Is Isobutylparaben safe in cosmetics?
Isobutylparaben has a safety rating of "POOR" in our database. EU status: prohibited. US status: permitted.
Isobutylparaben
Also known as: Isobutyl p-hydroxybenzoate, 3-10-00-00308, BRN 2642305, EINECS 224-208-8, 2-Methylpropyl 4-hydroxybenzoate (+2 more)
INCI: ISOBUTYLPARABEN
Isobutylparaben (CAS 4247-02-3) is a cosmetic preservative functioning as Preservative. EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 4247-02-3 →
Auto-generated CPSR Part A draft with source citations
Function
Preservative
Safety Rating
POOR
Chemistry & Identifiers
IUPAC Name
2-methylpropyl 4-hydroxybenzoate
InChIKey
XPJVKCRENWUEJH-UHFFFAOYSA-N
Regulatory Status
EU EU Status
prohibited
US US Status
permitted
US Notes
Not specifically banned in US cosmetics under FDA/MoCRA, but a long-chain paraben with documented endocrine disruptor activity that has no place in modern intimate care formulations.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Isobutylparaben.
Calculate MoS for your specific formulation with the MoS Calculator.
Sensitization Profile
Contact sensitization data for Isobutylparaben based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
paraben-group
Reaction Type
contact-dermatitis
Source: ESSCA; IVDK; SCCS/1348/10
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Confirmed
Evidence: High
(2022)
Health effects: Yes
Affected pathways: Estrogenic (ER agonist)
Regulatory framework: REACH
Source list: I
Cosmetic-Specific Mechanism
Category: paraben
Receptor targets: ERα, ERβ, AR
LOEC: 1 µM
EU status: restricted (max 0.14% leave-on); ECHA Candidate List 2023
agonist (ER); antagonist (AR)
Dose-Response Data Points
| Endpoint | Target | Value | Direction |
|---|---|---|---|
| Cell proliferation, reporter gene | ER | EC50/IC50: EC50 in range 10^-5 M (between propyl and butyl); LOEC: 10 uM; NOEC: 1 uM mixed | agonist |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
Ceased manufacture
Substance Type
SUBSTANCE
SVHC Candidate
Yes (since 17-Jan-2023)
Hazard classification: Restricted (Annex XVII)
SVHC reason: Endocrine disrupting properties (Article 57(f) - human health)
Substance of Very High Concern (SVHC)
Included: 17-Jan-2023
Endocrine disrupting properties (Article 57(f) - human health)
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
ASEAN Cosmetic Directive (II)
Ref:
Additional Jurisdictional Restrictions (2)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| AU | restricted | - | preservatives |
| BR | banned | - | - |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (1 records across 5 sources)
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_sccs_opinion | 0.4% | - | - | SCCP/1183/08 |
Additional Ingredient Properties
7 property records from structured ingredient metadata.
allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "preservative", "cross_reactivity_group": "paraben-group", "patch_test_frequency_pct": "0.2", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA; IVDK; SCCS/1348/10"}
pediatric_safety
{"safe_for_newborn_0_6m": "avoid", "safe_for_infant_6_12m": "avoid", "safe_for_toddler_1_3y": "caution", "safe_for_child_3_12y": "caution", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "0.028", "adult_max_concentration_pct": "0.14", "pediatric_dermal_absorption_factor": "higher", "immature_skin_barrier_risk": "moderate", "oral_ingestion_risk": "low", "eye_irritation_risk": "lo…
ph_stability
{"optimal_ph_min": "4.0", "optimal_ph_max": "8.0", "stable_ph_min": "3.5", "stable_ph_max": "8.5", "degrades_above_ph": "9.0", "degrades_below_ph": "3.0", "ph_dependent_function": "Function best pH 5-8; hydrolyze >pH 8.5", "formulation_note": "Similar to butylparaben", "source": "PMC 2023"}
pregnancy_detail
{"pregnancy_safe": "avoid", "breastfeeding_safe": "avoid", "trimester_restriction": "all", "risk_category": "not-rated", "reason": "Potential endocrine disruptor", "alternative_ingredient": "Phenoxyethanol; Sodium Benzoate", "source": "ACOG; dermatology literature"}
preservative
{"preservative_class": "Paraben", "antimicrobial_spectrum_bacteria_gp": "Yes", "antimicrobial_spectrum_bacteria_gn": "Good", "antimicrobial_spectrum_yeast": "Yes", "antimicrobial_spectrum_mold": "Yes", "mic_staph_aureus_ppm": "320", "mic_e_coli_ppm": "680", "mic_pseudomonas_ppm": "950", "mic_candida_albicans_ppm": "160", "mic_aspergillus_niger_ppm": "420", "challenge_test_pass_concentration_pct": …
regulatory
{"eu_status": "banned", "us_status": "restricted", "eu_max_concentration": "0", "restricted_in": "all products", "ban_date": "2014-10-30", "regulation_reference": "Annex II/1114"}
skin_suitability
{"oily_skin": "avoid", "dry_skin": "avoid", "sensitive_skin": "avoid", "combination_skin": "avoid", "normal_skin": "avoid", "acne_prone": "avoid", "rosacea": "avoid", "eczema": "avoid", "hyperpigmentation": "avoid", "aging_mature": "avoid", "dehydrated": "avoid", "skin_benefit_primary": "preservative", "skin_benefit_secondary": "antimicrobial", "mechanism_of_action": "Long-chain paraben, endocrine…
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Preservative
Regulatory List Membership (1)
EU Restricted for Children (Cosmetics)
Expert Verdict
Expert safety assessment and concern-level summary for Isobutylparaben.
Regulatory Flags
paraben
eu-banned
endocrine-disruptor
reach-candidate
long-chain-paraben
intimate-avoid
estrogenic
eu_children_restricted
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 0.4% | SCCS opinion extraction | - |
Known Synonyms
Isobutyl p-hydroxybenzoate
3-10-00-00308
BRN 2642305
EINECS 224-208-8
2-Methylpropyl 4-hydroxybenzoate
p-Oxybenzoesaureisobutylester
UNII-0QQJ25X58G
Chemical Function
Biocide
Preservative
Regulatory Lists
nondetect; Toys and children's products
nondetect; Toys and children's products
detected; Toys and children's products
detected; Toys and children's products
detected; Toys and children's products
detected; Toys and children's products
nondetect; Toys and children's products
active_ingredient; Europe; Pesticides
Europe; Personal care - body hygiene - hand soap
children; Europe; Personal care
children; Europe; Personal care
children; Europe; Personal care
children; Europe; Personal care
detected; Europe; Personal care - specialized bath products - bubble bath
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
ChEMBL ID
CHEMBL3182006
Frequently Asked Questions
Is Isobutylparaben allowed in the EU?
Isobutylparaben EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Isobutylparaben do in cosmetics?
Isobutylparaben functions as: Preservative. It is classified as a Preservative in our database. CAS number: 4247-02-3.
Is Isobutylparaben used outside cosmetics?
Isobutylparaben also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Isobutylparaben compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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