9.   ECOTOXICOLOGICAL INFORMATION

COLUMN 1

STANDARD INFORMATION REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

9.1.  Aquatic toxicity

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9.1.  Long-term toxicity testing other than the tests referred to in points 9.1.5 and 9.1.6 shall be proposed by the registrant or may be required by the Agency if the chemical safety assessment performed in accordance with Annex I indicates that it is needed to further investigate the effects of the substance on aquatic organisms.
The choice of the test(s) shall be made on the basis of the results of the chemical safety assessment.  ◄

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

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9.1.6.  Long-term toxicity testing on fish, (unless already provided as part of Annex VIII requirements).

The information shall be provided for subpoint 9.1.6.1 or subpoint 9.1.6.3.

9.1.6.  Fish short-term toxicity tests on embryo and sac-fry stages (OECD TG 212) that were initiated before 14 April 2022 shall be considered appropriate to address this standard information requirement provided that the substance is not highly lipophilic (log Kow > 4) or there is no indication of endocrine disrupting properties or any other specific mode of action.

9.1.6.1.  Fish early-life stage (FELS) toxicity test (OECD TG 210)

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9.1.6.3.  Fish juvenile growth test (OECD TG 215)

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9.2.  Degradation

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9.2.  Further degradation testing shall be proposed by the registrant or may be required by the Agency if the chemical safety assessment performed in accordance with Annex I indicates that it is needed to further investigate the degradation of the substance and its transformation or degradation products.
The choice of the appropriate test(s) and test media shall be made on the basis of the results of the chemical safety assessment.  ◄

9.2.1.  Biotic

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9.2.1.2.  Simulation testing on ultimate degradation in surface water

9.2.1.2.  The study need not be conducted if:

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

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

9.2.1.3.  The study need not be conducted:

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

9.2.1.4.  The study need not be conducted:

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9.2.3.  Identification of transformation and abiotic and biotic degradation products  ◄

9.2.3.  Unless the substance is readily biodegradable

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9.3.  Fate and behaviour in the environment

9.3.2.  Bioaccumulation in aquatic species, preferably fish

9.3.2.  The study need not be conducted if:

The study may not be waived on the basis of low octanol-water partition coefficient alone, unless the potential for bioaccumulation of the substance is solely driven by lipophilicity. For instance, the study may not be waived on the basis of low octanol-water partition coefficient alone if the substance is surface active or ionisable at environmental pH (pH 4 – 9).

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.

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

9.3.3.  The study need not be conducted if:

The study may not be waived on the basis of low octanol-water partition coefficient alone, unless the adsorptive properties of the substance are solely driven by lipophilicity. For instance, the study may not be waived on the basis of low octanol-water partition coefficient alone if the substance is surface active or ionisable at environmental pH (pH 4 – 9).

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.

9.4.  Effects on terrestrial organisms

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9.4.  These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.
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 test(s) shall be made on the basis of the results 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 propose or the Agency may require long-term toxicity testing as referred to in Annex X instead of short-term toxicity testing.  ◄

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9.4.1.  Short-term toxicity to invertebrates

9.4.2.  Effects on soil micro-organisms

9.4.3.  Short-term toxicity to plants