JAGUA (GENIPIN–GLYCINE) BLUE

Comments:

An ADI of 0–11 mg/kg bw was established by the Committee for Jagua blue, on a blue-polymer basis. This ADI was based on the absence of treatment-related long-term toxicity and of reproductive and developmental toxicity in the 12-month rat dietary study with in-utero exposure, in which the NOAEL was identified as 1127 mg/kg bw per day of the blue polymer, the highest dose tested. The ADI was established by applying an uncertainty factor of 100 to the NOAEL

Meeting:

89

Specs Code:

R

Report: 

Tox Monograph: 

Specification: 

Comments:

The Committee noted that the highest doses tested in two 90-day toxicity studies in rats and dogs were only 330 and 338 mg/kg bw per day (expressed on a “blue polymer” basisd), respectively. The Committee was concerned that the possible effects of the low molecular weight component of the “blue polymer” that could be absorbed were not adequately investigated. Because of the limited biochemical and toxicological database and the low margin of exposure, the Committee was unable to complete the evaluation for Jagua (Genipin–Glycine) Blue

Meeting:

84

Specs Code:

N, T

Report: 

Tox Monograph: 

Specification: