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Table 3 Comparison of US FDA ADI and effective oral doses from developmental studies with individual dyes

From: Potential impacts of synthetic food dyes on activity and attention in children: a review of the human and animal evidence

 

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

  1. 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
  2. aNOAEL used to derive FDA ADI
  3. bNOAEL for study
  4. cLOAEL for study
  5. 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
  6. e Calculated by OEHHA using standard assumptions about food intake and body weight