Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
7 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
3.5 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.7 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
2.41 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
90.6 µg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
177 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.074 mg/kg food
Assessment factor:
90

Additional information

Two studies are available for the short-term toxicity of delta-damascone to fish. One study is a semi-static GLP-compliant OECD 203 study with medaka (Oryzias latipes) (Kurume Laboratory, 2009). The concentrations were analytically verified, the 96-h LC50 was 0.97 mg/L based on measured concentrations. The other study is also a semi-static GLP-compliant OECD 203 study with the same species. The 96-h LC50 was 0.977 mg/L based on nominal concentrations (Kurume Laboratory, 2007b). The most critical value is used in the assessment, which is the 96-h LC50 of 0.97 mg/L.

No data is available on long-term toxicity in fish.

No short-term study on invertebrates is available, but instead a semi-static GLP compliant, OECD 211 study is available regarding long-term toxicity of delta-damascone to Daphnia magna (Huntingdon Life Sciences Ltd, 2009c). The concentrations were analytically verified and the 21-d NOEC for reproduction was 0.35 mg/L, this value is used in the assessment.

One GLP compliant OECD 201 study is available for growth inhibition of delta-damascone to Pseudokirchneriella subcapitata (Huntingdon Life Sciences Ltd, 2009d). The concentrations were analytically verified. The 72-h EbC50 was 2.47 mg/L, the 72-h ErC50 and NOErC were 4.54 mg/L and 0.883 mg/L, respectively. The effect concentrations based on growth rate are used in the assessment.

One GLP-compliant OECD 209 respiration inhibition study with micro-organisms is available for delta-damascone (Huntingdon Life Sciences Ltd, 2009e). The 3-h EC50 was 241 mg/L, this value is used in the assessment.

Data on sediment, terrestrial and bird toxicity is not available.

Conclusion on classification

According to the Amendment to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 dDamascone needs to be labelled as Acute Toxicity Category 1 (Very toxic to aquatic life; H400) as the lowest L(E) C50 value (96-h LC50 of 0.97 mg/L in Oryzias latipes) is below the limit of 1 mg/L. Based on the lowest available chronic NOEC for Daphnia between 0.1 and 1 mg/L (NOEC = 0.35 mg/L in aquatic invertebrates) and the substance being not rapidly degradable, dDamascone needs to be classified as Aquatic Chronic 2 (Toxic to aquatic life with long lasting effects; H411). However, based on acute data in combination with the non rapid degradability, the chronic classification based on acute ecotoxicity data will become H410 (Very toxic to aquatic life with long lasting effects) as the most stringent outcome needs to be taken.

According to the Dangerous Substance Directive 67/548/EC, the available ecotoxicological and environmental fate data warrants classification as N; R50/53 (Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment).