SODIUM BENZOATE
化粧品における 安息香酸Na (SODIUM BENZOATE) のグローバル配合基準と処方特性とは?
安息香酸Na(標準 INCI: SODIUM BENZOATE、CAS番号: 532-32-1)は、化粧品処方において主に香料, 防腐剤, 防錆剤として配合される原料です。日本厚労省/JCIA(規制なし)、韓国MFDS(配合制限)、欧州CosIng(配合制限)など6大法域の法定基準下で管理され、通常 0.15–1%(適正安定域 pH 3.5–5.2)で処方されます。
7大トラック 国別・用途別 公式全成分表示名称マトリクス
各国公的告示原典のみ収録 · 機械翻訳・任意音訳ゼロ| 法域・規制トラック | 公式全成分表示名称 | ワンクリックコピー |
|---|---|---|
| ① 韓国 (MFDS 化粧品標準名称) | SODIUM BENZOATE (KR MFDS Registered) | |
| ② 韓国旧名称履歴 (301 リダイレクト) | — | — |
| ③ 欧州連合 (EU CosIng EC 1223/2009) | SODIUM BENZOATE | |
| ④ 米国一般化粧品 (US PCPC / MoCRA INCI) | SODIUM BENZOATE | |
| ⑤ 米国 FDA OTC モノグラフ有効成分名 | — (米国 OTC 対象外 / 一般化粧品原料) | — |
| ⑥ 中国 (NMPA IECIC 標準中国語名称) | 苯甲酸钠 | |
| ⑦ 日本化粧品表示名称 / 医薬部外品外原規名称 (JCIA / MHLW) | 安息香酸Na · [QD: 安息香酸ナトリウム] |
Layer 1 — 6大法域 法定配合上限および規制ステータス
| 法域 | 規制ステータス | 配合上限 | 制限条件および一次法源出典 |
|---|---|---|---|
| 韓国 (MFDS) | 配合制限 | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| 欧州 (EU) | 配合制限 | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| 米国 (FDA) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| 中国 (NMPA) | 配合制限 | GMP | IECIC Entry #1289 |
| 日本 (MHLW) | 規制なし | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
| ASEAN (ACD) | 配合制限 | GMP | 公的化粧品原料目録収載 (GMP基準内使用) |
Layer 2 — 毒性・安全性評価上限 (US CIR / EU SCCS / CN IECIC)
「欧州 SCCS 安全性評価上限」は消費者安全科学委員会が安全域 (MoS≥100) と判定した毒性学的上限であり、「米国 CIR 市販製品最大報告濃度」および「中国 IECIC 最高歴史使用量」は市販製品における最大実績濃度です。
| 安全性評価基準 | 適用範囲・用途 | 安全濃度範囲 | 判定結果および文献参照 |
|---|---|---|---|
| 米国 CIR 市販製品最大報告濃度 | eye | 0.00001~0.4% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | ingestion | 0.001~0.6% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | spray | 0.0001~0.5% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | dermal | 0.000001~1% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | deodorant | 0.5~0.5% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | hair | 0.000005~1% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | hair_dye | 0.008~0.5% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | nail | 0.00001~0.001% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | mucous | 0.0004~1% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | bath | 0.004~1% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | baby | 0.3~1% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | leave_on | 0.000001~1% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | rinse_off | 0.000001~1% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | total | 0.000001~1% | 安全判定 (MoS≥100)119_draft_benzyl.pdf () |
| 米国 CIR 市販製品最大報告濃度 | powder | 0.3~0.3% | 安全判定 (MoS≥100)120_final_ba.pdf () |
| 中国 IECIC 最高歴史使用量 | leave_on | ≤ 2.5% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 00975 (2025) |
| 中国 IECIC 最高歴史使用量 | rinse_off | ≤ 0.5% | 安全判定 (MoS≥100)NMPA IECIC (2025) Entry 00975 (2025) |
Layer 3 Formulation Concentration Box-Plot vs. Statutory Limit
Layer 3 — 剤形別通常配合濃度 (四分位数 n≥5) & 物理化学・相溶性ガイド
| 剤形グループ | Min – Q1 – Median – Q3 – Max (%) | 処方役割・作用機序 | Source ID |
|---|---|---|---|
| 剤形群 C — 洗い流し用クレンザー・シャンプー | 0.15% · 0.25% · 0.4% · 0.5% · 1% | COSMOS-certified organic acid salt preservative for mild cleansers | EU Annex V #1 & CIR Benzoic Acid Assessment |
| 剤形群 A — 水성化粧水・美容液・アンプル | 0.1% · 0.2% · 0.3% · 0.4% · 0.5% | Low-pH toner organic salt preservative (Leave-on max 0.5% as acid) | KR/EU Preservative Notice Annex |
| 剤形群 B — 乳液・エマルジョン・クリーム | 0.15% · 0.15% · 0.15% · 0.575% · 1% | Emulsion cream & lotion structural / conditioning agent | Global Starter Formulation Library Statistical Distribution (n=7, GRANT 4 · SEPPIC 2 · EVONIK 1) |
| 剤形群 D — 日焼け止め (UV)・メイクアップ・ファンデーション | 0.15% · 0.15% · 0.15% · 0.1875% · 5% | Sun care & color cosmetics dispersion / sensory modifier | Global Starter Formulation Library Statistical Distribution (n=8, GRANT 7 · SEPPIC 1) |
Stratum Corneum Penetration Depth & Bio-Spicule Transdermal Delivery
Under passive topical application, molecules diffuse tortuously through intercellular lipids. Hydrophilic compounds >500 Da remain primarily on the outer stratum corneum.
