(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione

Toxicity to soil microorganisms

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil microorganisms

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Description of key information

The study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely, see column 2 of REACH Annex IX, point 9.4.

Moreover, LL-lactide is rapidly hydrolysed to lactic acid. Lactic acid is therefore the only relevant species in the environment. Lactic acid is practically non-toxic to aquatic organisms. Corrected for the pH effect, no hazard was identified for lactic acid/lactate. This can be safely extrapolated to the terrestrial compartment.

Therefore, based on the chemical safety assessment according to Annex I, testing of short-term toxicity to soil microorganisms is not required.

Additional information

Lactic acid is readily biodegradable (see 5.2.1) and is a ubiquitous and essential molecule of life. It will not adsorb to soil (see 5.4.1). Accordingly, there is no relevance in the hazard assessment for soil organisms. Since LL-lactide undergoes immediate hydrolysis in contact with water, forming lactic acid, this is the moiety of interest by read-across. According to REACH Annex IX, point 9.4, short-term toxicity to soil microorganisms can be assessed by the equilibrium-partitioning method if no terrestrial data are available. Lactic acid is practically non-toxic to aquatic organisms. Corrected for the pH effect, no hazard was identified for lactic acid/lactate. This can be safely extrapolated to the terrestrial compartment. Therefore, based on the chemical safety assessment according to Annex I, testing of short-term toxicity to soil microorganisms is not required.