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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

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