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Maleic hydrazide, carcinogenicity study in rats

C A Van der Heijden, E M Den Tonkelaar, J M Garbis-Berkvens

    Toxicology
    |January 1, 1981
    PubMed
    Summary

    Maleic hydrazide, a plant growth regulator, was found not to be carcinogenic in long-term rat and mouse studies. Kidney effects were observed at high doses, suggesting a lower safe intake level for maleic hydrazide.

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    Area of Science:

    • Toxicology
    • Carcinogenicity Studies
    • Agricultural Chemicals

    Background:

    • Conflicting carcinogenicity data for maleic hydrazide has led to debate among international health organizations.
    • Maleic hydrazide is widely used in agriculture on edible crops, necessitating clear safety assessments.

    Purpose of the Study:

    • To evaluate the carcinogenicity of maleic hydrazide in rats and mice.
    • To determine the potential health risks associated with maleic hydrazide exposure.
    • To identify the "no-toxic" effect level of maleic hydrazide in rats.

    Main Methods:

    • A 28-month oral carcinogenicity study was conducted on rats using dietary levels of 0, 1.0, and 2.0% maleic hydrazide.
    • A concurrent study with mice used the same batch of maleic hydrazide.
    • Impurity analysis confirmed less than 1.5 mg hydrazine/kg product.

    Main Results:

    • Maleic hydrazide treatment did not affect tumor incidence in either rats or mice.
    • High dietary levels (1.0% and 2.0%) of maleic hydrazide induced proteinuria and altered urine protein/creatinine ratios in rats.
    • No histopathological changes in the kidney or urinary tract were detected despite functional changes.

    Conclusions:

    • Maleic hydrazide itself is not considered a carcinogen.
    • Hydrazine impurity likely caused contradictory results in previous studies.
    • The "no-toxic" effect level for maleic hydrazide in rats is below 1.0% based on kidney function effects.

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