Butylated Hydroxytoluene
(in 23,462 products)

Potential Risk Index®:

ISCE InhaleISCE SwallowISCE ContactISCE Environment
PRI Legend

About:

Functions:
1. Antioxidant - Reduces oxidation to prevent the formation of free radicals which may be harmful to health.
2. Fragrance / Fragrance Component - Provides or enhances a particular smell or odor.
3. Preservative - Prevents and inhibits the growth of unwanted microorganisms which may be harmful
Hydroxytoluene (also known as butylated hydroxytoluene or BHT) is a synthetic antioxidant used in cosmetics and personal care products to extend the shelf life of the products and prevent spoilage due to oxidation. It is also commonly used in the food industry as a food preservative to prevent the oxidation of fats and oils, which can cause food to spoil or become rancid.
It is important to note that while Hydroxytoluene has been approved for use as a food and cosmetic ingredient by several regulatory agencies, including the US Food and Drug Administration (FDA), some studies have suggested that it may cause health concerns such as endocrine disruption, skin irritation, and liver and lung toxicity. However, these concerns are not widely supported by scientific evidence, and more research is needed to fully understand the potential risks associated with its use.
Consumers who are concerned about the use of Hydroxytoluene in their cosmetics and personal care products may choose to look for products that are labeled as "BHT-free" or to seek out alternative, natural preservatives. However, it is always important to carefully read the labels and ingredient lists of any products you use to make an informed decision about their safety and suitability.
Overall, Hydroxytoluene is a popular choice for those looking for a synthetic ingredient that can help to preserve the freshness and safety of their cosmetics and personal care products and food. However, it is important to be aware that some studies have suggested that long-term exposure to high levels of BHT may be harmful, and more research is needed to fully understand the potential risks associated with its use.
It is approved to use as food additive in EU and generally recognized as safe food substance in US.
Recent Findings:
BHT is labeled as a GRAS ingredient and is deemed to be safe in low concentrations via the Cosmetic Ingredient Review Expert Panel. Nevertheless, it could be used as an anti-cancer agent though there is definitive evidence showing the carcinogenicity of BHT in mice, rats, and dogs. [2] The Cosmetic Ingredient Review Expert Panel has concluded that clinical studies on humans have shown BHT to be safe to use due to its "extremely low concentrations" in commercial cosmetic products. Oral toxicity of BHT on humans has been found to be inconclusive and that there is no evidence that BHT causes skin cancer in humans. [3]
A Norwegian epidemiological study has shown no evidence of BHT causing gastric cancer. [4] BHT appears to be carcinogenic in certain mouse strains, but not in others. Overall, BHT has the potential to cause mutagenic changes in humans, with a higher susceptibility to the respiratory system. [2] BHT has shown to be a lung tumor promoter and cause urinary bladder cancers, liver cancers as well as its ability to "modify the genotoxicity of other [genotoxic] agents" in mice but not in humans. [5] The use of BHT on primate cells showed that it inhibits monkey kidney cell numbers via "depression of cellular metabolism". [6] More research will need to be carried out to ascertain the toxicity of BHT.
The number of articles reporting on the carcinogenicity of BHT has decreased dramatically from the 1980s to contemporary times. The controversy is due to the unique chemical composition of BHT being able to promote certain cancers while reducing others. The reduction in BHT as a carcinogen can be attributed to how different chemicals react differently to different cancers. Further human studies will need to be completed before the carcinogenicity/anticancer properties of BHT can be proven.
Scientific References:
2. The lung tumor promoter, butylated hydroxytoluene (BHT), causes chronic inflammation in promotion-sensitive BALB/cByJ mice but not in promotion-resistant CXB4 mice. (Toxicology. 2001 Dec 1;169(1):1-15)
3. Promoting activities of butylated hydroxyanisole and butylated hydroxytoluene on 2-stage urinary bladder carcinogenesis and inhibition of gamma-glutamyl transpeptidase-positive foci development in the liver of rats. (Carcinogenesis. 1983;4(7):895-9)
4. Final report on the safety assessment of BHT (Int J Toxicol. 2002;21 Suppl 2:19-94 doi:10.1080/10915810290096513)
5. Intake of butylated hydroxyanisole and butylated hydroxytoluene and stomach cancer risk: results from analyses in the Netherlands Cohort Study (Food Chem. Toxicol., 38(7), 599–605.) doi:10.1016/s0278-6915(00)00042-9 
6. Cytotoxicity and apoptosis induction by butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT) (Anticancer Res. 2003 Nov-Dec;23(6C):4693-701 doi:)
7. Effects of the Food Additive Butylated Hydroxytoluene on Monolayer Cultures of Primate Cells. (Nature, 216(5115), 557–560.) doi:10.1038/216557a0
8. Evaluation of antioxidant, anti-hemolytic and anticancer activity of various solvent extracts of Acacia hydaspica R. Parker aerial parts (BMC Complement Altern Med. 2016; 16: 258 doi:10.1186/s12906-016-1240-8)
9. Carcinogenicity and modification of the carcinogenic response by BHA, BHT, and other antioxidants (Crit Rev Toxicol. 1985;15(2):109-50 doi:10.3109/10408448509029322)
Regulatory References:
1. EU CosIng Annex III, SUBSTANCES WITH RESTRICTIONS IN COSMETIC PRODUCTS [2018]
- Ref: III/325
2. US FDA Food Additives Status List [2018]
- BHT (butylated hydroxytoluene)
3. EU Approved Food Additive [2018]
- E321
5. Japan’s List of Designated Food Additives under Article 10 of the Food Sanitation Act
- Butylated Hydroxytoluene
6. WHO International Agency for Research on Cancer (IARC) - Group 3 [2018]
- Butylated hydroxytoluene (BHT)
7. US FDA Generally Recognized As Safe (GRAS) (21 CFR 182) [2017]
- § 182.3173 - Butylated hydroxytoluene
8. International Fragrance Association Transparency List [2015]
- Butylated hydroxytoluene

