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Long-term toxicity to fish

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fish early-life stage toxicity
Data waiving:
exposure considerations
Justification for data waiving:

Description of key information

Long-term fish studies are not required based on exposure considerations.

A chronic fish test is available for the read-across substance OMC (NOEC = 30 mg/L). This test will be included in this IMC dossier as soon as the chronic data for the other trophic levels (invertebrates, lemna) are available as well.

As the currently derived PNEC based on the alge ErC50 of 0.2 mg/L with an assessment factor of 1000 (PNECfreshwater = 0.2 µg/L) is lower than the PNEC derived when including the NOEC of 30 µg/L with an assessment factor of 50 (PNEC freshwater = 0.6 µg/L), the current PNEC is used as worst case for now.

Key value for chemical safety assessment

Additional information

According to Regulation (EC) 1907/2006, Annex IX, column 2 long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. As the chemical safety assessment shows no need to investigate further the potential effects on aquatic organisms, performing long-term toxicity tests is not required.

Long-term toxicity testing is not needed, because there is no risk indicated from the chemical safety assessment (CSA). According to endpoint specific guidance R.7B (p.50), the CSA indicates a need to investigate long-term effects on aquatic organisms if the PEC/PNEC > 1, or for substances with log KOW>3 (or BCF >100) if a PEClocalor PECregional>1/100th of the water solubility.

For isopentyl p-methoxycinnamate both conditions are not fulfilled.