Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Toxicity studies on soil organisms covering invertebrates, micro-organisms and plants have been carried out on the registered substance. The soil toxicity data have been used in the chemical safety assessment to establish PNECsoil.

The observed LC50 from the acute earthworm test (OECD 207) was 127.8 mg/kg soil dw. Chronic or long-term toxicity testing on soil microorganisms (OECD 216) and terrestrial plants (OECD 208 with six species, two monocotyledonous and four dicoyledonous) gave respectively a NOEC of ≥500 mg/kg soil dw and EC10 of 89.3 mg/kg soil dw (tomato, most sensitive species). PNECsoil based on EC10 of 89.3 mg/kg soil dw from long-term toxicity to plants (lowest long-term toxicity value from two trophic levels). Both long-term terrestrial toxicity studies were performed in a Speyer 2.3 soil with soil Organic Carbon content of 0.67%. The standard assumption for soil Organic Carbon content is a default of 2 %. The PNEC for terrestrial organisms has, therefore, been normalised to take in to account the soil Organic Carbon content and assessment factor of 50 from Table R.10-10 of the ECHA Guidance on information requirements and chemical safety assessment Chapter R.10.  According to ECHA guidance (Chapter R.7c, section R. where data from chronic or long-term tests are available, they should be used in preference to short-term tests to derive the PNEC.  A PNECsoil of 5.33 mg/kg soil dw. This value leads to PECsoil/PNEC soil < 1.

Given that the outcome of the chemical safety assessment demonstrates safe use of the substance to the terrestrial compartment, additional long-term testing is not considered to be necessary.