Safety and Hazards (UN GHS):

1. Suspected of damaging fertility or the unborn child (H361)
2. Causes damage to organs (H370)
3. Causes damage to organs through prolonged or repeated exposure (H373)
4. Very toxic to aquatic life (H400)
5. Very toxic to aquatic life with long lasting effects (H410)

Potential Health Concerns For:

1. Abnormalities, Drug-Induced (PubMed ID:7191588)
2. Acute Kidney Injury (PubMed ID:277130)
3. Adenoma (PubMed ID:6500233)
4. Adenoma, Liver Cell (PubMed ID:3128505)
5. Bile Duct Diseases (PubMed ID:3026937)
6. Carcinoma, Hepatocellular (PubMed ID:3804114)
7. Cerebral Hemorrhage (PubMed ID:7419139)
8. Chemical and Drug Induced Liver Injury (PubMed ID:3026937)
9. Colonic Neoplasms (PubMed ID:3945967)
10. Dermatitis, Atopic (PubMed ID:15218738)
11. Drug-Related Side Effects and Adverse Reactions (PubMed ID:2370251)
12. Embryo Loss (PubMed ID:3949264)
13. Fibrosis (PubMed ID:3026937)
14. Gastrointestinal Neoplasms (PubMed ID:3804115)
15. Growth Disorders (PubMed ID:3804114)
16. Hematologic Diseases (PubMed ID:7286863)
17. Hemorrhage (PubMed ID:7419139)
18. Hemorrhagic Disorders (PubMed ID:7419139)
19. Hepatomegaly (PubMed ID:3026937)
20. Hyperplasia (PubMed ID:3026937)
21. Hypersensitivity (PubMed ID:17604070)
22. Kidney Diseases (PubMed ID:1555799)
23. Kidney Tubular Necrosis, Acute (PubMed ID:3395247)
24. Liver Neoplasms (PubMed ID:3804115)
25. Lung Neoplasms (PubMed ID:11246140)
26. Necrosis (PubMed ID:2006506)
27. Neoplasms (PubMed ID:3026937)
28. Papilloma (PubMed ID:1752781)
29. Pneumonia (PubMed ID:11893704)
30. Precancerous Conditions (PubMed ID:1752781)
31. Prenatal Exposure Delayed Effects (PubMed ID:7191588)
32. Proteinuria (PubMed ID:3395247)
33. Thyroid Neoplasms (PubMed ID:6500233)
34. Urinary Bladder Neoplasms (PubMed ID:1752781)

Potential Health Benefits For:

1. Alcoholic Intoxication (PubMed ID:8723618)
2. Arrhythmias, Cardiac (PubMed ID:8723618)
3. Cardiomyopathies (PubMed ID:2361559)
4. Heart Diseases (PubMed ID:6626733)
5. Mammary Neoplasms, Experimental (PubMed ID:1500032)
6. Pancreatic Neoplasms (PubMed ID:1906380)
7. Stomach Diseases (PubMed ID:3613839)

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