Also known as: 1,2-Benzenedicarboxylic acid, butyl phenylmethyl ester, Benzyl butylphthalate, BRN 2062204, Butyl phenylmethyl 1,2-benzenedicarboxylate, Caswell No. 125G (+8 more)
INCI: BUTYL BENZYL PHTHALATE
Butyl Benzyl Phthalate (CAS 85-68-7) is a cosmetic cosmetic ingredient functioning as Plasticizer; historically used in nail polish; not a standard cosmetic. NOAEL 2 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.
US NotesProhibited substance; no safe use level established for cosmetics
For full compliance data across multiple jurisdictions, use the
Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Butyl Benzyl Phthalate.
Calculate MoS for your specific formulation with the
MoS Calculator.
Toxicological Studies
7 study endpoints found for Butyl Benzyl Phthalate. 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
=180 mg/kg bw/day
oral
Rat
Toxicology study
INCHEM_WHO_cicads_cicads_cicad17
NOAEL
=217 mg/kg bw/day
oral
-
Toxicology study
INCHEM_WHO_cicads_cicads_cicad17
NOAEL
=446 mg/kg bw/day
oral
-
Reproductive toxicity
INCHEM_WHO_cicads_cicads_cicad17
NOAEL
=1852 mg/kg bw/day
oral
Dog
Subchronic toxicity
INCHEM_WHO_cicads_cicads_cicad17
NOAEL
=1973 mg/kg bw/day
oral
Dog
Subchronic toxicity
INCHEM_WHO_cicads_cicads_cicad17
NOAEL
=1500 mg/kg bw/day
oral
Rat
repeat dose other
ToxValDB_ECHA_IUCLID
NOAEL
=3000 mg/kg bw/day
oral
Rat
repeat dose other
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
Verdict: unknown
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Butyl Benzyl Phthalate across SCCS product categories, with measured dermal absorption where available.
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
3
Volume
Sup 7, 73
Evaluation Year
1998
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; Aquatic Chronic 1
Hazard Statements
H360Df
H400Very toxic to aquatic life
H410Very toxic to aquatic life with long lasting effects
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 %
3.6%
DPRA Lys %
0.1%
KeratinoSens IC50
4000 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.
ConfirmedEvidence: High(2017)
Health effects:Yes
Affected pathways:Anti-androgenic, Estrogenic
Regulatory framework:REACH
Source list: I
Cosmetic-Specific Mechanism
Category:phthalate
Receptor targets:ERα, AR, PPARγ
LOEC:1 µM
EU status:banned (CMR 1B); SVHC REACH (health + env)
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1 - 10 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) - human health)
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1152
(EC) 2009/1223
CMR:Reprotoxic Cat. 1B()
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: 1152
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (1)
Jurisdiction
Status
Max %
Product Type
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 (8)
Carcinogen Classification
3, not classifiable as to its carcinogenicity to humans. (L135)
Source: Toxin and Toxin Target Database (T3DB)
Carcinogen Classification
Butyl benzyl phthalate | Group 3: Not classifiable as to its carcinogenicity to humans | Volume Sup 7: Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42, 1987; 440 pages; ISBN 92-832-1411-0 (out of print) | Volume 73: (1999) Some Chemicals that Cause Tumours of the Kidney or Urinary Bladder in Rodents and Some Other Substances
Source: International Agency for Research on Cancer (IARC)
Carcinogen Classification
Butyl Benzyl Phthalate | TR-458: Toxicology and Carcinogenesis Studies of Butyl Benzyl Phthalate (CASRN 85-68-7) in F344 Rats (Feed Studies) (1997 ) | 06/20/95 | Some Evidence | Equivocal Evidence | Chemical Not Tested in Species/Sex | Chemical Not Tested in Species/Sex | Under the conditions of this 2-year feed study, there was some evidence of carcinogenic activity of butyl benzyl phtha
Source: NTP Technical Reports
Carcinogen Classification
Butyl benzyl phthalate | TR-213: Carcinogenesis Bioassay of Butyl Benzyl Phthalate (CASRN 85-68-7) in F344/N Rats and B6C3F1 Mice (Feed Study) (1982 ) | 06/23/81 | Inadequate Experiment | Clear Evidence | No Evidence | No Evidence | Under the conditions of this bioassay, butyl benzyl phthalate was probably carcinogenic for female F344/N rats, causing an increased incidence of mononuclear
Source: NTP Technical Reports
Evidence for Carcinogenicity
CLASSIFICATION: C; possible human carcinogen. BASIS FOR CLASSIFICATION: Based on statistically significant increase in mononuclear cell leukemia in female rats; the response in male rats was inconclusive and there was no such response in mice. HUMAN CARCINOGENICITY DATA: None. ANIMAL CARCINOGENICITY DATA: Limited. | Evaluation: There is inadequate evidence in humans for the carcinogenicity of buty
Source: Hazardous Substances Data Bank (HSDB)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
PlasticizerProcessing aids not otherwise specified
Regulatory List Membership (4)
California Proposition 65 (OEHHA)EU Banned in CosmeticsFDA Indirect Food Contact AdditivesEU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Butyl Benzyl Phthalate.
Construction and building materials; detected; Europedetected; Europe; Furniture and FurnishingsEurope; nondetect; Other indirect contact consumer goodsdetected; New Zealand; Toys and children's productsArts and crafts/Office supplies - children's art and toys - modeling clay; detecteddetected; Toys and children's productsEurope; nondetect; Toys and children's productsEurope; nondetect; Other direct contact consumer goodsEurope; nondetect; Toys and children's productsEurope; nondetect; Toys and children's productsEurope; nondetect; Other direct contact consumer goodsEurope; nondetect; Other direct contact consumer goodsEurope; nondetect; Other direct contact consumer goodsdetected; Toys and children's productsdetected; Toys and children's productsnondetect; Toys and children's productsnondetect; Toys and children's productsnondetect; 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.
SOURCEChEMBL / DrugCentral / FAERSDB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Butyl Benzyl Phthalate has a safety rating of "POOR" in our database. EU status: prohibited. US status: prohibited. 7 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.
Is Butyl Benzyl Phthalate allowed in the EU?
Butyl Benzyl Phthalate EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Butyl Benzyl Phthalate do in cosmetics?
Butyl Benzyl Phthalate functions as: Plasticizer; historically used in nail polish; not a standard cosmetic ingredient. It is classified as a cosmetic ingredient in our database. CAS number: 85-68-7.
What is the NOAEL for Butyl Benzyl Phthalate?
The NOAEL (No Observed Adverse Effect Level) for Butyl Benzyl Phthalate is =180 mg/kg bw/day based on a Toxicology study study via oral route in Rat. A total of 7 study endpoints are available. Source: INCHEM_WHO_cicads_cicads_cicad17.
Is Butyl Benzyl Phthalate used outside cosmetics?
Butyl Benzyl Phthalate 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 Butyl Benzyl Phthalate have different safety status in cosmetics vs industrial chemicals?
Butyl Benzyl Phthalate is prohibited in EU cosmetics but has active industrial GHS classifications (H360, H400, H410, H360Df, H303, H315, H320, H335).
Compliance Tools
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