PBT profiling of pre-registered substances – by QSAR ... - REACh
PBT profiling of pre-registered substances – by QSAR ... - REACh
PBT profiling of pre-registered substances – by QSAR ... - REACh
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Toxicity Assessment<br />
• Criteria<br />
<strong>–</strong> NOEC < 0.01 mg/l<br />
<strong>–</strong> Substance classified as CMR<br />
<strong>–</strong> Other evidence <strong>of</strong> chronic toxicity<br />
• Screening criteria<br />
<strong>–</strong> Acute aquatic Toxicity < 0.1<br />
<strong>–</strong> Avian Toxicity < 30mg/kg food<br />
• Role <strong>of</strong> Non-testing data<br />
<strong>–</strong> “<strong>QSAR</strong> models seem not to be applicable for the definitive<br />
assessment <strong>of</strong> the T criteria”<br />
<strong>–</strong> at a screening level can be performed using data obtained from<br />
<strong>QSAR</strong>’s for acute aquatic toxicity<br />
P<br />
B<br />
T<br />
ECHA: Guidance on Information requirements and safety assessment, (R11) <strong>PBT</strong> assessment<br />
Applicability domain<br />
Applicability domain<br />
P EPISUITE Biowin N = 295<br />
B CAESAR N =466<br />
T DSSTOX N =585<br />
PRS-<br />
Inventory<br />
Organic Substances<br />
Merged<br />
N = 62.000 <strong>substances</strong><br />
11<br />
12