Education and Research

Bismuth is a naturally occurring brittle metal. Bismuth-containing compounds can be found in several applications, particularly in cosmetics and personal care products. Because bismuth comes from the earth, it may contain trace amounts of heavy metals. The FDA regulates these levels in amounts consistent with good manufacturing practices. Restrictions include:

Lead - not more than 20 parts per million
Arsenic - not more than 3 parts per million
Mercury - not more than 1 part per million
Bismuth oxychloride - not less than 98 per million

SOURCE:

Cosmeticsinfo.org. Bismuth Oxychloride.Cosmeticsinfo.org. Retrieved from http://cosmeticsinfo.org/ingredient_details.php?ingredient_id=593

Cyclomethicone is a clear, alcohol-free, and odorless liquid added to personal skin care products to give them a smoother texture that is more easily applied to the skin. Safety assessments published by the International Journal of Toxicology indicate that minimal percutaneous absorption was associated with this ingredient and the available data do not suggest skin irritation or sensitization potential. Also, it is unlikely that dermal exposure to this ingredient from cosmetics would cause significant systemic exposure. The Cosmetic Ingredient Review expert panel concluded that this ingredient is safe in the modern practices of use and concentration.

SOURCE:

Johnson, W., Bergfled, W., Belsito D., Hill R., Klaassen C., Liebler D., Marks J., Shank R., Slaga T., Snyder P., & Andersen F. (2011). Safety assessment of cyclomethicone, cyclotetrasiloxane, cyclopentasiloxane, cyclohexasiloxane, and cycloheptasiloxane. International Journal of Toxicology, 30 (6), 149S-227S. doi: 10.1177/1091581811428184

Ferric ferrocyanide is a ferric hexacyanoferrate pigment used in externally applied drugs, including those intended for use in the area of the eye. The FDA indicates that this dye may be safely used in amounts consistent with good manufacturing practices. Restrictions include:

Lead - not more than 20 parts per million
Arsenic - not more than 3 parts per million
Nickel - not more than 200 parts per million
Cobalt - not more than 200 parts per million
Mercury - not more than 1 part per million

Lead

Lead is a dense, soft bluish-gray metal naturally occurring in the rock and soil of the earth's crust. Lead and lead compounds are reasonably anticipated to be a human carcinogen in the Twelfth Report on Carcinogens published by the National Toxicology Program. Short-term exposure of lead in cosmetics can cause eye irritation.

Arsenic

Arsenic is a silver-gray or white-metallic element that occurs naturally in the earth's crust. Arsenic is also listed as a human carcinogen in the Twelfth Report on Carcinogens. Short-term exposure to arsenic in cosmetics can cause skin warts and red or swollen skin.

Mercury

Mercury is a metal that occurs naturally in the environment. Short-term exposure may cause skin rash and irritation of the eyes.

SOURCES:

Food and Drug Administration. (2011, April). Sec. 73.1299 Ferric ferrocyanide. Code of Federal Regulations, 21 (1). Abstract retrieved from the Food and Drug Administration Department of Health and Human Services database. (Cite No: 21CFR73.1299).

Tox Town. (2012, March). Arsenic. U.S. National Library of Medicine. Retrieved from http://toxtown.nlm.nih.gov/text_version/chemicals.php?id=3

Tox Town. (2012, January). Lead. U.S. National Library of Medicine. Retrieved from http://toxtown.nlm.nih.gov/text_version/chemicals.php?id=16

Tox Town. (2012, January). Mercury. U.S. National Library of Medicine. Retrieved from http://toxtown.nlm.nih.gov/text_version/chemicals.php?id=17

Formaldehyde is a colorless, flammable, strong-smelling chemical used in building materials and the production of many household products. Formaldehyde sources in the home include pressed-wood products, cigarette smoke, and fuel-burning appliances. When exposed to formaldehyde, some individuals may experience various short-term effects. Formaldehyde has been classified as a known human carcinogen (cancer-causing substance) by the International Agency for Research on Cancer and as a probable human carcinogen by the U.S. Environmental Protection Agency. Research studies of workers exposed to formaldehyde have suggested an association between formaldehyde exposure and several cancers, including nasopharyngeal cancer and leukemia.

