MENTHOL
Denaturant; External Analgesic; Flavoring Agent; Fragrance Ingredient; Oral Health CareDrug; MASKING; REFRESHING; SOOTHING
MENTHOL may be an impurity the following product types:
lip balm (93)
moisturizer (67)
body wash/cleanser (54)
shampoo (52)
lip gloss (45)
exfoliant/scrub (45)
bar soap (44)
toothpaste (44)
foot moisturizer (40)
bath oil/salts/soak (36)
facial moisturizer/treatment (34)
facial cleanser (31)
conditioner (28)
body oil (28)
sunscreen: lip balm (22)
hand cream (22)
Also listed as
3-HYDROXY-P-MENTHANE; 2-ISOPROPYL-5-METHYLCYCLOHEXANOL; DL-MENTHOL; L-MENTHOL; P-METHAN-3-OL; RACEMIC MENTHOL; (+) -MENTHOL; (+-) -MENTHOL; 2-ISOPROPYL-5-METHYLCYCLOHEXANOL; 3-P-MENTHOL; AI3-08161
Given the incomplete information made available by companies and the government, EWG provides additional information on personal care product ingredients from the published scientific literature. The chart below indicates that research studies have found that exposure to this ingredient -- not the products containing it -- caused the indicated health effect(s) in the studies reviewed by Skin Deep researchers. Actual health risks, if any, will vary based on the level of exposure to the ingredient and individual susceptibility -- information not available in Skin Deep.
| This ingredient: | |
 | Cancer |
 | Developmental/reproductive toxicity |
| Violations, restrictions & warnings |
| Allergies/immunotoxicity |
| Contamination concerns |
 | Other strong concerns for this ingredient: Multiple, additive exposure sources |
 | Other moderate concerns for this ingredient: Organ system toxicity (non-reproductive) |
| Lesser or emerging concerns for this ingredient: Neurotoxicity, Irritation (skin, eyes, or lungs), Data gaps |
|
See products containing MENTHOL See ingredients that may have MENTHOL as an impurity See products that may have MENTHOL as an impurity | |
About MENTHOL: Menthol is the diterpene. In the United States, Menthol may be used as an active ingredient in OTC drug products. When used as an active drug ingredient, the established name is Menthol. See "Regulatory and Ingredient Use Information," regarding the labeling names for U.S. OTC Dr ug Ingredients in Volume 1, Introduction, Part A.
MENTHOL has reported used in the following product types: pain relief (88); facial cleanser (76); lip balm (65); sunscreen: lip balm (49); acne treatment (49); muscle/joint soreness (43); foundation (38); mouthwash (37); exfoliant/scrub (31); shampoo (31)
Multiple, additive exposure sources
| type of concern | product conditions | reference |
| Used in food or as an additive with limited or no toxicity information available | FDA Everything Added to Food | |
| Designated as safe for general or specific, limited use in food | FDA Food Additive Status | |
| Designated as safe for general or specific, limited use in food | FDA Everything Added to Food |
Organ system toxicity (non-reproductive)
| type of concern | product conditions | reference |
| One or more animal studies show sense organ effects at very low doses | products for use around the eyes, mouth, or lips | RTECS®- American Journal of Ophthalmology 1946 |
| show more | ||
Cancer
| type of concern | product conditions | reference |
| One or more in vitro tests on mammalian cells show positive mutation results | RTECS®- Environmental and Molecular Mutagenesis 1994 | |
| show more | ||
Neurotoxicity
| type of concern | product conditions | reference |
| One or more animal studies show brain and nervous system effects at moderate doses | RTECS®- Annales Pharmaceutiques Francaises 1952 | |
| show more | ||
Irritation (skin, eyes, or lungs)
| type of concern | product conditions | reference |
| One or more animal studies show skin irritation at moderate doses | RTECS®- Food and Cosmetics Toxicology 1976 |
Data gaps
