Registration Dossier

Ecotoxicological information

Long-term toxicity to fish

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Administrative data

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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.

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.