# ISOBUTYLPARABEN (isobutylparaben) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/isobutylparaben
- **Standard INCI**: `ISOBUTYLPARABEN`
- **KR MFDS Standard Name**: `아이소부틸파라벤`
- **CAS No.**: `4247-02-3`
- **EC / EINECS No.**: `224-208-8`
- **Origin**: `synthetic`
- **Functions**: 항균제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 아이소부틸파라벤 |
| KR (Former Names) | 이소부틸파라벤 |
| EU (CosIng 1223/2009) | ISOBUTYLPARABEN |
| US (PCPC / MoCRA INCI) | ISOBUTYLPARABEN |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 羟苯异丁酯 |
| JP (JCIA / MHLW QD) | ISOBUTYLPARABEN  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `restricted`
- **EU (1223/2009)**: `banned`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `banned` (Entry: `5219`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`

- **EU** [banned]: — —  (Regulation (EC) No 1223/2009 Annex II — via CosIng (EU Commission))
- **CN** [banned]: — —  (已使用化妆品原料目录 Ⅰ 备注 「《化妆品安全技术规范》禁用原料」 (NMPA 공고 2025년 제61호))
- **KR** [limited]: ≤ 0.8% —  (화장품 사용제한 원료 정보 (식약처 오픈API · 안전기준 [별표2]))

## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- Listed within general cosmetic GMP safety thresholds.

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4 – 8
- **Max Process Temp**: ≤ 50°C
- **Synergy Pairings**: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL
- **Incompatibilities**: Verify phase compatibility under extreme pH or high electrolyte loads

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: ISOBUTYLPARABEN | CAS No.: 4247-02-3 | EC No.: 224-208-8
  - Origin: SYNTHETIC | Functions: 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [ISOBUTYLPARABEN] · EU [ISOBUTYLPARABEN] · CN [羟苯异丁酯] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - ISOBUTYLPARABEN functions primarily as  in dermatological and cosmetic formulations. Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver  performance and structural formulation stability.
■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)]
  - Regional Summary: KR: RESTRICTED | EU: BANNED | US: NONE | CN: BANNED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 5219 (羟苯异丁酯))
  - [KR / COMPOSITION / limited] (Max 0.8%): 
  - [CN / COMPOSITION / banned]: 
  - [EU / COMPOSITION / banned]: 
  - Official Safety & Historical Use Concentration (Layer 2): Quantum satis (QS) within standard cosmetic safety margins
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [cleanser_rinse] Typical range: 0.3 ~ 0.6% (Median 0.3%, Ref: Global Starter Formulation Library Statistical Distribution (n=6, ELEMENTIS 6)) — Rinse-off cleanser & surfactant system modifier
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Water Phase or Cool-down Phase (< 45°C)
  - Optimal pH Range: pH 4.0 ~ 8.0 | Max Process Temp: Max 50°C | Electrolyte Tolerance: MEDIUM
  - Incompatibility / Caution: Verify phase compatibility under extreme pH or high electrolyte loads
  - Synergy Pairings: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | Reference Trade Names: ISOBUTYLPARABEN
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 41480865 (2025, Cell Physiol Biochem): Effect of Isobutylparaben and Phenylmercuric Acetate on Juvenile Female Rats with Special Reference to Development, Neur
  - PMID 39424158 (2024, Chemosphere): Toxic Beauty: Parabens and benzophenone-type UV Filters linked to increased non-alcoholic fatty liver disease risk
  - PMID 38619594 (2024, Arch Toxicol): Repeated-dose toxicity and toxicokinetic study of isobutylparaben in rats subcutaneously treated for 13 weeks

## 6. Linked PubMed Literature
- [PMID: 41480865] Effect of Isobutylparaben and Phenylmercuric Acetate on Juvenile Female Rats with Special Reference to Development, Neurobehavior, and Histopathology — *Cell Physiol Biochem* (2025)
- [PMID: 39424158] Toxic Beauty: Parabens and benzophenone-type UV Filters linked to increased non-alcoholic fatty liver disease risk — *Chemosphere* (2024)
- [PMID: 38619594] Repeated-dose toxicity and toxicokinetic study of isobutylparaben in rats subcutaneously treated for 13 weeks — *Arch Toxicol* (2024)
- [PMID: 31922297] Isobutylparaben Negatively Affects Porcine Oocyte Maturation Through Increasing Oxidative Stress and Cytoskeletal Abnormalities — *Environ Mol Mutagen* (2020)
- [PMID: 26359141] Toxicological evaluation of isopropylparaben and isobutylparaben mixture in Sprague-Dawley rats following 28 days of dermal exposure — *Regul Toxicol Pharmacol* (2015)
- [PMID: 25882402] The metal-organic framework HKUST-1 as efficient sorbent in a vortex-assisted dispersive micro solid-phase extraction of parabens from environmental waters, cosmetic creams, and human urine — *Talanta* (2015)
- [PMID: 23211298] Additional effects of bisphenol A and paraben on the induction of calbindin-D(9K) and progesterone receptor via an estrogen receptor pathway in rat pituitary GH3 cells — *J Physiol Pharmacol* (2012)
- [PMID: 41886927] Maternal paraben exposure during early pregnancy is associated with altered cord blood DNA methylation: The PREDO cohort — *Environ Int* (2026)
- [PMID: 35810903] Comprehensive assessment of estrogenic activities of parabens by in silico approach and in vitro assays — *Sci Total Environ* (2022)
- [PMID: 28318231] Paraben Concentrations in Maternal Urine and Breast Milk and Its Association with Personal Care Product Use — *Environ Sci Technol* (2017)
- [PMID: 23528233] Urinary excretion of phthalate metabolites, phenols and parabens in rural and urban Danish mother-child pairs — *Int J Hyg Environ Health* (2013)
- [PMID: 22237600] Measurement of paraben concentrations in human breast tissue at serial locations across the breast from axilla to sternum — *J Appl Toxicol* (2012)