Sophorolipids: fermentation products of glucose and rapeseed-oil fatty acids methyl esters with yeast Candida Bombicola

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

not GLP study

GLP compliance:

no

Remarks:

The testing lab was not GLP in 2009 but study of good quality (klimisch score 2) so can be used for registration purpose

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Daphnia magna

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

250mg/l +/- 25 mg (CaCO3)

Test temperature:

20°C +/- 2

pH:

7.8 +/- 0.2

Dissolved oxygen:

>7mg/l

Nominal and measured concentrations:

Nominal (test item sample): 12.00, 24.15, 48.61, 71.95 and 97.79 mg/L along with a control group without test item.
Nominal (based on 60.6% dry matter content): 7.27, 14.64, 29.46, 43.60 and 59.26 mg/L along with a control group without test item.

Reference substance (positive control):

yes

Remarks:

K2Cr2O7

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

24 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Remarks on result:

other: based on "dry matter" concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

40 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Validity criteria fulfilled:

yes

Conclusions:

CE 50-48h for dry matter is 24 mg/l.
CE 50-48h for raw material is 40 mg/l.

Description of key information

Commercial samples of the registered substances are typically produced as aqueous solutions. An acute daphnia study was performed on a commercial quality of Sophorolipids (Lot 01/09), which had been determined to contain 60.6% dry matter. The 48h EC50 was determined to be 40mg/L (based on test item) and 24mg/L (based on the dry matter content). The latter has been chosen as the key value as this represents the sophorolipids content in the commercial product.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

24 mg/L

Additional information

The acute toxicity of the Sophorolipids (60.6% dry matter) to Daphnia magna was determined in a 48h test according to the European Standard ISO 5341 and OECD Guideline 202. Based on the results of a range finding test, a definitive test was conducted at 5 test item concentrations of 12.00, 24.15, 48.61, 71.95 and 97.79 mg/L along with a control group without test item. The test item concentrations are equivalent to 7.27, 14.64, 29.46, 43.60 and 59.26 mg/L based on dry matter.

No cumulative immobilization was observed in the control and 12.00 mg/L test concentration (7.27mg/L based on dry matter), whereas 10, 70, 95 and 100% immobilization was observed in the tested concentrations of 24.15, 48.61, 71.95 and 97.79 mg/L respectively (14.64, 29.46, 43.60 and 59.26 mg/L based on dry matter).

Based on the results of this study, the 48h EC50 value for Sophorolipids was found to be 40mg/L (based on test item) and 24mg/L (based on the dry matter content).