pH Stability Window (0–14), Thermal Limit & HLB Colloidal Phase Behavior
Outside pH 3.5–5.2, risk of hydrolysis, viscosity loss, or ionic dissociation increases.
Thermally stable up to 80°C during standard emulsification.
Cellular & Molecular Target Mechanism Flow
Interactive Synergy Pairings (Solid) & Incompatibility Warnings (Dashed)
Click any green synergy node to jump directly to its monograph, or click a red dashed node to inspect the chemical incompatibility mechanism.
商品名は研究者がグレードを識別するための参考表記であり、各商標権は原メーカーに帰属します。
学術・毒性・処方統合モノグラフ
Tier 1 Synthesis本原料に紐づく NIH PubMed 査読付き論文アブストラクトおよび公的毒性評価報告書のみに基づいて作成された学術要約です。
関連査読付き学術論文 (NIH PubMed) (12)
Allergic Contact Dermatitis to Personal Care Products: A Focus on Established and Emerging Allergens [PMID: 42309282 · 2026]
Allergic contact dermatitis (ACD) to personal care products (PCPs) represents a significant and growing clinical challenge, with increasing use of diverse PCPs and their expanding range of ingredients. Common allergenic components include fragrances, botanicals, preservatives, surfactants, emollients, emulsifiers, vitamins, and ultraviolet filters. Patch testing remains the gold standard for diagnosing ACD and identifying causative allergens, but traditional panels often fail to capture emerging PCP-related allergens. This review highlights key established and emerging PCP allergens, such as limonene and linalool hydroperoxides, sodium benzoate, octocrylene, and benzophenone-4. Strategies are discussed to optimize diagnostic accuracy through targeted series and repeated open application tests. Patient education about PCP labeling is paramount when assisting patients with allergen avoidance. Clinicians must balance precise allergen identification with practical management knowledge to improve outcomes in PCP-related ACD.
Design of Antiacne Gel Containing Phloretin [PMID: 42163615 · 2026]
Acne vulgaris is a common and complex skin condition characterised by excess oil production, blocked pores, and inflammatory lesions, such as papules and nodules. While hormonal factors and sebum overproduction are key contributors, the bacterium Staphylococcus aureus has also been recognised as a contributing pathogen. Phloretin, a flavonoid present in plants, like apples, is a promising new compound for acne treatment. Its potential rests in a variety of biological activities beyond merely acting as an antioxidant. Phloretin displays anti-inflammatory and antibacterial properties, which could directly target both the inflammatory response and the bacterial component of acne. These multiple mechanisms of action indicate that a phloretin-based gel could offer a comprehensive solution for managing the condition. Antiacne gels containing varying concentrations of Carbopol and phloretin were prepared and evaluated. Key parameters included physical appearance, viscosity, pH, drug content, in vitro drug release, and antimicrobial activity against Staphylococcus epidermidis. The optimized hydrogel (F4) exhibited a pH of 6.68, viscosity of 35.9 cP, and drug content of 80.9%. In vitro release studies showed a maximum drug release of 75% over 120 minutes. The formulation displayed strong antimicrobial activity with an inhibition zone of 11 mm, comparable to the marketed benzoyl peroxide gel. The gel was also well tolerated, with no signs of skin irritancy. Antiacne gel containing phloretin can be regarded as a more effective treatment for acne. The optimized formulation consisted of phloretin, Carbopol, ethanol, sodium benzoate, PEG 400, propylene glycol, and triethanolamine, showing better results in terms of antimicrobial activity. Phloretin-based gel demonstrated promising antiacne potential, achieving effective drug release and significant antibacterial activity against Staphylococcus epidermidis, while maintaining acceptable physicochemical and dermatological properties.
