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    Acute Toxicity: Samson Y Raj

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    Samson Raj
    Acute toxicity refers to harmful effects caused by a single exposure or multiple exposures within a short period of time to a drug or toxic substance. The International Organization programme for the sound Management of Chemicals (IOMC) provides guidelines for classifying acute toxicity into five categories based on exposure dose levels determined from animal studies. These categories are used to determine appropriate hazard labels for substances and mixtures containing hazardous ingredients. An example is provided to demonstrate how the classification of a mixture would be determined based on the acute toxicity data available for its hazardous ingredient.

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    Acute Toxicity: Samson Y Raj

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    Samson Raj
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    Acute toxicity refers to harmful effects caused by a single exposure or multiple exposures within a short period of time to a drug or toxic substance. The International Organization programme for the sound Management of Chemicals (IOMC) provides guidelines for classifying acute toxicity into five categories based on exposure dose levels determined from animal studies. These categories are used to determine appropriate hazard labels for substances and mixtures containing hazardous ingredients. An example is provided to demonstrate how the classification of a mixture would be determined based on the acute toxicity data available for its hazardous ingredient.

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    An Overview

    Original Title

    ACUTE TOXICITY

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    Acute toxicity refers to harmful effects caused by a single exposure or multiple exposures within a short period of time to a drug or toxic substance. The International Organization programme for the sound Management of Chemicals (IOMC) provides guidelines for classifying acute toxicity into five categories based on exposure dose levels determined from animal studies. These categories are used to determine appropriate hazard labels for substances and mixtures containing hazardous ingredients. An example is provided to demonstrate how the classification of a mixture would be determined based on the acute toxicity data available for its hazardous ingredient.

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    83 views11 pages

    Acute Toxicity: Samson Y Raj

    Uploaded by

    Samson Raj
    Acute toxicity refers to harmful effects caused by a single exposure or multiple exposures within a short period of time to a drug or toxic substance. The International Organization programme for the sound Management of Chemicals (IOMC) provides guidelines for classifying acute toxicity into five categories based on exposure dose levels determined from animal studies. These categories are used to determine appropriate hazard labels for substances and mixtures containing hazardous ingredients. An example is provided to demonstrate how the classification of a mixture would be determined based on the acute toxicity data available for its hazardous ingredient.

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    ACUTE TOXICITY

    Dept. of Pharmacology
    PRESENTED BY:

    SAMSON
    IV B.Pharm
    Y RAJ
    KK COLLEGE OF PHARMACY
    TOXICITY
    The ability/extent of a drug to cause harmful
    effects (poison) to the body

    Determination of toxicity: can be practiced by


    observing the effects of a substance on an organism
    (LD50 )
    Based on the exposure time, toxicity can be grouped as:
    •Acute
    •Sub Acute
    •Sub Chronic
    •Chronic
    ACUTE TOXICITY
    Adverse effects occurring on administration of single or
    multiple does given in short term of duration (drug)

    i.e. Effects occurs as a result short term exposure

    Real time exposure:

    For Oral & Dermal products - with in 24 hours


    For Inhalation products - with in 4 hours
    ACUTE TOXICITY GUIDELINESS
    International Organization programme for the
    sound Management of Chemicals (IOMC)
    provided the

    CG/HCCS (Coordinating group for the


    Harmonization of chemical classification system)
    Categorized acute toxicity on five class. They are,
    Acute toxicity Hazard categories ( App. LD50/LC50)
    Exposure Category 1 Category 2 Category 3 Category 4 Category 5
    Route

    Oral 5 50 300 2000 5000 and


    (mg/kg) above
    Dermal 50 200 1000 2000
    (mg/kg)
    Gases 100 500 2500 5000
    (ppm)
    Vapours 0.5 2.0 10 20
    (mg/l)
    Dusts & 0.05 0.5 1.0 5
    Mists
    (mg/l)
    Acute toxicity label elements
    Category 1 Category 2 Category 3 Category 4 Category 5
    Symbol Skull and Skull and Skull and Exclamatio No symbols
    Crossbones Crossbones Crossbones n mark is used

    Signal word Danger Danger Danger Warning Warning

    Hazard Fatal if Fatal if Toxic if Harmful if May be


    Statement swallowed swallowed swallowed swallowed harmful if
    swallowed
    -Oral

    -Dermal Fatal in Fatal in Toxic in Harmful in May be


    contact contact contact contact harmful if
    with skin with skin with skin with skin contact
    with skin

    -Inhalation Fatal if Fatal if Toxic if Harmful if May be


    inhaled inhaled inhaled inhaled harmful if
    inhaled
    Example :
    Mixture A containing hazardous substance Y
    Substance Y is used as a carpet cleaner and supplied as
    mixture A that is an 18% solution of substance Y in water,
    How should Mixture A be classified and labeled?

    Mixture A = Substance Y + Water


    Acute toxicity of substance Y has been provide by existing literature
    Type of study Experimental Data GHS category
    Rat, single oral ATEi= 200 mg/kg Category 3
    administration
    Rat, single 4hour ATEi= 5 mg/kg Category 3
    inhalation to the
    vapor
    Dermal No data No classification
    administration
    Therefore, the classification of substance Y is as follows:

    Category 3
    Signal word Danger
    Symbol Skull & crossbones
    Hazard statement Toxic if swallowed and
    if inhaled

    The unknown dermal toxicity can be determined by


    following eqt.,
    ATEmix= 100 * ATEi /%

    Acute oral toxicity: Acute inhalation:


    ATE = 200mg/kg ATE = 5mg/l
    ATE = 100*200/18 ATE = 100*5/18
    ATE = 1111 mg/kg ATE = 27.8 mg/l
    Category 4 Category 5
    Having determined that mixture A should be classified in
    Category 4, we can determine from the labeling rules that
    the following label information is appropriate:

    Signal word Warning

    Symbol Exclamation mark

    Hazard statements Harmful if swallowed and may


    be harmful if inhaled
    REFERENCE:

    Draft integrated proposal of International


    organization programme for the sound management
    of chemicals from international labour organization
    (following can be used to download the guidelines)

    https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.ilo.o
    rg/legacy/english/protection/safework/ghs/ghsfinal/ghsc05.pdf&ved=2ahUKE
    wjd1uTG1PnyAhVGILcAHVQaDxsQFnoECD0QAQ&usg=AOvVaw3wlB1Ml0AgT
    _ECTYAJbRBC
    THANK YOU

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