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9.: ECOTOXICOLOGICAL INFORMATION


COLUMN 1

STANDARD INFORMATION REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

9.1.  Aquatic toxicity

9.1.  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.

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

 

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

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

 

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

 

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

 

9.1.6.3.  Fish, juvenile growth test

 

9.2.  Degradation

9.2.  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).

9.2.1.  Biotic

 

9.2.1.2.  Simulation testing on ultimate degradation in surface water

9.2.1.2.  The study need not be conducted if:

— the substances is highly insoluble in water, or

— the substance is readily biodegradable.

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:

— if the substance is readily biodegradable, or

— if direct and indirect exposure of soil is unlikely.

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:

— if the substance is readily biodegradable, or

— if direct and indirect exposure of sediment is unlikely.

9.2.3.  Identification of degradation products

9.2.3.  Unless the substance is readily biodegradable

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 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.

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:

— 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.

9.4.  Effects on terrestrial organisms

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. 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.

9.4.1.  Short-term toxicity to invertebrates

 

9.4.2.  Effects on soil micro-organisms

 

9.4.3.  Short-term toxicity to plants