Butylparaben is a widely used synthetic compound in the cosmetic industry, primarily known for its function as a preservative. It belongs to the paraben family, which includes other similar compounds that help extend the shelf life of products by preventing the growth of harmful bacteria and mold.
Butylparaben is commonly found in a variety of personal care items, including lotions, shampoos, and makeup products. Its effectiveness in maintaining product integrity has made it a popular choice among manufacturers, although its use has sparked discussions regarding potential health concerns and regulatory scrutiny.
CAS Number: 94-26-8
Molecular Formula: C11H14O3
Synonyms:
- butyl-p-hydroxybenzoate
Uses of Butylparaben in Cosmetics
Functional role in cosmetics:
- Butylparaben is used as a emulsifier and preservative/stabilizer agent in cosmetics.
Other uses:
- Used as a fragrance ingredient.
Cosmetic Products Containing Butylparaben
Recent products using Butylparaben in their cosmetic formulations
- Major Pharmaceuticals Ceta-klenz Gentle Skin Cleanser
- Obagi Nu-Derm Healthy Skin Protection
- CVS Health Acne Treatment Cream With 10% Benzoyl Peroxide, Maximum Strength
- Muji Moisturizing Cream Balancing
- Obagi Glycerine 20
- Obagi Tretinoin Gel Usp 0.05%
- Oceanside Pharmaceuticals TRETINOIN GEL 0.05%
- Valeant Pharmaceuticals International, Inc. Atralin® (tretinoin) gel 0.05%
- Vivier Corrector 2
- Bepanthen Antiseptic Cream
- Cetaphil Emulsja Micelarna Do Mycia Twarzy
- Eucerin Ultra White Therapy Body Lotion SPF7
- Obagi Clear
- Obagi Medical Clenziderm M.D. Therapeutic Moisturizer
- Sesderma Hidraderm Facial
- Bath & Body Works Body Lotion Japanese Cherry Blossom
- Ben Nye Neutral Set
- Obagi Clenziderm M.D. Therapeutic Moisturizer
- Vivier Sunscreen Lotion SPF 30
- Algologie Algae Gel Mask
- Avene Leche Desmaquillante
Top companies using Butylparaben in their cosmetic products
- Major Pharmaceuticals
- Obagi
- CVS Health
- Muji
- Oceanside Pharmaceuticals
- Valeant Pharmaceuticals International, Inc.
- Vivier
- Bepanthen
- Cetaphil
- Eucerin
- Obagi Medical
- Sesderma
- Bath & Body Works
- Ben Nye
- Algologie
- Avene
- Celeteque
- Dreamax
Regulatory Considerations for Using Butylparaben in Cosmetic Formulations
Few regulatory considerations are to be taken into account before using Butylparaben as an ingredient. Given below is the list of those regulations:
FDA Requirements: Butyl p-hydroxybenzoate is permitted as a synthetic flavoring substance and adjuvant in human food. It must be used in the minimum quantity required for its intended effect, following good manufacturing practices, and may be combined with other safe or regulated flavoring substances.
FIFRA Requirements: Butyl 4-hydroxybenzoate was listed on FIFRA’s pesticide reregistration program under List D. Its active ingredient status is ‘cancelled,’ with no products containing it actively registered. EPA may cancel registrations due to findings of unreasonable adverse effects or failure to meet regulatory commitments.
REACH Registered Substance: Butylparaben’s REACH registration status is ‘Cease Manufacture,’ updated on July 22, 2019.
New Zealand EPA Inventory of Chemical Status: Butylparaben does not have individual approval but may be used under an appropriate group standard.
REACH Substances of Very High Concern (SVHC): Butyl 4-hydroxybenzoate was included in the SVHC list on June 25, 2020, due to endocrine-disrupting properties affecting human health.
The Australian Inventory of Industrial Chemicals: Listed as Benzoic acid, 4-hydroxy-, butyl ester in the Australian Inventory of Industrial Chemicals.
California Safe Cosmetics Program (CSCP) Reportable Ingredient: Classified for endocrine toxicity, reproductive toxicity, and hazard traits under review. Reporting is required if used as a fragrance or flavor ingredient.
