Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.041 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.411 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.004 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.42 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.142 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:
0.26 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

In a GLP study conducted according to OECD TG 301F (Manometric Respirometry Test), biodegradation of pentyl propionate began soon after addition to the test mixtures, and after 28 days reached 90.1 ± 6.5% (mean ± 1 SD) based on biological oxygen demand (BOD) and exceeded 60% biodegradation within 5.9 days of the start of the test and within the 10-day window detailed in OECD 301F. The results of this test demonstrated that Pentyl Propionate can be classified as “readily biodegradable”, according to the OECD 301F: Manometric Respirometry Test.

In a GLP study conducted as per EPA-ASTM guidelines, the 96-hour LC50 of n-pentyl propionate to fathead minnows (Pimephales promelas) was 55.9 mg/l with 95% fiducial limits ranging between 43.2 - 72.0 mg/l.

In a GLP study conducted as per the methods laid out in the EPA Committee on Methods for Toxicity Tests with Aquatic Organisms, the 48-hour LC50 of pentyl propionate to Daphnia magna is 60 mg/l with 95% fiducial limits ranging between 50.6 - 71.2 mg/l.

In a GLP study conducted as per OECD TG 201, the 96-hour ErC50 (growth rate) of pentyl propionate to Selenastrum capricornutum was 41.7 mg/l with 95% fiducial limits renging between 40.3 - 44.2 mg/l and the 96-hour NOEC was 4.5 mg/l.

Based on this information and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, pentyl propionate will not be classified for aquatic toxicity (acute and chronic).

Conclusion on classification

In a GLP study conducted according to OECD TG 301F (Manometric Respirometry Test), biodegradation of pentyl propionate began soon after addition to the test mixtures, and after 28 days reached 90.1 ± 6.5% (mean ± 1 SD) based on biological oxygen demand (BOD) and exceeded 60% biodegradation within 5.9 days of the start of the test and within the 10-day window detailed in OECD 301F. The results of this test demonstrated that Pentyl Propionate can be classified as “readily biodegradable”, according to the OECD 301F: Manometric Respirometry Test.

In a GLP study conducted as per EPA-ASTM guidelines, the 96-hour LC50 of n-pentyl propionate to fathead minnows (Pimephales promelas) was 55.9 mg/l with 95% fiducial limits ranging between 43.2 - 72.0 mg/l.

In a GLP study conducted as per the methods laid out in the EPA Committee on Methods for Toxicity Tests with Aquatic Organisms, the 48-hour LC50 of pentyl propionate to Daphnia magna is 60 mg/l with 95% fiducial limits ranging between 50.6 - 71.2 mg/l.

In a GLP study conducted as per OECD TG 201, the 96-hour ErC50 (growth rate) of pentyl propionate to Selenastrum capricornutum was 41.7 mg/l with 95% fiducial limits renging between 40.3 - 44.2 mg/l and the 96-hour NOEC was 4.5 mg/l.

Based on this information and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, pentyl propionate will not be classified for aquatic toxicity (acute and chronic).