Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Hazard for air

Hazard for terrestrial organisms

Hazard for predators

Additional information

Conclusion on classification

Environmental classification and labelling of a substance is generally based on data from short-term aquatic toxicity results, the ready biodegradability of the substance and an experimentally determined BCF (or if absent the measured octanol/water partition coefficient, Kow). Available adequate chronic toxicity data is also relevant for the assessment of long-term aquatic hazards (Regulation 286/2011/EC).

 

Short-term aquatic toxicity data is available for two trophic levels (daphnia and algae). Based on valid studies for a closely related analogue, the daphnia 48 hour EC50 and algal 72 hour ErC50 for Gardamide are estimated to be 22 and 30 mg/L respectively. Since all EC50 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 (NOEC = 12.5 mg/L, based on read-across substance), which results in no chronic classification since the value is > 1mg/L, and

b) The acute aquatic toxicity data for daphnia (EC50 = 22 mg/L, based on read-across substance) and environmental fate data for Gardamide itself (not readily biodegradable), which results in a Category 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.

 

According to the old DSD regulation, Directive 67/548/EEC, the substance would be classified R52/53.