Optimized Strategies for Risk Assessment
of Industrial Chemicals through Integration
of Non-Test and Test Information

REACH: Information to be submitted in the technical dossier depending on tonnage

Ecotoxicological Information

≥1 t/a ≥10 t/a ≥100 t/a ≥1000 t/a
Ecotoxicological information
9.1 Aquatic toxicity
9.1.1 Short-term toxicity testing on invertebrates (preferred species Daphnia)
The registrant may consider long-term toxicity testing instead of short-term.

Specific Rules: The study does not need to be conducted if:
— there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes, or

— a long-term aquatic toxicity study on invertebrates is available, or

— adequate information for environmental classification and labelling is available.

The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5) shall be considered if the substance is poorly water soluble.

X X X X
9.1.2 Growth inhibition study aquatic plants (algae preferred)

Specific Rule: The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes.

X X X X
9.1.3. Short-term toxicity testing on fish
The registrant may consider long-term toxicity testing instead of shortterm.

Specific Rules: The study does not need to be conducted if:
— there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes, or

— a long-term aquatic toxicity study on fish is available.

Long-term aquatic toxicity testing as described in Annex IX shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further effects on aquatic organisms. The choice of the appropriate test(s) will depend on the results of the chemical safety assessment.
The long-term aquatic toxicity study on fish (Annex IX, Section 9.1.6) shall be considered if the substance is poorly water soluble.

X X X
9.1.4. Activated sludge respiration inhibition testing

Specific Rules: The study does not need to be conducted if:
— there is no emission to a sewage treatment plant, or

— there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the substance is highly insoluble in water, or

— the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant.

The study may be replaced by a nitrification inhibition test if available data show that the substance is likely to be an inhibitor of microbial growth or function, in particular nitrifying bacteria.

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

X X
9.2 Degradation
9.2.1 Biotic X X X X
9.2.1.1 Ready biodegradability X X X X
Specific Rule: 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). X X
9.2.1.2. Simulation testing on ultimate degradation in surface water

Specific Rule: The study need not be conducted:
— if the substances is highly insoluble in water, or

— if the substance is readily biodegradable.

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

Specific Rule: The study need not be conducted:
— if the substance is readily biodegradable, or

— if direct and indirect exposure of soil is unlikely.

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

Specific Rule: The study need not be conducted:
— if the substance is readily biodegradable, or

— if direct and indirect exposure of sediment is unlikely.

X X
Specific Rule: Further degradation testing shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance. The choice of the appropriate test(s) will depend on the results of the chemical safety assessment. X X X
9.2.2. Abiotic

9.2.2.1. Hydrolysis as a function of pH.

Specific Rules: The study does not need to be conducted if:
— the substance is readily biodegradable, or

— the substance is highly insoluble in water.

X X X
9.2.3. Identification of degradation products

Specific Rule: Unless the substance is readily biodegradable.

X X
9.3. Fate and behaviour in the environment
9.3.1. Adsorption/desorption screening

Specific Rules: The study does not need to 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 relevant degradation products decompose rapidly.

X X X
9.3.2. Bioaccumulation in aquatic species, preferably fish

Specific Rules: 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.

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

Specific Rules: 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.

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

Specific Rule: 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.

X
9.4. Effects on terrestrial organisms
Specific Rules: 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.
X X
9.4.1. Short-term toxicity to invertebrates X X
9.4.2. Effects on soil micro-organisms X X
9.4.3. Short-term toxicity to plants X X
Specific Rule: 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.

X
9.4.4. Long-term toxicity testing on invertebrates,
unless already provided as part of Annex IX requirements
X
9.4.6. Long-term toxicity testing on plants,
unless already provided as part of Annex IX requirements
X
9.5 Effects on sediment organisms
9.5.1. Long-term toxicity to sediment organisms

Specific Rule: 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.

X
9.6. Toxicity to birds
9.6.1. Long-term or reproductive toxicity to birds

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

X

OSIRIS Finished

The official end of the project was reached in September 2011. We thank all partners for their excellent cooperation. The public report giving an overview on the major achievements has been submitted to the European Commission. For legal reasons, please ask them in case you are interested in obtaining a copy. There are still OSIRIS related publications on their way. The OSIRIS publication page will still be updated, thus you may watch it regularly. However, this news column will no more be updated.

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