beta-apo-8'-CAROTENAL

Comments:

The Committee reaffirmed the conclusion from the eighty-fourth meeting that rats are not an appropriate model for deriving an ADI for β-carotene due to the relatively low bioavailability of β-carotene in rats compared with humans. Therefore, the Committee withdrew the two group ADIs of 0–5 mg/kg bw for (1) the sum of the synthetic carotenoids β-carotene, β-apo-8′-carotenal and β-apo-8′-carotenoic acid methyl and ethyl esters and (2) synthetic β-carotene and β-carotene derived from Blakeslea trisporae , which were based on a no-observed-adverse-effect level (NOAEL) from a rat study. The Committee established an ADI of 0–0.3 mg/kg bw for β-apo8′-carotenal on the basis of a NOAEL of 30 mg/kg bw per day in a 13-week study in rats and application of an uncertainty factor of 100.

Meeting:

87

Specs Code:

R

Report: 

Tox Monograph: 

Specification: 

ADI:

0-5 mg/kg bw

Comments:

Only specifications evaluated and revised

Specs Code:

R

Report: 

Specification: 

ADI:

0-5 mg/kg bw

Comments:

Group ADI expressed as the sum of the carotenoids: beta-carotene, beta-apo-8'-carotenal and beta-apo-8'-carotenoic acid, methyl and ethyl esters

Report: 

Tox Monograph: 

Specification: 

Previous Years: