Addendum to the Scientific Opinion on Hexyl Salicylate: Children’s Exposure (Ages 0–3 Years)

This addendum addresses the safety of Hexyl Salicylate, focusing specifically on exposure and safety for children aged 0–3 years. Hexyl Salicylate is a chemical commonly used in cosmetic products and other consumer goods.

1. Chemical and Physical Specifications:

• Chemical Identity:
• Details the chemical name, physical form, molecular weight, and purity of Hexyl Salicylate.
• Composition and Substance Codes:

Includes information on substance codes, impurities, and composition.

• Physical and Chemical Properties:

Covers solubility, partition coefficient, and additional specifications.

2. Exposure Assessment and Toxicokinetics:

• Function and Uses:

Assesses the role of Hexyl Salicylate in products and its usage.

• Dermal/Percutaneous Absorption:

Reviews studies on how the chemical is absorbed through the skin.

• Toxicokinetics:

Includes calculations of Systemic Exposure Dose (SED) and Local Exposure Dose (LED).

3. Toxicological Evaluation:

• Irritation and Corrosivity:

Evaluates potential irritation and corrosive effects.

• Skin Sensitization:

Assesses the potential for causing allergic reactions.

• Acute and Repeated Dose Toxicity:

Covers short-term and long-term toxicity.

• Reproductive Toxicity:

Examines potential effects on reproduction.

• Endocrine Disrupting Effects:

Investigates potential hormonal disruptions.

• Mutagenicity/Genotoxicity:

Looks at genetic and mutagenic effects.

• Carcinogenicity:

Assesses cancer risk.

• Photo-Induced Toxicity:

Evaluates potential toxicity when exposed to light.

• Human Data and Special Investigations:

Includes any available data on human exposure and special studies.

4. Safety Evaluation:

• Margin of Safety (MoS):

Calculation of the safety margin based on the available data.

• Safety Discussion:

Provides an overall assessment of the safety of Hexyl Salicylate.

5. Conclusion:

• Summary of Findings:

Concludes with the key findings of the assessment.

• Minority Opinions:

Includes any dissenting opinions or additional considerations.

6. References and Appendices:

• References:

Lists the literature and data sources used in the assessment.

• Appendices:

Provides detailed data and search results relevant to the toxicological evidence.

Request Information for this Addendum:

• Usage in Cosmetics:

Hexyl Salicylate is used as a fragrance ingredient in various consumer goods, including cosmetics, and is not currently restricted under the EU Cosmetic Regulation.

• European Risk Assessment Committee (RAC) Proposals:

RAC has proposed classifying Hexyl Salicylate as ‘Toxic for Reproduction Category 2’ and ‘Skin Sensitizer Category 1.’

• Previous Evaluations:

Evaluations of related compounds, such as salicylic acid and methyl salicylate, have been conducted by SCCS.

• Stakeholder Dossier (December 2022):

A dossier was submitted claiming safe use for adults but lacking data for children under 3 years.

• Additional Information (May 2024):

Further information was provided to address the safety of Hexyl Salicylate for children below 3 years.

• European Commission Request:

The European Commission has requested SCCS to assess the safety of Hexyl Salicylate for young children and identify any additional scientific concerns.

Source: “https://health.ec.europa.eu/document/download/7aa2f176-65af-494f-883e-3cf578b46cee_en?filename=sccs_o_290.pdf
https://health.ec.europa.eu/publications/sccs-addendum-scientific-opinion-hexyl-salicylate-sccs165823-casec-no-6259-76-3228-408-6-children_en“

Region: European Union