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Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013-11-29 to 2013-12-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study. GLP.
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Version / remarks:
2012
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
concentrations of the test item were analytically verified by HPLC-DAD of samples taken at the start of the exposure intervals on days 0, 10, 17 (0 h) and at the end of the exposure intervals on days 3, 12, 19 (48 or 72 h) of all concentration levels and the control
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
A stock solution (100 mg/L of the test item were weighed out) was freshly prepared with dilution water for each exposure interval.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain/clone: Daphnia magna STRAUS (Clone 5)
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu); breeder: DR. U. NOACK-LABORATORIEN, Käthe-Paulus-Str. 1, 31 157 Sarstedt, Germany
- Age of parental stock (mean and range, SD): < 24 h
- Feeding during test
- Food type / amount: Pseudokirchneriella subcapitata (0.162 - 0.294 mL) and Desmodesmus subspicatus (0.290 - 0.319 mL) suspension corresponding to 0.2 mg C per Daphnia and day
- Frequency: daily

ACCLIMATION
- Acclimation conditions (same as test or not): same
- Type and amount of food: At least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, with an algae cell density of > 1E6 cells/mL
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Hardness:
fresh media: 171 - 174 mg/L (control); 162 - 185 mg/L (97.3 mg/L test item)
old media: 135 - 164 mg/L (control); 148 - 194 mg/L (97.3 mg/L test item)
Test temperature:
20.0 - 22.0°C
pH:
fresh media: 7.41 - 7.98 (control); 7.15 - 7.54 (97.3 mg/L test item)
old media: 7.00 - 7.45 (control); 7.21 - 7.38 (97.3 mg/L test item)
Dissolved oxygen:
fresh media: 8.53 - 8.84 mg/L (control); 8.22 - 8.86 mg/L (97.3 mg/L test item)
old media: 6.98 - 9.14 mg/L (control); 6.16 - 9.03 mg/L (97.3 mg/L test item)
Nominal and measured concentrations:
nominal: 2.56, 6.40, 16.0, 40.0, 100 mg/L
measured (geometric mean): 1.59, 4.73, 13.6, 37.2, 97.3 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beakers (5 (ID) X 8 (H) cm), 100 mL capacity
- fill volume: 50 mL
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): medium renewal 3 times per week, i.e. after 48 and 72 h
- 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: Elendt M4, modified to a total hardness of 160 to 180 mg CaCO3/L
- Intervals of water quality measurement: once within 7 days, in fresh and old media, in one replicate of the control and the highest concentration of the test item

OTHER TEST CONDITIONS
- Photoperiod: 16/8 h light/dark cycle
- Light intensity: Max. 15 - 20 µE/m²/s
- Test temperature: 18 - 22"C, constant within 2"C

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality of parental daphnids (immobile or dying) – daily, dead specimens were removed
Neonates: First appearance of juveniles was checked daily. The number of neonates (alive and dead progeny) was counted and dates of release were recorded once a day from the first day of production of neonates until the end of the test. The neonates (alive and dead) were removed after counting and before addition
of algae to prevent them from consuming food intended for the adults. The number of aborted eggs or dead offspring and dates of observation was recorded.
Condition of parental daphnids: abnormalities (e.g. swimming behaviour, number of males and winter eggs): daily
Total length and dry body weight of parental daphnids: At the end of the test total length of each daphnid and dry body weight of the daphnids alive at each concentration level and the control was determined.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
38.8 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Remarks on result:
other: 95% c.l. 35.2 - 45.8 mg/L
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
37.2 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
97.3 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Relevant effect levels: 24 h EC50 = 1.65 mg/L (95% CI: 1.60 - 1.70 mg/L)
- Other: The EC50-value of the reference item potassium dichromate after 24 h is within the prescribed concentration range of 0.6 - 2.4 mg/L of quality criteria according to AQS P 912 (0212000) for daphnids clone 5 cultured in Elendt M4 medium. The ECso-value of the reference item is also within the recommended range of 0.6 - 2.1 mg/L according to OECD-Guideline 202
Reported statistics and error estimates:
Significant deviations of the number of living juveniles produced per surviving parental daphnid were determined by One Way Analysis of Variance, DUNNETT'SM ethod (P = 0.05).
Significant deviations of the day of first appearance of juveniles, the number of broods and the number of stillborn juveniles and aborted eggs were determined by KRUSKAL-WALLIOSn e Way Analysis of Variance on Ranks, DUNN'S Method (P = 0.05).
The EC10-values for the reduction of the reproductive output after 21 days were calculated by sigmoidal dose-response regression. The 95 % confidence limits for the EC-values were calculated from the best-fit values, the standard error and the t-distribution with the software GraphPad prism5.
The intrinsic rate of natural increase (IR) was calculated with the EULER-LOTKA-equation.

 

Effect

Geometric Mean Measured Concentration of the test item [mg/L]

0

1.59

4.73

13.6

37.2

97.3

Mean Number of Living Juveniles per

Producing Parent (Reproduction Rate±SD)

84±7

85±11

85±9

88±8

78±10

32±121)

Coefficient of Variation of theMean Number of Juveniles per Producing Parent [%]

8

12

11

9

13

382)

Mean Intrinsic Rates of Natural Increase

0.45

0.46

0.46

0.47

0.41

0.27

Percentage of Dead Juveniles Related to the Total Number of Juveniles [%]

0

0

1

1

1

53)

Mean Number of Broods

4.0

4.0

4.0

4.0

4.0

2.63)

Appearance of First Brood [Mean Day]

8.5

8.5

8.4

8.3

9.1

13.63)

Parent Animals: Mean Dry Weight [mg]

0.90

0.89

0.92

0.93

0.78

0.54

Parent Animals: Mean Body Length [mm]

5.00

4.95

5.00

4.98

4.97

4.63

Adult Mortality after 21 Days [%]

0

0

0

0

10

0

 

SD = standard deviation

1) = statistical significance (One Way Analysis of Variance, DUNNETT's method, P = 0.05)

2)= biologically significant variation between the test replicates (coefficient of variation > 25 %)

3)= statistical significance (KRUSKAL-WALLIS One Way Analysis of Variance on Ranks, DUNN's method, P = 0.05)

No males or ephippia were observed in the control or in the test groups during the test.

