CSA & SIEF
Information requirements for test studies used for CSA and in SIEF
All available information that has been gathered on a substance needs to be assessed for its adequacy for classification and labelling, determination of PBT or vPvB status and the derivation of a dose descriptor to be used in the chemical safety assessment (CSA). The information should be evaluated for its completeness (does the available information meet the information required under REACH) and quality (relevance, reliability and adequacy). Cost for data sharing is one of the crucial issues of negotiations in SIEFS. High quality data outsell a higher price than data of low quality. The objective of assessing data quality orientates to the REACH requirements.
TÜV SÜD validates existing test studies for completeness and reliability.
Reliability is the inherent quality of a test report or a publication relating to preferably standardized methodology and the way the experimental procedure and results are described to give evidence of the clarity and plausibility of the findings. It is important to distinguish between reliable methods and reliable information.
The Klimisch code consists of 4 reliability categories:
1 Reliable without restrictions
2 Reliable with restrictions
3 Not reliable
4 Not assignable
If necessary, we give recommendations for closing data gaps. Our target is to use as much information as possible from existing test studies by e.g. applying
- (Q)SAR
- read across
- grouping approaches
and in case of human data
- analytical epidemiology studies on exposed populations
- case reports
- descriptive or correlation epidemiology studies (If acceptable)
- controlled studies in human volunteers (if acceptable).