Preservatives in Leave-On Cosmetics Available on the Dutch Market [PMID: 41638886 · 2026]
Solid Shampoo Is Mostly Not Preserved, in Contrast to Liquid Shampoos Used in Hairdressing-A Market Survey in Four European Countries [PMID: 41560442 · 2026]
Hairdressers are frequently exposed to shampoos, both from neat liquid products and dilutions, often with unprotected hands. Shampoos usually contain preservatives. While the level of preservation is guided by risk assessment based on typical consumer exposure, this will underestimate sensitization risk in hairdressers. Lower exposure or avoidance of preservative-containing hair cosmetic products appears important for primary prevention of work-related allergic contact dermatitis among hairdressers. To assess the preservatives (Annex V of the EU Cosmetics Regulation (EC 1223/2009)) used in solid shampoos, compare these to preservatives present in liquid shampoos for professional use, and determine the presence of ingredients with "antimicrobial" function in solid shampoo. A physical store check and survey of online sales platforms was performed in four European countries in late 2024. Along with product descriptors, the full INCI labelling was recorded from package labels (or corresponding summaries online) and collected in a spreadsheet. The sample included 172 solid shampoos from various retail sources and 259 liquid shampoos from one online marketplace for professional users. Among solid shampoos, preservatives were found in 31.4%; if "antimicrobial" additives are additionally considered, this share increased to 41.3%. Benzyl alcohol (n = 29) and sodium benzoate (n = 18) were the most common preservatives, benzyl benzoate the most common "antimicrobial" (n = 8). By contrast, all liquid shampoos contained (multiple) preservatives. Solid shampoo shows potential to provide a less-allergenic working environment for hairdressers. Practical aspects should next be addressed to contribute to broader use of solid shampoos.
Mint condition? A survey of allergenic ingredients in UK toothpastes [PMID: 41503662 · 2026]
Toothpastes may induce cheilitis, intraoral lichenoid changes and immediate hypersensitivity reactions. There is little published information documenting the range of allergens in toothpastes. In 2024, a survey was conducted of 291 toothpastes sold by 5 of the UK's largest cosmetics suppliers. Labelling quality and ingredients were recorded. Of the 291 toothpastes, 2 (0.7%) had no ingredients list. Of the remaining 289 (99.3%), the mean number of ingredients was 16.6; 286 (99.0%) contained fragrance, often labelled nonspecifically as 'aroma'. Limonene was in 159/289 (55.0%) and menthol-related compounds were in 105/289 (36.3%). The most frequent preservatives were sodium benzoate or benzoic acid (36/289, 12.5%; 11/289, 3.8%). Polyaminopropyl biguanide, banned in cosmetics in 2015, was declared in 3/289 (1.0%). Sodium lauryl sulfate was present in 159/289 (55.0%). Stannous (tin) fluoride, associated with allergic cheilitis, was present in 21/289 (7.3%). Dermatologists should consider exposure to toothpaste allergens when managing patients with cheilitis, oral mucosal symptoms or immediate systemic symptoms associated with toothbrushing.
Sodium Benzoate Induces Fat Accumulation and Reduces Lifespan via the SKN-1/Nrf2 Signaling Pathway: Evidence from the Caenorhabditis elegans Model [PMID: 39519584 · 2024]
Sodium benzoate (SB) is widely used in food products, cosmetics, and medical solutions due to its antimicrobial properties. While it is generally considered safe and has potential neuroprotective benefits, SB has also been linked to adverse effects, including hepatic oxidative stress and inflammation. However, the potential effects of SB on obesity and lifespan remain poorly understood. In this study, we investigated the effects of SB on fat accumulation and lifespan using the nematode Caenorhabditis elegans ( C. elegans ) as a model system. Wild-type worms were exposed to various SB concentrations (0%, 0.0004%, 0.0008%, 0.004%, and 0.1%) and 0.016% glucose as a positive control for 72 h in liquid or on NGM agar plates. Fat accumulation was assessed through the Oil Red O staining, which revealed that SB induced more fat accumulation compared to vehicle control, even at low concentrations, including the dosage of 0.0004%. Lifespan analysis also demonstrated that SB significantly reduced lifespan in wild-type worms, even at low concentrations. Further investigations found that SKN-1 (an Nrf2 homolog) is necessary for SB-induced fat accumulation and lifespan reduction. Moreover, SB inhibited the nuclear localization of SKN-1 under oxidative stress conditions. These findings suggest that SB may induce fat accumulation and reduce lifespan by inhibiting the oxidative stress-mediated SKN-1 signaling pathway.
