Registration Dossier

Ecotoxicological information

Long-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

Testing for long-term toxicity to fish is not considered necessary because:

- Short-term toxicity of the test substance and degradation products to fish is low.

- The risk characterisation ratio (RCR) based on PNECaquatic(freshwater) derived from the short-term data is <1 (see Section 10 of the CSR).

The no need for further testing is supported by read-across from two structurally analogous substances part of the aminomethylene phosphonate group, where the long-term aquatic toxicity read-across data support the PNEC derived from the short-term data available with the HMDTMP category.

Key value for chemical safety assessment

Additional information

In accordance with Column 2 of REACH Annex IX, there is no need to further investigate the effects of this substance in a long-term aquatic toxicity to fish study because, as indicated in guidance R.7.8.4.3 (ECHA 2016), the quantitative chemical safety assessment (conducted according to Annex I of REACH) indicates that the Risk Characterisation Ratio is below 1, even with due consideration of contributing uncertainties, and therefore the risk is already adequately controlled and further testing is not justifiable.

The substance is highly water-soluble and not bioaccumulative, and the long-term aquatic toxicity data available with structural analogues does not suggest unpredictable long-term toxicity and suggest a simple acute:chronic relationship (i.e. aquatic freshwater PNECs for structurally analogous substances based on long-term data would be 0.46-0.52 mg/Lcompared to a PNEC 0.44 mg/Lbased on short-term data with HMDMTP). Therefore the occurrence of toxic effects that were not expressed in the existing short-term aquatic studies (conducted at concentrations up to 2200 mg/L) would be considered unlikely.

Based on the short-term aquatic data set, the most sensitive trophic level is fish.