Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

In accordance with Column 2 of REACH Annex X, studies on long term or reproductive toxicity to birds do not need to be conducted due to the existence of a large mammalian dataset for this substance. This substance is not classified as toxic to mammals indicating negligible risk for toxicity to birds. It is also unlikely that a secondary poisoning exists to birds for this substance as it has a very low potential for bioaccumulation. ECHA Chapter R.7B guidance states that if the substance is not considered a PBT or vPvB candidate, it is not necessary to conduct further testing on the compartment.

In addition, this substance is not directly applied to air or terrestrial compartments and based on its intended use will not enter the environment and therefore no testing of birds is required. The indirect exposure of the terrestrial environment to this substance via sewage sludge is also of no concern based on the treatment of the sludge. In accordance with Section 9.4 of REACH Annex IX and X, further tests do not need to be conducted if direct and indirect exposure of the environment is unlikely as in this case. REACH allows that certain tests may be waived based on exposure scenarios or an absent, unlikely, not relevant, or not significant exposure. In addition to the manner of use of this substance in formulated products at relatively low constituent volume, during production, formulation, use and waste stages strict management measures are in place to ensure that the substance or product is not released to the environment. It is therefore considered that there should be no exposure of the substance to air and soil and therefore no exposure to birds.

Key value for chemical safety assessment

Additional information