PESTICIDE RESIDUES IN FOOD - 1982


    Sponsored jointly by FAO and WHO






    EVALUATIONS 1982





    Data and recommendations of the joint meeting
    of the FAO Panel of Experts on Pesticide Residues
    in Food and the Environment and the
    WHO Expert Group on Pesticide Residues
    Rome, 23 November - 2 December 1982

    Food and Agriculture Organization of the United Nations
    Rome 1983

    ENDOSULFAN

    

    Explanation

         Endosulfan was reviewed by the Joint Meetings of 1965, 1967 and
    1968 (FAO/WHO 1965, 1968, 1969).1 An ADI of 0-0.0075 mg/kg bw was
    recommended in 1968 based on additional data, e.g. a three-generation
    reproduction study, reported by Industrial Bio-Test Laboratories (IBT)
    in 1965.

         The 1981 JMPR recommended that for compounds with no-effect
    levels partly taken from IBT data, information should be used as a
    partial basis for establishing no-effect levels, with the view to
    recommending further action at future Joint Meetings. Replacement
    study, independently obtained validation or additional data have not
    been submitted to FAO/WHO. Accordingly the ADI for endosulfan was
    re-evaluated.

    EVALUATION FOR ACCEPTABLE DAILY INTAKE

    COMMENTS

         The 1967 JMPR was unable to set an ADI, pending evaluation of the
    results on a reproduction study in rats. The reproduction study was
    evaluated by the 1968 JMPR and an ADI of 0-0.0075 mg/kg body weight
    was determined, based partly on the results of that study. However,
    this study and a teratogenicity study were performed by IBT, and no
    independently obtained validations, replacement studies or additional
    data have been submitted to the JMPR. The long-term rat feeding study
    and the one-year dog feeding study (Hazleton Laboratories 1959 a, b)
    provide sufficient information on the chronic effects of endosulfan.

         Endosulfan does not have cumulative properties, as determined
    from biochemical evaluations in several species (FAO/WHO 1969). The
    present ADI is therefore retained, but as a temporary ADI, pending
    receipt of data validation and/or replacement studies for the non-
    validated data.

              

    1  See Annex 2 for WHO and FAO documentation.

    TOXICOLOGICAL EVALUATION

    Level Causing no Toxicological Effect

    Rat : 30 ppm in the diet, equivalent to 1.5 mg/kg bw

    Dog : 0.75 mg/kg bw day

    Estimate of Temporary Acceptable Daily Intake for Man 

    (Endosulfan A, endosulfan B and endosulfan sulphate)

    0 - 0.008 mg/kg bw

    FURTHER WORK OR INFORMATION

    Required (by 1985)

    1.   A teratogenicity study in the rat.

    2.   A multi-generation reproduction study in the rat.

    Desirable

    Further information/observations in humans.

    REFERENCES

    Hazleton Laboratories. Report of 12 May 1959a submitted to the World
    1959a     Health Organization by Hazleton Laboratories. (Unpublished)

    1959b     Report of 22 May 1959b submitted to the World Health
              Organization by Hazleton Laboratories. (Unpublished)

    See Also:
       Toxicological Abbreviations
       Endosulfan (EHC 40, 1984)
       Endosulfan (HSG 17, 1988)
       Endosulfan (PIM 576)
       Endosulfan (FAO Meeting Report PL/1965/10/1)
       Endosulfan (FAO/PL:1967/M/11/1)
       Endosulfan (FAO/PL:1968/M/9/1)
       Endosulfan (WHO Pesticide Residues Series 1)
       Endosulfan (WHO Pesticide Residues Series 4)
       Endosulfan (WHO Pesticide Residues Series 5)
       Endosulfan (Pesticide residues in food: 1989 evaluations Part II Toxicology)
       Endosulfan (JMPR Evaluations 1998 Part II Toxicological)