One component of the complex and time-consuming KKDİK (Turkish REACH) Registration process is the creation and submission of a technical dossier to the MoEU. There are two kinds of registration: individual submission and joint submission. The registration dossier should include: physicochemical, toxicological, ecotoxicological properties of substances, human and environmental exposure, intended uses, classification and labelling, and proposed risk management measures.
Main KKDİK Registration Technical Dossier Services
KKDİK (Turkish REACH) Technical Dossier data gap analysis,
Consulting support from LISAM KKDİK chemical safety assessors,
SIEF and Consortia Management when needed,
Perform literature searches to locate available data on substances of interest,
Evaluate existing study reports and rate according to Klimisch criteria,
Analyze available data against the KKDİK requirements to identify key studies and any gaps,
Confirm key studies and prepare robust and endpoint summaries for KKS,
Develop Derived-No-Effect-Levels (DNELS),
Fill any gaps using scientific strategies that may include the use of: KKDİK testing, Exposure Scenarios, waiver arguments, (Q)SARs and extrapolation, read-across data,
Creation of IUCLID 5 Dossier and Submission of completed KKDİK Registration Dossier to MoEU,
In the checklist above, do you have three or more answers? Lisam Systems is the solution you are looking for!