Reaction mass of (3aR,5aS,9aS,9bR)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan and (3aS,5aR,9aR,9bS)-3a,6,6,9a-Tetramethyldodecahydronaphtho[2,1-b]furan

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

20 µg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

2 µg/L

Assessment factor:

100

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

10 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

10.572 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

1.057 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:

2 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

PNEC oral

PNEC value:

53.33 mg/kg food

Assessment factor:

300

Additional information

Environmental fate and pathways:

The substance is considered to be readily biodegradable (OECD Guideline 301F) and contains organic functional groups that are relatively or completely inert with respect of hydrolysis. The average bioconcentration factor (BCF) of the registered substance determined at 373 L/kg indicates that the substance did not bioaccumulate in the rainbow trout (in vivo OECD Guideline 305 and in vitro biotransformation assays). Finally, the adsorption coefficient (log Koc) of the substance was determined to be 3.72 (OECD Guideline 121). This result indicates that the substance is immobile in soil(according to McCall et al., 1980).

 

Aquatic toxicity:

No toxic effects were observed up to the attainable limit of solubility of the substance in experimental acute studies for the three trophic levels (fish, aquatic invertebrates and algae).

Regarding long-term exposure, no toxic effect was observed in the algae experimental study at the maximum attainable mean test concentration and in an experimental chronic Daphnia study ( NOACK, 2021) the LOEC value for aquatic invertebrates, based on reproduction, was determined to be > 0.937 mg/L. The value predited by calculation method (KREATiS, 2021)  21d - EL10 = 0.2 mg/L supports this value.

In addition, reliable calculation method result is available to assess chronic toxicity to fish 32d- EL10 value predicted was 0.4 mg/L.

Based on the respiration inhibition test, the substance had no inhibitory effect on the respiration rate of activated sludge, after the incubation period of 3 hours at the maximum test item concentration tested of 100 mg/L.

 

 

Terrestrial toxicity:

Effects of registered substance on mortality, biomass and the reproductive potential of the earthworm species Eisenia fetida (Annelida, Lumbricidae) were determined according to OECD 222 (2016) with GLP compliance . Under the test conditions, the NOEC was determined to be at least the nominal concentration 200 mg test item/kg SDW and EC10 at 92.2 mg test item/kg SDW.

Conclusion on classification

No harmonised classification is available.

 

Data available:

- readily biodegradable;

- average BCF value of 373 L/kg (in vivo OECD Guideline 305 and in vitro biotransformation assay using liver S9 fractions and hepatocytes from rainbow trout)

- acute data: no acute toxic effects were observed on all trophic levels at or even close to the water solubility of the substance;

- chronic data: LOEC  > 0.937 mg/L for Daphnia. Supportive chronic data were predicted by calculation method on fish and daphnid, with a lowest EC10 value at 0.2 mg/L for daphnid. 

Classification according to the Annex I of the Regulation (EC) No 1272/2008 (CLP): The registered substance is classified as Aquatic chronic 3 for the environment based on chronique toxicity data and the ready biodegradability.