Sucrose and glycerol, reaction products with C12-18, C18unsatd. fatty acids

Ecotoxicological Summary

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.016 mg/L

Assessment factor:

1 000

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.16 mg/L

Marine water

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.002 mg/L

Assessment factor:

10 000

Extrapolation method:

assessment factor

STP

Hazard assessment conclusion:

PNEC STP

PNEC value:

100 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

Sediment (freshwater)

Hazard assessment conclusion:

no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:

no exposure of sediment expected

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:

no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:

no potential for bioaccumulation

Additional information

Ecotoxicity studies in fish, daphnia, algae and bacteria with Sucroglyceride C12‐18, C18unsatd. did not show acute toxicity values < 1 mg/L.

 

Short-term toxicity studies

The 96 h-LC50 for fish obtained from a short-term toxicity study in Leuciscus idus (Golden Orfe) was 136 mg/L. A Daphnia sp. Acute Immobilisation Test resulted in a 48 h-LC50 of 28.5 mg/L. A 72 hour acute toxicity study in Pseudokirchneriella subcapitata resulted in an EC50 of 16 mg/L.

 

Long-term toxicity studies

In accordance with REACH Annex IX, 9.1.5 column 2, long-term toxicity testing to aquatic organisms does not need to be conducted. A test for long-term toxicity to aquatic organisms is only required, if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms. The choice of the appropriate test(s) depends on the results of the chemical safety assessment. As the registration substance does not need to be classified with regard to environmental effects, an exposure assessment is not required. The long-term exposure of aquatic organisms is unlikely as the substance is readily biodegradable. The ready biodegradability of the substance is proved in a number of tests conducted under different conditions (aerobic, anaerobic).

 

Toxicity to microorganisms

In a 1 hour toxicity study conducted according to DIN 38412 part 27 (Bacteria Respiration Test), cultures of Pseudomonas putida were exposed to Sucroglyceride C12-18, C18unsatd. at nominal concentration of 10 g/L under static conditions. No inhibition of the bacterial respiration with the tested concentration was observed.

The test conditions did not meet the current standards for PNEC derivation as given in TGD on risk assessment. However, the study is considered acceptable, because Sucroglyceride C12-18, C18unsatd. is readily biodegradable. In accordance with column 2 of REACH Annex VIII, the activated sludge respiration inhibition test does not need to be conducted as this substance was found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant.

It is considered appropriate to use the result obtained in the Bacteria Respiration Test according to DIN 38412 part 27 as starting point for PNEC derivation without conducting a further Activated Sludge Test (OECD guideline 209).

The DIN 38412 part 27-test is similar to OECD guideline 209, but uses only one species and an incubation time of only 1 hour. This fact is compensated by using a rather conservative assessment factor of 100 for PNEC derivation.

 

Bioaccumulation

Bioaccumulation in organisms is considered to be low. Therefore, secondary poisoning through the food chain is of no concern for Sucroglyceride C12‐18, C18unsatd.The substance is readily biodegradable, which will result in low environmental concentrations. Sucroglyceride C12‐18, C18unsatd. is metabolised in higher organisms. The substances are de-esterified and further degraded via the fatty-acid and glucose metabolic pathway.

Ozone layer

According to a low vapour pressure of the substance, the predicted environmental fate is not the atmosphere. The registration substance is not expected to reach the atmospheric stratosphere and therefore is not expected to present a danger to the structure and/or the functioning of the stratospheric ozone layer.

Conclusion on classification

In conclusion, ecotoxicity studies with Sucroglyceride C12‐18, C18unsatd. did not show acute toxicity values < 1 mg/L.

Further, the substance proved to be readily biodegradable under aerobic as well as anaerobic conditions. According to Directive 67/548/EEC, Sucroglyceride C12‐18, C18unsatd. does not need to be classified as “dangerous to the environment” and therefore labelling is not applicable.

According to GHS Regulation EC No 1272/2008, Sucroglyceride C12‐18, C18unsatd. does not need to be classified as “hazardous to the aquatic environment” and does not need to be classified as “hazardous to the ozone layer”. Therefore labelling is not applicable.