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Long-term toxicity to aquatic invertebrates

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Description of key information

The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to further investigate the long-term toxicity to aquatic invertebrates.

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According to Annex IX of Regulation (EC) No 1907/2006 a long-term toxicity test on aquatic invertebrates does not need to be conducted if the chemical safety assessment of a substance indicates the no need for a further investigation of the effects on aquatic organisms. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or is assessed to be a PBT or vPvB. The hazard assessment of Glycine indicates no need to either classify the as dangerous to the environment, nor is glycine a PBT or vPvB substance. Thus long-term toxicity tests on aquatic invertebrates are neither provided nor deemed necessary.

Glycine is readily biodegradable; therefore it is not likely that aquatic organisms are exposed to the test substance since it will be ultimately degraded in sewage treatment plants. Glycine also has no potential to bioaccumulate. Furthermore, glycine did not exhibit toxic effects on aquatic organisms at concentrations > 100 mg/L in acute aquatic toxicity tests. The amino acid is known to be a ubiquitous compound present mainly in protein molecules. Consequently, glycine is present in living organisms, in animal and vegetable foodstuff and in feed. Therefore, glycine is not expected to have any long-term toxic effects to aquatic organisms. This was confirmed in the toxicity to Algae study where a NOEC ≥ 1000mg/L (the highest tested concentration) was observed. Therefore the chemical safety assessment does not indicate a need to investigate the further effects of Glycine on aquatic organisms, hence long-term toxicity testing with aquatic invertebrates is considered as scientifically not necessary and unjustified.