Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

2,4,7,9-Tetramethyldec-5-yne-4,7-diol is used as a co-formulant in plant protection products. In-field use of plant protection products can result in exposure to agricultural soil orto edge-of-field water bodies mainly as a result of spray drift (spray formulations only).Therefore, in accordance with the requirements under REACH, it is necessary to conduct risk characterisation for the potentially exposed compartments if the substance 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. However, it is believed that the potential for environmental effects associated with this use of 2,4,7,9-Tetramethyldec-5-yne-4,7-diol is already inherently addressed as part of the registration procedure for plant protection products under Directive 91/414/EEC.

Annexes II and III of Directive 91/414/EEC set out the data requirements for the inclusion of a pesticide active substance into Annex I of the Directive and for the authorisation of a plant protection product atlevel. These requirements include the need for specific assessment of the potential environmental impact of formulated plant protection products, where relevant. This is to account for the possibility that a formulation may be more toxic than the technical active substance.

Under 91/414/EEC, the necessity of formulation-based assessment is dependent upon whether the integrity of the product will be maintained upon release to the environment.

In the case of emission to agricultural soil it is assumed thatexposure will be to the formulated product. Accordingly, applications for product authorisation under 91/414/EEC must consider the potential impact of formulated plant protection products on certain terrestrial non-target groups, such as terrestrial vertebrates, bees, other non-target arthropods, earthworms, soil micro-organisms and plants. In order to do thisit is often necessary to test the formulated product in addition to or instead of the technical active substance.

In the case of emission to surface water it is assumed thatexposure will initially be to the formulated product. Annex III of 91/414/EEC states that in principle, acute toxicity tests should be carried out on one species from each of the three groups of aquatic organisms (fish, aquatic invertebrates and algae). If the results of these tests indicate that the formulation is more acutely toxic than the active substance, then the risk characterisation (TER) is performed using formulation data.

As a result, the potential for risk to terrestrial and aquatic organisms presented by co-formulants contained within plant protection products will be inherently covered by evaluations already conducted under 91/414/EEC.