Registration Dossier

Diss Factsheets

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:
PNEC soil
PNEC value:
16 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

When CyreneTM is in aqueous solution, the keto group (C=O) gains water (H2O) to form the corresponding Gem Diol {(1S,5R)-6,8-dioxabicyclo[3.2.1]octane-4,4-diol}. An equilibrium is established rapidly (meaning that the reaction is rapidly reversible). The ratio of the two forms is dependent upon the amount of water present.

Further information is available in the physical and chemical properties endpoint summary (IUCLID Section 4, CSR Section 1.4) and in the attached assessment report in Section 13 of IUCLID.

Under the conditions of the short-term aquatic toxicity studies (nominal concentrations up to 100 mg/l Cyrene™), 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.

Measured, short-term aquatic toxicity data are available with the registration substance. No effects on the test organisms were reported at the highest test concentrations of 100 mg/l.

 

Long-term aquatic toxicity to fish and Daphnia data have been generated using an appropriate predictive model, ECOSAR v.2.0, using the properties of the Gem Diol. Toxicity to aquatic algae data have also been predicted for completeness, and to compare the estimated sensitivities of the test organisms. The predicted NOEC values are all ≥985 mg/l.

 

In the absence of short-term toxicity in the experimental tests, and toxicity predicted only at concentrations well in excess of the highest test concentrations required by the relevant OECD test guidelines, no aquatic toxicity is expected at environmentally relevant concentrations, therefore PNECaquatic has not been derived.

 

However, the long-term predicted values have been used to derive an indicative PNECaquatic for use in the equilibrium partitioning calculation so that PNECsoil can be determined and a screening assessment can be carried out.

 

According to the QSAR predicted data, algae is the most sensitive trophic level in terms of short-term E(L)C50 values and also has the lowest NOEC value. The predicted algal NOEC is therefore used to derive the indicative PNECaquatic. An assessment factor of 10 is appropriate because long-term data are available for three trophic levels.

Conclusion on classification

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