SOURCES:

National Cancer Institute. (2011, June). Formaldehyde and Cancer Risk. National Cancer Institute. Retrieved from http://www.cancer.gov/cancertopics/factsheet/Risk/formaldehyde

Tox Town. (2012, March). Formaldehyde. U.S. National Library of Medicine. Retrieved from http://toxtown.nlm.nih.gov/text_version/chemicals.php?id=14

There is growing concern about the interaction of nanoparticles with human health and their effects on the environment. The risk of pollution from nanoparticles and the associated health problems that arise from the manufacturing and use of products containing them is unknown. Scientists are concerned about the possible health risks of inhaled nanoparticles and nanoparticles absorbed through the skin. According to the Centers for Disease Control and Prevention, more research is needed on the human health risks associated with the exposure from commercially engineering nano-materials and the risks associated with consumer use of products containing nanoparticles.

SOURCE:

Tox Town. (2012, January). Nanoparticles. U.S. National Library of Medicine. Retrieved from http://toxtown.nlm.nih.gov/text_version/chemicals.php?id=67

Parabens may interfere with the production or activity of hormones in the endocrine system. They may cause reduced fertility and an increase in some diseases, including endometriosis and some cancers. Other human health concerns include changes to sperm levels, reproductive abnormalities, and early puberty. Exposure of infants and fetuses to endocrine disruptors can affect the developing reproductive and nervous systems and organs. Additonal concerns include changes to the nervous system and immune functions.

Studies from California Pacific Medical Center in San Francisco found that methylparaben (as well as the chemical BPA, used in food can linings and other applications) can not only cause healthy breast cells to behave like cancer cells, but also interfere with the effectiveness of tamoxifen, a critical drug used in the treatment of breast cancer.

The United States Food and Drug Administration continues to evaluate new data in this area. If they determine that a health hazard exists, they will advise the industry and the public, and will consider the agency’s legal options under the authority of the FD&C Act to protect the health and welfare of consumers.

SOURCES:

FDA (2022, February). Parabens in Cosmeticcs. Retrieved from https://www.fda.gov/cosmetics/cosmetic-ingredients/parabens-cosmetics

McCormack, K. (2011, September). Bisphenol-A causes normal breast cells to act like cancer. CPMC Sutter Health. Retrieved from http://www.cpmc.org/about/press/news2011/bisphenol-breastcells.html

National Toxicology Program. (2010, October). CAS Registry Number: 94-26-8 Toxicity Effects (Butylparaben). National Library of Medicine’s Hazardous Substance Database. Retrieved from http://ntp.niehs.nih.gov/index.cfm?objectid=E8844B58-BDB5-82F8-F5457A9FECC48821

Tox Town. (2011, October). Bisphenol A (BPA). U.S. National Library of Medicine. Retrieved from http://toxtown.nlm.nih.gov/text_version/chemicals.php?id=69

Tox Town. (2011, October). Endocrine Disruptors. U.S. National Library of Medicine. Retrieved from http://toxtown.nlm.nih.gov/text_version/chemicals.php?id=65

Pesticides are substances that prevent, destroy, repel, or reduce the severity of pests. Pesticides are common chemicals found in thousands of household and industrial products, including cosmetics and personal care products. Different types of pesticides can affect human health in different ways. Some pesticides are carcinogens known to cause cancer, while others can be linked to congenital defects and changes to the nervous system. Some pesticides are endocrine disruptors and affect the body's hormones and endocrine system and others irritate the skin and eyes. The amount of exposure to certain pesticides is as important as the level of toxicity the pesticide possesses.

SOURCE:

Tox Town. (2012, March). Pesticides. U.S. National Library of Medicine. Retrieved from http://toxtown.nlm.nih.gov/text_version/chemicals.php?id=23

The human health effects of phthalates are not yet fully known but are actively being studied by several government agencies, including the Food and Drug Administration, the National Institute of Environmental Health Sciences, and the National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction.

Phthalates are esters of plastic used to add flexibility and help dissolve other ingredients. They are also used in industrial adhesives as well as medical and consumer goods made with polyvinyl chloride plastic (PVC). Di(2-ethylhexyl) phthalate is listed as a substance "reasonably anticipated to be a human carcinogen" in the Eleventh Report on Carcinogens, published by the National Toxicology Program. Current levels of seven phthalates studied by the National Institute of Environmental Health Sciences posed "minimal" concern for causing reproductive effects. However, the National Toxicology Program concluded that high levels of one phthalate, di-n-butyl phthalate, may adversely affect human reproduction or development. High levels of exposure to di(2-ethylhexyl) phthalate through the use of medical tubing and other plastic devices for feeding, medicating, and assisting the breathing of newborn infants, may affect the development of the male reproductive system, according to the National Institute of Environmental Health Sciences.

