Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

toxicity to bees: chronic oral
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 on long-term toxicity to sediment 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 9.5.1,the Long-term toxicity to sediment organisms 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 sediment organisms.
Due to the lack of ecotoxicological data for sediment organisms an estimation of the PNEC for sediment 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 sediment compartment do not exceed the appropriate PNEC values (PECsed/PNECsed < 1). More specifically the resulting RCR values are all below 0.1 providing a high margin of safety for a potential underestimation of risk for sediment dwelling organisms.
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.
A tendency for accumulation in the sediment is considered negligible since the substance hydrolyses rapidly to the corresponding diamine or polyurea. The polyurea are insoluble in water and therefore not bioavailable.
Therefore, in accordance with section 3 of REACH Annex XI and column 2 of REACH Annex X; the testing on effects on sediment organisms is judged no more relevant.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion