Moderate Cosmetic Ingredient NOAEL Data GHS Classified SCCS/CIR Reviewed

DIBUTYL PHTHALATE

CAS Number
84-74-2
Function
Fragrance, Perfuming, Plasticiser, Solvent
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status Restricted
EU Max Conc. II/675
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR: S - IJT 36(Suppl 2):14-58, 2017

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Toxicological Studies

10 study endpoints found for DIBUTYL 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 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

DIBUTYL PHTHALATE is listed in the EU CosIng database with functions: Fragrance, Perfuming, Plasticiser, Solvent It is restricted under EU Cosmetics Regulation. Restriction: II/675.

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Concern Level: Medium

Regulatory Flags

cosing-sourced eu-restricted fragrance needs-enrichment endocrine_disruptor prop65 eu_banned_cosmetics ifra_fragrance eu_cosing_listed

Frequently Asked Questions

Is DIBUTYL PHTHALATE safe in cosmetics?

DIBUTYL PHTHALATE is listed in the EU CosIng database with functions: Fragrance, Perfuming, Plasticiser, Solvent It is restricted under EU Cosmetics Regulation. Restriction: II/675. The EU classifies DIBUTYL PHTHALATE as "Restricted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is DIBUTYL PHTHALATE allowed in the EU?

DIBUTYL PHTHALATE EU regulatory status: Restricted. Maximum allowed concentration: II/675. This is based on EU Regulation 1223/2009 and its amendments.

What does DIBUTYL PHTHALATE do in cosmetics?

DIBUTYL PHTHALATE functions as: Fragrance, Perfuming, Plasticiser, Solvent. It is classified as a cosmetic ingredient in our database. CAS number: 84-74-2.

What is the NOAEL for DIBUTYL PHTHALATE?

The NOAEL (No Observed Adverse Effect Level) for DIBUTYL PHTHALATE 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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