Although the International Fragrance Association generally regards fragrance oils as safe, in Coastal Classic Creations products, no phalate-containing fragances are used due to scholarship, which strongly suggests that fragrance oils do have neurotoxic potential. This scholarship goes back to 1986 when the National Academy of Sciences targeted synthetic fragrances as one of the six categories of chemicals that should be given high priority for neurotoxicity testing. The report states that 95 percent of chemicals used in fragrances are synthetic compounds derived from petroleum. They include benzene derivatives, aldehydes, and many other known toxins and sensitizers, capable of causing cancer, congenital disabilities, central nervous system disorders, and allergic reactions.

SOURCES:

DiGangi, J., Schettler, T., Cobbing, M., & Rossi, M. (2002, July). Aggregate exposures to phthalates in humans. Health Care without Harm. Retrieved from http://www.fda.gov/ohrms/dockets/dailys/02/Dec02/120502/02d-0325-c000018-02-vol1.pdf

Neurotoxins: At Home and the Workplace (Report by the Committee on Science and Technology. US House of Representatives, Sept. 16, 1986) [Report 99-827]

Tox Town. (2012, January). Phthalates. U.S. National Library of Medicine. Retrieved from http://toxtown.nlm.nih.gov/text_version/chemicals.php?id=24

New data suggests that the systemic exposure to this active ingredient is higher than previously thought, and further information about the potential risks from systemic absorption and long-term exposure is now available. The Food and Drug Administration has issued its final rule that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded.

SOURCE:

Federal Register (2016). Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use. Retrieved from https://www.federalregister.gov/articles/2016/09/06/2016-21337/safety-and-effectiveness-of-consumer-antiseptics-topical-antimicrobial-drug-products-for#h-13

1,4-dioxane is not listed on ingredient labels. It is a petroleum-derived contaminant formed in the manufacture of shampoos, body wash, children's bath products, and other foaming cosmetics. The International Agency for Research on Cancer (IARC) has ranked it as a possible carcinogen, and the National Toxicology Program (NTP) has identified it as a reasonably anticipated carcinogen. 1,4-dioxane is a byproduct of a petrochemical process called ethoxylation, which involves using ethylene oxide (a known breast carcinogen) to process other chemicals in order to make them less harsh. For example, sodium laurel sulfate is often converted to the gentler chemical sodium laureth sulfate by processing it with ethylene oxide (the "eth" denotes ethoxylation), which can result in 1,4-dioxane contamination.

SOURCE:

Breast Cancer Fund. (2010). Clear Science: Chemicals in cosmetics. Breast Cancer Fund. Retrieved from http://www.breastcancerfund.org/clear-science/chemicals-linked-to-breast-cancer/cosmetics/

American Cancer Society. (2012). Learn about Cancer: Cosmetics. American Cancer Society. Retrieved from http://www.cancer.org/Cancer/CancerCauses/OtherCarcinogens/AtHome/cosmetics

Breast Cancer Fund. (2010). State of the evidence: the connection between breast cancer and the environment (6th Edition). Breast Cancer Fund. Retrieved from http://www.breastcancerfund.org/media/publications/state-of-the-evidence/soe-2010-toc.html

Centers for Disease Control and Prevention. (2011, November). National Health and Nutrition Examination Survey. National Center for Health Statistics. Retrieved from http://www.cdc.gov/nchs/nhanes/about_nhanes.htm

Cornell University Library. (2012). Breast cancer and environmental risk factors. Cornell University. Retrieved from http://ecommons.library.cornell.edu/handle/1813/14300

Electronic Code of Federal Regulations. (2012, April). Subpart B- Drugs, Part 73- Listing of color additives exempt from certification. Electronic Code of Federal Regulations, 21 (1). Abstract retrieved from e-CFR database. (http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&rgn=div6&view=text&node=21:1.0.1.1.26.2&idno=21M).

National Library of Medicine: Fact Sheets. (2011). Chemical carcinogenesis research information system (CCRIS). National Library of Medicine. Retrieved from http://www.nlm.nih.gov/pubs/factsheets/ccrisfs.html

National Toxicology Program. (2012, January). About the report on carcinogens. National Institute of Environmental Health Sciences. Retrieved from http://ntp.niehs.nih.gov/?objectid=72016262-BDB7-CEBA-FA60E922B18C2540

Office of Environmental Health Hazard Assessment. (2012, March). Current Proposition 65 list: chemical listed effective March 16, 2012 as known to the state of California to cause reproductive toxicity- methanol. State of California: Environmental Protection Agency. Retrieved from http://oehha.ca.gov/prop65/prop65_list/Newlist.html

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