benzo[a]pyrene...benzo[a]pyrenein iarc monograph volume 32 ( iarc, 1983 ) no evaluation was made of...

34
111 1. Exposure Data 1.1 Identification of the agent Chem. Abstr. Services Reg. No.: 50-32-8 Chem. Abstr. Name: Benzo[ a ]pyrene IUPAC Systematic Name: Benzo[ a ]pyrene Synonyms: BaP; benzo[ def ]chrysene; 3,4-benzopyrene*; 6,7-benzopyrene*; benz[ a ]pyrene; 3,4-benz[ a ]pyrene*; 3,4-benzpyrene*; 4,5-benzpyrene* (*alternative numbering conventions) 1 2 3 4 5 6 7 8 9 10 11 12 C 20 H 12 Relative molecular mass: 252.31 Description: Yellowish plates, needles from benzene/methanol; crystals may be mono- clinic or orthorhombic Boiling-point: 310–312 °C at 10 mm Hg Melting-point: 179–179.3 °C; 178.1 °C Spectroscopy data: Ultraviolet/visual, infrared, fluorescence, mass and nuclear magnetic-resonance spectral data have been reported Water solubility: 0.00162 mg/L at 25 °C; 0.0038 mg/L at 25 °C log K ow (octanol–water): 6.35 Henry’s Law Constant: 0.034 Pa m 3 /mol at 20 °C From IARC (2010) 1.2 Occurrence and exposure Benzo[ a ]pyrene and other polycyclic aromatic hydrocarbons (PAHs) are widespread environ- mental contaminants formed during incomplete combustion or pyrolysis of organic material. ese substances are found in air, water, soils and sediments, generally at trace levels except near their sources. PAHs are present in some foods and in a few pharmaceutical products based on coal tar that are applied to the skin. Tobacco smoke contains high concentrations of PAHs (IARC, 2010). 1.2.1 Exposure of the general population e general population can be exposed to benzo[ a ]pyrene through tobacco smoke, ambient air, water, soils, food and pharmaceutical prod- ucts. Concentrations of benzo[ a ]pyrene in BENZO[ a ]PYRENE Benzo[ a]pyrene was considered by previous IARC Working Groups in 1972, 1983, and 2005 (IARC, 1973, 1983, 2010). Since that time new data have become available, which have been incorporated in this Monograph, and taken into consideration in the present evaluation.

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  • 111

    1. Exposure Data

    1.1 Identification of the agent

    Chem. Abstr. Services Reg. No.: 50-32-8Chem. Abstr. Name: Benzo[a]pyreneIUPAC Systematic Name: Benzo[a]pyreneSynonyms: BaP; benzo[def]chrysene; 3,4-benzopyrene*; 6,7-benzopyrene*; benz[a]pyrene; 3,4-benz[a]pyrene*; 3,4-benzpyrene*; 4,5-benzpyrene* (*alternative numbering conventions)

    1

    2

    3

    4

    567

    8

    9

    10

    11

    12

    C20H12 Relative molecular mass: 252.31Description: Yellowish plates, needles from benzene/methanol; crystals may be mono-clinic or orthorhombicBoiling-point: 310–312 °C at 10 mm HgMelting-point: 179–179.3 °C; 178.1 °CSpectroscopy data: Ultraviolet/visual, infrared, fluorescence, mass and nuclear

    magnetic-resonance spectral data have been reportedWater solubility: 0.00162 mg/L at 25 °C; 0.0038 mg/L at 25 °Clog Kow (octanol–water): 6.35Henry’s Law Constant: 0.034 Pa m3/mol at 20 °C

    From IARC (2010)

    1.2 Occurrence and exposure

    Benzo[a]pyrene and other polycyclic aromatic hydrocarbons (PAHs) are widespread environ-mental contaminants formed during incomplete combustion or pyrolysis of organic material. These substances are found in air, water, soils and sediments, generally at trace levels except near their sources. PAHs are present in some foods and in a few pharmaceutical products based on coal tar that are applied to the skin. Tobacco smoke contains high concentrations of PAHs (IARC, 2010).

    1.2.1 Exposure of the general population

    The general population can be exposed to benzo[a]pyrene through tobacco smoke, ambient air, water, soils, food and pharmaceutical prod-ucts. Concentrations of benzo[a]pyrene in

    BENZO[a]PYRENEBenzo[a]pyrene was considered by previous IARC Working Groups in 1972, 1983, and 2005 (IARC, 1973, 1983, 2010). Since that time new data have become available, which have been incorporated in this Monograph, and taken into consideration in the present evaluation.

  • IARC MONOGRAPHS – 100F

    sidestream cigarette smoke have been reported to range from 52 to 95 ng/cigarette — more than three times the concentration in mainstream smoke. Major sources of PAHs in ambient air (both outdoors and indoors) include residential and commercial heating with wood, coal or other biomasses (oil and gas heating produce much lower quantities of PAH), other indoor sources such as cooking and tobacco smoke, and outdoor sources like motor-vehicle exhaust (especially from diesel engines), industrial emissions and forest fires. Average concentrations of individual PAHs in the ambient air in urban areas typically range from 1 to 30 ng/m3; however, concentra-tions up to several tens of nanograms per cubic metre have been reported in road tunnels, or in large cities that make extensive use of coal or other biomass as residential heating fuel. Estimates of PAH intake from food vary widely, ranging from a few nanograms to a few micro-grams per person per day. Sources of PAHs in the diet include barbecued/grilled/broiled and smoke-cured meats; roasted, baked and fried foods (high-temperature processing); bread, cereals and grains (at least in part from gas/flame-drying of grains); and vegetables grown in contaminated soils, or in areas with surface contamination from atmospheric PAH fall-out (IARC, 2010).

    1.2.2 Occupational exposure

    Occupational exposure to PAHs occurs primarily through inhalation and via skin contact. Monitoring by means of ambient air-sampling or personal air-sampling at the workplace, to determine individual PAHs, sets of PAHs or surrogates (e.g. coal-tar pitch vola-tiles) has been used to characterize exposure via inhalation; more recently, biological monitoring methods have been applied to characterize the uptake of certain specific PAHs (e.g. benzo[a]pyrene) to be used as biomarkers of total expo-sure (IARC, 2010).

    Industries where occupational exposure to benzo[a]pyrene has been measured and reported include: coal liquefaction, coal gasification, coke production and coke ovens, coal-tar distillation, roofing and paving (involving coal-tar pitch), wood impregnation/preservation with creosote, aluminium production (including anode manu-facture), carbon-electrode manufacture, chimney sweeping, and power plants. Highest levels of exposure to PAHs are observed in aluminium production (Söderberg process) with values up to 100 μg/m3. Mid-range levels are observed in roofing and paving (e.g. 10−20 μg/m3) and the lowest concentrations (i.e. at or below 1μg/m3) are observed in coal liquefaction, coal-tar distil-lation, wood impregnation, chimney sweeping and power plants (IARC, 2010).

    2. Cancer in Humans

    No epidemiological data on benzo[a]pyrene alone were available to the Working Group.

    3. Cancer in Experimental Animals

    Benzo[a]pyrene was considered by three previous Working Groups (IARC, 1973, 1983, 2010).

    In IARC Monograph Volume 3 (IARC, 1973) it was concluded that benzo[a]pyrene produced tumours in all species tested (mouse, rat, hamster, guinea-pig, rabbit, duck, newt, monkey) for which data were reported following exposure by many different routes (oral, dermal, inhalation, intratracheal, intrabronchial, subcu-taneous, intraperitoneal, intravenous). Benzo[a]pyrene had both a local and a systemic carcino-genic effect, was an initiator of skin carcinogen-esis in mice, and was carcinogenic in single-dose studies and following prenatal and transplacental exposures.

    112

  • Benzo[a]pyrene

    In IARC Monograph Volume 32 (IARC, 1983) no evaluation was made of studies of carcino-genicity in experimental animals published since 1972, but it was concluded that there is sufficient evidence for the carcinogenicity of benzo[a]pyrene in experimental animals.

    Carcinogenicity studies with administra-tion of benzo[a]pyrene by multiple route of exposure, reported after the initial evaluations, were subsequently reviewed in IARC Monograph Volume 92 (IARC, 2010) and are summarized below (Table 3.1). See Table 3.2 for an overview of malignant tumours induced in different animal species.

    3.1 Skin application

    In several studies in which benzo[a]pyrene was applied to the skin of different strains of mice, benign (squamous cell papillomas and kerato-acanthomas) and malignant (mainly squamous-cell carcinomas) skin tumours were observed (Van Duuren et al., 1973; Cavalieri et al., 1977, 1988a; Levin et al., 1977; Habs et al., 1980, 1984; Warshawsky & Barkley, 1987; Albert et al., 1991; Andrews et al., 1991; Warshawsky et al., 1993). No skin-tumour development was seen in AhR−/− mice that lacked the aryl hydrocarbon receptor, whereas the heterozygous and wild-type mice developed squamous-cell carcinomas of the skin (Shimizu et al., 2000).

    In a large number of initiation–promotion studies in mice, benzo[a]pyrene was active as an initiator (mainly of squamous-cell papillomas) when applied to the skin (IARC, 2010).

    3.2 Subcutaneous injection

    In subcutaneous injection studies of benzo[a]pyrene, malignant tumours (mainly fibro-sarcomas) were observed at the injection site in mice (Kouri et al., 1980; Rippe & Pott, 1989) and rats (Pott et al., 1973a, b; Rippe & Pott, 1989). No fibrosarcomas were observed in AhR−/− mice that

    lacked the aryl hydrocarbon receptor, whereas the heterozygous and wild-type mice did develop these tumours (Shimizu et al., 2000).

    In another study, male and female newborn Swiss mice that were given benzo[a]pyrene subcutaneously showed a significant increase in lung-adenoma incidence and multiplicity (Balansky et al., 2007).

    A single study in 12 strains of hamsters resulted in sarcomas at the site of injection in both sexes of all 12 strains (Homburger et al., 1972).

    3.3 Oral administration

    After administration of benzo[a]pyrene by gavage or in the diet to mice of different strains (Sparnins et al., 1986; Estensen & Wattenberg, 1993; Weyand et al., 1995; Kroese et al., 1997; Culp et al., 1998; Hakura et al., 1998; Badary et al., 1999; Wijnhoven et al., 2000; Estensen et al., 2004), increased tumour responses were observed in lymphoid and haematopoeitic tissues and in several organs, including the lung, forestomach, liver, oesophagus and tongue.

    Oral administration of benzo[a]pyrene to XPA–/– mice resulted in a significantly higher increase of lymphomas than that observed in similarly treated XPA+/– and XPA+/+ mice (de Vries et al., 1997). Benzo[a]pyrene given by gavage to XPA–/–/p53+/– double-transgenic mice induced tumours (mainly splenic lymphomas and forestomach tumours) much earlier and at higher incidences than in similarly treated single transgenic and wild-type counterparts. These cancer-prone XPA–/– or XPA–/–/p53+/– mice also developed a high incidence of tumours (mainly of the forestomach) when fed benzo[a]pyrene in the diet (van Oostrom et al., 1999; Hoogervorst et al., 2003).