Alternatives of Butylparaben and Comparative Analysis
Given below is the list of alternative ingredients that can be used in place of Butylparaben in cosmetic formulations:
- Phenoxyethanol
- Sodium Benzoate
- Caprylyl Glycol
- Ethylhexylglycerin
- Benzyl Alcohol
Comparative analysis of Butylparaben alternative ingredients:
| Ingredients | Strengths | Limitations | Efficacy | Cost | Stability | Compatibility | Safety |
| Phenoxyethanol | Broad-spectrum antimicrobial preservative effective against bacteria and fungi Stable across a wide pH range and temperature conditions Less sensitizing and lower allergenic potential compared to parabens Widely accepted and used in many cosmetic formulations | May cause irritation at high concentrations Not effective against all fungal strains, often combined with other preservatives | High antimicrobial preservative efficacy | Moderate | High (stable in most formulations) | Compatible with most cosmetic ingredients; often used in combination for broad-spectrum protection | Generally safe but can cause irritation in sensitive skin |
| Sodium Benzoate | Effective antimicrobial and antifungal preservative Generally recognized as safe and used in natural and organic products Water-soluble and easy to formulate | Less effective at neutral or alkaline pH, best at acidic pH below 5.5 May require combination with other preservatives for broad-spectrum efficacy | Moderate antimicrobial activity, especially in acidic formulations | Low | High in acidic conditions | Good in aqueous and acidic formulations | Generally safe and well tolerated |
| Caprylyl Glycol | Antimicrobial booster enhancing efficacy of other preservatives Humectant properties improve skin hydration Compatible with a wide range of cosmetic formulations | Not effective as a standalone preservative Requires combination with stronger antimicrobial agents | Moderate as a preservative enhancer | Moderate | High | Good with most preservatives and cosmetic bases | Safe and non-irritating |
| Ethylhexylglycerin | Enhances antimicrobial efficacy of other preservatives Mild antimicrobial activity Improves skin feel and acts as a humectant | Insufficient as a sole preservative Needs to be combined with other preservatives for full protection | Moderate as a preservative booster | Moderate | High | Compatible with most cosmetic ingredients | Generally safe and well tolerated |
| Benzyl Alcohol | Natural origin (found in fruits and teas) Effective antimicrobial properties, especially against bacteria Used in natural and clean beauty formulations | Can cause irritation or sensitization at high concentrations Limited antifungal efficacy, often combined with other preservatives | Moderate antimicrobial activity | Low to moderate | Moderate (can oxidize over time) | Good in natural formulations; limited for sensitive skin | Potential allergen at higher concentrations |
How Butylparaben Works in Formulations
Butylparaben is a preservative commonly used in cosmetics due to its ability to protect formulations from bacteria, mold, and yeast. It helps extend the shelf life of products by preventing microbial spoilage, ensuring product safety and stability.
Ideal Concentration and Benefits in Different Formulations
Skin Care Products
Butylparaben is widely included in creams, lotions, and facial moisturizers to prevent microbial growth and spoilage.
- Concentration: 0.01%–0.3%
- Benefit: It protects products from bacterial, fungal, and yeast contamination, ensuring their longevity. It also extends shelf life while maintaining product integrity in skin care products.
Hair Care Products
In shampoos and conditioners, Butylparaben is used for its preservative benefits, helping to prevent the growth of microorganisms.
- Concentration: 0.01% to 0.1%
- Benefit: Inhibits microbial growth and extends product shelf life.
Makeup Products (e.g., Foundations)
Butylparaben is used in makeup formulations, particularly in foundations, to protect against microbial contamination.
- Concentration: 0.03% to 0.1%
- Benefit: Helps prevent contamination, ensuring a longer shelf life for makeup products. It preserves the stability and safety of cosmetic products.
Compatibility with Other Ingredients
Soluble in organic solvents and compatible with most cosmetic ingredients. Identified as a potential endocrine disruptor; concentrations must comply with regulatory limits. It may cause skin irritation or allergic reactions in sensitive individuals, therefore, patch testing is recommended.
Stability and Shelf Life
Butylparaben remains stable when stored properly, ensuring long-lasting efficacy in formulations.
- Shelf life: 12–24 months
- Best storage: Store in airtight containers, away from heat and moisture to preserve effectiveness. Use sealed bottles to minimize exposure to air and maintain product stability.
Formulation Challenges and Troubleshooting
Butylparaben presents several formulation challenges due to its potential for irritation and endocrine disruption:
Endocrine Disruption Concerns
Butylparaben has been linked to potential endocrine disruption, particularly estrogenic activity.
