Poor Cosmetic Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

Dibutyl Phthalate (DBP)

Also known as: 1,2-Benzenedicarboxylic acid, dibutyl ester, Di-n-butylorthophthalate, o-Benzenedicarboxylic acid, dibutyl ester, BRN 1914064, N-Butylphthalate (+14 more)

INCI: DIBUTYL PHTHALATE

Dibutyl Phthalate (DBP) (CAS 84-74-2) is a cosmetic cosmetic ingredient functioning as Plasticizer, film flexibility agent for nail polish. NOAEL 0.666667 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: prohibited; 1 safety opinion reviewed (cir). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.

View industrial chemical safety profile for CAS 84-74-2 →

Auto-generated CPSR Part A draft with source citations
Function
Plasticizer, film flexibility agent for nail polish
Safety Rating
POOR

Chemistry & Identifiers

Formula
C16H22O4
MW
278.34 g/mol
EC Number
201-557-4
PubChem CID
3026
IUPAC Name
dibutyl benzene-1,2-dicarboxylate
InChIKey
DOIRQSBPFJWKBE-UHFFFAOYSA-N

Regulatory Status

EU EU Status prohibited
US US Status permitted
US Notes No federal FDA restriction as of 2026. CIR reaffirmations from 1985, 2002, and 2012. Mislabeling documented: 14% of DBP-free products found to contain DBP up to 88,000 ppm. California analysis (2024) found some 3-free polishes with more DBP than conventional products.

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Dibutyl Phthalate (DBP).

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 study endpoints found for Dibutyl Phthalate (DBP). NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
NOAEL 152 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL =152 mg/kg bw/day oral Rat subchronic ToxValDB_ECHA_IUCLID
NOAEL =385 mg/kg bw/day oral Rat reproduction developmental ToxValDB_ECHA_IUCLID

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Long-term Exposure Effects
Animal tests show that this substance possibly causes toxicity to human reproduction or development.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol and by ingestion.

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir Number 3, 1985
Verdict: unknown

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Dibutyl Phthalate (DBP) across SCCS product categories, with measured dermal absorption where available.

EPA ToxValDB — Toxicity Values

10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint Value Species Route Duration Source
RfD =0.1 mg/kg-day Human oral - OW Drinking Water Standards
LOAEC =1.2 mg/m3 Rat inhalation short-term EU SCOEL
OEL =0.569222 mg/m3 Human inhalation - EU SCOEL
LEL =56922.2 mg/m3 Human inhalation - DOE Protective Action Criteria
NOEL =50 mg/kg-day Rat oral short-term (developmental) HAWC Project
LC50 >=15680 mg/m3 Rat inhalation - ECHA IUCLID
LD50 =6279 mg/kg Rat oral - ECHA IUCLID
LOAEL =20 ppm Rat oral - ECHA IUCLID
LOAEL =752 mg/kg-day Rat oral subchronic ECHA IUCLID
LOAEL =752 mg/kg-day Rat oral subchronic ECHA IUCLID

EU CLP Annex VI Harmonized Classification

Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.

Signal Word
Danger
Pictograms
Health HazardEnvironmental Hazard
Hazard Class and Category
Repr. 1B; Aquatic Acute 1
Hazard Statements
  • H360Df
  • H400 Very toxic to aquatic life

Inserted via ATP: CLP00

Sensitization AOP Dashboard

Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.

DPRA Cys %
0%
DPRA Lys %
0%
KeratinoSens IC50
500 µM
LLNA EC3
50%
NESIL
12500 µg/cm²
LLNA: Weak (1B) GHS: 1B

Source: LLNA: Kern et al. (2010); DPRA: Urbisch et al. 2015 [DOI:10.1016/j.yrtph.2014.12.008]; KS: Urbisch et al. 2015 [DOI:10.1016/j.yrtph.2014.12.008]

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 (2017)
Health effects: Yes
Affected pathways: Anti-androgenic
Regulatory framework: REACH

Source list: I

Cosmetic-Specific Mechanism
Category: phthalate
Receptor targets: ERα, AR, PPARγ
LOEC: 1 µM
EU status: banned (CMR 1B reproductive toxicant; Annex II)

agonist (ER, PPARγ); antagonist (AR)

Dose-Response Data Points
Endpoint Target Value Direction
toxic_dose general 10 mg/g µg/g -
dermal_epidermis skin 80 ± 65 µg/cm² -
dermal_dermis_MBP skin 1.9 ± 0.4 µg/cm² -
AED systemic >10 µg/kg/day (14 cosmetics co-used) µg/kg/day -
Beta-galactosidase reporter ER EC50/IC50: EC50 ~1-10 uM; LOEC: 0.1 uM; NOEC: 0.01 uM mixed agonist (weak)
Testosterone reduction, E2 alteration steroidogenesis EC50/IC50: Effects inconsistent in H295R alone; LOEC: ~10 uM (in vitro, variable); NOEC: 1 uM mixed modulator (downarrow T in vivo; limited in H295R)

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
Yes (since 28-Oct-2008)
Hazard classification: Restricted (Annex XVII)
SVHC reason: Toxic for reproduction (Article 57c)
Substance of Very High Concern (SVHC)
Included: 28-Oct-2008
Toxic for reproduction (Article 57c); Endocrine disrupting properties (Article 57(f) - environment); Endocrine disrupting properties (Article 57(f) - human health)

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex II — Prohibited
Ref: 675
(EC) 2009/1223
CMR: Reprotoxic Cat. 1B(),Reprotoxic Cat. 2()

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.