| type of concern | product conditions | reference |
| Not assessed for safety in cosmetics by industry panel | ||
| 595 studies in PubMed science library may include information on the toxicity of this chemical see search results -> | PubMed |
Ecotoxicology
| type of concern | product conditions | reference |
| Not suspected to be an environmental toxin | Environmental Canada Domestic Substance List |
Persistence and bioaccumulation
| type of concern | product conditions | reference |
| Not suspected to be persistent | Environmental Canada Domestic Substance List | |
| show more | ||
Government, industry, academic studies and classifications
| government/industry list/academic study | appears on list as | classification(s) |
| FDA Food Additive Status | MENTHOL | • Food additive: essential oil and/or oleoresin (solvent free) • GRAS (generally recognized as safe) - use in food presumed safe based either on a history of use before 1958 or on published scientific evidence; need not be approved by the FDA prior to use in food; most have not limit for use but must conform to good manufacturing practices; some GRAS substances have quantitative limit for use in foods; by definition under Sec 201(s) of FD&C Act, not food additives - CFR182.20 |
| FDA Everything Added to Food | PEPPERMINT PLANT | • There is no reported use of the substance and there is no toxicology information available in PAFA. |
| FDA Everything Added to Food | MENTHOL | • Fully up-to-date toxicology information has been sought. |
| Environmental Canada Domestic Substance List | CYCLOHEXANOL, 5-METHYL-2-(1-METHYLETHYL)-, (1_,2ß,5_)- | •This chemical was NOT flagged by CEPA for further attention. |
| IFRA Fragrance Ingredient List | MENTHOL | •The chemical has been reported as used in fragrance compounds by IFRA affiliated member companies in 2008. |
| RTECS®- American Journal of Ophthalmology 1946 | MENTHOL | • sense organ - Primary eye irritant (rabbit ) |
| RTECS®- American Journal of Ophthalmology 1946 | MENTHOL | • sense organ - Primary eye irritant (rabbit ) |
| RTECS®- Annales Pharmaceutiques Francaises 1952 | MENTHOL | • brain and nervous system - Hallucinations, distorted perceptions (rat LDLo) • brain and nervous system - Muscle weakness (rat LDLo) • brain and nervous system - Sleep (rat LDLo) |
| RTECS®- Archives Internationales de Pharmacodynamie et de Therapie 1939 | MENTHOL | • broad systemic - Broad systemic toxicity (mouse LDLo) |
| RTECS®- Environmental and Molecular Mutagenesis 1994 | MENTHOL | • mutagenic - Positive mutation assay: DNA Damage (rat lvr) |
| RTECS®- Farmatsevtichnii Zhurnal (Kiev) 1962 | MENTHOL | • sense organ - Primary eye irritant (rabbit ) |
| RTECS®- Food and Cosmetics Toxicology 1976 | MENTHOL | • skin - Primary skin irritant (rabbit ) |
| RTECS®- Food and Cosmetics Toxicology 1964 | MENTHOL | • brain and nervous system - Ataxia (rat LD50) |
| RTECS®- Mutation Research 1994 | MENTHOL | • mutagenic - Positive mutation assay: Unscheduled DNA Synthesis (rat orl) |
| RTECS®- Mutation Research 1995 | MENTHOL | • mutagenic - Positive mutation assay: other mutation test systems (mouse orl) |
| RTECS®- Mutation Research 1998 | MENTHOL | • mutagenic - Positive mutation assay: Cytogenetic Analysis (hamster ovr) • mutagenic - Positive mutation assay: DNA Inhibition (hamster ovr) |
| RTECS®- Mutation Research 2003 | MENTHOL | • mutagenic - Positive mutation assay: DNA Damage (hamster ovr) |
| RTECS®- Naunyn-Schmiedeberg's Archiv fuer Experimentelle Pathologie und Pharmakologie 1954 | MENTHOL | • broad systemic - Broad systemic toxicity (rat LD50) |
| RTECS®- Toksikologicheskii Vestnik 2001 | MENTHOL | • broad systemic - Broad systemic toxicity (mammal LD50) |
| RTECS®- Toksikologicheskii Vestnik 2002 | MENTHOL | • broad systemic - Broad systemic toxicity (rat LD50) • brain and nervous system - Food intake (animal) (mouse LD50) • brain and nervous system - Somnolence (general depressed activity) (mouse LD50) |
