Propanoic acid, 2-hydroxy-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester, (2S)-

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

3.11 µg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

31.1 µg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.311 µg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

6.5 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

0.36 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.036 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:

no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

PNEC soil

PNEC value:

0.07 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

365 mg/kg food

Additional information

The freshwater alga represents the most sensitive species with regard to acute exposure to the substance. The hazard assessment therefore is based on the effect levels of the algal study and the PNECs aqua will be derived from the ErC50 value of 3.11 mg/L. PNEC sediment and PNEC soil were being derived using the equilibrium-partitioning method. A valid respiration inhibition test is available, the EC50 value was 650 mg/L after 3 hours and this is used in the hazard assessment. The PNEC oral is derived from the NOAEL of 548 mg/kg/day observed in a chronic oral toxicity study with the substance DL menthol.

Conclusion on classification

Acute aquatic toxicity:

Freshwater algae represent the most sensitive species with regard to acute exposure to the substance with an ErC50 value of 3.11 mg/L (as derived from the study with read across substance menthyl acetate). Being above the trigger level for acute aquatic toxicity classification of 1.0 mg/L, no classification applicable according to CLP Regulation (Regulation (EC) No 1272/2008) or according to DSD Regulation (Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC)).

Chronic aquatic toxicity - CLP:

Since the 2nd Amendment of the CLP Regulation, data from long-term studies are preferred over data from short term studies. The only aquatic toxicity long-term study available is the algal growth inhibition study with read across substance menthyl acetate. The ErC10 and NOEC values were determined to 0.7 mg/L and 0.18 mg/L menthyl lactate, respectively. Based on the 2nd Amendment of the CLP Regulation, Table 4.10, classification as chronic aquatic toxicity category 3 is applicable, as the EC10 / NOEC are within the range 0.1 - 1.0 mg/L and the substance is rapidly degradable. The acute L(E)50 values for fish, daphnia and algae are not triggering chronic aquatic toxicity classification as the substance is rapidly degradable and has a log Kow < 4.0.

Chronic aquatic toxicity - DSD:

In the DSD Regulation only data from acute aquatic toxicity studies have been considered for chronic aquatic toxicity classification.

Comparing the results from the acute aquatic toxicity studies, the freshwater algae was found to be the most sensitive organism with an EC50 of 3.11 mg/L (growth rate). As the EC50 therefore is within the range 1.0 - 10.0 mg/L, and the substance furthermore has a log Kow > 3.0, classification R51/53 is applicable.