developmentb
D

FD&C RED NO. 40 (CI 16035)

 
This substance ranges from C to D depending on concentration/usage.
Asthma/Respiratory
 
No Data, Some Concern
 
Skin Allergies &
Irritation
 
Low Concern
 
Developmental &
Reproductive Toxicity
 
Low Concern
 
Cancer
 
No Data, Some Concern
 
Environment
 
No Data, Some Concern
 
Top scoring factors: Evidence of nervous system effects; general systemic/organ effects; respiratory effects
FD&C Red No. 40 (CI 16035) can be found in 10 products.
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Evidence

Health issue
 
Level of Concern
 
Source
EFSA finds that there is "limited evidence" that Allura Red in a mixture with other synthetic colors and sodium benzoate has a "small and statistically significant effect on activity and attention in children selected from the general population."
 
some
 
European Food Safety Authority (EFSA). 2009. Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. EFSA Journal 7(11), 1327.
EFSA concludes that some sensitive individuals may experience allergic reactions at dose levels within the ADI.
 
some
 
European Food Safety Authority (EFSA). 2009. Scientific Opinion on the re-evaluation of Allura Red AC (E 129) as a food additive. EFSA Journal 7(11), 1327.
NTP Toxcast scored 2.5-3.5
 
some
 
EWG Toxcast Analysis - National Toxicology Program (NTP)
A peer-reviewed study reports nervous system effects at the acceptable daily dose for humans.
 
some
 
Ali Noorafshan, Maedeh Hashemi, Saied Karbalay-Doust & Fatemeh Karimi. 2018. High dose Allura Red, rather than the ADI dose, induces structural and behavioral changes in the medial prefrontal cortex of rats and taurine can protect it. Acta histochemica 120(6), 586-594.
A peer-reviewed study reports that Red 40 affects the function of an enzyme important for the endocrine system.
 
some
 
Kanako Satoh, Rhouichi Nonaka, Fusako Ishikawa, Akio Ogata & Fumiko Nagai. 2008. In vitro screening assay for detecting aromatase activity using rat ovarian microsomes and estrone ELISA. Biological & pharmaceutical bulletin 31(3), 357-62.
Review article concluded that Red 40 caused hypersensitivity reactions.
 
some
 
Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46. - Peer Reviewed Literature
Review article concluded that Red 40 caused hypersensitivity reactions.
 
some
 
Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46. - Peer Reviewed Literature
Some data submitters indicate they consider this substance as Persistent, Bioaccumulative and Toxic
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
A review article reports equivocal evidence of carcinogenesis.
 
low
 
Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46. - Peer Reviewed Literature
A review article reports equivocal evidence of carcinogenesis.
 
low
 
Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46. - Peer Reviewed Literature
Not classified as a skin/eye irritant based on human, animal, and in vitro testing.
 
low
 
European Commission, Scientific Committee on Consumer Safety (SCCS). 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Curry Red.
Not classified as a skin/eye irritant based on human, animal, and in vitro testing.
 
low
 
European Commission, Scientific Committee on Consumer Safety (SCCS). 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Curry Red.
Not a sensitizer based on limited human and animal tests.
 
low
 
European Commission, Scientific Committee on Consumer Safety (SCCS). 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Curry Red.
A peer-reviewed article reports no evidence of genotoxicity in vivo.
 
low
 
Maria Bastaki, Thomas Farrell, Sachin Bhusari, Kamala Pant & Rohan Kulkarni. 2017. Lack of genotoxicity in vivo for food color additive Allura Red AC. Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association 105, 308-314.
A peer-reviewed study reports no genotoxicity in vivo.
 
low
 
Masamitsu Honma. 2015. Evaluation of the in vivo genotoxicity of Allura Red AC (Food Red No. 40). Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association 84, 270-5.
A review article reports a lack of evidence of developmental toxicity.
 
low
 
Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46. - Peer Reviewed Literature
A review article reports a lack of evidence of developmental toxicity.
 
low
 
Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46. - Peer Reviewed Literature
acute toxicity, oral LD50 (mg/kg)
 
low
 
European Commission, Scientific Committee on Consumer Safety (SCCS). 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Curry Red.
No evidence of developmental toxicity in animal testing.
 
low
 
European Commission, Scientific Committee on Consumer Safety (SCCS). 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Curry Red.
No evidence of genotoxicity in vitro.
 
low
 
European Commission, Scientific Committee on Consumer Safety (SCCS). 2004. OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS Concerning Curry Red.

