Poor Cosmetic Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

Dibutyl Phthalate (DBP)

INCI: DIBUTYL PHTHALATE

CAS Number
84-74-2
Function
Plasticizer, film flexibility agent for nail polish
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
high
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 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
LOAEL 752 mg/kg bw/day oral rat Subchronic COSMOS_DB
LOEL 5000 ppm oral rat oral REACH
NOEL ca.400 mg/kg bw/day dermal rat dermal REACH
NOEL 5000 ppm oral mouse oral REACH
NOAEL 152 mg/kg bw/day oral rat oral REACH
NOAEL ca.600 mg/kg bw/day oral rat oral REACH
NOAEL 62.5 mg/kg bw/day oral rat oral REACH
LOAEL >=250 mg/kg bw/day oral rat oral REACH
NOAEL 152 mg/kg bw/day oral rat oral REACH

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

Expert Verdict

EU-banned CMR plasticizer since 2004. Confirmed reproductive and developmental toxin with endocrine-disrupting activity. Dermal penetration documented with detection in blood, breast milk, and umbilical cord blood confirming fetal exposure. US lacks federal restriction and relies on unreliable brand self-reporting. Recommend avoiding entirely; acetyl tributyl citrate (ATBC) is a safer replacement.

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Concern Level: High

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

Frequently Asked Questions

Is Dibutyl Phthalate (DBP) safe in cosmetics?

EU-banned CMR plasticizer since 2004. Confirmed reproductive and developmental toxin with endocrine-disrupting activity. Dermal penetration documented with detection in blood, breast milk, and umbilical cord blood confirming fetal exposure. US lacks federal restriction and relies on unreliable brand self-reporting. Recommend avoiding entirely; acetyl tributyl citrate (ATBC) is a safer replacement. The EU classifies Dibutyl Phthalate (DBP) as "prohibited". Safety rating: POOR. 10 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 Margin of Safety for Dibutyl Phthalate (DBP)?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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 10 study endpoints are available. Source: COSMOS_DB.

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