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EC number: 226-394-6
CAS number: 5392-40-5
The present data
on carcinogenicity do not fulfill the criteria laid down in 67/548/EEC
and CLP, and a non-classification is warranted.
In the chosen key
studies, eqivalent to OECD TG 453 and according to GLP, Fischer
344 rats or B6C3F1 mice were fed diets with a microencapsulated
preparation with a load of 31.9% citral for 104 -105 weeks (NTP 2003).
Diet concentrations were 0 (vehicle control), 1000, 2000, or 4000 ppm
for rats and 0 (vehicle control), 500, 1000, and 2000 ppm for mice.
Daily dosages were 0, 50, 100, or 210 mg citral/kg bw/d for rats and 60,
120, and 260 mg citral/kg bw/d for mice.
rats, there were no increased incidences of neoplastic findings
the applied citral.
In mice,no citral
related increased tumour incidences were observed in male animals.
However, a positive trend in incidences of malignant lymphoma was
observed in females, beeing significantly increased
in the 260 mg/kg bw/d dose group versus the vehicle control group. Tissues
most commonly affected were the spleen, mesenteric lymph nodes, thymus,
and, to a lesser extent, the ovary. However,
malignant lymphoma is a common spontaneous systemic neoplasm in B6C3F1
mice and the incidence in the concurrent vehicle control group was at
the low end of the historical control ranges. Furthermore,
the observed incidences in the citral treated groups were within the
historical control ranges. Signs
of general toxicity (see Section "Repeated dose toxicity") indicate that
the minimal toxic dose (MTD) was reached for both species in these studies.
the conditions of this 2-year feed study, there was no evidence of
carcinogenic activity of citral in male or female F344/N rats.
the conditions of this 2-year feeding study, there was no evidence of
carcinogenic activity of citral in male B6C3F1 mice. Based on NTP
criteria there was equivocal evidence of carcinogenic activity in female
B6C3F1 mice based on increased incidences of malignant lymphomas.
Overall, no citral
related increases in incidences of neoplastic findings were observed in
rats and male mice. The species and gender dependent increase in the
incidence of malignant lymphoma at a low level within the historical
control ranges is not considered to provide sufficient evidence
warranting the classification of citral as carcinogen.
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