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Sediment toxicity

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Description of key information

The performance of a long-term toxicity study with sediment dwelling organisms is assumed to be scientifically not justifiable.

Key value for chemical safety assessment

Additional information

In Annex X of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity tests with sediment dwelling organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on sediment dwelling 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 Biofert Plusz reveals neither a need to classify the substance as dangerous for the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to aquatic organisms. According to reliable study results, Biofert Plusz is considered to be rapidly degraded in the environment and the bioaccumulation potential is regarded to be insignificant. Moreover, the amino acid threonine as the main constituent, is an essential protein constituent in living organisms and so no metabolites are expected to occur that pose a significant risk to living organisms. Therefore, with respect to animal welfare the performance of a long-term toxicity study with sediment dwelling organisms is assumed to be not justifiable.