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Table 6 Main elements of our proposal for a harmonized assessment of toxicity across regulatory frameworks

From: Proposal for a harmonised PBT identification across different regulatory frameworks

 

Toxicity

Definitive assessment

Screening assessment

Criteria

NOEC (long-term) < 0.01 mg/L, marine or freshwater species

≥1 value for acute LC50/EC50 < 0.1 mg/L: potentially toxic

CMR substances

Acute LC50/EC50 values < 0.01 mg/L: toxic

Other evidence of chronic toxicity

Proposal

Other information to consider

Other information to consider

 NOEC ≤ 30 mg/kg food, birds and mammals

 QSAR

 Long-term tests on terrestrial organisms

 Read-across from structurally related substances.

 High log KOW: sediment-dwelling species tests

 Information from non-standard aquatic studies and endpoints

 Endocrine-disrupting potential

  1. The T criteria for definitive and screening assessments is included.