Impurities

Health issue
 
Level of Concern
 
Source
Impurity: MERCURY
Causes damage to organs through prolonged or repeated exposure
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: MERCURY
Very toxic to aquatic life
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: MERCURY
Very toxic to aquatic life with long lasting effects
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: MERCURY
Fatal if inhaled
Only in: Household Cleaners
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: MERCURY
May damage the unborn child.
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: 6-METHOXY-M-TOLUIDINE
May cause cancer
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: 6-METHOXY-M-TOLUIDINE
Known to cause cancer
 
some
 
Proposition 65 List (2020 Update) - California OEHHA (Office of Environmental Health Hazard Assessment)
Impurity: ANILINE
Suspected of causing genetic defects
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: ANILINE
Suspected of causing cancer
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: ANILINE
Causes damage to organs through prolonged or repeated exposure
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: ANILINE
Very toxic to aquatic life
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: ANILINE
Known to cause cancer
 
some
 
Proposition 65 List (2020 Update) - California OEHHA (Office of Environmental Health Hazard Assessment)
Impurity: CADMIUM
Suspected of causing genetic defects
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: CADMIUM
May cause cancer
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: CADMIUM
Causes damage to organs through prolonged or repeated exposure
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: CADMIUM
Very toxic to aquatic life
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: CADMIUM
Very toxic to aquatic life with long lasting effects
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: CADMIUM
Fatal if inhaled
Only in: Household Cleaners
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: CADMIUM
Suspected of damaging fertility.
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: CADMIUM
Suspected of damaging the unborn child.
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: CADMIUM
Carcinogenic to humans
 
some
 
Agents classified by the IARC Monographs (through Volume 127) - International Agency for Research on Cancer (IARC)
Impurity: CADMIUM
Known To Be Human Carcinogen
 
some
 
NTP 14th Report on Carcinogens - National Toxicology Program (NTP)
Impurity: 6-METHOXY-M-TOLUIDINE
Reasonably Anticipated To Be Human Carcinogen
 
some
 
NTP 14th Report on Carcinogens - National Toxicology Program (NTP)
Impurity: ANILINE
Probably carcinogenic to humans
 
some
 
EPA Integrated Risk Information System (IRIS) - Cancer - Environmental Protection Agency (EPA)
Impurity: ANILINE
Probably carcinogenic to humans
 
some
 
Agents classified by the IARC Monographs (through Volume 127) - International Agency for Research on Cancer (IARC)
Impurity: CADMIUM
Probably carcinogenic to humans
 
some
 
EPA Integrated Risk Information System (IRIS) - Cancer - Environmental Protection Agency (EPA)
Impurity: ANILINE
Toxic if swallowed
Only in: Household Cleaners
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: ANILINE
Toxic in contact with skin
Only in: Household Cleaners
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: ANILINE
Toxic if inhaled
Only in: Household Cleaners
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: MERCURY
peripheral nervous system impairment
 
some
 
Threshold Limit Value (TLV) Basis - American Conference of Governmental Industrial Hygienists (ACGIH)
Impurity: MERCURY
kidney damage
 
some
 
Threshold Limit Value (TLV) Basis - American Conference of Governmental Industrial Hygienists (ACGIH)
Impurity: MERCURY
central nervous system impairment
 
some
 
Threshold Limit Value (TLV) Basis - American Conference of Governmental Industrial Hygienists (ACGIH)
Impurity: MERCURY
EPA's review of industry submitted toxicity data and the potential for human exposure concludes that this substance poses a high risk for human health.
 
