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

Endpoint summary

Additional information

Short-term toxicity to fish

In a 96 h acute toxicity study, Leuciscus idus (Golden Orfe) were exposed to Sucroglyceride C12-18, C18unsatd. at nominal concentrations of 0 (control), 100, 130, 150, 200 mg/L under static conditions. The 96-h LC50 was 136 mg/L (arithmetical determination). The LC0 and LC100 values, based on mortality, were 100 and 200 mg/L, respectively.

This toxicity study is classified as reliable with restrictions as no analytical monitoring was performed and dissolved oxygen concentration at some time points was less then 60% of the air saturation value.

 

Short-term toxicity to daphnia

The toxicity of Sucroglyceride C12-18, C18unsatd. was investigated in a study conducted according to OECD Guideline 202 I (Daphnia sp. Acute Immobilisation Test). In this testDaphnia magnawere exposed to a nominal test substance concentrations of 10, 18, 32, 58, 100 and 180 mg/L over a period of 48 h under static conditions. The study is considered reliable with restrictions as no analytical controls were performed. The 48 h-NOEC based on immobilization was determined to be 18 mg/L. The 48 h-EC50 was 28.5 mg/L (C.I. 26.4 to 30.8 mg/L).

Long-term toxicity tests

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 algae

In a 72 hour acute toxicity study, the cultures of Pseudokirchneriella subcapitata, strain NIVA CHL 1 were exposed to Sucroglyceride C12-18, C18unsatd. at nominal concentrations of 0 (control),1.0, 3.2, 10, 32 and 100 mg/L under static conditions in accordance with the OECD guideline 201. The EC50 for growth rate reduction (ErC50: 0-72 h) was 16 mg/L with a 95% confidence interval ranging from 11 to 24 mg/L. The EC50 for yield inhibition (EyC50: 0-72 h) was 6.0 mg/L with a 95% confidence interval ranging from 2.6 to 13 mg/L. The study is considered reliable with restrictions as no analytical controls were performed. The NOEC for growth rate reduction and yield inhibition was 3.2 and 1.0 mg/L, respectively.

 

Toxicity to microorganisms

In a 1 hour toxicity study conducted according to DIN 38412 part 27 (Bacteria Respiration Test), the cultures of Pseudomonas putida were exposed to Sucroglyceride C12-18, C18unsatd. at a nominal concentration of 10 g/L under static conditions. No inhibition of the bacterial respiration with the tested concentration was observed. This study is classified as reliable with restriction because in this test, performed according to national standard methods, no analytical control, no dilution series, no parallel tests were conducted.

The test conditions did not meet the current standards for PNEC derivation as given in TGD on risk assessment. However, the study is considered to be reliable and 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.