    Oral administration of benzo[a]pyrene by gavage to rats resulted in an increased incidence of mammary gland adenocarcinomas (el-Bayoumy et al., 1995).

    113

  • IARC MONOGRAPHS – 100F

    114

    Tabl

    e 3.

    1 Ca

    rcin

    ogen

    icit

    y st

    udie

    s of

    ben

    zo[a

    ]pyr

    ene

    in e

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    als

    Spec

    ies,

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    Dur

    atio

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    ence

    Dos

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    ty (v

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    men

    ts

    Skin

    app

    licat

    ion

    Mou

    se, S

    wis

    s IC

    R/

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    (F)

    52 w

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    al.

    (197

    3)

    0 (u

    ntre

    ated

    ), 0

    (veh

    icle

    con

    trol

    ), 5 

    μg/a

    nim

    al, 3

     × /w

    k, 5

    2 w

    k 50

    /gro

    up

    Skin

    T: 0

    /50,

    0/5

    0, 2

    3/50

    (46%

    ; 13 

    P; 1

    0 C

    )+

    NR

    (ace

    tone

    )

    Mou

    se, S

    wis

    s (F)

    38

    –65

    wk

    Cav

    alie

    ri et

    al.

    (197

    7)

    0 an

    d 0.

    396

    μmol

    [0.1

     mg]

    per

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    imal

    , tw

    ice/

    wk,

    30 

    wk

    40/g

    roup

    Skin

    T: 0

    % [0

    /29]

    , 78.

    9% [3

    0/38

    ] (7 

    P, 7

     K, 3

    6 C

    , 1

    mal

    igna

    nt S

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    +99

    % (a

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    F)

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    , 0.0

    2 [5

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    .4 [1

    05.7

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    ol/

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    dose

    giv

    en in

    two

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    Expe

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    0.02

    5 [6

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    .05

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    .1

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    mol

    /ani

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    e/2

    wk,

    60

     wk

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    Skin

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    Expe

    rim

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    –0%

    , 0%

    , 38%

    (13

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    00%

    (44 

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    Expe

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    –0%

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    63

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    Hab

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    , 4 μ

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    imal

    , tw

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    T: 0

    /20,

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    0 (4

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    17/2

    0 (8

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    )+

    > 96

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    3H/H

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    sky

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    (198

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    0 (u

    ntre

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    ), 0 

    (veh

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    ) or

    12.5

    μg/

    anim

    al, t

    wic

    e/w

    k 50

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    up

    Skin

    T: 0

    /50,

    0/5

    0, 4

    8/50

    (96%

    ; 47

    C, 1

    P)

    +99

    .5%

    (ace

    tone

    )

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    se, S

    wis

    s (F)

    42

    wk

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    alie

    ri et

    al.

    (198

    8a)

    0, 0

    .1 [2

    6.4

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    0.4

    [105

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    mol

    /an

    imal

    , tw

    ice/

    wk,

    20 

    wk

    30/g

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    Skin

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    cide

    nce:

    0/3

    0, 2

    6/29

    (90%

    ; SG

    A, 3

    P, 2

    3 SC

    C),

    26/3

    0 (9

    0%; 2

     P, 2

    6 SC

    C)

    +Pu

    rifie

    d [N

    R] (a

    ceto

    ne)

  • Benzo[a]pyrene

    115

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

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    ence

    Dos

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    ty (v

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    Com

    men

    ts

    Mou

    se, C

    3H/fC

    um

    (M) E

    xper

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    t 1:

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    o Ex

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    t 2:

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    peri

    men

    t 3:

    18 m

    o K

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    rim

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    : 0 (t

    rioc

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    cont

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    0 (D

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    con

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    ), 0.

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    ioct

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    rim

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    –0/1

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    9 (6

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    +Pu

    re (t

    rioc

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    )

    Expe

    rim

    ent 2

    : 0 (t

    rioc

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    in

    cont

    rol),

    0 (D

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    ), 0.

    9 µm

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    .23

    mg]

    in tr

    ioct

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    rim

    ent 2

    –0/2

    0, 0

    /18,

    14/

    18 (7

    8%),

    7/19

    (37%

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    rim

    ent 3

    : 0 (t

    rioc

    tano

    in/

    DM

    SO, 1

    00:1)

    , 0.9

     µm

    ol [0

    .23

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    in

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      20

    or 4

    0/gr

    oup

    Expe

    rim

    ent 3

    –0/2

    0, 3

    6/40

    (90%

    )

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    se, N

    R (F

    ) 78

    wk

    Rip

    pe &

    Pot

    t (19

    89)

    0, 1

    0, 1

    00 μ

    g/

    anim

    al, 1

     × N

    R/g

    roup

    S at

    inje

    ctio

    n sit

    e: 1

    /30

    (3%

    ), 13

    /30

    (43%

    ), 20

    /30

    (67%

    )+

    NR

    (tric

    apry

    lin)

    Mou

    se, S

    wis

    s (n

    ewbo

    rn) (

    M, F

    ) 75

    –200

    d

    Bala

    nsky

    et a

    l. (2

    007)

    0 an

    d 1.

    0 m

    g/an

    imal

    , 1 ×

      12

    –15

    M/g

    roup

    , 12–

    15 F

    /gro

    upLu

    ng A

    : M –

    0/1

    5, 9

    /12;

    F –

    0/1

    5, 1

    1/12

  • IARC MONOGRAPHS – 100F

    116

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Ham

    ster

    , Syr

    ian,

    RB

    (ran

    dom

    ly b

    red)

    , BI

    O in

    bred

    stra

    ins

    desig

    nate

    d as

    : 1.5

    , 4.

    22, 4

    .24,

    7.88

    , 12.

    14,

    15.16

    , 45.

    5, 5

    4.7,

    82.7

    3,

    86.9

    3, 8

    7.20

    (M, F

    ) 53

    wk

    Hom

    burg

    er et

    al.

    (197

    2)

    500

    μg/a

    nim

    al, 1

     × 

    25 M

    /gro

    up, 2

    5 F/

    grou

    pFi

    broS

    at i

    njec

    tion

    site:

    R

    B–M

    , 4/2

    5 (1

    6%);

    F, 6

    /23

    (26%

    ) 1.

    5–M

    , 5/2

    5 (2

    0%);

    F, 4

    /23

    (17%

    ) 4.

    22–M

    , 3/2

    5 (1

    2%);

    F, 8

    /25

    (32%

    ) 4.

    24–M

    , not

    test

    ed; F

    , 9/2

    5 (3

    6%)

    7.88

    –M, 1

    3/25

    (52%

    ); F,

    5/2

    3 (2

    3%)

    12.14

    –M, 3

    /25

    (12%

    ); F,

    9/2

    2 (4

    1%)

    15.16

    –M, 9

    /25

    (36%

    ); F,

    16/

    25 (6

    4%)

    45.5

    –M, 1

    2/25

    (48%

    ); F,

    7/1

    5 (4

    7%)

    54.7

    :–M

    , 5/2

    5 (2

    0%);

    F, 5

    /25

    (20%

    ) 82

    .73–

    M, 4

    /21

    (19%

    ); F,

    4/2

    4 (1

    7%)

    86.9

    3–M

    , 9/2

    5 (3

    6%);

    F, 8

    /25

    (32%

    ) 87

    .20–

    M, 1

    6/25

    (64%

    ); F,

    11/

    25 (4

    2%)

    +N

    R (tr

    icap

    rylin

    ) N

    o su

    bcut

    aneo

    us T

    obs

    erve

    d in

    his

    tori

    cal c

    ontr

    ols

    Ora

    l adm

    inis

    trat

    ion

    Mou

    se, A

    /J (F

    ) 26

    0 d

    Wey

    and

    et a

    l. (1

    995)

    0, 1

    6, 9

    8 pp

    m (t

    otal

    dos

    e; 0

    , 11,

    67

    mg)

    in th

    e di

    et

    30/g

    roup

    Lung

    T: 4

    /21

    (19%

    ; 4 A

    ; 0.1

    9 ± 

    0.09

    A/a

    nim

    al),

    9/25

    (36%

    *; 7 

    A, 2

    AdC

    ; 0.4

    8 ± 

    0.14

     T/a

    nim

    al),

    14/2

    7 (5

    2%*;

    14 A

    ; 0.5

    9 ± 

    0.12

    A/a

    nim

    al)

    Fore

    stom

    ach

    T: (0

    %) 0

    /21,

    (5/2

    5) (2

    0%; 3

    P, 2

    C;

    0.24

     ± 0

    .11**

    T/a

    nim

    al),

    27/2

    7 (1

    00%

    **; 1

    3 P,

    14

    C;

    4.22

     ± 0

    .41*

    *)

    *P <

     0.0

    5 **

  • Benzo[a]pyrene

    117

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Mou

    se, C

    SB–/

    – or w

    ild-

    type

    (CSP

     ±   o

    r CSB

    +/+ )

    (M

    , F)

    52 w

    k W

    ijnho

    ven

    et a

    l. (2

    000)

    0 an

    d 13

    mg/

    kg b

    w b

    y ga

    vage

    , 3 ×

     /w

    k, 1

    3 w

    k 6–

    18 M

    /gro

    up, 6

    –13

    F/gr

    oup

    Wild

    -typ

    e: 5

    /27

    (14

    M, 1

    3 F;

    19%

    ; 4 b

    ronc

    hiol

    o-al

    veol

    ar A

    , 2 ly

    mph

    oma)

    , 17/

    29* (

    18 M

    , 11 

    F; 5

    9%;

    6 br

    onch

    iolo

    -alv

    eola

    r A, 1

    0 fo

    rest

    omac

    h P,

    2

    fore

    stom

    ach

    SCC

    , 2 h

    istio

    cytic

    S, 2

    hep

    atoc

    ellu

    lar

    A, 1

    inte

    stin

    al A

    dC, 1

    skin

    P)

    CSB

    –/– :

    0/13

    (6 M

    , 7 F

    ), 7/

    12**

    (6 M

    , 6 F

    ; 58%

    ; 2

    bron

    chio

    lo-a

    lveo

    lar A

    , 2 u

    teri

    ne S

    , 1 fo

    rest

    omac

    h SC

    C, 1

    inte

    stin

    al A

    dC, 1

     skin

    his

    tiocy

    tic S

    )

    *P =

     0.0

    023

    **P 

    = 0.

    0017

    NR

    (soy

    a oi

    l)

    Rat,

    Crl:

    CD

    (SD

    )BR

    (F)

    49 w

    k el

    -Bay

    oum

    y et

    al.