Solution: Ensure concentrations comply with regulatory limits (e.g., up to 0.14% as recommended by SCCS). Consider alternative preservatives for sensitive applications.
Skin Irritation Potential
At higher concentrations, Butylparaben may cause skin irritation or allergic reactions.
Solution: Limit use to concentrations below 0.3% and conduct patch testing for sensitive users.
Packaging Compatibility
Butylparaben is generally compatible with most packaging materials but requires protection from moisture.
Solution: Use airtight, moisture-resistant containers to maintain product stability.
Regulatory Compliance
Ensure compliance with local regulations regarding maximum allowable concentrations and labeling requirements.
Solution: Consult regulatory guidelines for specific applications and regions.
Is Butylparaben Safe in Cosmetics?
Safety reports for Butylparaben are given below:
- Amended Safety Assessment of Parabens as Used in Cosmetics. Download PDF
- Final Amended Report on the Safety Assessment of Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben, Isobutylparaben, and Benzylparaben as used in Cosmetic Products. Download PDF
- Final Report on the Safety Assessment of Methylparaben, Ethylparaben, Propylparaben, and Butylparaben. Download PDF
Environmental and Sustainability Impact
Butylparaben is a synthetic preservative widely used in cosmetics to prevent microbial growth. Its use raises environmental and sustainability considerations:
Environmental Impact
- Water Pollution: Butylparaben is biodegradable but may pose risks to aquatic organisms due to its potential toxicity at higher concentrations. However, it is generally used in low concentrations in cosmetics.
- Carbon Footprint: The production of Butylparaben involves chemical synthesis, contributing to greenhouse gas emissions. Sustainable manufacturing practices can help reduce its environmental impact.
Sustainability
The sustainability of Butylparaben depends on its production methods and disposal practices.
- Raw Materials: Butylparaben is synthesized from 4-hydroxybenzoic acid and 1-butanol, which are derived from petrochemical sources. Greener synthesis methods could improve sustainability.
- Energy Use: Manufacturing requires moderate energy input. Cleaner production methods could reduce its environmental footprint.
- End-of-Life Impact: Butylparaben degrades into simpler compounds in the environment but may contribute to localized ecological effects if improperly disposed of.
Biodegradability and Toxicity
Butylparaben is biodegradable but has been identified as a potential endocrine disruptor and may exhibit mild aquatic toxicity.
Ammonia Toxicity: Not applicable. Butylparaben does not release ammonia or similar harmful byproducts during decomposition.
Eco-Friendly Alternatives
While Butylparaben is effective, alternative preservatives may offer greener options:
- Phenonip: A blend of preservatives that can replace parabens in some formulations with potentially lower environmental impact.
- Ethylhexylglycerin: A natural preservative booster that enhances the efficacy of other preservatives, reducing the need for strong antimicrobials.
- Natural Preservatives: Derived from plants or natural sources, these alternatives can provide similar antimicrobial effects with lower ecological risks.
Butylparaben Side Effects
Butylparaben exhibits skin irritant properties in humans, with some evidence of sensitization in dermatitis patients. In animal studies, it demonstrated low acute oral toxicity in mice, while its sodium salt showed moderate toxicity. Effects noted in mice included spleen and thymus alterations, along with liver damage.
Dietary exposure to Butylparaben led to cell proliferation in the forestomach of rats, though it was not found to be carcinogenic in a chronic feeding study. It did not show mutagenic effects in Ames tests. Reproductive toxicity was observed in rats, with decreased sperm viability at concentrations of 1 mg/mL and reduced epididymis and seminal vesicle weights following a 1% oral dose.
Additionally, maternal exposure to 100 mg/kg per day resulted in decreased sperm counts and motility in offspring. Butylparaben binds to estrogen receptors, albeit with significantly lower affinity than estradiol.
Potential Risks
Given below is the list of potential side effects associated with the use of Butylparaben in cosmetics:
- Contact dermatitis, allergic
Interactions
Butylparaben, commonly used in cosmetics and personal care products, has been shown to exhibit glucocorticoid-like activity, which may interfere with hormone function. In cell-based studies, Butylparaben alone increased glucocorticoid receptor activity by 1.60-fold at 1 µM concentration and 1.44-fold at 10 nM.
When combined with other endocrine-active compounds like propylparaben (PP) and diethylhexyl phthalate (DEHP), the mixture showed enhanced glucocorticoid-like effects, even at low concentrations. These findings highlight the potential risk of combined exposure to multiple endocrine-disrupting chemicals, even when individual levels are low.
