Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Aquatic toxicity:

Experimental studies on acute toxicity of the registered were performed for microorganisms and for two trophic levels of aquatic species: algae and crustacea. All tests were conducted under GLP conditions and are considered as valid. In addition, one QSAR prediction was performed using iSafeRat® High-Accuracy-Quantitative Structure-Activity Relationship to assess the acute toxicity of the registered substance to fish.

The key ecotoxicity values are as follow:

-Fish: 96h-LC50 was 2.2 mg/L (iSafeRat® QSAR prediction)

-Aquatic invertebrates: 48h-EC50 was 1.083 mg/L (experimenta study)

-Aquatic algae: 72h-ErC50 was 3.919 mg/L and 72h-ErC10 was1.963 mg/L (experimental study)

-Microorganisms: 3h-EC50 was > 1000 mg/L and 3h-NOEC was 10 mg/L (experimental study)

Environmental fate and pathways:

Based on the key biodegradation study (OECD Guideline 301D, GLP), the registered substance is not readily biodegradable (28% biodegradation after 28 days) but ultimately (completely) biodegradable (74% biodegradation after 60 days). Therefore, the registered substance is not persistent in the environment. In addition, with a log Kow value determined experimentally at 4.3, the substance is considered to be bioaccumulative according to CLP (>4.0) but not bioaccumulative according to PBT criteria (<4.5).

Conclusion on classification

No harmonised classification is available.

Data available:

- Lowest E(L)C50 value comprised between 1 and 10 mg/L (M-factor not applicable);

- Not rapidly degradable;

- log Kow > 4.

Classification according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP): The registered substance is classified as Aquatic Chronic 2 for the environment.