Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Administrative data

Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Data waiving:
exposure considerations
Justification for data waiving:
other:

Description of key information

Long-term studies with aquatic invertebrates are not required based on exposure considerations.

Chronic testing on aquatic invertebrates is currently ongoing for the read-across substance OMC. As soon as all results are available, the chronic data will be included in this dossier for IMC.

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.