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
Benefits
- 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.