    (199

    5)

    0 an

    d 50

     μm

    ol/a

    nim

    al, o

    nce/

    wk,

    wk

    by g

    avag

    e 30

    /gro

    up

    Mam

    mar

    y T

    inci

    denc

    e: 1

    1/30

    [37%

    ] [in

    cide

    nce

    not c

    lear

    ly sp

    ecifi

    ed] (

    8 de

    smop

    last

    ic A

    , 2 A

    , 1

    AdC

    ), 29

    /30

    (96.

    7%; 8

     fibr

    oA**

    , 17

    desm

    opla

    stic

    A*

    , 7 A

    , 22

    AdC

    **)

    Num

    bers

    of m

    amm

    ary

    T: c

    ontr

    ols,

    14 d

    esm

    opla

    stic

    A, 2

    A, 1

    AdC

    ; tre

    ated

    ani

    mal

    s, 14

    fibr

    oA*,

    35 d

    esm

    opla

    stic

    A, 1

    1 A

    , 56 

    AdC

    **

    *P <

     0.0

    5 **

  • IARC MONOGRAPHS – 100F

    118

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Vess

    elin

    ovitc

    h et

    al.

    (197

    5a, b

    ) C

    ontd

    .

    C3A

    /JF1

    mic

    e (a

    ll ag

    es c

    ombi

    ned)

    : Li

    ver T

    (A a

    nd h

    epat

    ocel

    lula

    r C)–

    M

    , 3/9

    7 (3

    %),

    30/1

    48 (2

    0%),

    33/1

    37 (2

    4%);

    F, 0

    /100

    (0

    %),

    1.3%

    2/1

    26 (1

    .3%

    ), 2/

    153

    1.3%

    ) Lu

    ng T

    (A a

    nd A

    dC)–

    M

    , 49/

    97 (4

    9%),

    1 43

    8/14

    8 (9

    3%),

    125/

    137

    (91%

    ); F,

    26

    /100

    (26%

    ), 11

    5/12

    6 (9

    1%),

    141/

    153

    (92%

    ) Fo

    rest

    omac

    h T

    (P a

    nd S

    CC

    )–

    M, 0

    /97

    (0%

    ), 18

    /148

    (12%

    ), 42

    /137

    (31%

    ); F,

    0/1

    00

    (0%

    ), 18

    /126

    (14%

    ), 31

    /153

    (20%

    ) Ly

    mph

    oret

    icul

    ar T

    (mai

    nly

    retic

    ulum

    -cel

    l S)–

    M

    , 0/9

    7 (0

    %),

    26/2

    85 (9

    %);

    F, 2

    /100

    (2%

    ), 50

    /278

    (1

    8%) (

    high

    - and

    low

    -dos

    e gr

    oups

    com

    bine

    d)

    +

    Mou

    se, C

    D-1

    (M, F

    ) 1 

    yr

    Wis

    lock

    i et a

    l. (1

    986)

    0 an

    d 56

    0 nm

    ol [1

    48 μ

    g] (t

    otal

    dos

    e;

    give

    n as

    1/7

    , 2/7

    , 4/7

    on

    PND

    0, 8

    , 15

    ) 37

    M/g

    roup

    , 27 

    F/gr

    oup

    Live

    r T: M

    , 2/2

    8 (7

    %; 2

     A),

    18/3

    7* (4

    9%; 1

    1 A

    , 7

    C*)

    ; F, n

    o liv

    er T

    foun

    d Lu

    ng T

    : M, 1

    /28

    (4%

    ; 1 A

    ), 13

    /37*

    * (35

    %; 1

    3 A

    ); F,

    0/

    31, 1

    3/27

    ** (4

    8%) (

    13 A

    ) M

    alig

    nant

    lym

    phom

    a: M

    , 1/2

    8 (4

    %),

    2/37

    (5%

    ); F,

    1/

    31 (3

    %),

    4/27

    (15%

    )

    *P <

     0.0

    05

    **P 

     

    99%

    (DM

    SO)

    Mou

    se, C

    D-1

    (M, F

    ) 52

    wk

    Lavo

    ie et

    al.

    (198

    7)

    0 an

    d 1.

    1 μm

    ol [2

    90 μ

    g] (t

    otal

    dos

    e;

    give

    n as

    1/6

    , 2/6

    , 4/6

    on

    PND

    1, 8

    , 15

    ) 17

    M/g

    roup

    , 14–

    18 F

    /gro

    up

    Live

    r T: M

    , 1/1

    7 (6

    %; 1

     H),

    13/1

    7* (7

    6%; 9

    hep

    atic

    A

    , 4 H

    ); F,

    0/1

    8, 0

    /14

    Lu

    ng A

    : M, 0

    /17,

    14/1

    7* (8

    2%);

    F, 0

    /18,

    9/1

    4**

    (64%

    )

    *P <

     0.0

    05

    **[P

     < 0

    .000

    5]> 

    99%

    (DM

    SO)

    Mou

    se, S

    wis

    s-W

    ebst

    er

    BLU

    : Ha(

    ICR)

    (M, F

    ) 26

    wk

    Busb

    y et

    al.

    (198

    9)

    0 an

    d 59

    .5 μ

    g (to

    tal d

    ose;

    giv

    en a

    s 8.

    5, 1

    7, 34

    μg

    on P

    ND

    1, 8

    , 15)

    N

    R/g

    roup

    Lung

    T: M

    , 12/

    91 (1

    3%; 1

    2 A

    , 1 A

    dC; 0

    .15 

    ± 0.

    04 T

    /m

    ouse

    ), 13

    /28

    (46%

    ; 13

    A; 0

    .71 

    ± 0.

    19 A

    /mou

    se);

    F,

    7/10

    1 (7

    %; 7

    A; 0

    .08 

    ± 0.

    03 A

    /mou

    se),

    18/2

    7 (6

    7%;

    18 A

    , 1 A

    dC; 1

    .19 

    ± 0.

    21 T

    /mou

    se)

    +> 

    99%

    (DM

    SO)

    stat

    istic

    s NR

    Mou

    se, N

    R, n

    ewbo

    rn

    (M, F

    ) 30

    wk

    Rip

    pe &

    Pot

    t (19

    89)

    0, 1

    0, 1

    00 μ

    g/an

    imal

    , 1 ×

      N

    R/g

    roup

    Lung

    T: 1

    3% [5

    /38]

    (0.1

    3 T/

    anim

    al),

    16%

    [5/3

    1]

    (0.2

    3 T/

    anim

    al),

    64%

    [21/

    33] (

    2.52

    T/a

    nim

    al)

    +N

    R (s

    alin

    e so

    lutio

    n +

    1%

    gela

    tine

    + 0.

    4% T

    wee

    n 20

    ) Ty

    pe o

    f lun

    g tu

    mou

    r NR;

    st

    atis

    tics N

    RM

    ouse

    , A/J

    (F)

    260

    d W

    eyan

    d et

    al.

    (199

    5)

    0 (u

    ntre

    ated

    ), 0 

    (veh

    icle

    con

    trol

    ), 1.

    79 m

    g/an

    imal

    , 1 ×

      29

    –30/

    grou

    p

    Lung

    T: 7

    /30

    (23%

    ; 7 A

    ; 0.2

    7 ± 

    0.12

    A/a

    nim

    al),

    11/3

    0 (3

    7%; 1

    1 A

    ; 0.4

    3 ± 

    0.11

    A/a

    nim

    al),

    29/2

    9*

    (100

    %; 2

    7 A

    , 2 A

    dC; 1

    5.8 

    ± 1.

    28**

    T/a

    nim

    al);

    fore

    stom

    ach

    T: 0

    /30

    (0%

    ), 0/

    30 (0

    %),

    24/2

    9** (

    83%

    ; 15

    P, 9

    C; 1

    .83 

    ± 0.

    25**

    T/a

    nim

    al)

    *P <

     0.0

    5 **

  • Benzo[a]pyrene

    119

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Mou

    se, B

    6C3F

    1 , in

    fant

    (M

    , F)

    26 w

    k, 3

    9 w

    k, 5

    2 w

    k Ro

    drig

    uez

    et a

    l. (1

    997)

    0 (u

    ntre

    ated

    ), 0 

    (veh

    icle

    con

    trol

    s),

    125,

    250

    , 375

     μg/

    7 g

    bw, 1

     × 

    > 30

    M/g

    roup

    , > 3

    0 F/

    grou

    p

    Live

    r T (M

    ): A

    t wk

    26: 0

    /41,

    0/5

    8, 0

    /29,

    0/2

    5, 3

    /34

    (9%

    ; m

    ultip

    licity

    , 1.0

    ); at

    wk

    39: 0

    /34,

    0/5

    9, 6

    /26

    (23%

    ; m

    ultip

    licity

    , 1.0

    ), 13

    /34

    (38%

    ; mul

    tiplic

    ity, 1

    .9),

    15/2

    3 (6

    5%; m

    ultip

    licity

    , 1.9

    ); at

    wk

    52: 4

    /64

    (6%

    ; m

    ultip

    licity

    , 1.0

    ), 3/

    63 (5

    %; m

    ultip

    licity

    , 1.0

    ), 13

    /29

    (45%

    ; mul

    tiplic

    ity, 1

    .8),

    14/2

    7 (5

    2%; m

    ultip

    licity

    , 2.

    2), 1

    9/24

    (79%

    ; mul

    tiplic

    ity, 2

    .5)

    No

    liver

    T in

    F

    +N

    R (c

    orn

    oil)

    No

    fore

    stom

    ach

    tum

    ours

    Mou

    se, C

    D-1

    (M)

    12 m

    o Vo

    n Tu

    ngel

    n et

    al.

    (199

    9)

    0, 1

    00, 4

    00 n

    mol

    [26,

    111

     μg]

    /an

    imal

    (tot

    al d

    ose;

    giv

    en a

    s 1/7

    , 2/7

    , 4/

    7 on

    PN

    D 1

    , 8, 1

    5)

    24/g

    roup

    Live

    r T: 3

    /20

    (15%

    ; 1 A

    , 2 C

    ; 1.7

    T/li

    ver s

    ectio

    n),

    5/21

    (24%

    ; 4 A

    , 1 C

    ; 1.5

    T/li

    ver s

    ectio

    n), 9

    /20

    (45%

    ; 7

    A*, 2

    C; >

     2.3

    T/li

    ver s

    ectio

    n)

    Lung

    T: 4

    /20

    (20%

    ; 4 A

    ; 1.0

    T/lu

    ng se

    ctio

    n), 1

    /21

    (5%

    ; 1 A

    ; 1.0

    T/lu

    ng se

    ctio

    n), 9

    /20

    (45%

    ; 7 A

    , 2 C

    ; 1.

    9 T/

    lung

    sect

    ion)

    *P =

     0.0

    234

    > 99

    % (D

    MSO

    )

    Rat,

    Wis

    tar (

    F)

    ~112

    wk

    Rolle

    r et a

    l. (1

    992)

    0 an

    d 5

    mg/

    anim

    al, 1

     × 

    NR

    /gro

    upA

    bdom

    inal

    mes

    othe

    liom

    a an

    d S:

    3/4

    1 (7

    .3%

    ), 33

    /37

    (89.

