Glycerol monomyristate

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:

18 - 21 April 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Use of THF as test material carrier

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Version 13 April 2004

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

The Department of Health of the Government of the United Kingdom, London, United Kingdom

Analytical monitoring:

yes

Details on sampling:

- Concentrations: water control, solvent control, 1 mg/L (nominal)
- Sampling method: At the start of the test the excess test solutions were sampled and at the end of the test one replicate of the dilution water control, solvent control and each test concentration was sampled. 5 ml of each sample was collected into 20 ml glass vials containing 5 ml of LCMS grade methanol and an aliquot transferred to autosampler vial.

Vehicle:

yes

Remarks:

Tetrahydrofuran (THF)

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item was ground using a pestle and mortar prior to weighing. A primary stock concentrate of the test item, with a nominal concentration of 10 g/L, was prepared by adding a nominal 0.1 g of test item to 10 mL of tetrahydrofuran (THF). The resultant stock was observed to be clear and colourless and was used to prepare the 1 mg/L test solution. This was achieved by the direct addition of the appropriate amount of concentrate to dilution water via a microliter syringe into a stirring solution in a volumetric flask. The solvent control was prepared in the same way using solvent only.
- Controls: water control, solvent control
- Chemical name of vehicle: tetrahydrofuran (THF)
- Concentration of vehicle in test medium: 0.1 mL/L

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: freshwater flea
- Source: in-house cultures
- Age of parental stock: 14 ± 1 days

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

211.7 CaCO3 mg/L

Test temperature:

T (0h) = 20.9°C
T (24h) = 19.7-21.0°C
T (48h) = 19.7-20.7°C

pH:

Control: 7.67-7.79
Solvent Control: 7.82-7.92
0.69 mg/L: 7.88-7.92

Dissolved oxygen:

Control: 9.00-9.04 mg O2/L
Solvent Control: 8.98-9.03 mg O2/L
0.69 mg/L: 8.86-8.98 mg O2/L

Conductivity:

615 μS/cm

Nominal and measured concentrations:

nominal (0h): water control, solvent control, 1 mg/L
measured (0h): < 0.08, < 0.08, 1.1 mg/L
nominal (48h): water control, solvent control, 1 mg/L
measured (48h): < 0.05, < 0.05, 0.28 mg/L
Mean measured concentration: 0.69 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beakers 250 mL
- Type: closed; covered with loose fitting glass lids
- Fill volume: 200 mL (approx. depth of 60 mm)
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: according to Elendt B P and Bias W R (1990). Trace Nutrient Deficiency in Daphnia magna Cultured in Standard Medium for Toxicity Testing. Effects of the Optimisation of Culture Conditions on Life History Parameters of D. magna. Water Research, 24, 1157-1167.
- Total organic carbon: 0.9 mg/L
- Particulate matter: <3 mg/L
- Sum of metals: < 680 µg/L
- Pesticides: <0.01 μg/L
- Alkalinity: 39.8 CaCO3 mg/L
- Conductivity: 615 μS/cm

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light: 8 hours dark, with 20-minute dusk and dawn transition periods

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : immobility; any other adverse reactions to exposure

VEHICLE CONTROL PERFORMED: yes

RANGE-FINDING STUDY
- Results used to determine the conditions for the definitive study: a 1 mg/L test concentration was selected based on a non-GLP range finding study

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.69 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Mortality of control: none observed

Table 1: Daphnia magna response

Time (hour)	Mean measured concentration of [tradename] (Glycerol Monomyristate) (mg/L)	Number immobilised per replicate				Total number tested	Total number immobilised	Percentage immobilised
		A	B	C	D
24	Control	0	0	0	0	20	0	0
	Solvent control	0	0	0	0	20	0	0
	0.69	0	0	0	0	20	0	0
48	Control	0	0	0	0	20	0	0
	Solvent control	0	0	0	0	20	0	0
	0.69	0	0	0	0	20	0	0

 

Table 2: Validity criteria for OECD 202.

Criterion from the guideline	Outcome	Validity criterion fulfilled
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized.	0%	yes
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.	>8 mg/L	yes

 

Validity criteria fulfilled:

yes

Remarks:

see Table 2 at "Any other information on results incl. tables"

Description of key information

Aquatic invertebrates: EC50 (48 h) > 0.69 mg/L (measured, arithm. mean)

Additional information

The acute toxicity of the source substance Glycerol monomyristate (CAS 27214-38-6) to aquatic invertebrateswas tested according to OECD 202 under GLP conditions. Daphnia magna were exposed for 48 hours to a nominal test substance concentration of 1 mg/L in a limit test. The test concentration was prepared using tetrahydrofuran (THF) as vehicle. The concentration of vehicle in test medium was 0.1 mL/L. The test substance concentration was analytically verified by HPLC at test start and after 48 hours. The mean measured concentration was 69% of nominal. Immobilisation of Daphnis was not observed. The determined EC50 (48 h) was > 0.69 mg/L (measured, arithm. mean) based on mobility.

Based on the results of the available short-term toxicity testacute toxic effects of Glycerol monomyristate (CAS 27214-38-6) on aquatic invertebrates are not expected up to the limit of water solubility.