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HOME / INGREDIENTS / Fd&c red no. 40 (ci 16035)


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FD&C Red No. 40 (CI 16035)

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COMMONLY FOUND IN


SYNONYMS

DSSTOX_CID_4436, CHEMBL3188816, DTXSID4024436, C18H14N2NA2O8S2, DSSTOX_GSID_24436, DSSTOX_RID_77395, EC 247-368-0, DISODIUM 6-HYDROXY-5-((6-METHOXY-4-SULFO-M-TOLYL)AZO)-2-NAPHTHALENESULFONATE, FD AND C RED NO.40, SCHEMBL324089


RESTRICTED

EWG VERIFIED products cannot contain this ingredient without adequate substantiation.

Common Concerns

See how this product scores for common concerns.

  • No Data
    Asthma / Respiratory
  • LOW
    Skin Allergies & Irritation
  • LOW
    Developmental & Reproductive Toxicity
  • No Data
    Cancer
  • No Data
    Environment


Top Scoring Factors

Evidence of nervous system effects; general systemic/organ effects; respiratory effects


Ingredient concerns

  • CONCERNS
Health Issue Level of Concern Source
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Synthetic food dyes are associated with adverse neurobehavioral outcomes in children.

Only in: Food Scores®

high

2021. Potential Neurobehavioral Effects of Synthetic Food Dyes in Children. California Environmental Protection Agency. Office of Environmental Health Hazard Assessment.

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.

Suspected of causing genetic defects

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Suspected of causing cancer

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Causes damage to organs through prolonged or repeated exposure

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Very toxic to aquatic life

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Known to cause cancer

some

California OEHHA (Office of Environmental Health Hazard Assessment): Proposition 65 List (2020 Update)

May cause cancer

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Known to cause cancer

some

California OEHHA (Office of Environmental Health Hazard Assessment): Proposition 65 List (2020 Update)

Causes damage to organs through prolonged or repeated exposure

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Very toxic to aquatic life

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Very toxic to aquatic life with long lasting effects

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Fatal if inhaled

Only in: Household Cleaners

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

May damage the unborn child.

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Suspected of causing genetic defects

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

May cause cancer

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Causes damage to organs through prolonged or repeated exposure

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Very toxic to aquatic life

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Very toxic to aquatic life with long lasting effects

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Fatal if inhaled

Only in: Household Cleaners

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Suspected of damaging fertility.

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Suspected of damaging the unborn child.

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Carcinogenic to humans

some

International Agency for Research on Cancer (IARC): Agents classified by the IARC Monographs (through Volume 127)

Known To Be Human Carcinogen

some

National Toxicology Program (NTP): NTP 14th Report on Carcinogens

Probably carcinogenic to humans

some

Environmental Protection Agency (EPA): EPA Integrated Risk Information System (IRIS) - Cancer

Probably carcinogenic to humans

some

International Agency for Research on Cancer (IARC): Agents classified by the IARC Monographs (through Volume 127)

Reasonably Anticipated To Be Human Carcinogen

some

National Toxicology Program (NTP): NTP 14th Report on Carcinogens

Probably carcinogenic to humans

some

Environmental Protection Agency (EPA): EPA Integrated Risk Information System (IRIS) - Cancer

Toxic if swallowed

Only in: Household Cleaners

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Toxic in contact with skin

Only in: Household Cleaners

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Toxic if inhaled

Only in: Household Cleaners

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

peripheral nervous system impairment

some

American Conference of Governmental Industrial Hygienists (ACGIH): Threshold Limit Value (TLV) Basis

kidney damage

some

American Conference of Governmental Industrial Hygienists (ACGIH): Threshold Limit Value (TLV) Basis

central nervous system impairment

some

American Conference of Governmental Industrial Hygienists (ACGIH): Threshold Limit Value (TLV) Basis

