Hexamethylene diisocyanate

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:

toxicity to soil macroorganisms except arthropods: long-term

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely

Justification for type of information:

Testing effects on terrestrial organisms has been judged to be not necessary in accordance with column 2 of REACH Annex X and also in accordance with section 3 of REACH Annex XI.
In accordance with column 2 of REACH Annex X 9.4.4,the Long-term toxicity testing on invertebrates is not proposed because the results of the chemical safety assessment do not indicate any need to investigate further the effects of the substance and/or relevant degradation products on terrestrial organisms.
Due to the lack of ecotoxicological data for terrestrial organisms an estimation of the PNEC for soil was performed using the equilibrium partitioning method (EPM) as recommended in the Guidance on information requirements and chemical safety assessment Chapter R.10 (ECHA, 2008).
On this basis the chemical safety assessment, conducted using the CHESAR-tool, demonstrates that for all uses, the exposure levels estimated (PEC) for the terrestrial compartment do not exceed the appropriate PNEC values (PEC/PNEC < 1). More specifically the resulting RCR values are all below 0.01 providing a high margin of safety for a potential underestimation of risk for agricultural soil.
These results are reported in the chemical safety report that comprises all uses of the life cycle and all relevant compartments in exposure scenarios for the substance. Therefore, in accordance with section 3 of REACH Annex XI and column 2 of REACH Annex IX and X; the testing on effects on terrestrial organisms is judged no more relevant.