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Essential data for a complete dossier

This dossier provides essential data for the derivation of EQS, including valid and referenced information at European/international levels. It covers physico-chemical properties, (eco)toxicological data for QSwater_eco and QSbiota_secpois, as well as quality standards for human health (QSbiota_hh and QSdw_hh). Contact INERIS for further information.

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Essential data for a complete dossier

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  1. Essential datafor a complete dossier so that this dossier can also be a strong basis for the derivation of EQS

  2. Validity and sources of data • All data shall be quoted with exact and complete bibliographic reference, and the level of validation. • All data presented shall be validated: • at a European and/or international level (EU, OECD, US-EPA, etc.) OR • by the Stakeholderspresenting the data • Any new data not validated at a European/international level but deemed to be of good quality and usable for the derivation of the EQS shall be reported, underlined and quoted, including the acceptance by any national program associated to a Klimisch code (Klimisch et al., 1997) Klimisch, H. J., M. Andreae, et al. (1997). "A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data." Regulatory Toxicology and Pharmacology 25: 1-5.

  3. Physico-chemical properties: • Solubility/Lipophility (KOW) [experimental/calculated – QSAR used, reference] • Adsorption capacity (KOC) [experimental/calculated – QSAR used, reference] • Bioaccumulation (BCF) [experimental/calculated – QSAR used, reference] • Biomagnification (BMF1, BMF2) [experimental / default value]

  4. (Eco)toxicological datafor derivation of QSwater_eco • (If available) Ecotoxicological data necessary for derivation of a PNEC -> an EQS, i.e. • at least: • 1 acute ecotoxicity data on algae [ • 1 acute ecotoxicity data on invertebrates (crustaceans) • 1 acute ecotoxicity data on fish • If possible: • As many chronic data as possible [For all data, report : species, duration of the test, effect and no effect concentration, validation status, reference]

  5. Toxicological datafor derivation of Quality standards for protection of human health • At least 1 NOAEL or NOEC for derivation of QSbiota_secpois • (If available) a toxicological reference value to evaluate the impact of the substance on mammalian species and the human, e.g.: • (Acute) Reference Dose ((A)RfD) • Tolerable/Acceptable Daily Intake (TDI/ADI) • Minimal Risk Level (MRL) The most secure data shall be underlined in order to be used for the derivation of the QSbiota_hh • Any (regulatory) standard for water intended for human consumption for derivation of QSdw_hh [For all data, report : species, duration of the test, dose, effect and no effect concentration, validation status, reference]

  6. Do you have questions ? Contact INERIS: Alice James (alice.james@ineris.fr) Sandrine Andres (Sandrine.ANDRES@ineris.fr)

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