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Ecotoxicological information

Toxicity to terrestrial plants

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Reference
Endpoint:
toxicity to terrestrial plants: long-term
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Description of key information

LL-lactide is rapidly hydrolysed to lactic acid. Lactic acid is therefore the only relevant species in the environment. Lactic acid is readily biodegradable and is a ubiquitous and essential molecule of life. It will not adsorb to soil (see 5.4.1). Direct and indirect exposure of the soil compartment is unlikely, and thus the study does not need to be conducted, see column 2 of REACH Annex IX, point 9.4.

Moreover, 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 and long-term toxicity to terrestrial plants is not required.

Key value for chemical safety assessment

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 terrestrial plants. 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 Regulation Annex IX, column 2 of section 9.4, long-term toxicity to terrestrial plants 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 long-term toxicity to terrestrial plants is not required.

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