| RTECS®- Toxicology Letters 1983 | MENTHOL | • liver - Changes in liver weight (rat TDLo) • blood - Changes in other cell count (unspecified) (rat TDLo) • brain and nervous system - Fluid intake (rat TDLo) |
references
| government/industry list/academic study | reference |
| FDA Food Additive Status | FDA (U.S. Food and Drug Administration) 2006. Food Additive Status List. Downloaded from http://www.cfsan.fda.gov/%7Edms/opa-appa.html, Oct 16, 2006. |
| FDA Everything Added to Food | FDA (U.S. Food and Drug Administration). 2008. EAFUS [Everything Added to Food]: A Food Additive Database. FDA Office of Food Safety and Applied Nutrition. |
| Environmental Canada Domestic Substance List | EC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry. |
| IFRA Fragrance Ingredient List | IFRA (International Fragrance Assocication). 2010. IFRA Fragrance Ingredient List based on 2008 Use Survey. Accessed online 01/04/2010: http://www.ifraorg.org/Home/News/Latest-News/page.aspx/66?xf_itemId=43&xf_selectionDatapartId=25 |
| RTECS®- American Journal of Ophthalmology 1946 | RTECS®- American Journal of Ophthalmology. (Ophthalmic Pub. Co., 435 N. Michigan Ave., Suite 1415, Chicago, IL 60611) Series 3: V.1- 1918- 29,1363,1946 |
| RTECS®- American Journal of Ophthalmology 1946 | RTECS®- American Journal of Ophthalmology. (Ophthalmic Pub. Co., 435 N. Michigan Ave., Suite 1415, Chicago, IL 60611) Series 3: V.1- 29,1363,1946 |
| RTECS®- Annales Pharmaceutiques Francaises 1952 | RTECS®- Annales Pharmaceutiques Francaises. (SPPIF, B.P.22, F-41353 Vineuil, France) V.1- 1943- 10,481,1952 |
| RTECS®- Archives Internationales de Pharmacodynamie et de Therapie 1939 | RTECS®- Archives Internationales de Pharmacodynamie et de Therapie. (Heymans Institute of Pharmacology, De Pintelaan 185, B-9000 Ghent, Belgium) V.4- 1898- 63,43,1939 |
| RTECS®- Environmental and Molecular Mutagenesis 1994 | RTECS®- Environmental and Molecular Mutagenesis. (Alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.10- 24,181,1994 |
| RTECS®- Farmatsevtichnii Zhurnal (Kiev) 1962 | RTECS®- Farmatsevtichnii Zhurnal (Kiev). (V/O Mezhdunarodnaya Kniga, 113095 Moscow, USSR) V.3- 1930- 17(3),53,1962 |
| RTECS®- Food and Cosmetics Toxicology 1976 | RTECS®- Food and Cosmetics Toxicology. (London, UK) V.1-19, 1963-81. For publisher information, see FCTOD7. 14,473,1976 |
| RTECS®- Food and Cosmetics Toxicology 1964 | RTECS®- Food and Cosmetics Toxicology. (London, UK) V.1-19, 1963-81. For publisher information, see FCTOD7. 2,327,1964 |
| RTECS®- Mutation Research 1994 | RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 320,189,1994 |
| RTECS®- Mutation Research 1995 | RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 343,157,1995 |
| RTECS®- Mutation Research 1998 | RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 400,169,1998 |
| RTECS®- Mutation Research 2003 | RTECS®- Mutation Research. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 537,151,2003 |
| RTECS®- Naunyn-Schmiedeberg's Archiv fuer Experimentelle Pathologie und Pharmakologie 1954 | RTECS®- Naunyn-Schmiedeberg's Archiv fuer Experimentelle Pathologie und Pharmakologie. (Berlin, Ger.) V.110-253, 1925-66. For publisher information, see NSAPCC. 222,244,1954 |
| RTECS®- Toksikologicheskii Vestnik 2001 | RTECS®- Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown (1),14,2001 |
| RTECS®- Toksikologicheskii Vestnik 2002 | RTECS®- Toksikologicheskii Vestnik. (18-20 Vadkovskii per. Moscow, 101479, Russia) History Unknown (5),52,2002 |
| RTECS®- Toxicology Letters 1983 | RTECS®- Toxicology Letters. (Elsevier Science Pub. B.V., POB 211, 1000 AE Amsterdam, Netherlands) V.1- 1977- 19,207,1983 |
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