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EC number: 292-697-5
CAS number: 90989-41-6
Long term experimental carcinogenicity bioassays have shown that benzene is a carcinogen producing a variety of tumours in animals (including lymphomas and
leukaemia). Human epidemiological studies indicate a causal relationship between benzene exposure and acute non-lymphatic leukaemia.
It is concluded that benzene is carcinogenic
in animals and humans and therefore is classified as follows:
Carcinogenic Cat 1A, H350 under Regulation
(EC) No 1272/2008 of the European Parliament.
cancer studies showed increased tumour rates in multiple organs, some of
which were also tumour sites in the inhalation studies. The majority of
tumour types at sites other than the haematopoietic system are of
epithelial origin. In mice benzene produced increased tumour incidences
in Zymbal gland, (Cronkite et al,1985; Farris et al, 1993; NTP, 1986;
Maltoni et al, 1989), lung (Farris et al, 1993; NTP, 1986; Maltoni et
al, 1989), Harderian gland (NTP, 1986), preputial gland (Farris et
al,1993; NTP, 1986), forestomach (Farris et al, 1993; NTP, 1996),
mammary gland (NTP, 1986; Maltoni et al, 1989), liver (Maltoni et al,
1989) and ovaries (Cronkite et al, 1985; NTP, 1986). In rats, benzene
treatment was associated to increased tumour incidences in the Zymbal
gland (NTP, 1986; Maltoni et al, 1989), oral cavity (NTP, 1986; Maltoni
et al, 1989), forestomach (Maltoni et al, 1989), nasal cavity (Maltoni
et al, 1989), and skin (NTP, 1986; Maltoni et al, 1989).
published data are available.
several animal studies with inhalation and oral exposure there is
evidence that benzene is carcinogenic. Target organs were similar in
several studies irrespective of the application route and include the
haematopoietic system and tissues of epithelial origin. The predominant
tumours induced in the inhalation studies were located in the
haematopoietic system, particularly lymphomas in mice (Farris et al,
1993; NTP 1986; Cronkite, 1985). In rats, increased frequencies of
leukaemia in comparison to controls were found in benzene-exposed
Sprague-Dawley rats and Wistar rats (Maltoni et al, 1989) and one case
(out of 40 animals) of chronic myelogenous leukaemia was reported in
Sprague-Dawley rats exposed to benzene (Goldstein et al, 1982).
For updated Human data (see section 7.10
Endpoint Summary). This section will be revised in the next the next
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Justification for selection of
carcinogenicity via oral route endpoint:
Rodent oral cancer studies showed increased tumour rates in multiple
organs, some of which were also tumour sites after inhalation. The
majority of tumour types at sites other than the haematopoietic system
are of epithelial origin.
Justification for selection of carcinogenicity via inhalation route
The predominant tumours induced in animal inhalation studies were
located in the haematopoietic system, particularly lymphomas in mice. In
rats, increased frequencies of leukaemia in comparison to controls were
found in benzene-exposed Sprague-Dawley rats and Wistar rats, with one
report of chronic myelogenous leukaemia. In humans, benzene causes acute
myelogenous (non-lymphocytic) leukaemia (AML or ANLL), however IARC has
concluded that evidence of an association between benzene exposure and
acute lymphocytic leukaemia (ALL), chronic lymphocytic leukaemia (CLL),
multiple myeloma and non-Hodgkin’s lymphoma (NHL) is limited, while
evidence for chronic myeloid leukaemia (CML) is inadequate.
Carcinogenicity: via oral route (target organ): other: all gross
lesions and masses
Carcinogenicity: via inhalation route (target organ): cardiovascular
/ hematological: bone marrow
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