Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

The Guidance on information requirements and chemical safety assessment, Chapter R.7C: Endpoint specific guidance (November 2014), section R. 7.11.6.3, Table R.7.11-2, page 145, specifies the information needed to waive the terrestrial studies based on soil hazard categories.

The log Pow of the registered substance is <3 and the toxicity to aquatic organisms is low. Furthermore, the substance is ready biodegradable. Therefore, accumulation and persistence of the registered substance in soil and organisms is very unlikely. A PNEC soil was calculated using the aquatic PNEC and the equilibrium partitioning method. Based on these characteristics, the registered substance is not expected to cause adverse effects on terrestrial organisms and consequently terrestrial toxicity tests are not needed.

However, a chronic earthworm study from a read across substance is available. The NOEC is 104 mg/kg dw. Read across is justified since there is a general trend of declining ecotoxicity with increasing C-chain length and the source substance has a longer C-chain. Furthermore, the acute ecotoxicity of the target substance was lower than the ecotoxicity of the source substance. Further information is provided in the read across argumentation.

The NOEC value from the earthworm study will be used for the risk assessment.