Registration Dossier

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Conclusion on classification

Acute toxicity data for the test item are available for three trophic levels (aquatic invertebrates, algae and fish). The lowest acute effect value the EC50 for Daphnia magna with a 48-h EC50 of 0.8 mg/L (based on dissolved test item concentration), was observed in a GLP-conform standard test according to OECD 202. This value is selected as the acute reference value for classification.

 

Long-term toxicity data for freshwater organisms are available for two trophic levels, algae and aquatic invertebrates.The chronic 72-h EC10 for algae is 4.24 mg/L (based on dissolved test item concentration) for the effect of the test item on growth rate of Pseudokirchneriella subcapitata in a GLP-conform standard test according to OECD 201. The chronic 21-d EC10 for aquatic invertebrates is 0.0807 mg/L (based on dissolved test item concentration) for the effect of the test item on reproduction of Daphnia magna in a GLP-conform standard test according to OECD 211.

These values were selected as chronic reference values for classification, as well as for the third trophic level fish, the acute 96-h LC50 of 1.41 mg/L (based on dissolved test item concentration) for Danio rerio, the readily biodegradability and the logPow of 4.3.

 

Acute (short-term) aquatic hazard:

48h-EC50= 0.8 mg/L

Since the 48h-EC50is < 1 mg/L, classification for ACUTE/SHORT-TERM AQUATIC HAZARD is required.

 

Chronic (long-term) aquatic hazard based on chronic & acute data and environmental fate of the product:

72-h EC10= 4.24 mg/L (algae)

21-d EC10= 0.0807 mg/L (daphnia)

96-h LC50= 1.41 mg/L (fish)

readily biodegradable

logPow = 4.3

Since the 21-d EC10is < 1 mg/L and the 96-h LC50is < 100 mg/L, classification for CHRONIC/LONG-TERM AQUATIC HAZARD is required.

 

According to Regulation (EC) No. 1272/2008 and subsequent regulations the test item is classified as hazardous to the aquatic environment, Category Acute 1 (H400: Very toxic to aquatic life) and Category Chronic 2 (H411: Toxic to aquatic life with long lasting effects).

 

According to Directive 67/548/EEC and its subsequent amendments, the substance has to be classified with ā€œNā€; R50: Very toxic to aquatic organisms and R53: May cause long-term adverse effects in the aquatic environment.