Division 9 ECOTOXICOLOGICAL INFORMATIONX1

Aquatic toxicity

Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.

Long-term toxicity testing on invertebrates (preferred species Daphnia ), (unless already provided as part of Annex VII requirements)

The information shall be provided for one of the Sections 9.1.6.1, 9.1.6.2 or 9.1.6.3.

Fish early-life stage (FELS) toxicity test

Fish short-term toxicity test on embryo and sac-fry stages

Fish, juvenile growth test

Degradation

Further biotic degradation testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance and its degradation products. The choice of the appropriate test(s) depends on the results of the chemical safety assessment and may include simulation testing in appropriate media (e.g. water, sediment or soil).

Biotic

Simulation testing on ultimate degradation in surface water

• the substances is highly insoluble in water, or

• the substance is readily biodegradable.

For nanoforms, the study may not be waived on the basis of high insolubility in water alone.

Soil simulation testing (for substances with a high potential for adsorption to soil)

• if the substance is readily biodegradable, or

• if direct and indirect exposure of soil is unlikely.

Sediment simulation testing (for substances with a high potential for adsorption to sediment)

• if the substance is readily biodegradable, or

• if direct and indirect exposure of sediment is unlikely.

Identification of degradation products

Unless the substance is readily biodegradable

Fate and behaviour in the environment

Bioaccumulation in aquatic species, preferably fish

• the substance has a low potential for bioaccumulation (for instance a log Kow ≤ 3) and/or a low potential to cross biological membranes, or

• direct and indirect exposure of the aquatic compartment is unlikely.

For nanoforms, use of any physicochemical property (e.g. octanol water partition coefficient, dissolution rate, dispersion stability) as a reason for waiving the study shall include adequate justification of its relevance to low potential for bioaccumulation or unlikely direct and indirect exposure of the aquatic compartment.

Further information on adsorption/desorption depending on the results of the study required in Annex VIII

• based on the physicochemical properties, the substance can be expected to have a low potential for adsorption (e.g. the substance has a low octanol water partition coefficient), or

• the substance and its degradation products decompose rapidly.

For nanoforms, use of any physicochemical property (e.g. octanol water partition coefficient, dissolution rate, dispersion stability) as a reason for waiving the study shall include adequate justification of its relevance to low potential for adsorption.

Effects on terrestrial organisms

In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied to assess the hazard to soil organisms. Where the equilibrium partitioning method is applied to nanoforms, this shall be scientifically justified.

The choice of the appropriate tests depends on the outcome of the chemical safety assessment.

In particular for substances that have a high potential to adsorb to soil or that are very persistent, the registrant shall consider long-term toxicity testing instead of short-term.

Short-term toxicity to invertebrates

Effects on soil micro-organisms

Short-term toxicity to plants