Inhalation - Expert Panel Meeting Memorandum - Draft Revised Respiratory Exposure Resource Document - 12/2024

Aug 23, 2026

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Memorandum prepared for the Expert Panel for Cosmetic Ingredient Safety outlines a draft revised Respiratory Exposure to Cosmetic Ingredients resource document focused on inhalation risk from spray products and loose powders. Revisions incorporate updated particle size distribution data, including propellant-based sprays such as dry shampoos, and expand sample exposure calculations against occupational permissible exposure limits. The document revises inhalation boilerplate to cover pump versus propellant products, emphasizes realistic-use particle sizing, considers TTC approaches and regional deposition tools, addresses interspecies differences, and raises concerns about nanoparticle exposures.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages158

Reading Time6 h 38 min

AccessFree to download

Memorandum for the Expert Panel

Purpose and scope of the revised resource document

Background on inhalation exposure and respiratory tract considerations

Updates to inhalation boilerplate and data incorporation

Review request and next steps for panel consideration

ADMIN Inhalation EXPERT PANEL MEETING December 2-3, 2024 Commitment & Credibility since 1976 Memorandum To: Expert Panel for Cosmetic Ingredient Safety Members and Liaisons From: Jinqiu Zhu, PhD, DABT, ERT, DCST, CIR Toxicologist Date: November 8, 2024 Subject: Draft Revised Respiratory Exposure to Cosmetic Ingredients Resource Document Enclosed is an updated draft of the Resource Document – Respiratory Exposure to Cosmetic Ingredients (report_InhalationDocument_ 122024), along with the transcripts from previous Panel discussions (transcripts_InhalationDocument_ 122024) . The Panel last approved the Document at the December 2021 meeting. Subsequent revisions were made at the December 2023 meeting to incorporate additional particle size data in some types of propellant-based sprays, such as dry shampoos in powdered galenic formulations. These findings highlighted the necessity to modify the inhalation boilerplate (BP) to more accurately reflect the Panel's perspective on the associated inhalation risks. At the September 2024 meeting, the Panel reviewed a Strategy Memo concerning updates to the Inhalation BP and discussed the required context for its application in the report. The Panel then requested updates to both the inhalation BP and the Respiratory Exposure Resource Document, aiming to clarify the rationale behind the changes and to better represent the Panel’s understanding of exposure to airborne particles/droplets from various cosmetic sprays, along with the associated health risks. The updated Document includes additional sample exposure calculations for dry shampoo and propellant deodorant, incorporating the latest particle size distribution data and comparing the results with permissible exposure limits in occupational settings. Additionally, the revisions expand on various aspects including measurement under realistic usage scenarios, the potential use of Threshold of Toxicological Concern (TTC) approaches, tools for assessing regional particle deposition, the examination of interspecies differences in predicting human effects, and concerns about nanoparticle exposures. The inhalation BP has been revised to accommodate different types of spray products (e.g., pump vs. propellant), and highlights the importance of measuring particle size distribution under realistic usage scenarios for accurate exposure estimate and inhalation risk assessment. Importantly, it emphasizes that the Panel would review all pertinent data and, when necessary, request specific exposure and inhalation toxicity data on a case-by-case basis, especially when existing data are absent or insufficient to ensure the safety of ingredients in aerosolized products. For the Panel's review, the modifications ofthe Resource Document and Inhalation BP have been highlighted in yellow. Comments provided by the Council on the Inhalation Resource Document (submitted on November 30, 2023) and on the Strategy Memo for the Inhalation BP Revision (submitted on September 24, 2024) have been addressed (identified as Councilcomment_inhalationDocument_122014 and Councilcomment_inhalation BP_ 122024, respectively) . On October 30, 2018, the CIR Science and Support Committee (CIR SSC) submitted comments proposing a tiered approach for evaluating inhalation safety. The comments also include particle size data for aerosol hair sprays and aerosol deodorants/antiperspirants, which were measured by laser diffraction from companies that market these types of products. These comments are also included in this package for the Panel’s consideration (identified as CIRSSCcomment_2018_inhalationDocument_ 122024) . The Panel should review the revised Document to assess the relevance and applicability of the inhalation BP, and update it as necessary to align with their understanding of exposure to airborne particles/droplets from the use of spray products, and issue the document to replace the currently posted version. If there are concerns that are not a

FAQs

What prompted the revised inhalation resource document and inhalation boilerplate updates?

Subsequent revisions were made to incorporate additional particle size data for some propellant-based sprays, and the Panel reviewed a strategy memo to update the inhalation boilerplate with clearer application context.

What products and data are emphasized in the updated document?

The update includes additional sample exposure calculations for dry shampoo and propellant deodorant using the latest particle size distribution data, with comparisons to occupational permissible exposure limits.

How does the inhalation boilerplate revision support different spray product types?

It is revised to accommodate different spray product types, such as pump versus propellant, and stresses measuring particle size distribution under realistic usage scenarios for more accurate exposure and inhalation risk assessment.

Aug 23, 2026

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