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    PESTICIDE RESIDUES IN FOOD - 1981


    Sponsored jointly by FAO and WHO






    EVALUATIONS 1981







    Food and Agriculture Organization of the United Nations
    Rome

    FAO PLANT PRODUCTION AND PROTECTION PAPER 42

    pesticide residues in food:
    1981 evaluations

     the monographs

    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

    Geneva, 23 November-2 December 1981

    FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS
    Rome 1982


    sec-BUTYLAMINE

    Explanation

         In 1975, the Joint Meeting evaluated sec-butylamine. A temporary
    ADI (0-0.1 mg base/kg bw) wag allocated.*

         Further work or information required by 1981 (FAO/WHO 1979)
    included the following: required by 1981: (1) further studies to
    resolve the question of carcinogenic risk; desirable: (1)
    quantitative metabolic studies to determine whether metabolites in
    test animals are the same as those in food, plants and animals; (2)
    information on the formation and, if found, toxicity of potential
    nitrosated derivatives; (3) mutagenicity studies with techniques
    currently available and (4) clinical and metabolic observations in
    humans.

         Of the remaining required and desirable information, only
    information on mutagenesis for sec-butylamine has been received for
    evaluation in 1981.

    DATA FOR THE ESTIMATION OF ACCEPTABLE DAILY INTAKE

    TOXICOLOGICAL STUDIES

    Special studies on mutagenicity

         A recent study examined  sec-butylamine and sec-butylamine
    + H3PO4 for mutagenic activity. Tests included  Escherichia coli 
    WP2 and the standard  Salmonella/microsome assay with  Salmonella 
     typhimurium strains TA 1535, 1537, 1538, 98 and 100, as well as the
    induction of mitotic recombination in the yeast S. cerevisiae D3. Each
    assay was performed with or without a rat liver S9 mix for metabolic
    activation. Neither sec-butylamine nor sec-butylamine + H3PO4
    exhibited a mutagenic or recombinogenic response in these systems
    (Mortelmans and Riccio 1980).

         The compound was tested in  S. typhimurium and  E. coli WP2
    over a range of 0.1 to 50.0 Ál/plate (about 0.07 to 36.5 mg/plate,
    density  approx. or = 0.73) and retested at doses ranging from 0.1 to
    25.0 Ál/plate (approx. 0.07 to 18.3 mg/plate). No reproducible, dose-
    related increases in the number of revertants was observed. Toxicity
    was seen with all strains at 25.0 Ál/plate except for WP2, which
    showed toxicity at 50.0 Ál/plate. No recombinogenic activity was

              

    *    See Annex II for FAO and WHO documentation.

    observed with this compound when it was tested in  S. cerevisiae D3
    over concentrations ranging from 0.05 to 0.5% and retested from 0.05
    to 0.18%. Toxicity was observed at 0.2% without metabolic activation
    and at 0.3% with metabolic activation.

         In another  Salmonella and  E. coli WP2 assays, the compound
    was first tested over a concentration range of 1 to 100 Ál/plate. A
    second experiment was conducted over the same range for all strains
    except TA 98 and TA 100, which were tested up to 500 Ál/plate. This
    was due to the shortage of samples remaining and the desirability of
    testing this toxicity with strains of TA 98 and TA 100. A toxic
    response was obtained at the concentration of 500 Ál/plate with these
    two strains, both with and without metabolic activation.

         In another  S. cerevisiae D3 assay, the compound was first
    tested at concentrations ranging from 0.1 to 5.0% and then retested at
    higher concentrations ranging from 1.0 to 7.5%. No reproducible, dose-
    related increase in the number of mitotic recombinants was observed
    (Mortelmans and Riccio 1980).

    EVALUATION

    COMMENTS

         Although data were received pertaining to mutagenic potential of
     sec-butylamine, they were deemed to be insufficient to permit
    assessment of carcinogenic risk. Thus, although data was received that
    alleviated doubts regarding genotoxic potential, the overall concern
    regarding the carcinogenic potential of  sec-butylamine remains
    unresolved.

         As  sec-butylamine is a primary amine, the possibility of
    nitrosamine formation was considered to be remote.

         Concern regarding this compound, although reduced, has not been
    eliminated. The temporary ADI of 0.01 mg free amine/kg bw/day was
    extended for a further three years.

    Level causing no toxicological effect

    Rat: 686 ppm free amine (1250 ppm acetate salt in the diet),
         equivalent to 35 mg free amine/kg bw/day (63 mg acetate salt/kg
         bw/day).

    Dog: 69 mg free amine/kg bw/day (125 mg acetate salt/kg bw/day).

    Estimate of temporary acceptable daily intake for mail

         0 - 0.1 mg free amine/kg bw.

    FURTHER WORK OR INFORMATION

    Required (by 1984)

    1.   Further studies to resolve the question of carcinogenic
         potential.

    Desirable

    1.   Adequate toxicological studies on a non-rodent species.

    2.   Clinical and metabolic observations in humans.

    REFERENCES

    Mortelmans, K. and Riccio, E.S.  In vitro microbiological genotoxicity
    1980      assay of acetonitrile,  sec-butylamine (2-AB) and  sec-
              Butylamine (2-AB) + H3PO4. SRI International Project
              LSU-7558-24. Contract No. 68-02-2947, Final Report, March
              1980. (Unpublished)


    See Also:
       Toxicological Abbreviations
       Butylamine, sec- (WHO Pesticide Residues Series 5)
       Butylamine, sec- (Pesticide residues in food: 1977 evaluations)
       Butylamine, sec- (Pesticide residues in food: 1978 evaluations)
       Butylamine, sec- (Pesticide residues in food: 1979 evaluations)
       Butylamine, sec- (Pesticide residues in food: 1980 evaluations)