Registration Dossier

Diss Factsheets

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 biodegradable and therefore is not persistent. In addition, the log Kow value was determined as 3.32 and therefore the substance is not considered likely to bioaccumulate.

Aquatic toxicity:

One experimental study of reliability 1 (based on international guideline and GLP compliance) and two QSAR results are available to assess the aquatic toxicity of the registered substance, on aquatic invertebrates and algae.

The experimental short-term toxicity study on the aquatic invertebrate, Daphnia magna, was performed on the registered substance. In this study, the 48h-EC50 value, based on analytically confirmed nominal concentrations, was determined to be 30.3 mg/L (95%-Confidence Limit: 28.0 – 32.1 mg/L). This study was supported by a conservative QSAR result on aquatic invertebrates performed on the registered substance also.

The QSAR predictions (iSafeRat holistic approach v1.4) have been validated to be compliant with the OECD recommendations for QSAR modeling (OECD, 2004) and predict the ecotoxicological values which would be expected when testing the substance under experimental conditions in a laboratory following OECD Guidelines. The immobility of the daphnids was determined using a validated QSAR for the Mode of Action in question, (MOA 1, non-polar narcosis) using training sets for which the concentrations of the test substance had been determined by chemical analyses over the test period. The 48h-EC50 value based on mobility of aquatic invertebrates was determined to be 9.2 mg/L (95%-Confidence Limit: 8.4 - 10 mg/L). Based on this data, this QSAR result is considered more conservative than the in vivo result. For the algae endpoint, the iSafeRat QSAR model was validated for use with the same applicability domain and under the same conditions as the daphnid QSAR using a holistic approach. Thus the prediction method can be considered sufficient to assess, in a conservative way, the toxicity of the registered substance to algae. The 72h-ErC50 value based on growth rate of algae was determined to be 8.5 mg/L (95%-Confidence Limit: 7.5 – 9.7 mg/L). An in vivo algae study is therefore not considered necessary.

Conclusion on classification

No harmonised classification is available.

1 < lowest EC50 value < 10 mg/L; readily biodegradable; log Kow = 3.32.

Classification according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP): The registered substance is not classified for the environment.

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