    2%)

    +N

    R (3

    :1 m

    ixtu

    re o

    f tr

    icap

    rylin

    / bee

    swax

    ) Li

    mite

    d re

    port

    ing

    Rat,

    Wis

    tar (

    F)

    ~116

    wk

    Rolle

    r et a

    l. (1

    992)

    5 m

    g/an

    imal

    , 1 ×

      N

    R/g

    roup

    Abd

    omin

    al m

    esot

    helio

    ma

    and

    S: 1

    9/38

    (50%

    ); hi

    stor

    ical

    con

    trol

    s, 11

    /369

    (3%

    )+

    NR

    (sal

    ine

    solu

    tion)

    N

    o co

    ntro

    l; lim

    ited

    repo

    rtin

    g of

    tum

    our d

    ata

    Inha

    lati

    onH

    amst

    er, S

    yria

    n go

    lden

    (M)

    Life

    time

    Thys

    sen

    et a

    l. (1

    981)

    0, 2

    .2, 9

    .5, 4

    6.5 

    mg/

    m3,

    4.5

     h/d

    , 7 d

    /w

    k, 1

    0 w

    k; th

    erea

    fter 3

     h/d

    , 7 d

    /wk

    (tota

    l ave

    rage

    dos

    es: 0

    , 29,

    127

    , 383

    m

    g/an

    imal

    ) 24

    /gro

    up (+

    ani

    mal

    s add

    ed d

    urin

    g th

    e st

    udy)

    Resp

    irat

    ory

    trac

    t T:

    (pol

    yps,

    P, S

    CC

    )–

    0/27

    , 0/2

    7, 34

    .6%

    [9/2

    6; 3

    nas

    al, 8

     lary

    ngea

    l, 1 

    trac

    heal

    ], 52

    % [1

    3/25

    ; 1 n

    asal

    , 13 

    lary

    ngea

    l, 3

    trac

    heal

    ; no

    bron

    chog

    enic

    T]

    Upp

    er d

    iges

    tive

    trac

    t T:

    (pol

    yps,

    P, S

    CC

    )–

    0/27

    , 0/2

    7, 26

    .9%

    [6/2

    6; 6

     pha

    ryng

    eal,

    1 fo

    rest

    omac

    h], 5

    6% [1

    4/25

    ; 14

    phar

    ynge

    al,

    2 oe

    soph

    agea

    l, 1 

    fore

    stom

    ach]

    +N

    R (0

    .1% sa

    line

    solu

    tion)

    ; pa

    rtic

    le si

    ze, >

     99%

    dia

    met

    er

    0.2–

    0.5

    μm, >

     80%

    dia

    met

    er

    0.2–

    0.3 

    μm

    Surv

    ival

    dec

    reas

    ed fo

    r hig

    h do

    se-e

    xpos

    ed a

    nim

    als (

    59

    wk)

    vs o

    ther

    gro

    ups (

    96 w

    k).

    Tabl

    e 3.

    1 (c

    onti

    nued

    )

  • IARC MONOGRAPHS – 100F

    120

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Intr

    apul

    mon

    ary

    inje

    ctio

    nRa

    t, O

    M (F

    ) 64

    (hig

    h-do

    se

    grou

    p)–1

    33 w

    k (u

    ntre

    ated

    con

    trol

    s)

    Deu

    tsch

    -Wen

    zel e

    t al.

    (198

    3)

    0 (u

    ntre

    ated

    ), 0

    (veh

    icle

    con

    trol

    ), 0.

    1, 0

    .3, 1

    .0 m

    g/an

    imal

    , 1 ×

      35

    /gro

    up

    Lung

    T: [

    0/35

    ] (0%

    ), [0

    /35]

    (0%

    ), [1

    0/35

    ] (28

    .6%

    ) (4

    epid

    erm

    oid

    C; 6

    ple

    omor

    phic

    S),

    [23/

    35] (

    65.7

    %)

    (21

    epid

    erm

    oid

    C; 2

    ple

    omor

    phic

    S),

    [33/

    35]

    (94.

    3%) (

    33 e

    pide

    rmoi

    d C

    )

    +99

    .1% (1

    :1 m

    ixtu

    re o

    f bee

    swax

    an

    d tr

    ioct

    anoi

    n)

    Rats

    , F34

    4/N

    Slc

    (M)

    104

    wk

    Iwag

    awa

    et a

    l. (1

    989)

    0, 0

    .03,

    0.1

    , 0.3

    , 1.0

     mg/

    an

    imal

    , 1 ×

      N

    R/g

    roup

    Lung

    T: 0

    /40,

    1/2

    9 (3

    %; 1

    und

    iffer

    entia

    ted

    T), 7

    /30

    (23%

    ; 6 S

    CC

    , 1 u

    ndiff

    eren

    tiate

    d T)

    , 22/

    29 (7

    6%; 2

    0 SC

    C, 2

    und

    iffer

    entia

    ted

    T), 9

    /13

    (69%

    ; 9 S

    CC

    )

    +N

    R (1

    :1 m

    ixtu

    re o

    f bee

    swax

    /tr

    icap

    rylin

    )

    Rat,

    Osb

    orne

    -Men

    del

    (F)

    134

    wk

    (low

    -dos

    e gr

    oup)

    –140

    wk

    (veh

    icle

    co

    ntro

    ls)

    Wen

    zel-H

    artu

    ng et

    al.

    (199

    0)

    0 (u

    ntre

    ated

    ), 0

    (veh

    icle

    con

    trol

    ), 30

    , 100

    , 300

     μg/

    an

    imal

    , 1 ×

      35

    /gro

    up

    Lung

    T: [

    0/35

    ] (0%

    ), [0

    /35]

    (0%

    ), [3

    /35]

    (8.6

    %; 3

    SC

    C),

    [11/

    35] (

    31.4

    %; 1

    1 SC

    C),

    [27/

    35] (

    77.1%

    ; 27

    SCC

    ).

    +99

    .6%

    (bee

    swax

    /tri

    octa

    noin

    m

    ixtu

    re o

    f var

    ying

    co

    mpo

    sitio

    n)

    SCC

    pre

    dom

    inan

    tly

    kera

    tiniz

    ed

    Rat,

    F344

    /DuC

    rj (M

    ) 10

    0 w

    k H

    orik

    awa

    et a

    l. (1

    991)

    0, 5

    0, 1

    00, 2

    00 μ

    g/an

    imal

    , 1 ×

      9–

    10/g

    roup

    Lung

    T: 0

    /19,

    0/1

    0, 3

    /10

    (30%

    ; 2 S

    CC

    , 1 A

    dSC

    ), 4/

    9 (4

    4.4%

    ; 3 S

    CC

    , 1 u

    ndiff

    eren

    tiate

    d T)

    +N

    R (1

    :1 m

    ixtu

    re o

    f bee

    swax

    /tr

    icap

    rylin

    )

    Intr

    atra

    chea

    l ad

    min

    istr

    atio

    nRa

    t, W

    ista

    r-W

    U/

    Kis

    slegg

    (F)

    124–

    126

    wk

    Pott

    et a

    l. (1

    987)

    0 an

    d 1

    mg/

    anim

    al, o

    nce/

    wk,

    20 

    wk

    NR

    /gro

    upLu

    ng T

    : 0/4

    0, 7

    /36

    (19%

    ; 1 A

    , 5 S

    CC

    , 1 m

    ixed

    A

    dC/S

    CC

    )+

    NR

    (0.9

    % sa

    line

    solu

    tion)

    Rat,

    Spra

    gue-

    Daw

    ley

    (M, F

    ) C

    ontr

    ols,

    131 

    wk;

    tr

    eate

    d an

    imal

    s, 11

    2 w

    k St

    einh

    off et

    al.

    (199

    1)

    0 an

    d 0

    (phy

    siolo

    gica

    l sal

    ine)

    , 7 

    mg/

    kg b

    w/in

    still

    atio

    n (p

    hysio

    logi

    cal s

    alin

    e w

    ith T

    wee

    n 60

    ), on

    ce/2

    wk,

    44

    wk

    20 o

    r 50/

    grou

    p

    M: 0

    /50,

    0/5

    0, 1

    9/20

    (95%

    ; 19 

    mal

    igna

    nt lu

    ng T

    ) F:

    0/5

    0, 0

    /50,

    19/

    20 (9

    5%; 1

    8 m

    alig

    nant

    , 1 b

    enig

    n lu

    ng T

    )

    +N

    R (p

    hysio

    logi

    cal s

    alin

    e so

    lutio

    n w

    ith o

    r with

    out

    Twee

    n 60

    ) Li

    mite

    d hi

    stol

    ogy

    Tabl

    e 3.

    1 (c

    onti

    nued

    )

  • Benzo[a]pyrene

    121

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    , F)

    78 w

    k Fe

    ron

    (197

    2)

    0 (o

    nly

    for M

    ), 1 

    mg/

    anim

    al, o

    nce/

    wk,

    36 

    wk

    35/g

    roup

    Resp

    irat

    ory

    trac

    t T/a

    deno

    mat

    oid

    lesio

    ns:

    M–6

    /27

    (22%

    ; 1 tr

    ache

    al P

    , 5 p

    ulm

    onar

    y ad

    enom

    atoi

    d le

    sion)

    , 19/

    29 (6

    6%; 1

    trac

    heal

    P,

    17 S

    CC

    , 26

    pulm

    onar

    y ad

    enom

    atoi

    d le

    sion,

    5 A

    , 1 

    AdC

    , 1 S

    CC

    ) F–

    22/2

    7 (8

    1%; 1

    lary

    ngea

    l SC

    C, 1

    6 tr

    ache

    al S

    CC

    , 2 

    bron

    chia

    l A, 1

     AdC

    , 21 

    pulm

    onar

    y ad

    enom

    atoi

    d le

    sion,

    8 A

    , 1 A

    dC)

    +> 

    99%

    (0.9

    % sa

    line

    solu

    tion)

    N

    o fe

    mal

    e co

    ntro

    ls; S

    tatis

    tics

    NR

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    ) 78

    wk

    Fero

    n et

    al.

