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Table 4 Comparison of US FDA ADI and effective oral dose from adult 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

 

Tanaka 2001

Dalal and Poddar 2009

Dalal and Poddar 2010

Noorafshan et al., 2018

Tanaka et al., 2012

Tanaka et al., 2006

Tanaka

et al., 2008

Gao et al., 2011 (rats)

Gao et al., 2011 (mice)

Rafati et al., 2017

Tanaka 1996

Dye

Red No. 3

Red No. 3

Red No. 3

Red No. 40

Blue No. 1

Yellow No. 5

Yellow No. 5

Yellow No. 5

Yellow No. 5

Yellow No. 5

Yellow No. 6

FDA ADI

2.5

2.5

2.5

7.0

12

5.0

5.0

5.0

5.0

5.0

3.75

100 x ADIa mg/kg/d

250

250

250

700

1200

500

500

500

500

500

375

Study Doses

NOAELb

LOAELc

0,

0.005, 0.015 b, 0.045c

% diet

0,

1b,

10c,

100,

200 mg/kg/d

0,

1b,

10c,

100,

mg/kg/d

0,

7c,

70

mg/kg/d

0,

0.08c,

0.24,

0.72% diet

0,

0.05b,

0.15c,

0.45% diet

0,

0.05,

0.15,

0.45b

% diet

0,

175b

350

700

mg/kg/d

0,

125b

250

500

mg/kg/d

0,

5c,

50

mg/kg/d

0,

0.15, 0.30, 0.60 b

% diet

Studyd NOAEL or LOAEL in mg/kg/d

NOAEL

28e

NOAEL

1.0

NOAEL

1

LOAEL

7.0

LOAEL 122e

NOAEL 73e

NOAEL 824e

NOAEL 175

NOAEL 125

LOAEL 5 & 50

NOAEL 1052e

LOAEL < FDA ADI NOAEL

yes

yes

yes

yes

yes

yes

no

yes

yes

yes

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 (Tanaka studies), 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. eFor studies using % diet as dosing metric, doses in mg/kg/d were calculated by OEHHA from data on food consumption and body weight provided in the paper