some
 
EPA Hazard-Based Prioritizations - Risks - Environmental Protection Agency (EPA)
Impurity: CADMIUM
kidney damage
 
some
 
Threshold Limit Value (TLV) Basis - American Conference of Governmental Industrial Hygienists (ACGIH)
Impurity: CADMIUM
suspected human carcinogen
 
some
 
Threshold Limit Value (TLV) Basis - American Conference of Governmental Industrial Hygienists (ACGIH)
Impurity: 6-METHOXY-M-TOLUIDINE
Harmful if swallowed
Only in: Household Cleaners
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: 6-METHOXY-M-TOLUIDINE
Possibly carcinogenic to humans
 
some
 
Agents classified by the IARC Monographs (through Volume 127) - International Agency for Research on Cancer (IARC)
Impurity: AROMATIC AMINES
Structurally related substances are classified as IARC Group 2B: possible human carcinogen (International Agency for Research on Carcinogens).
 
some
 
Agents classified by the IARC Monographs (through Volume 127) - International Agency for Research on Cancer (IARC)
Impurity: MERCURY
Fatal if swallowed
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: MERCURY
fatal if inhaled
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: ANILINE
suspected of causing genetics defects
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: ANILINE
causes damage to organs through prolonged or repeated exposure
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: ANILINE
confirmed animal carcinogen with unknown relevance to humans
 
some
 
Threshold Limit Value (TLV) Basis - American Conference of Governmental Industrial Hygienists (ACGIH)
Impurity: ANILINE
May cause an allergic skin reaction
Only in: Household Cleaners
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: ANILINE
Toxic in contact with skin
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: ANILINE
toxic if inhaled
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: ANILINE
Toxic of swallowed
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: ANILINE
Causes serious eye damage
Only in: Drain Opener/Clog Remover; Oven Cleaner; Household Cleaners
 
some
 
GHS Hazard Codes - EU GHS Hazard Labeling Codes
Impurity: ANILINE
may cause damage to organs through prolonged or repeated exposure
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: ANILINE
May cause an allergic skin reaction
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: ANILINE
may cause respiratory irritation
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: 6-METHOXY-M-TOLUIDINE
NTP Toxcast scored 1.5-2.5
 
some
 
EWG Toxcast Analysis - National Toxicology Program (NTP)
Impurity: ANILINE
Causes skin irritation
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: ANILINE
Causes serious eye damage
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: 6-METHOXY-M-TOLUIDINE
causes serious eye irritation
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: ANILINE
causes serious eye irritation
Only in: Household Cleaners
 
some
 
GHS Data from ECHA Website - European Chemicals Agency (ECHA)
Impurity: MERCURY
Not classifiable as to its carcinogenicity to humans
 
low
 
Agents classified by the IARC Monographs (through Volume 127) - International Agency for Research on Cancer (IARC)
Impurity: MERCURY
Not classifiable as to human carcinogenicity
 
low
 
EPA Integrated Risk Information System (IRIS) - Cancer - Environmental Protection Agency (EPA)
Impurity: MERCURY
not classifiable as a human carcinogen
 
low
 
Threshold Limit Value (TLV) Basis - American Conference of Governmental Industrial Hygienists (ACGIH)
Impurity: ANILINE
Not classifiable as to its carcinogenicity to humans
 
low
 
Agents classified by the IARC Monographs (through Volume 127) - International Agency for Research on Cancer (IARC)
Impurity: ANILINE
EPA testing shows this substance has moderate acute toxicity to aquatic life
 
low
 
EPA Fathead Minnow Acute Toxicity Database - Environmental Protection Agency (EPA)
Impurity: ANILINE
EPA testing shows this substance has low acute toxicity to aquatic life
 
low
 
EPA Fathead Minnow Acute Toxicity Database - Environmental Protection Agency (EPA)
 
 
About the ratings About the ratings
EWG provides information on cleaning product ingredients from the published scientific... continue reading →
EWG provides information on cleaning product ingredients from published scientific literature, to supplement incomplete data available from companies and the government. The ratings indicate the relative level of concern posed by exposure to the ingredients in this product - not the product itself - compared to other product formulations. The ratings reflect potential health hazards but do not account for the level of exposure or individual susceptibility, factors that determine actual health risks, if any. (Hide)
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