    (197

    3)

    0, 0

    .062

    5, 0

    .125

    , 0.2

    5, 0

    .5, 1

    .0 m

    g/an

    imal

    , onc

    e/w

    k, 5

    2 w

    k 30

    /gro

    up

    Resp

    irat

    ory

    trac

    t T:

    0/29

    , 3/3

    0 (1

    0%; 3

    trac

    heal

    P, 1

     pul

    mon

    ary

    A),

    4/30

    (13%

    ; 1 tr

    ache

    al P

    , 4 p

    ulm

    onar

    y A

    ), 9/

    30

    (30%

    ; 5 tr

    ache

    al P

    , 7 p

    ulm

    onar

    y A

    ), 25

    /29

    (86%

    ; 2

    trac

    heal

    pol

    yp, 9

    P, 5

     SC

    C, 1

    AdS

    C, 1

     fibr

    oS,

    2 br

    onch

    ial p

    olyp

    , 1 P

    , 2 S

    CC

    , 1 A

    dSC

    ), 26

    /28

    (93%

    ; 6 tr

    ache

    al P

    , 11

    SCC

    , 1 A

    dSC

    , 1 b

    ronc

    hial

    po

    lyp,

    2 P

    , 4 S

    CC

    , 2 A

    dSC

    , 4 A

    dC, 1

    ana

    plas

    tic

    C, 1

    6 pu

    lmon

    ary

    A, 4

    SC

    C, 3

    AdS

    C, 1

    AdC

    , 2

    anap

    last

    ic C

    )

    +N

    R (0

    .9%

    salin

    e so

    lutio

    n)

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    , F)

    M, 6

    7–88

    wk;

    F, 6

    0–88

    w

    k H

    enry

    et a

    l. (1

    973)

    0, 1

    3.3–

    15.5

    mg/

    anim

    al, o

    nce/

    wk,

    wk

    50/g

    roup

    , 25

    cont

    rols/

    grou

    p

    Resp

    irat

    ory

    trac

    t T:

    Con

    trol

    s–

    1 tr

    ache

    al p

    olyp

    , 6 p

    ulm

    onar

    y br

    onch

    iola

    r ad

    enom

    atoi

    d le

    sions

    /47

    anim

    als

    Trea

    ted

    anim

    als–

    26

    /65

    (40%

    ; 1 n

    asal

    pol

    yp; 6

    lary

    ngea

    l pol

    yps,

    1 P,

    1 A

    , 1 A

    dC, 7

    trac

    heal

    pol

    yps,

    1 A

    dC, 1

    SC

    C, 1

    fibr

    oS, 2

    bro

    nchi

    al A

    dC, 1

    3 pu

    lmon

    ary

    bron

    chio

    lar a

    deno

    mat

    oid

    lesio

    n, 3

    A, 5

    AdC

    , 1 

    SCC

    , 2 a

    napl

    astic

    C, 1

    mix

    ed C

    , 1 m

    yelo

    geno

    us

    leuk

    aem

    ia, 1

    neu

    rofib

    roS)

    T

    at o

    ther

    site

    s: C

    ontr

    ols–

    1

    rena

    l A

    Trea

    ted

    anim

    als–

    3

    blas

    t-ce

    ll le

    ukae

    mia

    , 2 a

    dren

    ocor

    tical

    A, 1

     rena

    l A

    dC, 1

    oes

    opha

    geal

    fibr

    oS, 1

     hae

    man

    giom

    a

    +N

    R (0

    .5%

    gel

    atin

    e in

    0.9

    %

    salin

    e so

    lutio

    n)

    Tum

    our d

    ata

    for M

    and

    F

    com

    bine

    d; st

    atis

    tics N

    R

    Tabl

    e 3.

    1 (c

    onti

    nued

    )

  • IARC MONOGRAPHS – 100F

    122

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    , F)

    60 w

    k K

    obay

    ashi

    (197

    5)

    0 an

    d 1

    mg/

    anim

    al, o

    nce/

    wk,

    30

    wk

    20–3

    2 M

    /gro

    up, 2

    0–28

    F/g

    roup

    Resp

    irat

    ory

    trac

    t T:

    M–0

    /20,

    11/

    26 (4

    2.3%

    ; 1 la

    ryng

    eal p

    olyp

    , 1

    trac

    heal

    pol

    yp, 1

    P, 1

     bro

    nchi

    al S

    CC

    , 9 lu

    ng A

    , 7

    AdC

    , 3 S

    CC

    , 1 a

    napl

    astic

    C, 2

     AdS

    C)

    F–0/

    20, 1

    4/26

    (53.

    8%; 1

    lary

    ngea

    l P, 2

    trac

    heal

    po

    lyps

    , 1 b

    ronc

    hial

    SC

    C, 1

    0 lu

    ng A

    , 3 A

    dC, 1

    SC

    C)

    +N

    R (0

    .9%

    salin

    e)

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    , F)

    78 w

    k K

    ruys

    se &

    Fer

    on

    (197

    6)

    0 (u

    ntre

    ated

    ), 0 

    (veh

    icle

    con

    trol

    s),

    1 m

    g/an

    imal

    , onc

    e/2

    wk,

    52

    wk

    17 o

    r 40/

    grou

    p

    Resp

    irat

    ory

    trac

    t T:

    M–0

    /40,

    0/4

    0, 1

    3/14

    (93%

    ; 2 la

    ryng

    eal P

    , 1 S

    CC

    , 4

    trac

    heal

    P, 3

     SC

    C, 1

    ana

    plas

    tic C

    , 1 S

    , 1 b

    ronc

    hial

    SC

    C, 1

    AdC

    , 5 p

    ulm

    onar

    y A

    , 1 A

    dC)

    F–0/

    40, 0

    /40,

    7/1

    2 (5

    8%; 2

     trac

    heal

    P, 3

    SC

    C,

    1 br

    onch

    ial P

    , 5 p

    ulm

    onar

    y A

    )

    +> 

    99%

    (sal

    ine

    solu

    tion)

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    ) 10

    0 w

    k Se

    llaku

    mar

    et a

    l. (1

    976)

    0 (u

    ntre

    ated

    ), 3

    mg/

    anim

    al, o

    nce/

    wk,

    10

    wk

    48/g

    roup

    Resp

    irat

    ory

    trac

    t T:

    0/48

    , 7/4

    8 (1

    5%; 2

    lary

    ngea

    l P, 4

     trac

    heal

    P, 1

    lung

    A

    ) T

    at o

    ther

    site

    s: 6/

    48 (1

    3%; 3

    fore

    stom

    ach

    P, 2

     lym

    phom

    a, 1

    an

    apla

    stic

    C),

    26/4

    8 (5

    4%; 2

    1 fo

    rest

    omac

    h P,

    1 sk

    in m

    elan

    oma,

    1 li

    ver h

    aem

    angi

    oma,

    adre

    noco

    rtic

    oA, 3

    adr

    enoc

    ortic

    oC)

    +> 

    99%

    (0.9

    % sa

    line

    solu

    tion)

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    , F)

    Expe

    rim

    ent 1

    : up

    to

    89 w

    k fo

    r M a

    nd 7

    0 w

    k fo

    r F

    Expe

    rim

    ent 2

    : up

    to

    83 w

    k fo

    r M a

    nd 6

    8 w

    k fo

    r F

    Ket

    kar e

    t al.

    (197

    7)

    Expe

    rim

    ent 1

    : 0,

    4, 8

    , 16

    mg

    in 0

    .9%

    salin

    e so

    lutio

    n/an

    imal

    , 1 ×

      30

    /gro

    up

    Resp

    irat

    ory

    trac

    t T:

    Expe

    rim

    ent 1

    – M

    0/2

    4, 3

    /30

    (10%

    ; 1 la

    ryng

    eal P

    , 1 tr

    ache

    al P

    , 1 

    lung

    S),

    5/28

    (18%

    ; 1 la

    ryng

    eal S

    CC

    , 1 tr

    ache

    al P

    , 4

    lung

    S),

    4/27

    (15%

    ; 3 tr

    ache

    al P

    , 1 lu

    ng A

    , 1 S

    ) F

    0/28

    , 3/2

    9 (1

    0%; 1

    trac

    heal

    P, 2

     lung

    A),

    1/30

    (3

    %; 1

    lung

    A),

    3/28

    (13%

    ; 1 la

    ryng

    eal P

    , 2 lu

    ng A

    )

    +97

    % (0

    .9%

    salin

    e so

    lutio

    n or

    Tr

    is b

    uffer

    )

    Expe

    rim

    ent 2

    : 0,

    4, 8

    , 16

    mg

    in T

    ris b

    uffer

    / an

    imal

    , 1 ×

      30

    /gro

    up

    Expe

    rim

    ent 2

    – M

    0/2

    7, 5/

    24 (2

    1%; 1

    trac

    heal

    P, 5

     lung

    A),

    13/2

    5 (5

    2%; 1

     lary

    ngea

    l P, 7

     trac

    heal

    P, 4

     lung

    A, 3

    AdC

    ), 8/

    27 (3

    0%; 2

    lary

    ngea

    l P, 1

    SC

    C, 3

     trac

    heal

    P, 3

    lu

    ng A

    ) F

    0/27

    , 3/2

    7 (1

    1%; 2

    trac

    heal

    P, 1

     lung

    AdC

    ), 2/

    29

    (7%

    ; 2 tr

    ache

    al P

    ), 8/

    29 (2

    8%; 1

     lary

    ngea

    l P, 4

    tr

    ache

    al P

    , 5 lu

    ng A

    )

    +

    Tabl

    e 3.

    1 (c

    onti

    nued

    )

  • Benzo[a]pyrene

    123

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    , F)

    81 w

    k Fe

    ron

    & K

    ruys

    se

    (197

    8)

    0 (u

    ntre

    ated

    ), 0 

    (veh

    icle

    con

    trol

    s),

    0.35

    , 0.7

    mg/

    anim

    al, o

    nce/

    wk,

    52

    wk

    15 o

    r 30/

    grou

    p

    Resp

    irat

    ory

    trac

    t T:

    M–0

    /30

    (unt

    reat

    ed a

    nd v

    ehic

    le c

    ontr

    ols

    com

    bine

    d), 4

    /29

    (14%

    ; 2 tr

    ache

    al P

    , 1 b

    ronc

    hial

    P,

    2 p

    ulm

    onar

    y A

    ), 19

    /30

    (63%

    ; 1 la

    ryng

    eal P

    , 5

    trac

    heal

    P, 1

    SC

    C, 1

     ana

    plas

    tic C

    , 1 S

    , 2 b

    ronc

    hial

    P,

    1 A

    dC, 1

    1 pu

    lmon

    ary

    A, 2

    AdC

    , 1 S

    CC

    , 1

    anap

    last

    ic C

    ) F–

    0/28

    (unt

    reat

    ed a

    nd v

    ehic

    le c

    ontr

    ols

    com

    bine

    d), 3

    /27

    (11%

    ; 1 la

    ryng

    eal P

    , 1 b

    ronc

    hial

    P,

    1 pu

    lmon

    ary

    A),

    7/24

    (29%

    ; 1 tr

    ache

    al P

    , 2 S

    CC

    , 1

    bron

    chia

    l AdC

    , 5 p

    ulm

    onar

    y A

    )

    +> 

    99%

    (0.9

    % sa

    line

    solu

    tion)

    St

    atis

    tics N

    R

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    , F)

    Aver

    age

    surv

    ival

    up

    to 4

    1 w

    k fo

    r M a

    nd 3

    5 w

    k fo

    r F

    Ket

    kar e

    t al.

