Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Long-term toxicity tests on terrestrial organisms are a requirement of REACH Annex X (section 9.4). In column 2 of this Annex, the following specific rule for adaptation is described: "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."

The reciprocal of this sentence is therefore that long-term toxicity tests on terrestrial organisms are not needed if the chemical safety assessment according to Annex I indicates there is no need to investigate further the effects of the substance and/or degradation products on terrestrial organisms.

As part of the CSA performed on the registered substance, the environmental and PBT/vPvB assessments revealed it neither fulfills the criteria to be classified for the environmental compartment, nor is assessed as a PBT or vPvB substance (see IUCLID section 2 and the chemical safety report attached to section 13). Therefore, there is no need to refine the CSA, in particular with respect to terrestrial ecotoxicity, and the long-term on terrestrial organisms were thus waived on this basis.

Additional information

Given very low toxicity in all organisms tested, particularly in mammals (NOAEL 150 mg/kg bw/d), and indication of low toxicity in plants, toxicity in soil compartment is not expected. Furthermore, acute and chronic aquatic data all demonstrate that there is no toxicity at the solubility limits.