Registration Dossier
Registration Dossier
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EC number: 219-091-5 | CAS number: 2353-45-9
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
In an in-vivo study conducted on 3 male and female adult Osborne-Mendel rats, who were administered 200 mg of the color FD&C Green No.3 as a single dose, almost complete recovery (94%) of the administered color was found in the excreta of the rats. None of the colors was found in the urine. The spectra in the visible range, and the solubility of the recovered colors were identical with the original compounds indicating the colors were little altered, if at all. This indicates poor metabolism of the administered color.
Thus, it can be concluded that the color FD&C Green No.3 when administered as a single dose by the oral route to the rats is likely to exhibit low bio-accumulation potential.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
In an in-vivo study conducted on 3 male and female adult Osborne-Mendel rats, who were administered 200 mg of the color FD&C Green No.3 as a single dose, almost complete recovery (94%) of the administered color was found in the excreta of the rats. None of the colors was found in the urine.The spectra in the visible range, and the solubility of the recovered colors were identical with the original compounds indicating the colors were little altered, if at all. This indicates poor metabolism of the administered color.
Thus, it can be concluded that thecolor FD&C Green No.3 when administered as a single dose by the oral route to the rats is likely to exhibit low bio-accumulation potential.
There are certain reports though which indicate that these colorsare capable of producing tumors in rats at the site of subcutaneous injections repeated over periods of months.
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