SA Saudi SFDA (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: 675
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (2)
Jurisdiction Status Max % Product Type
AU banned - all
KR prohibited - -

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Aggregated DA Values (2 records across 5 sources)
Type DA % Method Skin Model SCCS Ref
measured_sccs_opinion 5.0% - - SCCP/1016/06
measured_sccs_opinion 5.0% - - SCCP/1016/06

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Safety (6)
Carcinogen Classification
No indication of carcinogenicity to humans (not listed by IARC).
Source: Toxin and Toxin Target Database (T3DB)
Carcinogen Classification
Di-n-butyl phthalate | TR-600: Toxicology and Carcinogenesis Studies of Di-n-butyl Phthalate (CASRN 84-74-2) Administered in Feed to Sprague Dawley (Hsd:Sprague Dawley SD) Rats and B6C3F1/N Mice (2021 ) | 04/02/21 | Equivocal Evidence | No Evidence | No Evidence | No Evidence | Under the conditions of these 2‑year feed studies, there was equivocal evidence of carcinogenic activity of di
Source: NTP Technical Reports
Evidence for Carcinogenicity
Cancer Classification: Group D Not Classifiable as to Human Carcinogenicity | CLASSIFICATION: D; not classifiable as to human carcinogenicity. BASIS FOR CLASSIFICATION: Pertinent data regarding carcinogenicity was not located in the available literature. HUMAN CARCINOGENICITY DATA: None. ANIMAL CARCINOGENICITY DATA: None.
Source: Hazardous Substances Data Bank (HSDB)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
ICSC Safety Card
0036
Source: ILO-WHO International Chemical Safety Cards (ICSCs)

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Deodorizer Fragrance Plasticizer Solvent
Regulatory List Membership (6)
California Proposition 65 (OEHHA) EU Banned in Cosmetics IFRA Fragrance Transparency List FDA Indirect Food Contact Additives Consumer Product Chemical EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Dibutyl Phthalate (DBP).

Regulatory Flags

toxic_trio eu_prohibited cmr reproductive_toxin endocrine_disruptor detected_breast_milk fetal_exposure mislabeling_risk phthalate prop65 eu_banned_cosmetics ifra_fragrance eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Dibutyl Phthalate (DBP) by CAS number or substance name.

Studies
42
Lowest NOAEL
19.9 mg/kg bw/day
Highest NOAEL
500 mg/kg bw/day
COSMOS_DB ToxValDB_ECHA_IUCLID ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip

Dermal Absorption

View details ->
Absorption % Method Vehicle
5.0% SCCS opinion extraction -
5.0% SCCS opinion extraction -

Known Synonyms

1,2-Benzenedicarboxylic acid, dibutyl ester Di-n-butylorthophthalate o-Benzenedicarboxylic acid, dibutyl ester BRN 1914064 N-Butylphthalate Caswell No. 292 EINECS 201-557-4 EPA Pesticide Chemical Code 028001 Ersoplast FDA Hatcol DBP Phthalate, dibutyl- Phthalate, di-n-butyl RC Plasticizer DBP RCRA waste number U069 Uniflex DBP Di-n-butylester kyseliny ftalove UNII-2286E5R2KE Benzene-o-dicarboxylic acid di-n-butyl ester Benzenedicarboxylic acid dibutyl ester

Chemical Function

Solvent Plasticizer Deodorizer Fragrance

Regulatory Lists

artificial_sweat; detected; emissions; Europe; Toys and children's products Construction and building materials; detected; Europe detected; Europe; Other indirect contact consumer goods detected; Europe; Furniture and Furnishings detected; Europe; Other indirect contact consumer goods detected; Europe; Other direct contact consumer goods detected; Europe; Other direct contact consumer goods detected; Europe; Toys and children's products detected; Europe; Toys and children's products detected; Europe; Toys and children's products detected; Europe; Other direct contact consumer goods detected; Europe; Other direct contact consumer goods detected; Europe; Other direct contact consumer goods detected; New Zealand; 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

Australian Status

AICIS status: listed_with_terms

Specific information requirements: Obligations to provide information apply. These obligations are: 1. A person introducing this chemical must tell us in writing within 28 calendar days if any of the following circumstances have occurred in relation to their introduction (importation or manufacture): a. additional information becoming available on the...

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.

Compound
DIBUTYL PHTHALATE
ChEMBL ID
CHEMBL272485
Max Phase
-1
View full pharmaceutical profile →

Frequently Asked Questions

Is Dibutyl Phthalate (DBP) safe in cosmetics?

Dibutyl Phthalate (DBP) has a safety rating of "POOR" in our database. EU status: prohibited. US status: permitted. 3 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is Dibutyl Phthalate (DBP) allowed in the EU?

Dibutyl Phthalate (DBP) EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Dibutyl Phthalate (DBP) do in cosmetics?

Dibutyl Phthalate (DBP) functions as: Plasticizer, film flexibility agent for nail polish. It is classified as a cosmetic ingredient in our database. CAS number: 84-74-2.

What is the NOAEL for Dibutyl Phthalate (DBP)?

The NOAEL (No Observed Adverse Effect Level) for Dibutyl Phthalate (DBP) is 152 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 3 study endpoints are available. Source: COSMOS_DB.

Is Dibutyl Phthalate (DBP) used outside cosmetics?

Dibutyl Phthalate (DBP) also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does Dibutyl Phthalate (DBP) have different safety status in cosmetics vs industrial chemicals?

Dibutyl Phthalate (DBP) is prohibited in EU cosmetics but has active industrial GHS classifications (H360, H400, H317, H335, H372, H411, H360Df, H370).

Is Dibutyl Phthalate (DBP) in Your Products?

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