Levoglutamide

Endpoint summary

Additional information

Toxicity to daphniae:

The toxic effect of the test item L-glutamine to Daphnia magna was assessed in a semi-static limit-test. At the nominal concentration of 100 mg/L of the test item L-glutamine, no effects were observed on Daphnia magna. The 48-hour NOEC was determined to be 100 mg test item/L. The 48-hour LOEC was determined to be > 100 mg test item/L and the 48-hour EC50 value was determined to be > 100 mg test item/L. L-Glutamine did not show short-term toxicity to Daphnia magna.

Toxicity to algae:

The toxic effect of the test item L-glutamine to Algae was assessed in a growth inhibition test. L-Glutamine was found not to inhibit the growth of the freshwater green alga Desmodesmus subspicatus after 72 hours. The NOEC-value of the test item for both inhibition of growth rate and inhibition of yield after 72 hours was 100 mg/L. The EC50-values of the test item for both inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were > 100 mg/L.

Toxicity to fish:

According to REACH Annex VIII, 9.1.3., column 2, a short-term toxicity study on fish does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur. This applies for L-glutamine, as no toxicity at the limit concentration was observed in acute toxicity studies with daphnia (according to OECD202) and algae (according to OECD201) indicating that the substance has a very low / no hazard potential for aquatic organisms. Further, as the substance (in protein) is a basic component of fish food it is very unlikely that fish in an OECD203 study exposed to limit concentrations (100 mg/l) of L-glutamine show any adverse effect. Therefore and for animal welfare reasons short-term toxicity study on fish was not conducted for the substance L-glutamine.

The toxicity of L-glutamine to fish was predicted by calculation (PNN model). The LC50 was predicted to be ca. 951.5 mg/L.

Toxicity to microorganisms:

According to Annex VIII no. 9.1.4. column 2 the study does not need to be conducted i.a. when there are mitigating factors indicating that microbial toxicity is unlikely to occur. In this case the mitigating factor is that the substance is a nutrition factor used by the microbial population in sewage treatment plants.

The results do not trigger classification for aquatic toxicity.

In respect of REACH Art. 14 in conjunction with REACH Annex I a CSA is required which includes an exposure assessment if the particular substance fulfils the criteria for any of most hazard classes or categories set out in Annex I to regulation 1272/2008 or is assessed to be a PBT / vPvB (for details see REACH Annex I, Section 0.6.3.). Annex I, Section 5.0 of the REACH Regulation states that the exposure assessment “shall cover any exposures that may relate to the hazards identified in Sections 1 to 4”.

Thus REACH requires that the exposure assessment is closely linked to the hazard assessment, which may identify hazards either for the environment, or for human health, or for both. The hazard assessment (including the classification) as well as the performance of an exposure assessment are focused either on possible effects on the environment or on possible effects on human health. L-glutamine is not hazardous for the environment, nor for human health. Thus an exposure assessment within the Chemical Safety Assessment for L-glutamine is not required.