Chronic toxicity/carcinogenicity study of carmine of cochineal in the rat

Scientific Opinion on the re‐evaluation of cochineal, carminic acid, carmines (E 120) as a food additive

“…This unpublished report of a long-term study with amaranth showed acinar cell hyperplasia incidences in control female Wistar rats in the order of 84 % (73/87), whereas among the three treated groups the incidences were 36/53 (68 %), 40/54 (74 %) and 38/53 (72 %). These incidences were very similar to those reported by Ford et al (1987) for carmine: 39/53 (73 %), 35/52 (67 %) and 36/54 (67 %). However, the reported incidences in controls were much lower: 23/86 (27 %) than those reported in the amaranth study from the same institute.…”

“…However, these effects did not show a dose-response relationship and no unusual lesions were reported in the mammary tissue, only a difference in the distribution of common findings was noted. These incidences were very similar to those reported by Ford et al (1987) for carmine: 39/53 (73 %), 35/52 (67 %) and 36/54 (67 %). The tumour incidences in treated animals did not differ statistically significantly from those in controls.…”

“…The tumour incidences in treated animals did not differ statistically significantly from those in controls. The incidence of acinar cell hyperplasia reported in the control animals of the Ford et al (1987) study was low in comparison with that reported in a contemporary report on amaranth from the same institute (BIBRA, 1982). This unpublished report of a long-term study with amaranth showed acinar cell hyperplasia incidences in control female Wistar rats in the order of 84 % (73/87), whereas among the three treated groups the incidences were 36/53 (68 %), 40/54 (74 %) and 38/53 (72 %).…”

“…The mammary hyperplasia seen in the rat study was not reported in the mouse study (Mori et al, 1991). Ford et al (1987) described this effect as a trend to a more active state in the mammary glands of all female rats treated with carmine. However, these effects did not show a dose-response relationship and no unusual lesions were reported in the mammary tissue, only a difference in the distribution of common findings was noted.…”

“…Based on the aforementioned observations, the Panel concluded that the incidence of mammary hyperplasias observed in the controls of the study by Ford et al (1987) was low, whereas the incidence of mammary hyperplasias observed in the groups treated with carmine were within historical control incidences of Wistar rats used in that institution. Moreover, since there was no dose-response relationship in mammary hyperplasia incidences, the authors concluded that the effects are not treatment related.…”

Scientific Opinion on the re‐evaluation of cochineal, carminic acid, carmines (E 120) as a food additive

“…This unpublished report of a long-term study with amaranth showed acinar cell hyperplasia incidences in control female Wistar rats in the order of 84 % (73/87), whereas among the three treated groups the incidences were 36/53 (68 %), 40/54 (74 %) and 38/53 (72 %). These incidences were very similar to those reported by Ford et al (1987) for carmine: 39/53 (73 %), 35/52 (67 %) and 36/54 (67 %). However, the reported incidences in controls were much lower: 23/86 (27 %) than those reported in the amaranth study from the same institute.…”

“…However, these effects did not show a dose-response relationship and no unusual lesions were reported in the mammary tissue, only a difference in the distribution of common findings was noted. These incidences were very similar to those reported by Ford et al (1987) for carmine: 39/53 (73 %), 35/52 (67 %) and 36/54 (67 %). The tumour incidences in treated animals did not differ statistically significantly from those in controls.…”

“…The tumour incidences in treated animals did not differ statistically significantly from those in controls. The incidence of acinar cell hyperplasia reported in the control animals of the Ford et al (1987) study was low in comparison with that reported in a contemporary report on amaranth from the same institute (BIBRA, 1982). This unpublished report of a long-term study with amaranth showed acinar cell hyperplasia incidences in control female Wistar rats in the order of 84 % (73/87), whereas among the three treated groups the incidences were 36/53 (68 %), 40/54 (74 %) and 38/53 (72 %).…”

“…The mammary hyperplasia seen in the rat study was not reported in the mouse study (Mori et al, 1991). Ford et al (1987) described this effect as a trend to a more active state in the mammary glands of all female rats treated with carmine. However, these effects did not show a dose-response relationship and no unusual lesions were reported in the mammary tissue, only a difference in the distribution of common findings was noted.…”

“…Based on the aforementioned observations, the Panel concluded that the incidence of mammary hyperplasias observed in the controls of the study by Ford et al (1987) was low, whereas the incidence of mammary hyperplasias observed in the groups treated with carmine were within historical control incidences of Wistar rats used in that institution. Moreover, since there was no dose-response relationship in mammary hyperplasia incidences, the authors concluded that the effects are not treatment related.…”

