Excellent Humectant NOAEL Data SCCS/CIR Reviewed

Propanediol

Also known as: Bio-PDO, NSC 65426, BRN 0969155, EINECS 207-997-3, UNII-5965N8W85T (+10 more)

INCI: PROPANEDIOL

Propanediol (CAS 504-63-2) is a cosmetic humectant functioning as Humectant; solvent; antimicrobial contributor; water activity reduction agent;. Reported NOAEL =15 mg/kg/day in rat (CIR_vision_codex); EU Regulation 1223/2009 status: permitted; 5 safety opinions 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 504-63-2 →

Auto-generated CPSR Part A draft with source citations
CAS Number
504-63-2
View industrial chemical safety profile →
Function
Humectant; solvent; antimicrobial contributor; water activity reduction agent; self-preservation contributor
Safety Rating
EXCELLENT

Chemistry & Identifiers

EC Number
207-997-3
ChEBI: CHEBI:16109 UNII: 5965N8W85T Wikidata: Q161514

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes FDA GRAS status confirmed via GRN No. 302 (September 7, 2009) for food use; no cosmetic-specific restrictions under FD&C Act. Not an OTC monograph ingredient. Fully permitted for cosmetic use without limitation.

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Propanediol.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Propanediol. 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 =15 mg/kg/day oral rat repeated dose toxicity CIR_vision_codex
NOAEL =15 mg/kg/day oral rat repeated dose toxicity CIR_vision_codex
NOAEL =15 mg/kg/day oral rat repeated dose toxicity CIR_vision_codex
NOAEL =15 mg/kg/day oral rat repeated dose toxicity CIR_vision_codex
NOAEL =23 mg/kg/day inhalation rat inhalation toxicity CIR_vision_codex
NOAEL =23 mg/kg/day inhalation rat inhalation toxicity CIR_vision_codex
NOAEL =23 mg/kg/day inhalation rat inhalation toxicity CIR_vision_codex
NOAEL =23 mg/kg/day inhalation rat inhalation toxicity CIR_vision_codex
NOAEL =50 mg/kg/day oral rat oral toxicity CIR_vision_codex
NOAEL =50 mg/kg/day oral rat oral toxicity CIR_vision_codex

Safety Opinions

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

cir
Verdict: safe
NOAEL: 200 mg/kg/day (oral)

ngredients, and concluded that seven alkane diols are safe in cosmetics in the present practices of use and concentration described in this safety assessment, but that the available data are insufficient to make a determination of safety for three ingredients, namely 1,4-Butanediol, 2,3-Bu- taned

cir
Verdict: safe
NOAEL: 400 mg/kg/day (oral)

ngredients, and concluded that seven alkane diols are safe in cosmetics in the present practices of use and concentration described in this safety assessment, but that the available data are insufficient to make a determination of safety for three ingredients, namely 1,4-Butanediol, 2,3-Bu- taned

cir
Verdict: safe
NOAEL: 1000 mg/kg/ day (oral)

ngredients, and concluded that seven alkane diols are safe in cosmetics in the present practices of use and concentration described in this safety assessment, but that the available data are insufficient to make a determination of safety for three ingredients, namely 1,4-Butanediol, 2,3-Bu- taned

cir
Verdict: safe
NOAEL: 1000 mg/kg/day (oral)

ngredients, and concluded that seven alkane diols are safe in cosmetics in the present practices of use and concentration described in this safety assessment, but that the available data are insufficient to make a determination of safety for three ingredients, namely 1,4-Butanediol, 2,3-Bu- taned

cir
Verdict: safe
NOAEL: 15 mg/kg/day (oral)

ngredients, and concluded that seven alkane diols are safe in cosmetics in the present practices of use and concentration described in this safety assessment, but that the available data are insufficient to make a determination of safety for three ingredients, namely 1,4-Butanediol, 2,3-Bu- taned

ECHA REACH Registration

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

Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No

Additional Ingredient Properties

7 property records from structured ingredient metadata.

comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "0", "skin_type_suitability": "all,oily,dry,combination,normal,acne-prone", "acne_safe": "yes", "source": "Bio-based solvent"}
pediatric_safety
{"safe_for_newborn_0_6m": "yes", "safe_for_infant_6_12m": "yes", "safe_for_toddler_1_3y": "yes", "safe_for_child_3_12y": "yes", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "10.0", "adult_max_concentration_pct": "50.0", "pediatric_dermal_absorption_factor": "normal", "diaper_area_safe": "yes", "pediatric_allergy_prevalence": "low", "banned_in_children_products_eu": "no", "bann…
regulatory
{"eu_status": "allowed", "us_status": "allowed"}
sensory
{"silky": "liquid", "smooth, glides easily": "smooth, solvent", "dry-touch, non-greasy": "hydrated, soft", "instant": "fast", "low": "low", "w/o": "o/w", "very-high": "excellent", "no": "no", "yes": "no", "1.40": "1.05", "transparent": "transparent", "colorless": "colorless", "excellent": "excellent", "light": "light", "synthetic": "botanical"}
solubility_hlb
{"water_soluble": "yes", "oil_soluble": "partial", "soluble_in": "water, ethanol, glycerin", "insoluble_in": "oils", "log_p": "-0.7", "melting_point_c": "-27", "appearance": "clear liquid", "source": "Dupont Tate & Lyle"}
synergy
{"inci_name_2": "Ethylhexylglycerin", "synergy_type": "preservation-boost", "synergy_description": "Natural solvent with booster for mild preservation", "combined_benefit": "Gentle preservation, multifunctional benefits, natural-derived", "efficacy_multiplier": "1.8x", "mechanism_of_action": "Propanediol provides mild antimicrobial activity; EHG enhances preservation", "optimal_ratio": "10:1 (3% p…
uv_stability
{"uv_stable": "yes", "uv_degradation_rate": "stable", "photosensitizer": "no", "phototoxic": "no", "photoallergic": "no", "requires_uv_protection_packaging": "no", "color_change_uv": "no", "odor_change_uv": "no", "efficacy_loss_uv_pct": "0", "spf_contribution": "no", "uva_protection": "no", "uvb_protection": "no", "photostable_sunscreen": "no", "boost_spf_of_others": "no", "antioxidant_under_uv": …

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Chemical reaction regulator Fragrance Humectant Solvent Stabilizing agent
Regulatory List Membership (2)
IFRA Fragrance Transparency List EPA Safer Chemical Ingredients List (SCIL)

Expert Verdict

Expert safety assessment and concern-level summary for Propanediol.

Regulatory Flags

eu-unrestricted cir-approved gras-fda non-sensitizing epa_safer_alternative ifra_fragrance

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Propanediol by CAS number or substance name.

Studies
40
Lowest NOAEL
15 mg/kg/day
Highest NOAEL
1000 mg/kg/day
CIR_vision_codex

Known Synonyms

Bio-PDO NSC 65426 BRN 0969155 EINECS 207-997-3 UNII-5965N8W85T (HOCH2)2CH2 2-(hydroxymethyl)ethanol CH2(CH2OH)2 HO(CH2)3OH HOCH2CH2CH2OH beta-propylene glycol omega-propanediol Susterra Zemea Zemea propanediol

Chemical Function

Fragrance Chemical reaction regulator Solvent Stabilizing agent Humectant

Regulatory Lists

IFRA Transparency SCIL (9/2019) Canada; pharmaceutical

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.

Compound
1,3-PROPANEDIOL
ChEMBL ID
CHEMBL379652
View full pharmaceutical profile →

Frequently Asked Questions

Is Propanediol safe in cosmetics?

Propanediol has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is Propanediol allowed in the EU?

Propanediol EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Propanediol do in cosmetics?

Propanediol functions as: Humectant; solvent; antimicrobial contributor; water activity reduction agent; self-preservation contributor. It is classified as a Humectant in our database. CAS number: 504-63-2.

What is the NOAEL for Propanediol?

The NOAEL (No Observed Adverse Effect Level) for Propanediol is =15 mg/kg/day based on a repeated dose toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: CIR_vision_codex.

Is Propanediol used outside cosmetics?

Propanediol 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.

Compliance Tools

Check Propanediol compliance across multiple jurisdictions:

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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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