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EC number: 923-725-2
CAS number: -
The performance of a long-term toxicity study with sediment dwelling organisms is assumed to be scientifically not justifiable.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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