    (197

    8)

    0, 0

    .1, 0

    .33,

    1.0

     mg/

    anim

    al, o

    nce/

    wk

    30/g

    roup

    Resp

    irat

    ory

    trac

    t T:

    M–0

    /29,

    5/2

    6 (1

    9%; 5

    bro

    nchi

    ogen

    ic A

    ), 7/

    29

    (24%

    ; 5 tr

    ache

    al P

    , 2 b

    ronc

    hiog

    enic

    A),

    6/27

    (22%

    ; 5 

    trac

    heal

    P, 2

    bro

    nchi

    ogen

    ic A

    ) F–

    0/30

    , 12/

    30 (4

    0%; 1

    trac

    heal

    P, 1

    SC

    C, 1

    0 br

    onch

    ioge

    nic

    A),

    10/2

    8 (3

    6%; 7

    trac

    heal

    P, 5

    br

    onch

    ioge

    nic

    A, 1

    SC

    C),

    6/30

    (20%

    ; 3 tr

    ache

    al P

    , 3

    bron

    chio

    geni

    c A

    , 3 S

    CC

    )

    +97

    % (1

    0% b

    ovin

    e se

    rum

    al

    bum

    in)

    Aver

    age

    surv

    ival

    tim

    e m

    uch

    low

    er in

    the

    high

    -dos

    e gr

    oup

    than

    in th

    e ot

    her g

    roup

    s

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    , F)

    Life

    time,

    up

    to 9

    0 w

    k St

    enbä

    ck &

    Row

    land

    (1

    978)

    0, 3

    mg

    larg

    e pa

    rtic

    les,

    3 m

    g sm

    all

    part

    icle

    s/an

    imal

    , onc

    e/w

    k, 1

    8 w

    k 48

    (M +

    F)/g

    roup

    Resp

    irat

    ory

    trac

    t T (M

    + F

    com

    bine

    d): 0

    /46,

    31

    /47

    (66%

    ; 5 la

    ryng

    eal P

    , 12

    trac

    heal

    P, 2

    0 SC

    C,

    2 un

    spec

    ified

    T, 2

    bro

    nchi

    al P

    , 9 S

    CC

    , 3 A

    , 2

    anap

    last

    ic C

    ), 5/

    46 (1

    1%; 1

    lary

    ngea

    l P, 1

    SC

    C,

    4 tr

    ache

    al P

    )

    +99

    .4%

    (0.9

    % sa

    line

    solu

    tion)

    ; pa

    rtic

    le si

    ze b

    y w

    eigh

    t: la

    rge-

    98%

    < 3

    0 μm

    , 90%

    < 2

    0 μm

    , 36%

    < 1

    0 μm

    , 10%

    < 5

    μm

    ; sm

    all-9

    8% <

     10 

    μm, 7

    9%

  • IARC MONOGRAPHS – 100F

    124

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    , F)

    105

    wk

    Fero

    n et

    al.

    (198

    0)

    0 (u

    ntre

    ated

    ), 0

    (gel

    atin

    e in

    0.9

    %

    salin

    e), 0

    .5, 1

    .0 m

    g fin

    e pa

    rtic

    les,

    0.5,

    1.0

    mg

    coar

    se p

    artic

    les,

    1.0

    mg

    wid

    e-ra

    nge

    part

    icle

    s/an

    imal

    , onc

    e/w

    k, 5

    2 w

    k 30

    –35/

    grou

    p

    Resp

    irat

    ory

    trac

    t T:

    M–0

    /29,

    2/3

    4 (6

    %; 2

    lary

    ngea

    l P),

    7/34

    (21%

    ; 1

    lary

    ngea

    l P, 6

    trac

    heal

    P, 1

    lung

    A),

    6/31

    (19%

    ; 2

    lary

    ngea

    l P, 1

    trac

    heal

    P, 1

    S,1

    pul

    mon

    ary

    A),

    13/3

    1 (4

    2%; 2

    lary

    ngea

    l P, 3

     trac

    heal

    P, 9

    pu

    lmon

    ary

    A),

    25/3

    4 (7

    4%; 2

    lary

    ngea

    l P, 9

    tr

    ache

    al P

    , 4 S

    CC

    , 2 S

    , 1 p

    ulm

    onar

    y A

    , 1 A

    dC),

    23/3

    4 (6

    8%; 2

     lary

    ngea

    l P, 1

    SC

    C, 6

    trac

    heal

    P, 2

    SC

    C, 1

     bro

    nchi

    al P

    , 1 S

    CC

    , 13 

    pulm

    onar

    y A

    , 2

    AdC

    , 2 a

    napl

    astic

    C)

    F–0/

    28, 2

    /33

    (6%

    ; 1 tr

    ache

    al P

    , 1 p

    ulm

    onar

    y A

    ), 2/

    34 (6

    %; 1

    bro

    nchi

    al P

    , 1 A

    ), 5/

    32 (1

    6%;

    1 la

    ryng

    eal P

    , 2 tr

    ache

    al P

    , 3 p

    ulm

    onar

    y A

    ), 9/

    32

    (28%

    ; 2 la

    ryng

    eal P

    , 5 tr

    ache

    al P

    , 6 p

    ulm

    onar

    y A

    ), 19

    /32

    (31%

    ; 4 tr

    ache

    al P

    , 1 S

    CC

    , 1 S

    , 1 b

    ronc

    hial

    P,

    7 pu

    lmon

    ary

    A, 1

     AdC

    ), 11

    /34

    (34%

    ; 1 la

    ryng

    eal

    P, 3

    trac

    heal

    P, 2

     bro

    nchi

    al P

    , 7 p

    ulm

    onar

    y A

    , 1 

    AdC

    )

    +N

    R; p

    artic

    les s

    ize

    by w

    eigh

    t: fin

    e, 7

    7% <

     5.2

     μm

    , 60%

     

    99%

    (0.5

    % g

    elat

    ine

    in 0

    .9%

    sa

    line

    solu

    tion)

    Intr

    atra

    chea

    l adm

    inis

    trat

    ion

    of c

    ombi

    nati

    ons o

    f ben

    zo[a

    ]pyr

    ene

    and

    ‘par

    ticl

    es/fi

    bres

    ’Ra

    t, Sp

    ragu

    e-D

    awle

    y (M

    , F)

    Up

    to 1

    30 w

    k St

    einh

    off et

    al.

    (199

    1)

    0, (u

    ntre

    ated

    ), 0

    (phy

    siolo

    gica

    l sa

    line)

    , 10–

    40 m

    g/kg

    bw

    Bay

    ferr

    ox

    130

    (96.

    2% c

    ubic

    α-F

    e 2O

    3),

    10–4

    0 m

    g/kg

    bw

    Bay

    ferr

    ox 9

    20

    (86.

    1% fi

    brou

    s α-F

    eOO

    H),

    7 m

    g/kg

    bw

    , 7 m

    g/kg

    bw

    + 1

    0–40

    mg/

    kg b

    w

    Bayf

    erro

    x 13

    0, 7

     mg/

    kg b

    w +

    10

    –40 

    mg/

    kg b

    w B

    ayfe

    rrox

    920

    , ~o

    nce/

    2 w

    k, 4

    4–~1

    30 w

    k 20

    or 5

    0/gr

    oup

    Lung

    T:

    M–0

    /50,

    0/5

    0, 0

    /50,

    0/5

    0, 1

    9 m

    alig

    nant

    T in

    20

    anim

    als,

    21 m

    alig

    nant

    and

    1 b

    enig

    n T

    in 2

    0 an

    imal

    s, 17

    mal

    igna

    nt a

    nd 1

     ben

    ign

    T in

    20

    anim

    als

    F–0/

    50, 0

    /50,

    0/5

    0, 1

    mal

    igna

    nt a

    nd 1

     ben

    ign

    T in

    50

    anim

    als,

    18 m

    alig

    nant

    and

    1 b

    enig

    n T

    in 2

    0 an

    imal

    s, 16

     mal

    igna

    nt T

    in 2

    0 an

    imal

    s, 17

     mal

    igna

    nt a

    nd 2

    ben

    ign

    T in

    20 

    anim

    als

    +N

    R (p

    hysio

    logi

    cal s

    alin

    e so

    lutio

    n w

    ith o

    r with

    out

    Twee

    n 60

    ); Ba

    yfer

    rox

    130,

    Ba

    yfer

    rox

    920

    Lim

    ited

    hist

    olog

    y

    Tabl

    e 3.

    1 (c

    onti

    nued

    )

  • Benzo[a]pyrene

    125

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    , F)

    Life

    time

    (up

    to 1

    40

    wk)

    Sa

    ffiot

    ti et

    al.

    (197

    2)

    Expe

    rim

    ent 1

    0,

    50

    mg

    ferr

    ic o

    xide

    , 5 m

    g +

    45 m

    g fe

    rric

    oxi

    de, 1

    2.5

    mg

    + 37

    .5 m

    g fe

    rric

    oxi

    de/ a

    nim

    al,

    1 × 

    Expe

    rim

    ent 2

    (2

    gro

    ups/

    dose

    leve

    l) 5

    mg

    + 5

    mg

    ferr

    ic o

    xide

    , 10

    mg

    + 10

    mg

    ferr

    ic o

    xide

    , 15

    mg

    + 15

    mg

    ferr

    ic o

    xide

    , onc

    e/w

    k, 1

    5 w

    k 23

    –110

    M/g

    roup

    , 18–

    107

    F/gr

    oup

    Expe

    rim

    ent 1

    : Re

    spir

    ator

    y tr

    act T

    – M

    0/4

    5, 0

    /101

    , 3/9

    2 (3

    %; 1

    trac

    heal

    pol

    yp, 1

    P,

    1 b

    ronc

    hial

    A),

    3/27

    (11%

    ; 1 b

    ronc

    hial

    A, 1

    br

    onch

    ogen

    ic S

    CC

    , 1 a

    napl

    astic

    C)

    F 0/

    44, 0

    /89,

    4/9

    7 (4

    %; 1

    trac

    heal

    pol

    yp, 1

    P, 1

    br

    onch

    iola

    r A, 1

    AdC

    ), 6/

    33 (1

    8%; 1

    bro

    nchi

    al

    P, 1

    A, 2

     bro

    ncho

    geni

    c SC

    C, 1

    ana

    plas

    tic C

    , 2 

    bron

    chio

    lar A

    ) Fo

    rest

    omac

    h P–

    M

    5/4

    5 (1

    1%; 6

    T),

    5/10

    1 (5

    %; 5

    T),

    15/9

    2 (1

    6%; 3

    5 T)

    , 8/2

    7 (3

    0%; 1

    6 T)

    F

    2/44

    (5%

    ; 2 T

    ), 2/

    89 (2

    %; 3

    T),

    5/97

    (5%

    ; 5 T

    ), 4/

    33 (1

    2%; 6

    T)

    +N

    R (0

    .9%

    salin

    e so

    lutio

    n);

    ferr

    ic o

    xide

    Expe

    rim

    ent 2

    : Re

    spir

    ator

    y tr

    act T

    (M +

    F c

    ombi

    ned)

