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9.: ECOTOXICOLOGICAL INFORMATION


COLUMN 1

STANDARD INFORMATION REQUIRED

COLUMN 2

SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

9.2.  Degradation

9.2.  Further biotic degradation testing shall be proposed 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

 

9.3.  Fate and behaviour in the environment

9.3.4.  Further information on the environmental fate and behaviour of the substance and/or degradation products

9.3.4.  Further testing shall be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if the chemical safety assessment according to Annex I indicates the need to investigate further the fate and behaviour of the substance. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.

9.4.  Effects on terrestrial organisms

9.4.  Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment according to Annex I indicates the need to investigate further the effects of the substance and/or degradation products on terrestrial organisms. The choice of the appropriate test(s) depends on the outcome of the chemical safety assessment.

These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely.

9.4.4.  Long-term toxicity testing on invertebrates, unless already provided as part of Annex IX requirements.

 

9.4.6.  Long-term toxicity testing on plants, unless already provided as part of Annex IX requirements.

 

9.5.1.  Long-term toxicity to sediment organisms

9.5.1.  Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assessment indicates the need to investigate further the effects of the substance and/or relevant degradation products on sediment organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment.

9.6.1.  Long-term or reproductive toxicity to birds

9.6.1.  Any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level.