Scientific Opinion on the re‐evaluation of cochineal, carminic acid, carmines (E 120) as a food additive

“…This unpublished report of a long-term study with amaranth showed acinar cell hyperplasia incidences in control female Wistar rats in the order of 84 % (73/87), whereas among the three treated groups the incidences were 36/53 (68 %), 40/54 (74 %) and 38/53 (72 %). These incidences were very similar to those reported by Ford et al (1987) for carmine: 39/53 (73 %), 35/52 (67 %) and 36/54 (67 %). However, the reported incidences in controls were much lower: 23/86 (27 %) than those reported in the amaranth study from the same institute.…”

“…However, these effects did not show a dose-response relationship and no unusual lesions were reported in the mammary tissue, only a difference in the distribution of common findings was noted. These incidences were very similar to those reported by Ford et al (1987) for carmine: 39/53 (73 %), 35/52 (67 %) and 36/54 (67 %). The tumour incidences in treated animals did not differ statistically significantly from those in controls.…”

“…The tumour incidences in treated animals did not differ statistically significantly from those in controls. The incidence of acinar cell hyperplasia reported in the control animals of the Ford et al (1987) study was low in comparison with that reported in a contemporary report on amaranth from the same institute (BIBRA, 1982). This unpublished report of a long-term study with amaranth showed acinar cell hyperplasia incidences in control female Wistar rats in the order of 84 % (73/87), whereas among the three treated groups the incidences were 36/53 (68 %), 40/54 (74 %) and 38/53 (72 %).…”

“…The mammary hyperplasia seen in the rat study was not reported in the mouse study (Mori et al, 1991). Ford et al (1987) described this effect as a trend to a more active state in the mammary glands of all female rats treated with carmine. However, these effects did not show a dose-response relationship and no unusual lesions were reported in the mammary tissue, only a difference in the distribution of common findings was noted.…”

“…Based on the aforementioned observations, the Panel concluded that the incidence of mammary hyperplasias observed in the controls of the study by Ford et al (1987) was low, whereas the incidence of mammary hyperplasias observed in the groups treated with carmine were within historical control incidences of Wistar rats used in that institution. Moreover, since there was no dose-response relationship in mammary hyperplasia incidences, the authors concluded that the effects are not treatment related.…”

Scientific Opinion on the re‐evaluation of cochineal, carminic acid, carmines (E 120) as a food additive

“…This unpublished report of a long-term study with amaranth showed acinar cell hyperplasia incidences in control female Wistar rats in the order of 84 % (73/87), whereas among the three treated groups the incidences were 36/53 (68 %), 40/54 (74 %) and 38/53 (72 %). These incidences were very similar to those reported by Ford et al (1987) for carmine: 39/53 (73 %), 35/52 (67 %) and 36/54 (67 %). However, the reported incidences in controls were much lower: 23/86 (27 %) than those reported in the amaranth study from the same institute.…”

“…However, these effects did not show a dose-response relationship and no unusual lesions were reported in the mammary tissue, only a difference in the distribution of common findings was noted. These incidences were very similar to those reported by Ford et al (1987) for carmine: 39/53 (73 %), 35/52 (67 %) and 36/54 (67 %). The tumour incidences in treated animals did not differ statistically significantly from those in controls.…”

“…The tumour incidences in treated animals did not differ statistically significantly from those in controls. The incidence of acinar cell hyperplasia reported in the control animals of the Ford et al (1987) study was low in comparison with that reported in a contemporary report on amaranth from the same institute (BIBRA, 1982). This unpublished report of a long-term study with amaranth showed acinar cell hyperplasia incidences in control female Wistar rats in the order of 84 % (73/87), whereas among the three treated groups the incidences were 36/53 (68 %), 40/54 (74 %) and 38/53 (72 %).…”

“…The mammary hyperplasia seen in the rat study was not reported in the mouse study (Mori et al, 1991). Ford et al (1987) described this effect as a trend to a more active state in the mammary glands of all female rats treated with carmine. However, these effects did not show a dose-response relationship and no unusual lesions were reported in the mammary tissue, only a difference in the distribution of common findings was noted.…”

“…Based on the aforementioned observations, the Panel concluded that the incidence of mammary hyperplasias observed in the controls of the study by Ford et al (1987) was low, whereas the incidence of mammary hyperplasias observed in the groups treated with carmine were within historical control incidences of Wistar rats used in that institution. Moreover, since there was no dose-response relationship in mammary hyperplasia incidences, the authors concluded that the effects are not treatment related.…”