Registration Dossier
Registration Dossier
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EC number: 273-868-3 | CAS number: 69103-01-1
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Hazard for air
Hazard for terrestrial organisms
Hazard for predators
Additional information
Conclusion on classification
Neobergamate Forte is a UVCB substance. For a mixture, the acute effect loading level (typically expressed as the EL50) may be used directly for classification. Short-term aquatic toxicity data is available for two trophic levels (algae and daphnia). In an algal inhibition study the 72h EL 50 for growth rate was determined to be 45 mg/L based on loading level. In an acute daphnia study the EC50 was > 18 mg/L based on nominal concentrations. Since all values are > 1mg/L the substance is not classified for short-term hazards to the aquatic environment according to the CLP Regulation 1272/2008/EC.
Chronic aquatic toxicity data is only available for one trophic level (algae). Therefore, the long-term hazard has been assessed based on both:
a) The chronic aquatic toxicity data for algae (EL10 = 14 mg/L) which results in no classification and
b) The acute aquatic toxicity data (daphnia EC50 > 18mg/L; algae EL50 = 45 mg/L*) and environmental fate data (not readily biodegradable and log Kow range of 2.9 to 4.1) which results in a chronic 3 classification,
and classifying according to the most stringent outcome.
Thus it is concluded that the substance is classified Aquatic Chronic 3 (H412) according to the CLP Regulation 1272/2008/EC & adaptation 286/2011/EC.
Under the old DSD regulation the substance would be classified as R52/53 (harmful to aquatic organisms and may cause long-term adverse effects in the aquatic environment).
*Although the acute algae endpoint would not normally be considered in step (b) because it is a trophic level for which adequate chronic toxicity data is available, it has been taken into account in this case since the EC50 value for daphnia is greater than the maximum tested concentration but that the latter does not necessarily correspond to the solubility limit in the test media. In the daphnia study a 100mg/L stock solution was prepared and test solutions prepared by dilution.
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