    – 7/

    50 (1

    4%; 2

    trac

    heal

    P, 1

    SC

    C, 1

     bro

    nchi

    al P

    , 1 A

    , 2

    SCC

    , 1 a

    napl

    astic

    C, 1

    pul

    mon

    ary

    SCC

    ), 8/

    58 (1

    4%; 2

    trac

    heal

    pol

    yps,

    1 br

    onch

    ial p

    olyp

    , 2

    SCC

    , 2 A

    dC, 2

     pul

    mon

    ary

    A, 2

    AdC

    ), 17

    /61

    (28%

    ; 2 tr

    ache

    al p

    olyp

    s, 2

    P, 5

    SC

    C, 5

     bro

    nchi

    al

    SCC

    , 1 p

    ulm

    onar

    y A

    , 1 S

    CC

    , 1 A

    dC, 1

    ana

    plas

    tic

    C),

    25/6

    0 (4

    2%; 4

    trac

    heal

    pol

    yps,

    3 P,

    3 S

    CC

    , 4 

    anap

    last

    ic C

    , 1 b

    ronc

    hial

    P, 1

    SC

    C, 2

     ana

    plas

    tic

    C, 4

    AdC

    , 1 A

    , 2 p

    ulm

    onar

    y SC

    C, 2

    ana

    plas

    tic

    C, 6

     A),

    25/3

    9 (6

    4%; 1

    trac

    heal

    P, 1

    0 SC

    C, 1

    an

    apla

    stic

    C, 3

    bro

    nchi

    al P

    , 7 S

    CC

    , 11

    anap

    last

    ic

    C, 2

    AdC

    , 2 p

    ulm

    onar

    y SC

    C, 2

    A),

    35/5

    5 (6

    4%;

    2 la

    ryng

    eal S

    CC

    , 11

    trac

    heal

    P, 1

    pol

    yp, 1

    2 SC

    C, 1

     car

    cino

    S, 2

    fibr

    oS, 1

    6 br

    onch

    ial S

    CC

    , 10

    anap

    last

    ic C

    , 6 A

    dC, 3

    A, 2

     pul

    mon

    ary

    A)

    +

    Fore

    stom

    ach

    T–

    M 8

    /22

    (36%

    ; 13

    P, 1

    SC

    C),

    6/

    28 (2

    1%; 9

    P),

    11/3

    4 (3

    2%; 2

    8 P,

    1 S

    CC

    ), 11

    /30

    (37%

    ; 18

    P), 5

    /22

    (23%

    ; 10

    P), 1

    /28

    (4%

    ; 1 P

    ) F

    9/28

    (32%

    ; 14

    P), 6

    /30

    (20%

    ; 9 P

    ), 5/

    27 (1

    9%; 2

    0 P)

    , 8/3

    0 (2

    7%; 1

    0 P,

    1 S

    CC

    ), 5/

    17 (2

    9%; 1

    1 P)

    , 3/2

    7 (1

    1%; 3

     P)

    Tabl

    e 3.

    1 (c

    onti

    nued

    )

  • IARC MONOGRAPHS – 100F

    126

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Ham

    ster

    , Syr

    ian

    gold

    en (F

    ) Pr

    esum

    ably

    life

    time

    Pott

    et a

    l. (1

    973b

    )

    340

    µg in

    tric

    apry

    lin,

    340

    µg in

    Tw

    een

    60/s

    alin

    e so

    lutio

    n,

    340

    µg in

    Tw

    een

    60/s

    alin

    e so

    lutio

    n +

    850

    µg a

    tmos

    pher

    ic d

    ust/a

    nim

    al,

    45 ×

     with

    in a

    per

    iod

    of 6

    .5 m

    o (to

    tal d

    ose,

    ~15

     mg;

    dus

    t, 38

     mg)

    48

    /gro

    up

    Resp

    irat

    ory

    trac

    t T (b

    enig

    n an

    d m

    alig

    nant

    T o

    f th

    e la

    rynx

    , tra

    chea

    or b

    ronc

    hi):

    2/48

    (4%

    ), 14

    /48

    (29%

    ), 16

    /48

    (33%

    )

    +N

    R (tr

    icap

    rylin

    , Tw

    een

    60/

    salin

    e so

    lutio

    n); a

    tmos

    pher

    ic

    dust

    from

    Boc

    hum

    , Ger

    man

    y (p

    artic

    le si

    ze <

     5 μ

    m)

    Ham

    ster

    , Syr

    ian

    (M, F

    ) 10

    0 w

    k Se

    llaku

    mar

    et a

    l. (1

    973)

    0 (u

    ntre

    ated

    ), 3

    mg

    + 3

    mg

    ferr

    ic

    oxid

    e, 3

     mg

    + 6

    mg

    ferr

    ic o

    xide

    , 3 

    mg

    + 9

    mg

    ferr

    ic o

    xide

    , onc

    e/2

    wk,

    20

    wk

    36/g

    roup

    , 193

    con

    trol

    s/gr

    oup

    Resp

    irat

    ory

    trac

    t T (M

    + F

    com

    bine

    d):

    0/19

    3, 2

    6/67

    (39%

    ; 3 la

    ryng

    eal p

    olyp

    , 3 P

    , 3 S

    CC

    , 7

    trac

    heal

    pol

    yp, 6

    P, 2

    SC

    C, 2

    bro

    nchi

    al p

    olyp

    , 5

    SCC

    , 9 A

    dC, 1

     ana

    plas

    ic C

    , 7 lu

    ng A

    , 1 A

    dC),

    28/6

    4 (4

    4%; 1

    lary

    ngea

    l pol

    yp, 3

    P, 6

     SC

    C, 3

    tr

    ache

    al p

    olyp

    , 9 P

    , 3 S

    CC

    , 3 b

    ronc

    hial

    pol

    yp, 1

    P,

    4 SC

    C, 3

     AdC

    , 1 a

    napl

    astic

    C, 7

    lung

    A, 4

     AdC

    ), 26

    /66

    (39%

    ; 3 la

    ryng

    eal p

    olyp

    , 6 S

    CC

    , 6 tr

    ache

    al

    poly

    p, 1

    1 P,

    1 S

    CC

    , 1 b

    ronc

    hial

    pol

    yp, 1

    P, 4

     SC

    C,

    4 A

    dC, 2

    ana

    plas

    tic C

    , 6 lu

    ng A

    , 6 A

    dC)

    Fore

    stom

    ach

    T:

    M–0

    /193

    (M +

    F),

    17/3

    2 (5

    3%; 3

    7 P)

    , 10/

    31 (3

    2%;

    16 P

    , 1 S

    CC

    ), 6/

    35 (1

    7%; 1

    5 P)

    F–

    0/19

    3 (M

    + F

    ), 10

    /35

    (29%

    ; 30

    P), 1

    2/33

    (36%

    ; 25

     P),

    15/3

    1 (4

    8%; 3

    3 P)

    +N

    R (0

    .9%

    salin

    e so

    lutio

    n);

    ferr

    ic o

    xide

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    , F)

    Life

    time

    (up

    to 1

    20

    wk)

    St

    enbä

    ck et

    al.

    (197

    5)

    0 (u

    ntre

    ated

    ),

    2 m

    g +

    1 m

    g m

    agne

    sium

    oxi

    de/

    anim

    al, o

    nce/

    wk,

    20

    wk,

    3 m

    g +

    3 m

    g fe

    rric

    oxi

    de/a

    nim

    al, o

    nce/

    wk,

    15

     wk

    48 o

    r 90/

    grou

    p

    Resp

    irat

    ory

    trac

    t tum

    ours

    (M +

    F c

    ombi

    ned)

    : 0/

    89, 3

    2/45

    [71%

    ] (11

     lary

    ngea

    l P, 3

    SC

    C, 1

    tr

    ache

    al p

    olyp

    , 20

    P, 5

    SC

    C, 1

    AdC

    , 1 b

    ronc

    hial

    P,

    3 A

    , 8 A

    dC, 9

    SC

    C, 1

     AdS

    C),

    31/4

    4 (7

    0%;

    10 la

    ryng

    eal P

    , 4 S

    CC

    , 8 tr

    ache

    al P

    , 12

    SCC

    , 2

    anap

    last

    ic C

    , 2 b

    ronc

    hial

    P, 4

    A, 2

    AdC

    , 17

    SCC

    , 3

    anap

    last

    ic C

    )

    +N

    R (0

    .2%

    salin

    e so

    lutio

    n);

    ferr

    ic o

    xide

    , mag

    nesiu

    m

    oxid

    e

    Tabl

    e 3.

    1 (c

    onti

    nued

    )

  • Benzo[a]pyrene

    127

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    , F)

    Life

    time

    (up

    to 1

    00

    wk)

    St

    enbä

    ck &

    Row

    land

    (1

    979)

    0 (u

    ntre

    ated

    ), 0 

    (sal

    ine)

    , 0 (g

    elat

    ine

    in sa

    line)

    , 3 m

    g si

    licon

    dio

    xide

    in

    salin

    e, 1

    .5 m

    g m

    anga

    nese

    dio

    xide

    in

    salin

    e, 3

    mg

    in sa

    line,

    3 m

    g in

    ge

    latin

    e/sa

    line,

    3 m

    g +

    3 m

    g si

    licon

    di

    oxid

    e in

    salin

    e, 1

    .5 m

    g +

    1.5 

    mg

    man

    gane

    se d

    ioxi

    de in

    salin

    e/an

    imal

    , onc

    e/w

    k, 2

    0 w

    k

    50/g

    roup

    All

    T (M

    + F

    com

    bine

    d): 2

    /100

    (2%

    ; 2

    lym

    phom

    a), 1

    /48

    (2%

    ; 2 fo

    rest

    omac

    h P)

    , 2/4

    5 (4

    %;

    2 ly

    mph

    oma)

    , 0/4

    8 (0

    %),

    2/48

    (4%

    ; 1 fo

    rest

    omac

    h P,

    1 ly

    mph

    oma)

    , 18/

    46 (3

    9%; 1

    lary

    ngea

    l P, 1

    SC

    C, 4

     trac

    heal

    P, 1

    5 fo

    rest

    omac

    h P)

    , 11/

    47 (2

    3%;

    2 tr

    ache

    al P

    , 1 S

    CC

    , 3 b

    ronc

    hial

    SC

    C, 1

    sple

    nic

    haem

    angi

    oma,

    1 a

    dren

    al c

    ortic

    al A

    , 1 ly

    mph

    oma,

    2

    fore

    stom

    ach

    SCC

    ), 25

    /48

    (52%

    ; 1 la

    ryng

    eal S

    CC

    , 8 

    trac

    heal

    P, 2

    SC

    C, 3

    bro

    nchi

    al S

    CC

    , 6 lu

    ng A

    , 3 

    AdC

    , 10 

    fore

    stom

    ach

    P, 1

    thyr

    oid

    A, 1

     ute

    rine

    fib

    rom

    a, 1

    A, 1

    lym

    phom

    a), 2

    0/48

    (42%

    ; 1

    lary

    ngea

    l P, 3

    trac

    heal

    P, 1

    SC

    C, 1

    bro

    nchi

    al S

    CC

    , 24

     fore

    stom

    ach

    P, 1

    ova

    rian

    fibr

    oma,

    1 th

    yroi

    d A

    , 2

    fore

    stom

    ach

    SCC

    , 1 sq

    uam

    ous-

    cell

    fibro

    ma)

    +> 

    99%

    (sal

    ine,

    0.5

    % g

    elat

    ine

    in sa

    line)

    ; man

    gane

    se

    diox

    ide,

    silic

    on d

    ioxi

    de

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    , F)

    82 w

    k Re

    ynde

    rs et

    al.

