Table 3.
Comparison of US FDA ADI and effective oral doses from developmental studies with individual dyes
| Vorhees et al., 1983a | Tanaka 2001 | Vorhees et al.,1983b | Tanaka 1994 | Tanaka et al., 2012 | Sobotka et al., 1977 | Tanaka et al., 2006 | Tanaka et al., 2008 | Tanaka 1996 | |
|---|---|---|---|---|---|---|---|---|---|
| Dye | Red No. 3 | Red No. 3 | Red No. 40 | Red No. 40 | Blue No. 1 | Yellow No. 5 | Yellow No. 5 | Yellow No. 5 | Yellow No. 6 |
| FDA ADI | 2.5 | 2.5 | 7.0 | 7.0 | 12.0 | 5.0 | 5.0 | 5.0 | 3.75 |
| 100 X ADIa (mg/kg/d) | 250 | 250 | 700 | 700 | 1200 | 500 | 500 | 500 | 375 |
| Study Doses (as % diet) NOAELb LOAELc | 0, 0.25c, 0.5, 1.0 | 0, 0.005, 0.015b, 0.045c | 0, 2.5c, 5.0, 10.0 | 0, 0.42, 0.84, 1.68b | 0, 0.08c, 0.24, 0.72 | 0, 1.0, 2.0b | 0, 0.05, 0.15, 0.45b | 0, 0.05, 0.15, 0.45 | 0 0.15, 0.30, 0.60b |
| Study d NOAEL or LOAEL in mg/kg/d | LOAEL 125e | NOAEL 24 | LOAEL 1250e | NOAEL 3534 | LOAEL 127 | NOAEL 1000e |
NOAEL 841 |
Significant trend tests only | NOAEL 1146 |
| LOAEL < FDA ADI NOAEL | yes | yes | no | no | yes | no | no | N/A | no |
Effective doses are those at which statistically significant differences between dose group and control group were reported by authors. Endpoints are behavior or brain measures
aNOAEL used to derive FDA ADI
bNOAEL for study
cLOAEL for study
dFor studies from the Tokyo Metropolitan Laboratory of Public Health, for NOAELS without LOAELS, the mean value for males and females were used. For LOAELs and NOAELs with LOAELs, the value for the sex affected at the LOAEL was used
e Calculated by OEHHA using standard assumptions about food intake and body weight