Registration Dossier

Diss Factsheets

Ecotoxicological information

Toxicity to birds

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

The performance of a long-term toxicity study with birds 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 chronic toxicity tests in birds shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on birds. 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 L-threonine mother liquor reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. 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 and therefore secondary poisoning is unlikely to be a relevant exposure route. 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. Based on the composition of Biofert Plusz this statement applies likewise to the test material under investigation (L-threonine mother liquor). Therefore, the performance of a long-term toxicity study with birds is assumed to be not justifiable.