Zinc abates sodium benzoate -induced testicular dysfunction via upregulation of Nrf2/ HO-1/ Nf-κB signaling and androgen receptor gene [PMID: 39106537 · 2024]
Sodium Benzoate (SB) is used in daily products such as drinks, juices, sauces, oils, ketchup, toothpaste, mouthwashes, cosmetics, dentifrices, and pharmaceutical products. However, SB has been implicated in gonadotoxicity even at a dosage within the safe limit. Zinc (Zn), on the other hand, has been shown to improve various fertility indices. Hence, this study was designed to explore the possible ameliorative effect of Zn on SB-induced testicular toxicity. Animals were randomly divided into control, SB, Zn, and SB+Zn. All treatment lasted for 28 days. SB treatment caused a derangement in reproductive hormone levels, sperm function, and kinematics and a down-regulation of the Androgen receptor (ANDR). Also, a decrease in testicular levels of SOD, CAT, GSH, Nrf2, and HO- 1 activity and an increase in IL-1β, TNF-α, Nf-κB, and Caspase 3 were observed. These SB-induced distortions were ameliorated in SB-treated rats exposed to Zn. Our study suggests that zinc abates SB-induced testicular toxicity by modulating Nrf2/HO-1/ Nf-κB signaling and ANDR upregulation.
Parental sodium benzoate diet induces fat accumulation in offspring via histone H3K9me3 and SKN-1/Nrf2 [PMID: 41551184 · 2026]
Sodium benzoate is a commonly used food preservative and chemical additive with well-established antimicrobial and antifungal activities, and is widely applied in the food, cosmetic, and pharmaceutical industries. Despite its extensive use, increasing evidence has raised concerns regarding its potential adverse effects on metabolic homeostasis, including the induction of oxidative stress, hepatic inflammation, lipid accumulation, and reduced lifespan. However, whether sodium benzoate-induced obesity phenotypes can be transmitted to subsequent generations via epigenetic mechanisms remains largely unexplored. In this study, we used Caenorhabditis elegans as a model organism to investigate whether the high-lipid phenotype induced by sodium benzoate could be inherited epigenetically by offspring. Our results demonstrated that exposure to sodium benzoate led to a high-lipid phenotype that persisted across multiple generations through epigenetic inheritance. Mechanistically, the transcription factor SKN-1 functioned not only as an effector regulating lipid metabolism but also as a key mediator transmitting epigenetic information to progeny. Furthermore, we identified histone H3 lysine 9 trimethylation (H3K9me3) as a critical epigenetic modification underlying this transgenerational effect. Collectively, these findings indicate that sodium benzoate induces heritable lipid accumulation through the SKN-1/Nrf2 signaling pathway, accompanied by a reduction in H3K9me3 levels.
Integrating multi-wavelength HPLC fingerprinting and electrochemical profiling with chemometrics for comprehensive quality assessment of Kangfuxin Liquid [PMID: 41385803 · 2026]
Kangfuxin Liquid (KFX), a complex zoogenic medicine, faces challenges in quality control due to its multi-component nature and batch-to-batch variability. This study presents a novel integrated quality assessment strategy combining Four-wavelength maximization profiling (Four-WMP) HPLC with electrochemical fingerprinting (ECFP) for comprehensive evaluation of KFX. The Four-WMP method integrated chromatographic data from four wavelengths (236, 254, 265, and 280 nm) into a unified fingerprint, significantly enhancing chemical comprehensiveness compared to conventional single-wavelength approaches. Concurrently, ECFP provided unique insights into redox-active properties. Strong correlations were established between chemical fingerprints and antioxidant efficacy through Partial Least Squares (PLS) modeling (R 2 =0.8672, Q 2 =0.789), identifying critical quality markers including protocatechuic acid and adenosine. Substantial inter-manufacturer variation was observed, particularly in sodium benzoate content, highlighting significant quality inconsistencies. This multi-parametric framework provides a holistic and robust paradigm for quality control of KFX and similar complex medicines, effectively bridging chemical composition with bioactive relevance.
