Moderate Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed Sensitization Data

Hexyl Salicylate

INCI: HEXYL SALICYLATE

CAS Number
6259-76-3
Function
Fragrance ingredient with sweet, floral, fruity odour
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 2% hydroalcoholic fragrances, 0.5% rinse-off, 0.3% leave-on, 0.001% oral care
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted โ€” no specific 21 CFR 700 restriction currently in force

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Hexyl Salicylate. 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 =75 mg/kg/day oral rat developmental SCCS
NOAEL 180 mg/kg bw/day - - reproductive SCCS_PDF_extraction
NOAEL 75 mg/kg bw/day oral - - SCCS_PDF_extraction
NOAEL 1127 mg/kg bw/day oral - - SCCS_PDF_extraction
NOAEL 1000 mg/kg bw/day oral - - SCCS_PDF_extraction
NOAEL 370 mg/kg bw/day - - - SCCS_PDF_extraction
NOAEL 540 mg/kg bw/day - - reproductive SCCS_PDF_extraction
NOAEL 75 mg/kg bw/day - - - SCCS_PDF_extraction
NOAEL 180 mg/kg bw/day - - reproductive SCCS_PDF_extraction
NOAEL 75 mg/kg bw/day oral - - SCCS_PDF_extraction

Safety Opinions

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

sccs SCCS/1658/23 28 February 2024
Verdict: safe
NOAEL: 180 mg/kg bw/day (not specified)
Max Concentration: 0.5% in oral care

ed to potential endocrine disrupting properties, the SCCS considers Hexyl Salicylate safe when used up to the maximum concentrations as provided in Table 1 of this Opinion. Product type, Body parts Maximum concentration (% w/w) Hydroalcoholic-based fragrances 2 All Rinse-off prod

sccs SCCS/1658/23 28 February 2024
Verdict: safe
NOAEL: 75 mg/kg bw/day (oral)
Max Concentration: 0.5% in oral care

ed to potential endocrine disrupting properties, the SCCS considers Hexyl Salicylate safe when used up to the maximum concentrations as provided in Table 1 of this Opinion. Product type, Body parts Maximum concentration (% w/w) Hydroalcoholic-based fragrances 2 All Rinse-off prod

sccs SCCS/1658/23 28 February 2024
Verdict: safe
NOAEL: 1127 mg/kg (oral)
Max Concentration: 0.5% in oral care

ed to potential endocrine disrupting properties, the SCCS considers Hexyl Salicylate safe when used up to the maximum concentrations as provided in Table 1 of this Opinion. Product type, Body parts Maximum concentration (% w/w) Hydroalcoholic-based fragrances 2 All Rinse-off prod

sccs SCCS/1668/24 25 October 2024
Verdict: safe
NOAEL: 180 mg/kg bw/day (not specified)
Max Concentration: 0.5% in oral care

ncluding potential endocrine disrupting effects, the SCCS considers Hexyl Salicylate safe for children up to 3 years old when used up to the maximum concentrations as below: o 0.1 % (w/w) for shower gel, hand soap, shampoo, hair conditioner, body lotion, face cream, hand cream, lips

sccs SCCS/1668/24 25 October 2024
Verdict: safe
NOAEL: 75 mg/kg bw/day (oral)
Max Concentration: 0.5% in oral care

ncluding potential endocrine disrupting effects, the SCCS considers Hexyl Salicylate safe for children up to 3 years old when used up to the maximum concentrations as below: o 0.1 % (w/w) for shower gel, hand soap, shampoo, hair conditioner, body lotion, face cream, hand cream, lips

SCCS NOAEL Values

NOAEL/LOAEL values cited in official SCCS opinions for Hexyl Salicylate.

NOAEL LOAEL Route Species Study DA% (SCCS) Opinion
75 mg/kg/day 165 mg/kg/day Oral Rat (Wistar) Developmental toxicity (read-across from salicylic acid) (GD 8-14 (gestational days)) 100 SCCS/1658/23 (2024)

Sensitization Profile

Contact sensitization data for Hexyl Salicylate based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
fragrance
EU Allergen Listed
yes
Patch Test Positive Rate
0.2%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis
IFRA Restricted

Source: EU 2023/1545; SCCS

Expert Verdict

Restricted ingredient with toxicity for reproduction (Category 2 suspected) and skin sensitization (Category 1); potential endocrine disrupting properties under evaluation with concentration limits applied across product categories.

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Concern Level: High

Regulatory Flags

fragrance-component epa_safer_alternative ifra_fragrance

Frequently Asked Questions

Is Hexyl Salicylate safe in cosmetics?

Restricted ingredient with toxicity for reproduction (Category 2 suspected) and skin sensitization (Category 1); potential endocrine disrupting properties under evaluation with concentration limits applied across product categories. The EU classifies Hexyl Salicylate as "restricted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is Hexyl Salicylate allowed in the EU?

Hexyl Salicylate EU regulatory status: restricted. Maximum allowed concentration: 2% hydroalcoholic fragrances, 0.5% rinse-off, 0.3% leave-on, 0.001% oral care. This is based on EU Regulation 1223/2009 and its amendments.

What does Hexyl Salicylate do in cosmetics?

Hexyl Salicylate functions as: Fragrance ingredient with sweet, floral, fruity odour. It is classified as a cosmetic ingredient in our database. CAS number: 6259-76-3.

What is the Margin of Safety for Hexyl Salicylate?

adequate 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 Hexyl Salicylate?

The NOAEL (No Observed Adverse Effect Level) for Hexyl Salicylate is =75 mg/kg/day based on a developmental study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS.

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