Reactionmass of dodecan-2-yl prop-2-enoate and dodecan-3-yl prop-2-enoate and dodecan-4-yl prop-2-enoate

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:

25th-27th September, 2019

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M FMRD, CPDC lot 6
- Expiration date of the lot/batch: 09.27.2021
- Purity test date: 99.1 wt.%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the sample chamber of this facility, stored at room temperature (15-25 C).
- Stability under test conditions: Unstable

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L
- Sampling method: A sample of ~50 mL was taken from each test solution and control solution. The sample was taken from the leftover test solution for fresh samples and from one replicate for old samples. 10 mL of the sample was extracted before analysis. The remaining sample was stored in a refrigerator for possible re-analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Preparation of the test solutions started with the highest concentration of 100 mg/L, applying a 24 hour period of magnetic stirring ( 350 to 360 rpm) to attempt dissolution of the test item in medium. The test item was allowed to separate to the surface of solution for about 30 minutes, and the test solution on the bottom was taken to use for exposure.
- Controls: Test medium without test substance or other additives.
Chemical name of vehicle: No vehicle

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain/clone: Daphnia magna (Straus)
- Source: Applied Chemistry Department Pesticide Environmental Evaluation Lab of the China Agricultural University
-Age at study initiation: <24 hours
- Feeding during test: No
-Culture conditions: Adult daphnids were cultured in tap water treated with Aquapro Pure Water Systems. During the period preceding the test, water temperatures were 18 - 22°C, photoperiod of 16h light, 8 h dark. Daphnids in the cultures were fed daily a suspension of concentrated alga suspension. Neonates were not the first brood.
-Health: The test Daphnia magna was derived from a healthy stock (i.e. showing no signs of stress such as high mortality, presence of males and ephippia, delay in the production of the first brood, discolored animals, etc.)

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

180 mg/L (CaCO3)

Test temperature:

19.1-19.5 C

pH:

8.05-8.29

Dissolved oxygen:

8.4-8.72

Nominal and measured concentrations:

Nominal concentrations: 0 mg/L, 100 mg/L
Measured: 0.76 mg/L (fresh solution), 0.0073 mg/L (old solution)*, reported as 0.075 mg/L (Geom. mean). *Value reported as less than the LOQ, but above the LOD.
Controls

Details on test conditions:

TEST SYSTEM
- Test vessel: 250 mL, glass beakers.
- Test solution volume: 100 mg/L
- Aeration: No
-Renewal rate: 24 hours
- No. of organisms per vessel: five
- No. of vessels per concentration (replicates):four
- No. of vessels per control: four

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water treated with Aquapro Pure Water System
- Total organic carbon:<2 mg/L
- Particulate matter: <5 mg/L suspended solids
- Metals:All less than detection limits
- Culture medium different from test medium: No
-Pesticides: All less than detection limits

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16h light, 8h dark
- Culture medium different from test medium: No

EFFECT PARAMETERS MEASURED : Immobilization (including mortality) at 24 and 48 hours.


RANGE-FINDING STUDY
- Test concentrations: 0 mg/L (control) and 100 mg/L (nominal)
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.075 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behaviorall abnormalities: None
- Mortality of control: No mortality in control Daphnids
- Effect concentrations exceeding solubility of substance in test medium: yes

Results with reference substance (positive control):

24 hour LC50 = 1.39 mg/L for daphnia batch

Table 1. Concentrations of Test Item in the Exposure Solution

Nominal concentration (mg/L)	Time	Measured concentration (Component 1 -22.8%)	Measured concentration (Component 2 -68.1%)	Measured concentration (Total -90.9%)	Dilution Factor	Sample Concentration (mg/L)	Geometric Mean of Fresh (mg/L)	Geometric Mean of Old (mg/L)	Geometric mean of overall (mg/L)
Control	0d-Fresh	<LOD	<LOD	<LOD	1	<LOD	/	/	/
	1d-Old	<LOD	<LOD	<LOD	1	<LOD	/	/	/
	1d-Fresh	<LOD	<LOD	<LOD	1	<LOD	/	/	/
	2d-Fresh	<LOD	<LOD	<LOD	1	<LOD	/	/	/
100	0d-Fresh	0.0046	0.0091	0.0137	50	0.6850	0.76	0.0073	0.075
	1d-Old	0.0016	0.0057	0.0073	1	0.0073*	0.76	0.0073	0.075
	1d-Fresh	0.0036	0.0134	0.0170	50	0.8500	0.76	0.0073	0.075
	2d-Fresh	0.0018	0.0056	0.0074	1	0.0074*	0.76	0.0073	0.075

Note: LOD is 0.005 mg/L, LOQ is 0.01 mg/L, "/" means not calculated

"*" the values between the LOQ and LOD are reported with the actual measurement, but flagged as being between LOD and LOQ.

Components percentages are % weight of total acrylate esters

Validity criteria fulfilled:

yes

Remarks:

<10% mortality in controls (0%), Dissolved oxygen concentration was ≥ 3 mg/L during test period (DO=8.4-8.72).

Conclusions:

48 hour EC50 >100 mg/L (nominal) in Daphnia magna (OECD 202).
48 hour EC50>0.075 mg/L (measured) in Daphnia magna (OECD 202).

Executive summary:

The 48 hour EC50 to Daphnia magna was determined in a limit test according to OECD 202 guidelines. Nominal concentrations of 100 mg/L and a blank control were run using 5 animals per vessel in four replicates and no dispersant. Measured geometric mean concentrations of the substance during the test were 0.075 mg/L. No immobilization nor mortalities were observed throughout the test. An EC50 >100 mg/L (nominal concentration) and EC50> 0.075 mg/L (measured) was determined.

Study was conducted under international guidelines and was compliant with GLP criteria. Test substance concentrations were not maintained at >=80% of the nominal throughout the test and were below LOD after 24 hours (at renewal). However, the test was conducted with a semi static method and is therefore considered reliable with restrictions. The result is considered suitable for use in Risk Assessment, Classification & Labeling, and PBT analysis.

Description of key information

48 hour EC50 >100 mg/L (nominal) in Daphnia magna (OECD 202).

48 hour EC50>0.075 mg/L (measured) in Daphnia magna (OECD 202).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L

Additional information

The 48 hour EC50 to Daphnia magna was determined in a limit test according to OECD 202 guidelines. Nominal concentrations of 100 mg/L and a blank control were run using 5 animals per vessel in four replicates and no dispersant. Measured geometric mean concentrations of the substance during the test were 0.075 mg/L. No immobilization nor mortalities were observed throughout the test. An EC50 >100 mg/L (nominal concentration) and EC50> 0.075 mg/L (measured) was determined.

Study was conducted under international guidelines and was compliant with GLP criteria. Test substance concentrations were not maintained at >=80% of the nominal throughout the test and were below LOD after 24 hours (at renewal). However, the test was conducted with a semi static method and is therefore considered reliable with restrictions. The result is considered suitable for use in Risk Assessment, Classification & Labeling, and PBT analysis.