Registration Dossier

Ecotoxicological information

Toxicity to soil microorganisms

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
toxicity to soil microorganisms
Data waiving:
other justification
Justification for data waiving:
the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely
other:

Description of key information

Data waiving in accordance with REACH Annex IX, 9.4, Column 2

Key value for chemical safety assessment

Additional information

Soil microorganism toxicity is highly unlikely: two reliable tests on STP microorganism toxicity are available, covering the sensitive endpoint of nitrification. Up to the highest tested concentration of 100 mg/L, no effect on nitrification could be observed (NOEC), while only a slight inhibition of 5% was observed in the activated sludge respiration inhibition test with prolonged incubation time (7 days). According to ECHA guidance document on IR and CSA R.7c, section R.7.11.5.3, under such circumstances an additional test on soil microbial activity is not necessary. Furthermore, in accordance with REACH Annex IX, 9.4, Column 2, direct or indirect exposure of the soil compartment is unlikely and the submission substance is readily biodegradable. Furthermore, the substance is not classified according to 67/548/EEC and regulation (EU) no. 286/2011. The substance does not have a potential to bioaccumulate nor is it considered as a PBT/vPvB substance. The EPM method may be applied to assess the hazard for soil organisms.