    (198

    5)

    0 an

    d 8

    mg

    + 6

    mg

    ferr

    ic o

    xide

    /an

    imal

    , onc

    e/w

    k, 6

    wk

    35/g

    roup

    Resp

    irat

    ory

    trac

    t T:

    M–0

    /32,

    12/

    24 (5

    0%; 1

    5 T:

    3 la

    ryng

    eal P

    , 1

    trac

    heal

    P, 1

    SC

    C, 2

     bro

    nchi

    al p

    olyp

    , 2 S

    CC

    , 1A

    dC, 3

     pul

    mon

    ary

    SCC

    , 1 A

    dSC

    , 1 A

    dC)

    F–0/

    35, 9

    /26

    (35%

    ; 12

    T: 1

    lary

    ngea

    l P, 5

     trac

    heal

    P,

    2 b

    ronc

    hial

    pol

    yp, 2

     pul

    mon

    ary

    SCC

    , 1 A

    dSC

    , 1 

    AdC

    )

    +N

    R (0

    .9%

    salin

    e so

    lutio

    n);

    ferr

    ic o

    xide

    Bucc

    al p

    ouch

    Ham

    ster

    , Syr

    ian

    gold

    en (M

    ) U

    p to

    40–

    44 w

    k w

    ith

    inte

    rim

    kill

    s afte

    r 5,

    20, a

    nd 2

    4–32

    wk

    Solt

    et a

    l. (1

    987)

    Pain

    ting

    of b

    oth

    bucc

    al p

    ouch

    with

    0,

    20

    mM

    solu

    tion/

    anim

    al, t

    wic

    e/w

    k, 2

    0 w

    k 28

    /gro

    up, 2

    0 co

    ntro

    ls/gr

    oup

    Fore

    stom

    ach

    P: 0

    /6, 8

    /10*

    (afte

    r 40–

    44 w

    k)

    Bucc

    al p

    ouch

    SC

    C: 0

    /6, 1

    /10

    (afte

    r 40–

    44 w

    k)*[

    P  

    99%

    (no

    vehi

    cle)

    Tabl

    e 3.

    1 (c

    onti

    nued

    )

  • IARC MONOGRAPHS – 100F

    128

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Rat,

    Spra

    gue-

    Daw

    ley

    (F)

    45 w

    k C

    aval

    ieri

    et a

    l. (1

    988a

    , b)

    0 an

    d 4

    μmol

    [1 m

    g]/m

    amm

    ary

    glan

    d (2

    nd, 3

    rd, 4

    th a

    nd 5

    th

    mam

    mar

    y gl

    and

    on b

    oth

    sides

    in

    ject

    ed),

    1 × 

    20

    /gro

    up

    Epith

    elia

    l mam

    mar

    y T:

    [3/2

    0] (1

    5%; 3

     fibr

    oA),

    [14/

    20] (

    70%

    ; 13

    AdC

    , 3 fi

    broA

    ); m

    ultip

    licity

    : co

    ntro

    ls, 3

    /3 [1

    ]; tr

    eate

    d ra

    ts: A

    dC, 1

    8/13

    [1.4

    ]; fib

    roA

    , 4/3

    [1.3

    ] M

    esen

    chym

    al (m

    amm

    ary)

    T: [

    0/20

    ] (0%

    ), [1

    1/20

    ] (5

    5%; 1

    1 fib

    roS;

    mul

    tiplic

    ity, 2

    0/11

    [1.8

    ])

    Skin

    T: [

    0/20

    ] (0%

    ), [9

    /20]

    (45%

    ; 9 S

    CC

    ; m

    ultip

    licity

    , 11/

    9 [1

    .2])

    +> 

    99%

    (tri

    octa

    noin

    )

    Rat,

    Spra

    gue-

    Daw

    ley

    (F)

    24 w

    k C

    aval

    ieri

    et a

    l. (1

    991)

    0, 0

    .25

    [66

    µg],

    1 μm

    ol [2

    64 μ

    g]/

    mam

    mar

    y gl

    and

    (the

    2nd,

    3rd

    , 4th

    an

    d 5t

    h on

    bot

    h sid

    es),

    1 × 

    20

    /gro

    up

    Epith

    elia

    l mam

    mar

    y gl

    and

    T: 1

    /18

    (6%

    ; 1 fi

    broA

    ), 1/

    20 (5

    %; 1

    AdC

    ), 0/

    20 (0

    %)

    Mes

    ench

    ymal

    (mam

    mar

    y) T

    : 0/1

    8 (0

    %),

    6/20

    (3

    0%; 6

    fibr

    oS; m

    ultip

    licity

    , 7/6

    ), 8/

    20 (4

    0%; 8

    fib

    roS;

    mul

    tiplic

    ity, 1

    0/8)

    Sk

    in T

    : 0/1

    8 (0

    %),

    0/20

    (0%

    ), 1/

    20 (5

    %; 1

    SC

    C)

    +> 

    99%

    (tri

    octa

    noin

    ) St

    atis

    tics N

    R

    Intr

    acol

    onic

    inst

    illat

    ion

    Mou

    se, S

    wis

    s alb

    ino

    (M, F

    ) 12

    0 w

    k To

    th (1

    980)

    0, 2

    00, 2

    000 

    μg/g

    bw

    (tot

    al d

    oses

    ); co

    ntro

    l and

    hig

    h-do

    se g

    roup

    , 10 

    × /

    wk

    inst

    illat

    ions

    of 0

    and

    200

     μg,

    re

    spec

    tivel

    y; lo

    w-d

    ose

    grou

    p,

    1 in

    still

    atio

    n

    50/g

    roup

    /sex

    Mal

    igna

    nt ly

    mph

    oma:

    M

    –0/5

    0, 6

    /50*

    (12%

    ; 1 h

    istio

    cytic

    , 4 ly

    mph

    ocyt

    ic,

    1 m

    ixed

    ), 7/

    50**

    (14%

    ; 2 h

    istio

    cytic

    , 3

    lym

    phoc

    ytic

    , 2 m

    ixed

    ) F–

    11/4

    9 (2

    2%; 5

     his

    tiocy

    tic, 6

     lym

    phoc

    ytic

    ), 21

    /50*

    ** (4

    2%; 5

     his

    tiocy

    tic, 1

    6 ly

    mph

    ocyt

    ic),

    18/4

    9 (3

    6%; 6

    his

    tiocy

    tic, 8

     lym

    phoc

    ytic

    , 4 m

    ixed

    ) O

    esop

    hagu

    s T:

    M–n

    o tu

    mou

    r F–

    0/49

    , 0/5

    0, 5

    /49

    (10%

    ) Fo

    rest

    omac

    h T:

    M

    –0/5

    0, 2

    /50

    (4%

    ; 2 P

    ), 10

    /50*

    *** (

    20%

    ; 9 P

    , 1 

    SCC

    ) F–

    1/49

    (2%

    ; 1 S

    CC

    ), 5/

    10 (2

    0%; 3

     P, 2

     SC

    C),

    11/4

    9***

    * (22

    %; 9

    P, 2

     SC

    C)

    *P <

     0.0

    4 **

  • Benzo[a]pyrene

    129

    Spec

    ies,

    stra

    in (s

    ex)

    Dur

    atio

    n R

    efer

    ence

    Dos

    ing

    regi

    men

    A

    nim

    als/

    grou

    p at

    star

    tIn

    cide

    nce

    of tu

    mou

    rsR

    esul

    t or

    sign

    ifica

    nce

    Puri

    ty (v

    ehic

    le)

    Com

    men

    ts

    Toth

    (198

    0)

    Con

    td.

    Ana

    l T :

    M–0

    /50,

    0/5

    0, 7

    /50*

    * (14

    %; 4

    P, 3

     SC

    C)

    F–0/

    49, 1

    /50

    (2%

    ; 1 P

    ), 6/

    49* (

    12%

    ; 1 P

    , 4 S

    CC

    , 1

    K)

    Skin

    T :

    M–1

    /50

    (2%

    ; 1 K

    ), 0/

    50, 1

    3/50

    ****

    * (26

    %; 5

    P,

    7 SC

    C, 1

     K)

    F–0/

    49, 2

    /50

    (4%

    ; 2 S

    CC

    ), 11

    /49*

    *** (

    22%

    ; 4 P

    , 5

    SCC

    , 2 K

    )M

    ouse

    , C57

    Bl/6

    (F)

    18 m

    o A

    nder

    son

    et a

    l. (1

    983)

    0 (u

    ntre

    ated

    , oliv

    e oi

    l or

    β-na

    phth

    oflav

    one

    in o

    live

    oil),

    mg/

    anim

    al (i

    n ol

    ive

    oil),

    onc

    e/w

    k, 1

    4 w

    k 45

    –60/

    grou

    p

    Fore

    stom

    ach

    P: 7

    /34

    (21%

    ; mul

    tiplic

    ity, 1

    .1 ±

     0.4

    ), 17

    /18*

    (94%

    ; mul

    tiplic

    ity, 3

    .2 ±

     2.3

    *)

    Peri

    tone

    al S

    : 0/4

    0, 5

    /32*

    Ly

    mph

    oma:

    1/4

    0 (2

    .5%

    ), 9/

    32* (

    28%

    )

    *P <

     0.0

    599

    % (o

    live

    oil,

    enzy

    me

    indu

    cer β

    -nap

    htho

    flavo

    ne)

    No

    colo

    n tu

    mou

    rs fo

    und

    Intr

    avag

    inal

    app

    licat

    ion

    Mou

    se, C

    57B1

    (F)

    5 m

    o N

    äslu

    nd et

    al.

    (198

    7)

    Cot

    ton

    swab

    soak

    ed in

    ace

    tone

    (c

    ontr

    ols)

    or 1

    % so

    lutio

    n of

    be

    nzo[

    a]py

    rene

    in a

    ceto

    ne, t

    wic

    e/w

    k 10

    or 7

    6/gr

    oup

    0/10

    , 17/

    76 (2

    2%; i

    nvas

    ive

    cerv

    ical

    C)

    +N

    R (a

    ceto

    ne)

    Intr

    afet

    al in

    ject

    ion

    Mou

    se, S

    wis

    s (M

    , F)

    12 w

    k Ro

    ssi e

    t al.

    (198

    3)

    0, 0

    .4, 4

    .0, 9

    .9, 1

    9.8 

    nmol

    [0

    , 0.1

    , 1, 2