Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Environmental fate and pathways:

The registered substance is readily and ultimately biodegradable and therefore is not persistent in the environment.

Aquatic toxicity:

One experimental study and two reliable QSAR results are available to assess the aquatic toxicity of the registered substance.

- To assess the short-term toxicity to aquatic invertebrates, one experimental study and one QSAR result are available on the registered substance.

The experimental study (NOACK, 2018) was assessed as the key study and was performed on the registered substance according toOECD Guideline 202 with GLP statement using a passive dosing system. The test substance was exposed to Daphnia magna at five concentrations (at and below maximum achievable water solubility) and a control, under static conditions for 48 hours. According to the results of this study, the 48h-EC50 was determined at 0.682 mg/L (95% CL: 0.627 - 0.753 mg/L), based on initial measured concentrations of the test substance.

The QSAR prediction (KREATiS, 2017; Model:iSafeRat® holistic HA-QSAR v1.7), assessed as a supporting data,was performed on the registered substance. The immobility of the daphnids was determined using a validated QSAR for the Mode of Action in question, (MOA 1, non-polar narcosis), using a training set of 58 chemicals derived from 48 -hour tests on daphnids, for which the concentrations of the test substance had been determined by chemical analyses over the test period. The 48h-EC50 value on the registered substance based on mobility was determined at 1.1 mg/L (95% CL: 1.1-1.2 mg/L).This QSAR result supports the experimental key study performed on the same substance with an EC50 value in the same order of magnitude, considering the biological and experimental variabilities (factor <2) . Therefore, this QSAR is considered relevant and sufficient to assess, alone, the toxicity of the registered substance to aquatic algae, without the use of an experimental study.

- To assess the toxicity of the registered substance to aquatic algae, the QSAR model presented above (iSafeRat holistic approach v1.7) was used.The growth inhibition of algae was determined using a validated QSAR for the Mode of Action in question, (MOA 1, non-polar narcosis), using a training set of 40 chemicals derived from 72 -hour ErC50 tests on algae, for which the concentrations of the test substance had been determined by chemical analyses over the test period.The 72h-ErC50 value on the registered substance based on growth rate was determined at 0.98 mg/L (95% CL: 0.92 - 1.0 mg/L). Anin vivoalgae study is not considered necessary as this QSAR is considered sufficient to cover this endpoint.

Conclusion on classification

No harmonised classification is available on the registered substance.

Data available:

- E(L)C50 value lower than 1.0 mg/L (0.682 mg/L for aquatic invertebrates and 0.98 mg/L for algae);

- Readily biodegradable;

- Log Kow value greater than 4.0 (= 5.15).

Classification according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP):

The registered substance is classified as Aquatic Acute 1 and Aquatic Chronic 1 for the environment.