Reaction products of decanoic acid and lauric acid with glycerol and polyglycerol

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

Study period:

2011-04-11 to 2011-04-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control, 25, 50 and 100 mg/L at 0, 24 and 48 h

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
6.25 mg test item + 1000 mL M4 medium
12.5 mg test item + 1000 mL M4 medium
25 mg test item + 1000 mL M4 medium
50 mg test item + 1000 mL M4 medium
100 mg test item + 1000 mL M4 medium
stirred for 24 h, then filtered through a filter paper
- Controls: 1000 mL M4 medium
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): slight turbidity increasing with the concentration.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: Daphnia magna straus
- Source: Landesumweltamt NRW
- Food type (during holding): algae, Desmodesmus subspicatus
- Amount: not specified
- Frequency: monday to friday

ACCLIMATION
- Acclimation conditions: same as test
- Type and amount of food: Desmodesmus subspicatus
- Feeding frequency: daily, monday- friday

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

2.2-3.2 (mmol/L)

Test temperature:

20.6 - 21.6°C

pH:

7.85 - 8.33

Dissolved oxygen:

5.6 - 6.3 mg/L

Conductivity:

500-700 µS/cm

Nominal and measured concentrations:

nominal: 6.25, 12.5, 25, 50 and 100 mg/L (measured within 91-100% of nominal)

Details on test conditions:

TEST SYSTEM
- Test vessel: 50 mL beakers
- Material, size, headspace, fill volume: Glass beakers of 50 mL volume filled with 30 mL medium
- Aeration:
- No. of organisms per vessel: 5 daphnia
- No. of vessels per concentration (replicates): 5
- No. of vessels per control (replicates): 5

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4
- Total organic carbon: 7.2 mg/L (TOC in the control was above the preset range von - Alkalinity: 0.928 mmol/L
- Conductivity: 596 µS/cm

OTHER TEST CONDITIONS
- Adjustment of pH: yes to pH 7.4
- Photoperiod: 16 /8 light/dark cycle
- Light intensity: 700 ± 50 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilisation at 0, 24 and 48 h

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: yes, non-GLP pre-test, concentrations not specified
- Results used to determine the conditions for the definitive study: The test item was identified to be poorly soluble in M4 medium, therefore the nominal concentrations 6.25, 12.5, 25, 50 and 100 mg/L were used in the test.

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

32.1 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

25 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: none
- Mortality of control: 0%
- Other adverse effects control: none

Table 1: Nominal and measured concentrations for [48 h] TOC calculation

	Measured concentration (Unit) results
Nominal concentr.	control (M4 medium)	25	50	100
TOC (mg/L)	7.6	11.1	23.8	42.9
% of nominal (ref. to TOC at 0h)	105.55	94.87	91.89	90.88

Validity criteria fulfilled:

yes

Conclusions:

The 48 h EC50 of polyglycerin caprylate/caprinate to Daphnia magna was 32.1 mg a.i./L (analytically verified nominal concentration). 

Executive summary:

The 48 h acute toxicity of polyglycerin caprylate/caprinate to Daphnia magna (Straus) was studied under static conditions according to OECD Guideline 202 (2004) and EU method C.2 (2008). Daphnids were exposed to control and test chemical at nominal concentration of 6.25, 12.5, 25, 50 and 100 mg a.i./L for 48 h (analytical verification by TOC measurement). Immobilization and sublethal effects were observed daily and at test termination. The 48 hour EC50 was 32.1 mg a.i./L. The NOEC based on immobilization was 25.0 mg a.i./L.

 

Results Synopsis

Test Organism Age:< 24 h

Test Type: Static

48 h EC50:  32.1 mg a.i./L                       95% C.I.: n.d.

Endpoint Effected:  Immobilisation

 

Description of key information

48 h EC50:  32.1 mg a.i./L (OECD TG 202; RL1; GLP: static, Daphnia magna)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

32.1 mg/L

Additional information

The 48 h acute toxicity of polyglycerin caprylate/caprinate to Daphnia magna (Straus) was studied under static conditions according to OECD Guideline 202 (2004). Daphnids were exposed to control and test chemical at nominal concentration of 6.25, 12.5, 25, 50 and 100 mg a.i./L for 48 h (analytical verification by TOC measurement). Immobilization and sublethal effects were observed daily and at test termination. The 48 hour EC50 was 32.1 mg a.i./L. The NOEC based on immobilization was 25.0 mg a.i./L.