Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 212-728-8 | CAS number: 860-22-0
Mortality summary for rats fed 0-2% FD & C Blue No. 2 in the diet for up to 30 months
No. of deaths in group
Dietary level (%)
Category of death
Unscheduled, up to month 12
Interim kill, at month 12
Unscheduled, after month 12
*One animal originally in the high-dose female group was found during wk 1 to be a male and was therefore transferral to the high-dose male group
Incidence of neoplams of the urinary bladder, mammary gland and brain in male rats fed 0-2 % FD & C Blue No. 2 in the diet for up to 30 months
No. of rats affected* in group
Organ and turnout
Dietary level (%)...
*No. affected/no, examined.
ɫ Only grossly visible lesions or masses were examined histologically in groups II and III.
In long-term toxicity/carcinogenicity study study, CD male and female rats were treated with FD & C Blue No. 2 in the concnetration of 0, 304, 632 and 1282 mg/kg/day for male and 0, 363, 775 and 1592 mg/kg/day for female inbasal diet. No effect on survival, body weight and food consumption of treated rats were observed as compared to control in F0 generation. No effect on numbers of pregnant females per group and pup viability at birth were observed in treated rats as compared to control. No effect on pup viability at birth were observed although pup mortality were increased at 1282 for male and 1592 mg/kg/day for female during lactation and weaning period and at 632 mg/kg/day for male and 1592 mg/kgday for female during weaning period as compared to control. Sufficient pups were available in F1 generation. Hair loss (apparently due to friction against the cage), nasal and ocular discharge, staining of the hair in the anogenital region and soft stools were observed in treated pups but these random observations are not uncommon in the CD rat and therefore were not considered to be related to compound administration. Slightly decreased body weight were observed at 1282 for male and 1592 mg/kg/day for female and 632 mg/kg/day for male and 1592 mg/kg/day for female as compared to control. This was due to low number of pups prior to the random selection of pups for the F1 generation.Dose-related increase in food consumption was observed in treated rats as compared to control. The increased food consumption was probably due to the influence of the non-nutritive character of the test compound at these high concentrations in F1 generation. Similarly,Focal and diffuse retinopathy, conjunctivitis, uveitis and cataracts were observed in treated rats but observed changes were not related to compound administration. No significant effect on hematology, Clinical chemistry and urine-analysis of treated rats were observed as compared to controlin F1 generation.At 1592 mg/kg/day decrase in relative thyroid and kidney weight at 12 month and increased mean relative spleen and liver weights at 30 month and at 363 mg/kg/day decrase in relative thyroid at 12 month in female were observed as compared to control. Blue discoloration of the gastro-intestinal tract was noted in the treated groups. In addition, Increase in grossly visible abnormalities in urinary bladders of treateed male rats at 1282 mg/kg/day were observed as compared to control in F1 ganaration. The observed findings were consistent with those reported in the literature for aged rats of this strain. Non-neoplastic mycoplasma pulmonis, infection by Corynebacterium kutcheri, Periarteritis nodosa, characterized by fibrinoid necrosis of the arterial walls, occurred most commonly in the arteries of the pancreas, mesentery and testes and atrophy of the seminiferous tubules, accompanied by oligospermia or aspermia. All non-neoplastic lesions were randomly distributed in treated and control animals and were not dose related. In male rats at 1282 mg/kg/day Neoplastic Pituitary-gland neoplasms, carcinomas/adenocarcinomas of mammary-gland and transitional-cell neoplasms of the urinary bladder were observed in treated rats as compared to control. The observed effect were not statistically significant as compared to control. Statistically significant increase in carcinomas/adenocarcinomas of mammary-gland and gliomas were observed in treated rats as compared to control. In female rats, Pituitary-gland neoplasms and malignant mammary-gland neoplasms (carcinoma, adenocarcinoma) observed in treated rats as compared to control. The observed effect were not statistically significant as compared to control. Therefore, NOAEL for F0 and F1 generation was considered to be 1282 mg/kg/day for male and 1592 mg/kg/day for female rats when CD male and female rats were treated with FD & C Blue No. 2 orally for 30 months.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again