Adverse Effects
Butylparaben is considered a potential occupational hepatotoxin, with evidence of liver toxicity primarily based on ingestion cases and animal studies. It is also classified as a skin sensitizer, meaning it can cause allergic skin reactions upon contact in sensitive individuals.
Carcinogen Classification
No indication of carcinogenicity to humans (not listed by IARC).
Non-Human Toxicity Values
LD50 (Lethal Dose, 50%) of Butylparaben in mice via intraperitoneal (ip) injection is 230 mg/kg.
Antidote and Emergency Treatment
In cases of severe exposure to Butylparaben, advanced treatment measures should be considered. Airway control is essential for patients who are unconscious, experiencing severe pulmonary edema, or in respiratory distress; orotracheal or nasotracheal intubation may be necessary.
Positive-pressure ventilation with a bag valve mask may be beneficial. Pulmonary edema may require appropriate drug therapy, and a beta-agonist like albuterol can be used for severe bronchospasm. Cardiac rhythm should be continuously monitored, and arrhythmias treated as needed.
Intravenous fluids such as D5W (to keep open flow) should be initiated, with 0.9% saline or lactated Ringer’s solution if there are signs of hypovolemia. Fluids should be administered cautiously to avoid fluid overload. Seizures should be managed with diazepam or lorazepam. For eye exposure, proparacaine hydrochloride may assist in eye irrigation.
Properties of Butylparaben
Chemical Identifiers
| EC Number | 202-318-7 |
| UNII | 3QPI1U3FV8 |
| InChIKey | QFOHBWFCKVYLES-UHFFFAOYSA-N |
| SMILES | CCCCOC(=O)C1=CC=C(C=C1)O |
| IUPAC Name | butyl 4-hydroxybenzoate |
| InChI | InChI=1S/C11H14O3/c1-2-3-8-14-11(13)9-4-6-10(12)7-5-9/h4-7,12H,2-3,8H2,1H3 |
Physical and Chemical Properties
Butylparaben, chemically known as N-butyl-p-hydroxybenzoate, is characterized by its appearance as colorless, odorless crystalline solids or powders. It is tasteless, though it can produce a numbing sensation on the tongue. When dissolved in water, its solutions exhibit a slightly acidic nature, which can be detected through litmus testing. This compound is commonly used as a preservative due to its antimicrobial properties.
| Property | Value |
| LogP | log Kow = 3.57 |
| Odor | Odorless |
| Color/Form | Small, colorless crystals or powder |
| Solubility | less than 1 mg/mL at 63°F |
| Flash Point | 181°C |
| Boiling Point | 156.00 to 157.00°C @ 3.50 mm Hg |
| Melting Point | 154 to 156°F |
| Decomposition | When heated to decomposition it emits acrid smoke and irritating fumes. |
| Vapor Pressure | 0.000186 mmHg |
| Stability/Shelf Life | Stable under recommended storage conditions. |
| Dissociation Constants | pKa = 8.47 |
| Kovats Retention Index | 1671 |
| Collision Cross Section | 150.14 Ų [M-H]- |
| Autoignition Temperature | 495°C |
| Other Experimental Properties | Very hygroscopic |
Structural Properties
Butylparaben is a compound with a relatively simple structure, consisting of 14 atoms. It has a molecular weight of 194.23 grams per mole and is non-charged. This substance can form hydrogen bonds with both donors and acceptors, making it useful for interactions in various chemical processes.
It also has five rotatable bonds, adding flexibility to its structure. Butylparaben is stable and exists in a canonical form, meaning its structure is well-defined. It is known to have a topological polar surface area, which plays a role in its interactions with other molecules, especially in biological systems.
| Property | Value |
| XLogP3 | 3.6 |
| Complexity | 171 |
| Exact Mass | 194.094294304 g/mol |
| Formal Charge | 0 |
| Heavy Atom Count | 14 |
| Molecular Weight | 194.23 g/mol |
| Monoisotopic Mass | 194.094294304 g/mol |
| Isotope Atom Count | 0 |
| Rotatable Bond Count | 5 |
| Compound Is Canonicalized | Yes |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 3 |
| Covalently-Bonded Unit Count | 1 |
| Topological Polar Surface Area | 46.5 Ų |
| Defined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
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