Validity criteria fulfilled:
yes
Conclusions:
The reduction of the reproductive output was the most sensitive effect in this study. Based on the significant reduction of the reproductive output at the concentration level of 97.3 mg/L, 21 d NOEC(reproduction) was 37.2 mg/L, the 21 d LOEC(reproduction) was 97.3 mg/L. The 21 d EC10-value for the reduction of the reproductive output was calculated by sigmoidal dose-response regression to be 38.8 mg/L (95% confidence limits: 35.2 - 45.8 mg/L).
Executive summary:

The 21-day-chronic toxicity of Tetrahydrofurfuryl methacrylate (99.0% a.i.) to Daphnia magna STRAUS (clone 5) was studied under static renewal conditions according to OECD guideline 211 (adopted 2 October 2012). Daphnids were exposed to control and test chemical at nominal concentrations of 2.56, 6.40, 16.0, 40.0 and 100 mg/L, corresponding to measured (geometric mean) concentrations of 1.59, 4.73, 13.6, 37.2 and 97.3 mg/L.

The reduction of the reproductive output was the most sensitive effect in this study. The EC10 for the reduction of the reproductive output was calculated to be 38.8 mg/L (95% confidence limits: 35.2 - 45.8 mg/L); the 21 d NOEC(reproduction) was 37.2 mg/L.

 

No stillborn juveniles or aborted eggs were observed in the control and in the geometric mean measured concentration of 1.59 mg/L. The percentage of dead juveniles was 1 % at the concentration levels of 4.73 to 37.2 mg/L and 5% at the concentration level of 97.3 mg/L.

The first brood was released between days 8 and 11 by all parental daphnids of the control and the concentration levels of 1.59 to 37.2 mg1L. At the concentration level of 97.3 mg/L, the first brood was released between days 13 and 16, which is statistically significant delayed in comparison to the control group.

No biologically significant adult mortality was observed during the test period of 21 days.

The mean values of the body length of the surviving parental daphnids in the tested concentration levels of 1.59 to 97.3 mg/L were determined to be in the range of 4.63 to 5.00 mm per daphnid and 5.00 mm per daphnid in the control group.

The mean dry body weight of the surviving parental daphnids was determined to be in the range of 0.54 to 0.93 mg per daphnid in the concentration levels 1.59 to 97.3 mg/L and 0.90 mg per daphnid in the control.

No males or ephippia were observed in the control or in the test groups during the test.

 

Results Synopsis

Test Organism Age: < 24 h old daphnids

Test Type: Static Renewal

 

21 d NOEC: 37.2 mg/L

21 d EC10: 38.8 mg/L                95% confidence limits: 35.2 – 45.8 mg/L

21 d LOEC: 97.3 mg/L                  Endpoint(s) Effected: reproduction

NOTE: Any of data in this dataset are disseminated by the European Union on a right-to-know basis and this is not a publication in the same sense as a book or an article in a journal. The right of ownership in any part of this information is reserved by the data owner(s). The use of this information for any other, e.g. commercial purpose is strictly reserved to the data owners and those persons or legal entities having paid the respective access fee for the intended purpose.

Description of key information

21 d EC10 = 38.8 mg/L; OECD Guideline 211; GLP

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
38.3 mg/L

Additional information

One study on long-term toxicity of THFMA to aquatic invertebrates is available, which is considered as reliable without restrictions (RL=1):

 

The 21-day-chronic toxicity of Tetrahydrofurfuryl methacrylate (99.0% a.i.) to Daphnia magna STRAUS (clone 5) was studied under static renewal conditions according to OECD guideline 211 (adopted 2 October 2012). Daphnids were exposed to control and test chemical at nominal concentrations of 2.56, 6.40, 16.0, 40.0 and 100 mg/L, corresponding to measured (geometric mean) concentrations of 1.59, 4.73, 13.6, 37.2 and 97.3 mg/L.

No stillborn juveniles or aborted eggs were observed in the control and in the geometric mean measured concentration of 1.59 mg/L. The percentage of dead juveniles was 1 % at the concentration levels of 4.73 to 37.2 mg/L and 5% at the concentration level of 97.3 mg/L.

The first brood was released between days 8 and 11 by all parental daphnids of the control and the concentration levels of 1.59 to 37.2 mg1L. At the concentration level of 97.3 mg/L, the first brood was released between days 13 and 16, which is statistically significant delayed in comparison to the control group.

No biologically significant adult mortality was observed during the test period of 21 days.

The mean values of the body length of the surviving parental daphnids in the tested concentration levels of 1.59 to 97.3 mg/L were determined to be in the range of 4.63 to 5.00 mm per daphnid and 5.00 mm per daphnid in the control group.

The mean dry body weight of the surviving parental daphnids was determined to be in the range of 0.54 to 0.93 mg per daphnid in the concentration levels 1.59 to 97.3 mg/L and 0.90 mg per daphnid in the control. No males or ephippia were observed in the control or in the test groups during the test.

The reduction of the reproductive output was the most sensitive effect in this study. The EC10 for the reduction of the reproductive output was calculated to be 38.8 mg/L (95% confidence limits: 35.2 - 45.8 mg/L); the 21 d NOEC(reproduction) was 37.2 mg/L.