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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
no hazard identified

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:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Aquatic toxicology:

γ-decalactone is a linear saturated 4-hydroxycarboxylic acid derived-lactone with 10 carbons.γ-nonalactone andγ-undecalactone are structurally similar compounds of aliphatic lactones with 9 and 11 carbons, respectively. These substance are considered adequate for read-across purpose with nonalactone expected to be slightly less ecotoxic and undecalactone slightly more ecotoxic than decalactone.

 

To assess short-term toxicity effects, a compilation of QSAR results and available experimental values was made for these three lactones. QSAR results were obtained with ECOSAR v1.11 model (Ecological Structure Activity Relationships), which is a computerized predictive system that estimates the toxicity of chemical substance to aquatic organisms such as fish, aquatic invertebrates, and aquatic plants by using computerized Structure Activity Relationships (SARs). A correlation between the chemical acute toxicity on each aquatic trophic level (fish, aquatic invertebrates and algae) and the number of carbons was observed, showing that the aquatic toxicity (whatever the organism) increased with the carbon chain length (See " Read-Across justification for-lactones" document in Chapter 13).

For γ-decalactone, the key acute values are summarised below:

- 48h-EC50 (aquatic invertebrates) = 13.1 mg/L (estimated value);

- 72h-ErC50 (algae,Pseudokirchneriella subcapitata) = 37.2 mg/L (experimental result);

- 96h-LC50 (fish,Leuciscus idus) = 21.5 mg/L (experimental result).

In acute conditions, the most sensitive species for γ-decalactone is aquatic invertebrates with an estimated EC50 at 13.1 mg/L.

Read-across and interpolation have been used in this dossier (γ-nonalactone and γ-undecalactone) to support the conclusions and complete the data set (interpolation for the daphnid acute test and direct read-across for the daphnid chronic study using γ-undecalactone which is considered as the most ecotoxic substance of the three.

A test plan for long-term effects on fish is scientifically unjustified for the following reasons: reduce testing on vertebrate animals (in accordance with REACH regulation), the fish is not the most sensitive species in acute conditions, the chemical safety assessment indicated no need for further investigation.

For γ-decalactone, the key chronic values are summarised below:

- 21d-EC10 (Daphnia magna) = 1.02 mg/L (experimental result, based on reproduction); read-across study from undecalactone;

- 72h-ErC10 (algae,Pseudokirchneriella subcapitata) = 11.2 mg/L (experimental result on decalactone).

The lowest EC10 value, determined at 1.02 mg/L for the 21 d daphnid EC10, was used to read-across to fill the chronic toxicity endpoint for invertebrates even though this is a conservative estimate as derived from a more ecotoxic substance. These values do not result in classification.

 

For toxicity to microorganisms, a weight of evidence approach was used with two studies. The 30min-EC50 for γ-decalactone was determined to be 800 mg/L for Pseudomonas putida.

Terrestrial toxicity:

γ-decalactone is considered as readily biodegradable, it can be assumed that it will be biodegraded within the STP process and as a consequence a transfer to the soil compartment is not expected. For this reason, waiving are proposed for terrestrial toxicity endpoints.

Conclusion on classification

10 mg/L < acute E(L)C50 < 100 mg/L; 1 mg/L < chronic EC10 < 10 mg/L; readily biodegradable; log Kow = 3.0.

Classification according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP): The test substance is not classified for the environment.