Registration Dossier

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Based on the integrated testing strategy [ECHA R.7c, 2008] a stepwise approach to hazard identification on terrestrial organisms is required. Tests of toxicity on earthworm were considered as first step, due to the fact that earthworms are exposed via multiple uptake routes (soil pore water, ingestion of soil material, soil air, secondary poisoning).

Within the ‘red disazo condensation pigments’ two acute toxicity tests on earthworms (Eisenia fetida) (CAS 68516-75-6 and CAS 71566-54-6) were performed. In this tests no acute effects on earthworms occurred after 14 days exposure to 1000 mg/kg soil dw. This confirms the results from the aquatic tests where no hazard was identified.

It can be expected that ‘red disazo condensation pigments’ are essentially not bioavailable, due to the large molecular size together with the negligible low solubility. Therefore it can be assumed with sufficient confidence, that further tests on terrestrial organisms would not provide any additional information for improving the risk assessment. Hence tests on plants and terrestrial microorganisms are not required.

Since the molecular structure and the physico-chemical properties of the ‘red disazo condensation pigments’ are quite similar, the available studies are sufficient to cover the terrestrial toxicity endpoints. This read across approach is in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. Grouping of substance and read across approach as it is explained within the analogue justification in Annex I.