Fraunhofer Institute for Toxicology and Experimental Medicine
Fraunhofer Institute for Toxicology and Experimental Medicine

Inhalation Safety for Cosmetic Sprays and Aerosols

Your Expert Partner in Next-Generation Safety Assessment

Cosmetic sprays and aerosols require a dedicated safety assessment due to potential inhalation exposure. Fraunhofer ITEM supports cosmetic manufacturers and regulatory stakeholders with comprehensive, science-based inhalation safety solutions – from exposure characterization and human-relevant in-vitro testing to integrated risk assessment.

With decades of experience in toxicology, exposure science and regulatory risk assessment, Fraunhofer ITEM develops product-specific, guideline-compliant strategies for cosmetic sprays, perfumes and aerosols. As an active contributor to the development and international acceptance of New Approach Methodologies (NAMs), we enable modern, animal-free inhalation safety assessment and support Safe by Design product development from an early stage.

Our strengths at a glance

Aerosol exposition
© Fraunhofer ITEM, Ralf Mohr

Safe by Design

Early identification of inhalation risks to support the development of safer cosmetic products from the outset.
 

Integrated, tailored solutions

End-to-end strategies ranging from inhalation exposure measurement and in-vitro toxicology to regulatory risk assessment – customized to your specific product and use scenario.
 

Next-Generation Cosmetic Safety Assessment

Innovative exposure science, advanced human-relevant lung models and predictive in-silico tools for state-of-the-art inhalation safety evaluation.
 

Trusted by industry and authorities

Decades of recognized scientific excellence and active involvement in OECD activities, SCCS-related work, and EU-funded research projects.

Our Services

In-vitro inhalation testing

  • Human-relevant lung models including air-liquid interface (ALI) cultures, primary cells, cell lines and co-culture systems
  • Advanced exposure systems for realistic application of cosmetic sprays and aerosols
  • Quantitative dose-response studies
  • Comprehensive endpoint analysis, including cytotoxicity, genotoxicity, oxidative stress, inflammatory markers, barrier integrity, transcriptomics, and more
  • In-vitro to in-vivo extrapolation (IVIVE) and derivation of points of departure (PODs)

Inhalation exposure characterization and assessment

  • Real-world inhalation exposure measurements for cosmetic sprays and aerosols
  • Flexible model chambers with controlled and adjustable air exchange rates for reliable exposure assessment
  • Development and application of inhalation exposure models (e.g. 2-box models, ConsExpo, SprayExpo)
  • Lung dosimetry and inhalation-focused physiologically based pharmacokinetic (PBPK) modeling
  • Product-specific exposure concepts, including guideline-compliant measurements and Safe by Design optimization

Integrated inhalation safety assessment

  • Integration of exposure and toxicological data for inhalation risk characterization
  • EU-compliant exposure and safety assessments, including margin of safety calculations
  • Preparation and support of Cosmetic Product Safety Reports (CPSR)
  • Evaluation of existing data and study monitoring (e.g. product stability)
  • Use of non-animal inhalation safety approaches, including NAMs, PBPK and in-silico tools, , to support state-of-the-art regulatory dossiers and exposure modeling
  • Computational methods such as PBPK modeling, QSAR and TTC to complement experimental data