Registration Dossier

Diss Factsheets

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. Therefore, accumulation and persistence of the registered substance in soil and organisms is very unlikely and the aquatic acute EC50/LC50 values are > 1 mg/L..

However, a chronic earthworm study from a read across substance is available. The NOEC is 104 mg/kg dw. The read across is justified since the the target substance has a lower ecotoxicity (about a factor of 2) than the source substance. Further information is provided in the read across justification documents.

The NOEC value from the earthworm study will be used for the risk assessment. Based on the substance characteristics, it can be concluded that further terrestrial tests are not needed.