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

Environmental Protection Agency (EPA): EPA Hazard-Based Prioritizations - Risks

kidney damage

some

American Conference of Governmental Industrial Hygienists (ACGIH): Threshold Limit Value (TLV) Basis

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.

suspected human carcinogen

some

American Conference of Governmental Industrial Hygienists (ACGIH): Threshold Limit Value (TLV) Basis

Harmful if swallowed

Only in: Household Cleaners

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Possibly carcinogenic to humans

some

International Agency for Research on Cancer (IARC): Agents classified by the IARC Monographs (through Volume 127)

NTP Toxcast scored 2.5-3.5

some

National Toxicology Program (NTP): EWG Toxcast Analysis

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

Peer Reviewed Literature: Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46.

Review article concluded that Red 40 caused hypersensitivity reactions.

some

Peer Reviewed Literature: Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46.

suspected of causing genetics defects

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

causes damage to organs through prolonged or repeated exposure

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

Fatal if swallowed

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

fatal if inhaled

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

confirmed animal carcinogen with unknown relevance to humans

some

American Conference of Governmental Industrial Hygienists (ACGIH): Threshold Limit Value (TLV) Basis

May cause an allergic skin reaction

Only in: Household Cleaners

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Toxic in contact with skin

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

toxic if inhaled

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

Toxic of swallowed

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

Causes serious eye damage

Only in: Drain Opener/Clog Remover; Oven Cleaner; Household Cleaners

some

EU GHS Hazard Labeling Codes: GHS Hazard Codes

Some data submitters indicate they consider this substance as Persistent, Bioaccumulative and Toxic

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

may cause damage to organs through prolonged or repeated exposure

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

May cause an allergic skin reaction

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

may cause respiratory irritation

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

NTP Toxcast scored 1.5-2.5

some

National Toxicology Program (NTP): EWG Toxcast Analysis

Causes skin irritation

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

Causes serious eye damage

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

causes serious eye irritation

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

causes serious eye irritation

Only in: Household Cleaners

some

European Chemicals Agency (ECHA): GHS Data from ECHA Website

A review article reports equivocal evidence of carcinogenesis.

low

Peer Reviewed Literature: Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46.

A review article reports equivocal evidence of carcinogenesis.

low

Peer Reviewed Literature: Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46.

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 classifiable as to its carcinogenicity to humans

low

International Agency for Research on Cancer (IARC): Agents classified by the IARC Monographs (through Volume 127)

Not classifiable as to its carcinogenicity to humans

low

International Agency for Research on Cancer (IARC): Agents classified by the IARC Monographs (through Volume 127)

Not classifiable as to human carcinogenicity

low

Environmental Protection Agency (EPA): EPA Integrated Risk Information System (IRIS) - Cancer

not classifiable as a human carcinogen

low

American Conference of Governmental Industrial Hygienists (ACGIH): Threshold Limit Value (TLV) Basis

EPA testing shows this substance has moderate acute toxicity to aquatic life

low

Environmental Protection Agency (EPA): EPA Fathead Minnow Acute Toxicity Database

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.

EPA testing shows this substance has low acute toxicity to aquatic life

low

Environmental Protection Agency (EPA): EPA Fathead Minnow Acute Toxicity Database

A review article reports a lack of evidence of developmental toxicity.

low

Peer Reviewed Literature: Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46.

A review article reports a lack of evidence of developmental toxicity.

low

Peer Reviewed Literature: Kobylewski, S. & Jacobson, M.F. 2012. Toxicology of food dyes. International journal of occupational and environmental health 18(3), 220-46.

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.



Understanding scores

EWG provides information on cleaning product ingredients from the 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 which determine actual health risks, if any.

HOW WE DETERMINE SCORES

Hazard score

The Healthy Cleaning ingredient hazard score, from A to F, reflects known and suspected hazards linked to the ingredients. The EWG VERIFIED® mark means a product meets EWG’s strictest criteria for transparency and health.

Score legend


4

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