Safety evaluation of certain food additives - ipcs inchem

88 PAPRIKA EXTRACT
other organs did not reveal any lesions attributable to the chilli exposure. The
authors concluded that red chilli was relatively non-toxic at the doses tested in
male B6C3F1 mice. No information about the carotenoid content of the red chilli
preparation was provided (Jang et al., 1992).
(b) Rats
A 13-week toxicity study with paprika extract was performed in F344 rats.
The study was conducted using a paprika colour preparation (hexane extract) with
a colour value of 1570, which corresponds to a total carotenoid content of
approximately 7.5%. To establish a no-observed-adverse-effect level (NOAEL) for
application in subsequent long-term studies, rats were fed powdered diet containing
paprika colour at dose levels of 0 (basal diet), 0.62, 1.25, 2.5 or 5% for 13 weeks.
During the experiment, there were no remarkable changes in general appearance,
and no deaths occurred in any experimental group. Although serum total cholesterol
was dose-dependently increased in both sexes, no related histopathological
changes were observed in the liver. Slight inflammatory cell infiltration in the
myocardium and vacuolation of hepatocytes were noted in both control and treated
animals, but there were no clear differences between groups. In conclusion, paprika
oleoresin at 5% in the diet (2948.4 mg/kg body weight [bw] per day for male rats
and 3197.4 mg/kg bw per day for female rats) did not cause adverse effects in F344
rats. Thus, the NOAEL and the maximum dose level for carcinogenicity testing of
paprika extract were concluded to be 5% in the diet, equivalent to approximately
3000 mg/kg bw (Kanki et al., 2003).
The effects of red chilli were examined in 12-week-old male Wistar rats fed
a commercial diet mixed with ground Capsicum frutescens L. fruits at levels of 2%
or 10% w/w for 8 weeks. General health, body weight gain, feed intake and feed
efficiency were not adversely affected in the rats fed with 2% Capsicum, whereas
feed intake and growth rate were depressed and exfoliation of the intestinal
epithelium into the lumen and cytoplasmic fatty vacuolation and necrosis of the
centrilobular hepatocytes were observed in rats at 4 and 8 weeks with 10%. This
correlated with changes in haematology, serum enzyme profiles and other serum
constituents. The authors did not provide any information about the capsaicin
content of the fruits, which had been purchased from a local market in Saudi Arabia
(Al-Qarawi & Adam, 1999).
2.2.2 Long-term studies of toxicity and carcinogenicity
Akagi et al. (1998) conducted a long-term study in groups of 50 male and
50 female B6C3F1 mice that were given graded doses of 0, 0.025, 0.083 or 0.25%
of a mixture consisting of 64% capsaicin and 32.6% dihydrocapsaicin. Food
consumption was reduced in all treated groups compared with controls. The authors
reported that there was no evidence of carcinogenicity.
Recently, Inoue et al. (2008) published a report of a chronic toxicity study
and a carcinogenicity study conducted on paprika extract. In this study, groups of
60 male and 60 female rats were provided with dietary concentrations of 0, 2.5
or 5% paprika extract. In both studies, haematological parameters and serum