Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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). 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) for a closely related analogue. Read-across is justified based on similar physico-chemical properties, similar structure and the same aquatic toxicity mode of action for the source substance (Pelargene) and target substance (Rosyrane). Furthermore, based on log Kow Rosyrane is expected to be less toxic than the source substance (log Kow 3.3 and 3.8, respectively) and therefore the read-across is considered to be conservative and worst case. The lowest short-term L(E)C50 is for algae: the 72-hour ErC50 is 10.2 mg/l. Since the EC50 is > 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; the 72 hour ErC10 is 8.2 mg/L, which results in no chronic classification, and

b) The acute aquatic toxicity data for algae (ErC50 = 10.2mg/L) and environmental fate data (not readily biodegradable and log Kow of 3.3), 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 as R52/53 based on the ErC50 of 10.2mg/L and log Kow of > 3.