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EC number: 203-396-5
CAS number: 106-42-3
The key chronic study was conducted by NTP (1986).
The study comprises the oral gavage administration of mixed xylenes to rats (0, 250, or 500 mg/kg/day) and mice (0, 500 or 1000 mg/kg/day) for 5 days/week for 103 weeks. There was no evidence of carcinogenicity.
No studies are available regarding cancer in animals exposed via inhalation to mixed xylene or the individual xylene isomers.
The carcinogenicity of mixed xylene was
investigated in male and female F344/N rats following oral (gavage)
administration at doses of 0, 250 or 500 mg/kg bw/day for 103 weeks.
Animals were observed for survival, clinical signs and body weight gain
and subject to a full necropsy with tissue histopathology at sacrifice.
There was no evidence of treatment-related carcinogenicity in either sex
under these conditions.
No classification of xylenes for
carcinogenicity is warranted under CLP.
carcinogenicity of mixed xylenes and the xylene isomers was reviewed and
reported by ATSDR (2007).
carcinogenicity of mixed xylene following oral exposure has been
evaluated in chronic studies with rats and mice; however, no animal
studies are available on the carcinogenic effects of the individual
xylene isomers following oral exposure. Results of the chronic oral
studies with mixed xylene have been negative (NTP, 1986), with no
increase in tumour incidence compared with the control animals.
Treatment involved administration of 0, 250, or 500 mg/kg/day doses of
mixed xylene in corn oil by gavage 5 days/week for 103 weeks to groups
of F344/N rats, 50 animals per group. B6C3F1 mice were treated in a
similar manner but given 0, 500 or 1000 mg/kg/day of mixed xylenes in
corn oil by gavage. A large number of gavage-related deaths were a
confounding factor. This
study did not comprehensively examine systemic effects but it did
include a complete histopathological examination of all tissues as well
as determination of body weight gain. Based on histopathology of all
organ systems, a NOAEL of 500 mg/kg/day was observed for rats and a
NOAEL of 1000 mg/kg/day was observed for mice. In conclusion there was
no evidence of carcinogenicity of mixed xylenes following oral
results reported by Maltoni et al (1983, 1985) are viewed to be
unreliable (IPCS, 1997) as analysis was conducted by combining all
tumours; an unacceptable basis for analysis particularly in aged animals. In
addition, no data were provided to allow an analysis on an individual
studies are available regarding cancer in animals exposed via inhalation
or dermal routes to mixed xylene or xylene isomers.
is no data indicating any convincing evidence of an increased risk of
cancer as a consequence of exposure to xylenes. IARC
placed xylenes in Group 3: "The agent is not classifiable as to its
carcinogenicity to humans". The animal data indicates that xylenes would
not be carcinogenic or genotoxic in humans.
Justification for selection of
carcinogenicity via oral route endpoint:
Results of chronic oral studies with mixed xylenes have been
negative, with no increase in tumour incidence in treated rats given up
to 500 mg/kg bw/d for 103 weeks or in mice following chronic oral
treatments of up to 1000 mg mixed xylenes/kg bw/d (NTP, 1986).
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