Sodium Benzoate Inhibits Osteoblast Differentiation and Accelerates Bone Loss by Regulating the FGF2/p38/RUNX2 Pathway [PMID: 40404584 · 2025]
Sodium benzoate (NaB) is a commonly used food ingredient that is also found in cosmetics and medicines. Previous studies have demonstrated that long-term NaB intake has detrimental effects on human health, while its effects on bone mass remain unknown. In the present study, intragastric NaB administration was found to decrease bone mass and deteriorate bone microstructure in vivo , while prolonged NaB gavage further accelerated bone loss. The in vitro study revealed that NaB inhibited osteoblast differentiation of bone marrow mesenchymal stem cells and MC3T3-E1 cells. Mechanistically, RNA sequencing analysis elucidated that NaB greatly suppressed fibroblast growth factor 2 (FGF2) expression. Further studies revealed that NaB inhibited p38/RUNX2 signaling transduction, which was downstream of FGF2 for modulating osteoblast differentiation. The rescue studies suggested that NaB inhibited RUNX2 expression and osteoblast differentiation through the p38/MAPK signaling pathway. Collectively, NaB accelerated bone loss by inhibiting osteoblast differentiation through downregulating FGF2/p38/RUNX2 signaling pathway. The present study revealed that the long-term intake of NaB-containing food increased the risk of bone loss and osteoporosis (OP). Therefore, a reasonable oral intake of NaB-containing food is an important but convenient initiative for preventing OP.
Development of Alginate Hydrogels Incorporating Essential Oils Loaded in Chitosan Nanoparticles for Biomedical Applications [PMID: 39598707 · 2024]
A hybrid alginate hydrogel-chitosan nanoparticle system suitable for biomedical applications was prepared. Chitosan (CS) was used as a matrix for the encapsulation of lavender ( Lavandula angustifolia ) essential oil (LEO) and Mentha ( Mentha arvensis ) essential oil (MEO). An aqueous solution of an acidic Natural Deep Eutectic Solvent (NADES), namely choline chloride/ascorbic acid in a 2:1 molar ratio, was used to achieve the acidic environment for the dissolution of chitosan and also played the role of the ionic gelator for the preparation of the chitosan nanoparticles (CS-NPs). The hydrodynamic diameter of the CS-MEO NPs was 130.7 nm, and the size of the CS-LEO NPs was 143.4 nm (as determined using Nanoparticle Tracking Analysis). The CS-NPs were incorporated into alginate hydrogels crosslinked with CaCl 2 . The hydrogels showed significant water retention capacity (>80%) even after the swollen sample was kept in the aqueous HCl solution (pH 1.2) for 4 h, indicating a good stability of the network. The hydrogels were tested (a) for their ability to absorb dietary lipids and (b) for their antimicrobial activity against Gram-positive and Gram-negative foodborne pathogens. The antimicrobial activity of the hybrid hydrogels was comparable to that of the widely used food preservative sodium benzoate 5% w / v .
Cocaine(Archived) [PMID: 28613520 · 2026]
よくある質問 (FAQ)
- Q1. 安息香酸Na (SODIUM BENZOATE) の各国公式全成分表示名称(7トラック)はどのように異なりますか?
- 日本化粧品工業連合会(JCIA)表示名称は '安息香酸Na'、米国PCPC・欧州CosIng INCIは 'SODIUM BENZOATE'、中国NMPA IECIC標準中国語名は '苯甲酸钠' です。
- Q2. 安息香酸Na (SODIUM BENZOATE) のグローバル6大法域における法定配合基準 (Layer 1) は?
- 6大法域規制ステータス — 日本(JP): none、韓国(KR): restricted、欧州(EU): restricted、米国(US): none、中国(CN): restricted、ASEAN: restricted。
- Q3. 処方設計における 安息香酸Na (SODIUM BENZOATE) の通常配合濃度 (Layer 3) と適正 pH は?
- 主要剤形 (cleanser_rinse) において通常 0.15〜1%(中央値 0.4%)で配合され、適正pH範囲は 3.5〜5.2 です。
- Q4. 安息香酸Na (SODIUM BENZOATE) の配合禁忌 (Incompatibilities) と推奨シナジー成分は?
- 推奨シナジーペアは POTASSIUM SORBATE, CITRIC ACID, GLUCONOLACTONE, XANTHAN GUM、配合上の注意点は Loses antimicrobial activity completely at pH > 5.5 (requires pH 4.0~5.2); Strong electrolyte that collapses Carbomer gels; Never combine with Ascorbic Acid in the presence of trace metal ions/UV due to potential trace benzene formation です。