Product Safety

 (Chemicals, Biocides, Excipients)

  • Recommending necessary toxicology programmes under consideration of existing data to meet the respective regulatory guidelines (e.g. OECD and OPPTS).

  • Assessing the need for conducting inhalation studies versus applying for a waiver.

  • Advising on study designs including selection of vehicle and target concentrations based on existing data as appropriate.

  • Recommending CRO facility based on quality, experience, timing, capacity and price.

  • Monitoring of studies from CRO quality audit, through protocol development, practical atmosphere generation and monitoring up to report review.

  • Preparation of IUCLID files


  • Ensuring a high quality standard of the performed studies with valid atmosphere data resulting in study reports being acceptable by the respective authorities
    → Meet planned schedule for registration.

  • Proposal of appropriate and taylor-made testing strategies and study designs in a ‘fit-for-purpose’ approach.
    → Selecting only relevant options and study designs for an efficient use of resources.

  • Advising on selection of appropriate target concentrations, enabling to get the best data for the test compound (maximizing safety factors).
    → Defining an optimal low NOAEC (no observed adverse effect concentration) is maximizing the probability for a less toxic classification and economic advantages against competitor(s).

  • Taking over administrative work including scheduling as required.
    → Saving time and internal costs/resources.

Collaboration with other specialists, consultants, laboratories as appropriate to the project.