS: MISCELLANEOUS FOOD ADDITIVES AND 
    CONTAMINANTSa
                                                                     
    Substance                             Acceptable daily 
                                          intake for man1
                                          (mg/kg body-weight)
                                                                     

    Brominated vegetable oilsb            No ADI

    Carrageenanc  )                       0-502
    Furcellaran   )

    Cyclamates, calcium and sodiumd       No ADI3

    Copper and cupric sulfatee             No ADI4

    Ethyl maltole                         0-2

    Food grade mineral oile               Use limited by good
                                          manufacturing practice

    Mercurial compounds                   No ADI

    Monosodium L-glutamatee               0-1205

    Oleoresins of paprikae                Self limiting as a spice

    Phosphoric acid and phosphatesf       0-306

    Tin and stannous chloridee            No ADI4
                                                                     

    a  Specifications are also available for gelatine mid sodium
       caseinate.
    b  Identification test only.
    c  Specifications available (Annex 1, ref. 21).
    d  Specifications available (Annex 1, ref. 16; also Section 5.3.1(b)).
    c  Specifications available (see P. 3).
    e  Specifications available (see Annex 1, ref. 7).
    1  Unconditional ADIs unless otherwise indicated.
    2  As carrageenan or furcellaran, or the sum of both. (There was a
       printing error in the thirteenth report (Annex 1. ref. 19) but the
       monographs (Annex 1, ref. 20) are correct).
    3  Use in the management of diabetes and gross obesity not considered
       in this evaluation.
    4  For evaluation see section 5.3.3.
    5  Additional to the amount naturally occurring in the diet.
       Applicable to the general population except infants under one year
       of age.
    6  Conditional acceptable daily intake 30-70 mg/kg. Both the
       unconditional and conditional ADIs include the amount occurring in
       the diet.

    TOXICOLOGICAL EVALUATIONS: FILTRATION AIDS AND RELATED SUBSTANCES

                                                                     

    Substances                            Acceptable daily 
                                          intake for man
                                          (mg/kg body-weight)
                                                                     

    Activated vegetable carbonsa          No limit except for good
    (food grade)                          manufacturing practice

    Asbestos                              Decision postponedc

    Tannins (food grade)b

      Derived from Peruvian tara          0-0.6d

      Derived from Turkish aleppo,
      Chinese tara, and                   0-0.3d
      Sicilian sumac
                                                                     

    a  Specification available (see p. 6).
    b  Tentative specifications available (see p. 6) when used as a
       flocculant.
    c  See the fourteenth report of the Joint FAO/WHO Expert Committee on
       Food Additives: FAO Nutrition Meetings Report Series,; Wld Hlth
       Org. techn. Rep. Ser.,(in press).
    d  Temporary ADI.


    TOXICOLOGICAL EVALUATIONS: EXTRACTION SOLVENTS

    1.   Substances considered

         Acetone                  Petroleum hydrocarbon

         1,2-Dichlorethane        fractions (heptane and hexane)

         Dichloromethane          Propan-2-ol

         Ethanol                  1,1,2-Trichloroethylene

         Methanol

    2.   Evaluations

         (a) The evaluations for these solvents, with the exception of
    trichloroethylene as a caffeine extractant and ethanol, are tentative,
    and are subject to re-evaluation when the relevant data become
    available (see section 4.3.1).

         (b) These solvents should be used only in accordance with good
    manufacturing practice, in the expectation that this will result in
    minimal residues.

         (c) With 1,2-dichloroethane and 1,1,2-trichloroethylene, care
    must be taken to avoid the formation of toxic interaction products
    with certain treated foods.

    3. Specifications available for all these solvents with the exception
    of hexane and heptane, for which only tentative specifications were
    prepared.





















    See Also:
       Toxicological Abbreviations