Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
50 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

In the presence of water, CyreneTM, with its anhydrous keto group [C=O], gains water (H2O) to form the corresponding hydrated Gem Diol [C(OH)2]. An equilibrium is established rapidly and is completely reversible. When the amount of water is reduced, the Gem Diol loses water, regenerating the anhydrous CyreneTM in its keto form. The ratio of the two forms depends upon the amount of water present and hence the polarity of the solution. Further information is available in the Physical and chemical properties endpoint summary (IUCLID Section 4, CSR Section 1.4).

Under the conditions of the short-term aquatic toxicity studies (nominal concentrations up to 100 mg/l CyreneTM), the test organisms were exposed predominantly to the Gem Diol form. Since this is the relevant form under dilute environmental conditions, the data are considered to be appropriate for the purposes of environmental hazard assessment and classification.

Conclusion on classification

Cyrene™ has reliable short-term E(L)C50 values for fish, invertebrates and algae of >100 mg/l for all three. It has a reliable NOEC of 100 mg/l in algae.

The registered substance is readily biodegradable. The aquatic toxicity studies and biodegradation studies reflect the form of the substance present in environmentally relevant scenarios.

These data are consistent with the following classification under Regulation (EC) No 1272/2008 (as amended) (CLP):

Acute toxicity: Not classified.

Chronic toxicity: Not classified.