2-(2-ethoxyethoxy)ethyl acetate

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From August 18, 2020 to December 17, 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Version / remarks:

2012-10-02

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source of test material:
Production lot
- Lot/batch number of test material: P230220120

- Expiration date of the lot/batch:
2023-04-29

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Cool, well ventilated place
- Stability under storage conditions: Stable
- Stability under test conditions: Stable

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0, 2.0, 3.0, 4.5, 6.8 and 10.1 mg/L
- Sampling method: 5 mL of test samples from each replicate were drawn and mixed together for each group at 0 (fresh medium) and 48 hours (exhausted medium) of formulations prepared on days 0, 10 and 18.
- Sample storage conditions before analysis: If required, at -20 ± 5 ºC

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Dilution from stock solution of test substance prepared with test medium
- Controls: Test medium alone
- Chemical name of vehicle: None used
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Age at study initiation: 1st instar daphnids, less than 24 hours old
- Feeding during test : Yes
- Food type: unicellular alga, Pseudokirchneriella subcapitata
- Amount: 0.1 - 0.2 mg carbon/daphnid/day
- Frequency: Daily

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Hardness:

179.2 - 196.0 mg/L as CaCO3

Test temperature:

20.0 - 20.9 °C

pH:

7.59 and 7.96

Dissolved oxygen:

7.39 - 9.23 mg/L

Nominal and measured concentrations:

Nominal: 0.0, 2.0, 3.0, 4.5, 6.8 and 10.1 mg/L
Measured: 0.0 (< LOD), 2.1, 3.2, 4.7, 7.3 and 10.8 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 600 mL capacity glass beaker
- Material, size, headspace, fill volume: Glass, 600 mL capacity, 120 mL fill volume
- Renewal rate of test solution (frequency/flow rate): Semi-static, medium changed every 48 hours
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water prepared as described by OECD test giuidelines
- Culture medium different from test medium: No
- Intervals of water quality measurement: Weekly

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light / 8 hours dark
- Light intensity: 1300 - 1380 Lux

EFFECT PARAMETERS MEASURED
The adults were observed for mortality, if any, on a daily basis.
The numbers of live and dead offspring produced were recorded daily and removed from the glass beakers.
On termintion of the study absolute length (body length excluding the anal spine) of parent daphnids was measured using a stereo zoom microscope following anaesthesia.
Temperature, pH, dissolved oxygen and hardness, were measured at least once a week, in fresh and old media.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.5
- Range finding study: Yes
- Test concentrations: Range-finding study - 0.0, 0.1, 1.0, 5.0, 10.0 and 50.0 mg/L
- Results used to determine the conditions for the definitive study: Yes

Reference substance (positive control):

no

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

> 10.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

10.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

> 10.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality: Total number living offspring produced at the end of the test per parent daphnia at the start of the test excluding from the analysis parental accidental and/or inadvertent mortality {TG 211}

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

10.1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality: Total number living offspring produced at the end of the test per parent daphnia at the start of the test excluding from the analysis parental accidental and/or inadvertent mortality {TG 211}

Details on results:

- Behavioural abnormalities: No treatment related effects
- Observations on body length: No treatment related effects
- Other biological observations: Time to release of first brood - 8 days in control and all treatment groups
- Mortality of control: None
- Other adverse effects control: None
- Immobilisation of control: None
- Abnormal responses: None observed
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No

Reported statistics and error estimates:

Brood number and body length were assessed using Bartlett’s Test and Analysis of Variance followed by Dunnett’s procedure.
As no effects of treatment were observed, the EC10, EC20 and EC50, values for reproductive output could not be calculated.

Live and Dead Offspring and Adult Mortality

 

Nominal Concentration (mg/L)	Number of Daphnids/ Group	Total Number of Adult Mortality	Total Number of Dead Offspring	Total Number of Live Offspring	Live Offspring		% Inhibition in Offspring
					Mean	CV
0.0 (Control)	10	0	0	803	80.3	1.2	-
2.0	10	0	0	802	80.2	1.1	0.12
3.0	10	0	0	805	80.5	1.8	-0.25
4.5	10	0	0	802	80.2	2.3	0.12
6.8	10	0	0	804	80.4	1.9	-0.12
10.1	10	0	0	804	80.4	4.4	-0.12

Key:    CV = Coefficient variation, - = Not applicable

 

 

Daphnia Length

 

Nominal Concentration (mg/L)	Mean Value Daphnia Length in Millimeter (mm)	SD
0.0 (Control	3.38	0.18
2.0	3.34	0.20
3.0	3.34	0.16
4.5	3.33	0.16
6.8	3.35	0.21
10.1	3.40	0.17

Key: SD = Standard deviation

Validity criteria fulfilled:

yes

Conclusions:

2-(2-ethoxyethoxy)ethyl acetate has no toxic effect up to 10.1 mg/L on daphnia magna and this is deemed the No Observed Effect Concentration (NOEC).

Executive summary:

The reproductive output of Daphnia magna exposed to different concentrations of 2 -(2 -ethoxyethoxy)ethyl acetate over a period of 21 days has been examined using methods described by OECD TG 211.

The substance has no toxic effect at concentrations up to 10.1 mg/L and this is deemed the No Observed Effect Concentration (NOEC).

Description of key information

The substance has no toxic effect at concentrations up to 10.1 mg/Land this is deemed the No Observed Effect Concentration (NOEC).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

NOEC

Effect concentration:

10.1 mg/L

Additional information

A single study is available examining the reproductive output of Daphnia magna exposed to different concentrations of 2 -(2 -ethoxyethoxy)ethyl acetate over a period of 21 days. Methods used were as described by OECD TG 211. The substance has no toxic effect at concentrations up to 10.1 mg/Land this is deemed the No Observed Effect Concentration (NOEC).

A further, unreliable, study has been published investigating the long-term effects to Ceriodaphnia dubia (Devillers et al., 2003). The study was performed according to AFNOR NF T 90-376. After an exposure of 7 days an EC10 of 0.125 mg/L resulted. This study has not been considered for classification purposes due to the presence of a more recent study using test methods and organisms as specified by Regulation (EC) 1272/2008.